Contact Carol Webb for questions, concerns, or updates at cwebb2@kumc.edu or 913-945-5793

Clinical Trial Flow Charts Open and Pending Trials

07/05/2018

Oncology Trials

1. Brain Cancer ..................................................................... 2

2. Breast Cancer ................................................................... 3-4

3. GI Cancer .......................................................................... 5-6

4. GU Cancer ........................................................................ 7-8

5. GYN Cancer ...................................................................... 9-10

6. Head and Neck Cancer ..................................................... 11

7. Melanoma and Sarcoma ................................................... 12-13

8. Thoracic Cancer ................................................................ 14

Hematology and BMT Trials

9. Leukemia .......................................................................... 15-16

10. Lymphoma ........................................................................ 17-18

11. Myelodysplastic Syndromes (MDS) .................................. 19

12. Myeloproliferative Neoplasms (MPN) ................................ 20

13. Myeloma ........................................................................... 21

14. Transplant Related & GVHD ............................................. 22-23

1

Updated 7/5/2018 Page 1 of 1 Associate Brain Project Director: Jessica Schwent Clinical Trial Nurse Navigator Early Phase Project Director: Jecinta Scott Phone: 913-945-7552

CTNurseNav@kumc.edu

Pending Hold CCP IIT

Study Contact Pager Phone

Stacy Anderson 4453 5-7543

Sasha Moores 0811 8-5520

Jessica Schwent 2515 8-4254

Brain Cancer

Newly Diagnosed Recurrent

Grade 3

No trials

Low Grade

No trials

No trials

EGFR mutat-Grade 4

NRG-BN001 HSC: 03071 PI: Mammen SC: Sasha Dose-Escalated Photon IMRT or Proton Beam Rad. Therapy VS. Standard-Dose Rad. Therapy & Te-mozolomide in Pts W/ Newly Dx GBM WW, CCP

No trials

Methylated NAT-101 HSC: 04195 PI: Salacz SC: Sasha A Feasibility Study of the Nativis Voy-ager® Sys-tem in Pa-tients With Recurrent Glioblasto-ma Multi-forme (GBM)

WW, Hos., CCP– OP

TG-511-15-01 HSC: 03644 PI: Salacz SC: Jessica & Sasha

Grades 3 & 4

The Toca 5 Trial: Toca 511 & Toca FC Versus Stand-ard of Care in Patients With Recurrent High Grade Glioma (Toca5)

WW, MOB

Supportive

HSC: n/a PI: In Young Choi SC: tba Metabolic Markers of glioblasto-ma multi-forme ac-tivity in living brain

WW & CCP

Multi Diseases

TAS 120-101 HSC: 142341 PI: Al-Rajabi SC: tba Status: 7.2 IC comments to SP Phase 1/2 Study of TAS-120 in Pa-tients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations CRC

2

Updated 7/5/2018 Page 1 of 2 Breast Project Director: Kelly Daniels Clinical Trial Nurse Navigator Early Phase Project Director: Jecinta Scott Phone: 913-945-7552 CTNurseNav@kumc.edu Pending Hold CCP IIT

Breast Cancer (BC) – Med Onc

Adjuvant Advanced/Metastatic Neoadjuvant

S1207 HSC: 0615 PI: Sharma SC: Jena Hormone Therapy w/ or w/o Everoli-mus in Treating Patients With BC WW, CCP, MCA

NSABP B-55 HSC: 01746 PI: Sharma SC: Sidrah

Only BRCA carriers

Olaparib as Adjuvant Tx in Pts. W/ Germline BRCA Mu-tated High Risk HER2 Neg. Pri-mary BC WW, CCP, MCA

HER 2-

ONT-380-206 HER2 CLIMB HSC: 140365 PI: Khan SC: Sidrah ONT-380 vs Placebo in Combo w/ Cape-citabine & trast-uzumab in Pts w/ Met. HER2+ BC WW

HER 2+ HER 2+

No trials

HER 2- ER+/ HER2-

CLEE011XUS10T (FELINE) HSC: 02972 PI: Khan SC: Julia Letrozole + Ribo-ciclib or Placebo as Neo-adjuvant Therapy in ER+, HER2-, Early BC

WW & CCP

2015-X7-7-LQT HSC: 02962 PI: Khan SC: Jena Capecit-abine in Meta-static Breast and GI Cancers (X7-7). WW, CRC, CCP, MCA

SPI-POZ-201 HSC: 140323 PI: Sharma SC: Sidrah Study of Poziotinib in Pa-tients With HER2-Positive Met. BC WW

HER 2+

IIT-2016-HER-MET HSC: 140673 PI: Khan SC: Julia

Neo-adj. chemo. w/ or w/o Met-formin for HER2+ operable BC

WW, CCP

IMMU-132-05 HSC: 141662 PI: Sharma SC: Julia Saci-tuzumab Govitecan in R/R TNBC WW

S1418 HSC: 140733 PI: Mam-maen SC: Julia Pem-brolizumab in Treating Patients With TNBC WW, Hos.,

MCA

Study Contact (SC) Pager Phone

Annie Anderson n/a 5-7741

Stacy Anderson 4453 5-7543

Chris Baierl 0361 8-3058

Karissa Finke 2613 8-6079

Santana Fortney 4451 8-4769

Jennifer Inman n/a 5-9887

Jena McCall n/a 5-7045

Andrea McConnell n/a 5-7045

Leah Miller n/a 8-3670

Sidrah Sheik 8320 8-2437

Sherri Smith n/a 5-7658

Julia Urban 3264 8-7549

Alice Wang 2613 8-8548

IIT-2014-CISRomi-NivoTNBC HSC: 02219 PI: Shar-ma SC: San-tana

Romidep-sin + Cis-platin in Locally Recurrent or Met. TNBC (or BRCA 1/BRCA 2)

WW. CRC, CCP

E2112 HSC: 02227 PI: Doolittle SC: Sherri Exemes-tane w/ or w/o Entino-stat in Treating Postmeno-pausal Pts. W/ Recur-rent HR+ BC That Is Locally adv. or met.

CCP & MCA

10020 HSC: 141972 PI: Khan SC: Santa-na Veliparib & Atezoli-zumab Ei-ther Alone or in Combo in Treating Patients With Stage III-IV TNBC CRC

S1501 HSC: 141492 PI: O’Dea SC: Jena Carvedilol in Pre-venting Cardiac Toxicity in Patients With Met-astatic HER-2-Positive BC WW, CCP, MCA

HER2 AS-PIRE HSC: 142203 PI: Nye SC: tba Status: 7.6 FDA ex-empt submit

Palbociclib, Letrozole & T-DM1 in trastusum-ab refracto-ry ER+ and HER2+ met. BC

tba

IIT-2017-MM-BRST-Her2noRT HSC: 140798 PI: Mitch-ell SC: Leah Omission of Radia-tion in Patients With Her-2 Positive BC WW

HER 2-

IIT-2017-NeoPACT HSC: 142487 PI: Sharma SC: tba Status: 6.25 ICF for internal review

Neoadj. Study of Pembroli-zumab & Carboplatin plus Docet-axel in TNBC

tba

POLARIS (A5481082) HSC: tba PI: Nye SC: tba Status: 6.28 resubmit to HSC Palbociclib in HR+ Adv. BC: A Pro-spective Multicenter Non Inter-ventional Study tba

CBYL719X2402 HSC: 141890 PI: Khan SC: Julia Alpelisib + Fulvestrant or Letrozole in Pts W/ PIK3CA Mu-tant, HR+, HER2 neg. aBC, Who Progressed on or After CDK 4/6 Inhibitor WW

107CS-6 HSC: 141779 PI: Sharma SC: Julia PK, Effica-cy & Safe-ty Study of DHP107 in Patients W/Recurrent or Met. BC (OPERA) WW, CCP, CRC

3

Updated 7/5/2018 Page 2 of 2 Breast Project Director: Kelly Daniels Clinical Trial Nurse Navigator Early Phase Project Director: Jecinta Scott Phone: 913-945-7552 CTNurseNav@kumc.edu Pending Hold CCP IIT

Pre-Op

Breast Cancer–

Surgery & Radiation

Post-Op

Breast Cancer–

Registry, Ancillary, Prevention, Survivorship

Prevention Registry

BRCA Registry HSC: 12614 PI: Shar-ma SC: Alice & Karissa TNBC pts. & germline mutation carriers (regardless of per-sonal can-cer hx). WW & CCP

A011202 Alliance HSC: 0937 PI: Wag-ner SC: Julia

Lymph Node Dis-section & Radiation Therapy in Treating Pts. W/ BC Previ-ously Treated w/ Chemo & Surgery WW, CCP, MCA

NSAP B-51 RTOG 1304 HSC: 079 PI: Mitchell SC: Chris B. Standard or Comprehen-sive Radia-tion Therapy in Treating Pts. W/ Ear-ly-Stage BC Previously Treated With Chemo & Surgery WW, CCP, MCA

IIT-2017-MM-BRST-HypoFra-cRT HSC: 141304 PI: Mitchell SC: Leah

Hypofrac-tionated radiation therapy for pts with BC receiv-ing region-al nodal irradiation

WW

Multi Diseases

NCT00291096 HSC: 4601 PI: Fabian RPFNA for risk assess-ment & screen-ing BCPC

A211102 HSC: 4304 PI: Fabi-an SC: An-nie

Metfor-min Hy-drochloride in pts. w/ Atypi-cal Hy-perplasia or In Situ BC VS Placebo

BCPC

NCT02729701 HSC: 02440 PI: Fabian SC: tba Pilot Study-Effect of Duavee® on Be-nign Breast Tissue Prolifera-tion BCPC

IIT-2016-Epaca-dostat +SIROAdv HSC: 141107 PI: Huang SC: Xuan

Epaca-dostat, INCB24360, in com-bo w/ siro-limus in adv. Mals

CRC

A011401 HSC: 04581 PI: Klemp SC: Andrea BC Weight Loss Study (BWEL Study)

BCPC, WW, CCP MCA

R3767-ONC-1613 HSC: 141280 PI: Jewell SC: Xuan Status: 5.9 activation pending

REGN3767 (Anti-LAG-3) w/ or w/o REGN2810 (Anti-PD1) in Adv. Cancers CRC

Ancillary

L-Dex HSC: 02206 PI: Wag-ner SC: Jen-nifer Bioimped-ance Spectros-copy VS. Tape Measure in Preven-tion of Lymphedema WW, CCP– Indian Creek

GBR 1302-101 HSC: 141283 PI: Khan SC: San-tana GBR 1302 in Subjects With HER2+ Cancers (GBR 1302-101)

CRC, Hos

TCD14678 HSC: 141226 PI: Wil-liamson SC: Stacy SAR439459 Mono-therapy & combo SAR439459 & REG-N2810 in Pts With Adv. Solid Tumors CRC, WW consent

TP-0184-101 HSC: tba PI: Baranda SC: tba Status: ERC ap-proved 5.21

First-in-human Study of Oral TP 0184 in Patients With Adv. Solid Tu-mors

CRC

AFT-25 HSC: 141444 PI: Amin SC: Sid-rah & Jennifer

Compare Operative to Moni-toring & Endo-crine Therapy (COMET) Trial For Low Risk DCIS

WW, Indian Crk.

Moderate Dose Omega 3 HSC: 141224 PI: Nye SC: Annie Feasibility Study of Moder-ate Dose Ome-ga 3 Fatty Acid supplementation

in Premenopau-sal Women at High Risk for BC Considering future Pregnan-cy

WW, CRC

TEPR Pilot Study HSC: 140761 PI/SC: Myers Task Evoked Pupillary Response (TEPR): Cognitive Effort for BC Survi-vors

WW, CCP, OMC

NRG-BR005 HSC: 141222 PI: Wagner SC: Jena & Jennifer Assessing the Accura-cy of Tumor Biopsies After Chemo to Deter-mine if Pts Can Avoid Breast Sur-gery

WW, CCP, MCA

FN-1501-UP1 HSC: 141902 PI: Wil-liamson SC: Stacy

Eval. FN-1501 monother-apy in patients with adv. solid tu-mors

CRC

A011104 HSC: 141192 PI: Wag-ner SC: Jen-nifer MRI & Mam-mography Before Surgery in Pts With Stage I-II BC WW, CCP

NKTR 16-214-02 HSC: 141187 PI: William-son SC: Santa-na

NKTR-214 & Nivolumab in Pts With Select Lo-cally Adv. or Met. Solid Tu-mors

CRC

Study Contact (SC) Pager Phone

Annie Anderson n/a 5-7741

Stacy Anderson 4453 5-7543

Chris Baierl 0361 8-3058

Karissa Finke 2613 8-6079

Santana Fortney 4451 8-4769

Jennifer Inman n/a 5-9887

Jena McCall n/a 5-7045

Andrea McConnell n/a 5-7045

Leah Miller n/a 8-3670

Sidrah Sheik 8320 8-2437

Sherri Smith n/a 5-7658

Julia Urban 3264 8-7549

Alice Wang 2613 8-8548

4010-01-001 HSC: 141177 PI: Jewell SC: Stacy

MSI-H solid tumor

TSR-042 an Anti-PD-1 Mon-oclonal Antibody -GARNET

CRC (WW Consent)

IIT-2017-MM-BRST-Her2noRT HSC: 140798 PI: Mitchell SC: Leah Omission of Radia-tion in Pts With Her-2 Positive BC WW

TAS 120-101 HSC: 142341 PI: Al-Rajabi SC: tba Status: 7.2 IC comments to SP

Ph. 1/2 Study of TAS-120 in Pts With Adv. Solid Tumors Harboring FGF/FGFR Aberrations

CRC

A221505 HSC: 142044 PI: Wagner SC: Chris Hypofractionated Post Mastec-tomy Radia-tion W/ Breast Recon-struction WW, CCP, MCA

ePOST HSC: tba PI: Klemp SC: tba Efficacy of Point Of Ser-vice Testing in MBC. tba

4

Updated 7/5/2018 Page 1 of 2 GI Project Director: Ashley Shores Clinical Trial Nurse Navigator Early Phase Project Director: Jecinta Scott Phone: 913-945-7552 CTNurseNav@kumc.edu Pending Hold CCP IIT

GI Cancers

Colorectal

Advanced/Met.

Esophageal/Gastric

Adv. /Met.

Study Contact Pager Phone

Stacy Anderson 4453 5-7543

Santana Fortney 4451 8-4769

Emily Kelly 0844 8-2545

Xuan Lam 4655 5-7551

Amarachi Ojajuni 5178 8-0545

Kayra Thompson 2480 8-1886

S1613 HSC: 141842 PI: Kasi SC: Kayra Trastuzumab and per-tuzumab (TP) compared to cetuximab and irinotec-an (CETIRI) in adv/met CRC with HER-2 ampli-fication

WW

IIT-2017-Cabozant_DurvaGI HSC: 141879 PI: Saeed SC: tba Status: 6.25 con-tract pending Cabozantinib in combo w/ Durval-umab in previously treated patients with adv. gas-troesophageal can-cer and other GI malignancies

tba

FPA144-004 HSC: 142604 PI: Saeed SC: tba Status: 7.3 CF to finance A Study of FPA144 Com-bined With Modified FOL-FOX6 in Gas-tric/Gastroesophageal Can-cer (FIGHT)

tba

NRG-GI004-S1610 HSC: 141960 PI: Saeed SC: Kayra

Combo Chemo, Bevacizumab, and/or Atezoli-zumab in Treat-ing Patients With Deficient DNA Mismatch Repair Metastat-ic CRC

WW, CCP, MCA

2015-X7-7-LQT HSC: 02962 PI: Khan SC: Kayra Capecit-abine in Meta-static Breast and GI Cancers (X7-7). WW, CRC, CCP, MCA

2015-X7-7-LQT HSC: 02962 PI: Khan SC: Kay-ra

Capecit-abine in Metastat-ic Breast and GI Cancers (X7-7)

WW, CRC, CCP, MCA

Prevention

No trials

Adjuvant

IIT-2017-Periop-mFOLFOXPem HSC: 141863 PI: Sun SC: Amarachi Periopera-tive mFOL-FOX Plus Pembroli-zumab in GEJ and Stomach Adenocarci-noma

WW, Hop. CRC consent

Neoadjuvant

N1048 HSC: 04323 PI: Lomin-ska SC: Kayra PRO-SPECT: Chemo Alone or chemo + Radiation Therapy in pts With Locally Adv. Rectal Can-cer Under-going Sur-gery WW, CCP, MCA

PCYC-1128-CA HSC: 04055 PI: William-son SC: Emily K. Ibrutinib Combina-tion Thera-py in Pa-tients With Selected GI & GU Tumors-gastric & CRC

CRC, WW

PCYC-1128-CA HSC: 04055 PI: Wil-liamson SC: Emily K. Ibrutinib Combina-tion Thera-py in Pa-tients With Selected GI & GU Tumors Gastric & CRC

CRC, WW

IIT-2016-MA-GI-MelphVMitC-HIPEC- HSC: 140206 PI: Al-Kasspooles SC: Kayra

Comparing Morbidity of Cytoreductive Surgery & CRS-HIPEC using Mitomy-cin-C VS Mel-phalan for Col-orectal Perito-neal Carcino-matosis WW

ARRAY-818-302 (BEACON CRC) HSC: 140716 PI: Al-Rajabi SC: Kayra

Encorafenib + Cetuxi-mab +/- Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/ Folinic Acid (FA)/ Iri-notecan (FOLFIRI)/ Cetuximab With a Safe-ty Lead-in of Encoraf-enib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Met. CRC WW

Adjuvant

A021502 HSC: 141801 PI: Saeed SC: Kayra Chemother-apy w/ or w/o Atezoli-zumab in Treating Patients With Stage III Colon Cancer & Deficient DNA Mis-match Re-pair WW, CCP, MCA, CRC for consent

IIT-2017-Cabozant_DurvaGI HSC: 141879 PI: Saeed SC: tba Status: 6.25 contract pend-ing Cabozantinib in combo w/ Durvalumab in prev. treated patients with adv. gas-troesophageal cancer and other GI mals

tba

MK3475-590 HSC: 142159 PI: Saeed SC: tba Status: 7.3 revised CF to Sp First-line Esophageal Carcinoma Study W/ Chemo vs. Chemo Plus Pembroli-zumab (KEYNOTE-590)

tba

SGNTV-001 HSC: 142260 PI: Saeed SC: tba Status: 6.28 SP still has CF Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors

tba

5

Updated 7/5/2018 Page 2 of 2 GI Project Director: Ashley Shores Clinical Trial Nurse Navigator Early Phase Project Director: Jecinta Scott Phone: 913-945-7552 CTNurseNav@kumc.edu Pending Hold CCP IIT

GI Cancers

Multi Diseases

Pancreas

No trials

Locally Advanced/met.

HCC

JX594-HEP204 HSC: 03788 PI: Al-Rajabi SC: Ama-rachi HCC Study Comparing Vaccinia Virus Based Immuno-therapy + So-rafenib vs So-rafenib Alone (PHOCUS) WW

Bowel Obstruc-

S1316 HSC: 03516 PI: Al-Kass-pooles SC: Kayra Surgery or Non-Surgical

mgmt. in Treating Pts With Intra-Abdominal Cancer & Bowel Obstruc-tion

WW, CCP, MCA

2nd line

2015-X7-7-LQT HSC: 02962 PI: Khan SC: Kay-ra Capecita-bine in Metastat-ic Breast and GI Cancers (X7-7) WW, CRC, CCP, MCA

S1609 HSC: 140807 PI: Al-Rajabi SC: Ben Nivolumab and Ipili-mumab in Treat-ing Pa-tients With Rare Tumors

CRC, WW, CCP

IIT-2016-Epaca-dostat +SIROAdv HSC: 141107 PI: Huang SC: Xuan Epaca-dostat (INCB24360) in combina-tion with sirolimus

CRC

Bile Duct

INCB-54828-202 HSC: 04482 PI: Al-Rajabi SC: Ama-rachi INCB054828 in Subjects With Adv/Met or Surgically Unresectable Cholangio-carcinoma Including FGFR2 Transloca-tions Who Failed Previ-ous Therapy WW

R3767-ONC-1613 HSC: 141280 PI: William-son SC: Xuan Status: 5.9 open soon REGN3767 (Anti-LAG-3) w/ or w/o REG-N2810 (Anti-PD1) in Adv. Cancers

CRC

TCD14678 HSC: 141226 PI: Wil-liamson SC: Stacy SAR439459 Mono-therapy & Combo of SAR439459 & REG-N2810 in Pts W/ Adv. Solid Tumors

CRC, WW Consent

TP-0184-101 HSC: tba PI: Baranda SC: tba Status: ERC ap-proved 5.21 First-in-human Study of Oral TP 0184 in Patients With Adv. Solid Tu-mors

CRC

Neo-Adjuvant

A021501 HSC: 141530 PI: Kasi SC: Kayra Combo Chemo w/ or w/o Hypofrac-tionated Radiation Before Sur-gery in pts W/ Pancre-atic Cancer WW, MCA

Anal

No trials

PL3397-A-U126 HSC: 141309 PI: William-son SC: Ben Pexidartinib Effects on How the Body Pro-cesses Midazolam & S-warfarin (PKs) CRC , WW Consent

GBR 1302-101 HSC: 141283 PI: Khan SC: Santana GBR 1302 in Subjects With HER2 Positive Cancers CRC, Hos

FN-1501-UP1 HSC: 141902 PI: Wil-liamson SC: Stacy Evaluate ... FN-1501 monother-apy in patients with adv. solid tu-mors

CRC

1st line

HALO-109-301 HSC: 141270 PI: Kasi SC: Kayra PEGylated Re-combinant Hu-man Hyaluroni-dase in Combo W/ Nab-Paclitaxel + Gemcitabine VS Placebo + Nab-Paclitaxel & Gemcitabine in Pts w/ Hyalu-ronan-High Stage IV Prev. Untreated PDAC

WW, CCP, Hos.

IIT-2017-Cabozant_DurvaGI HSC: 141879 PI: Saeed SC: tba Status: 6.25 contract pending

Cabozantinib in combo w/ Durvalumab in previously treated pts w/ adv. gas-troesophageal cancer & other GI mals tba

IIT-2017-NI-RA_PANC HSC: 141862 PI: Kasi SC: tba Status: 6.25 pro-tocol and ICF revi-sions Niraparib in met. pancreatic cancer after previ-ous chemo tba

CA209-9DX HSC: 142160 PI: Al-Rajabi SC: tba Status: 7.3 CF to legal Nivolumab in Pts W/ HCC Who Are at High Risk of Recurrence After Cura-tive Hepatic Resection or Ablation (CheckMate 9DX) tba

D419CC00002 HIMA-LAYA HSC: 142216 PI: Al-Rajabi SC: tba Status: 7.3 PI to submit to HSC Durvalumab and Tremelimumab as First-line Treat-ment in Pa-tients With Unresec-table HCC tba

4010-01-001 HSC: 141177 PI: Jewell SC: Stacy

MSI-H solid tumor

TSR-042 an Anti-PD-1 Monoclo-nal Anti-body -GARNET

CRC (WW Consent)

Study Contact Pager Phone

Stacy Anderson 4453 5-7543

Santana Fortney 4451 8-4769

Emily Kelly 0844 8-2545

Xuan Lam 4655 5-7551

Amarachi Ojajuni 5178 8-0545

Kayra Thompson 2480 8-1886

8374-CL-0101 HSC: 142212 PI: William-son SC: 6.5 IRB approved ASP8374, an Immune Checkpoint Inhibitor, in Subjects With Adv. Solid Tu-mors

CRC

TAS 120-101 HSC: 142341 PI: Al-Rajabi SC: tba Status: 7.2 IC com-ments to SP TAS-120 in Pts With Advanced Solid Tu-mors Har-boring FGF/FGFR Aberrations

CRC

SGNTV-001 HSC: 142260 PI: Saeed SC: tba Status: 6.28 SP still has CF Efficacy and Safety Study of Tisotumab Vedotin for Pa-tients With Solid Tu-mors

tba

6

Updated 7/5/2018 Page 1 of 2 GU Project Director: Ashley Shores Clinical Trial Nurse Navigator Early Phase Project Director: Michelle Cairns Phone: 913-945-7552 CTNurseNav@kumc.edu

Hold Pending CCP IIT

Non-Metastatic Metastatic

Neo- adjuvant

No trials

Radiation

RTOG 0924 HSC: 13031 PI: Shen SC: Christina Androgen-Deprivation Therapy and Radia-tion Thera-py in Treat-ing Pa-tients With Prostate Cancer

WW, CCP, MCA

Survivorship

No trials Asymptomatic

No trials

GU Cancers: Prostate Bladder, RRC & Others on pg 2

Biochemical recurrent

No trials

Symptomatic

No trials NRG-GU002 HSC: 140796 PI: Shen SC: Christina Antiandro-gen Therapy and Radia-tion Therapy w/ or w/o Docetaxel in Pts With Prostate Cancer Re-moved by Surgery WW, CCP

Hormone Naïve/ sensitive

EA8153 HSC: tba PI: Parikh SC: tba Status: ERC approved 3.26 Cabazitaxel with Abi-raterone versus Abiraterone alone Random-ized Trial for Extensive Dis-ease following Docetaxel: the CHAARTED2 Trial tba

NRG-GU005 HSC: 141962 PI: Shen SC: tba

Status: 6.27 resubmit to HSC Stereotactic Body Radiation Therapy or In-tensity-Modulated Radi-ation Therapy in Treating Pa-tients With Stage IIA-B Prostate Cancer

tba

Study Contact Pager Phone

Stacy Anderson 4453 5-7543

Ashlee Curtis 5376 8-7566

Santana Fortney 4451 8-4769

Christina Hopkins 5457 8-2566

Emily Kelly 0844 8-2545

Xuan Lam 4655 5-7551

Benjamin Roberts 5178 8-0545

IIT-2017-XS-PROS-Ul-traHypoFracRT HSC: 141963 PI: Shen SC: Christi-na Ultra-hypofrac-tionated Radiation in Prostate Cancer Hos, CCP

NRG-GU006 HSC: 142731 PI: Shen SC: tba Status: ERC approved 6.27 Radiation Therapy With or Without Apalutamide in Treating Patients With Stage III-IV Prostate Cancer tba

7

Updated 7/5/2018 Page 2 of 2 GU Project Director: Ashley Shores Clinical Trial Nurse Navigator Early Phase Project Director: Michelle Cairns Phone: 913-945-7552 CTNurseNav@kumc.edu

Hold Pending CCP IIT

Renal (RCC)

GU Cancers: Prostate on pg 1

Bladder

Local Advanced

PCYC-1128-CA HSC: 04055 PI: Wil-liamson SC: Emi-ly K. Ibrutinib Combina-tion Ther-apy in Patients With Se-lected GI & GU Tumors CRC, WW

Multi Diseases

Untreated

No trials CA-ALT-803-01-14 HSC: 04082 PI: Holzbeier-lein SC: Christi-na Intravesical BCG in Combo w/ ALT-803 in Pts w/ Non-Muscle Invasive Bladder Cancer WW

IIT-2016-Epacadostat +SIROAdv HSC: 141107 PI: Huang

SC: Xuan Status: SP hold Epacadostat (INCB24360) in combo with siroli-mus in adv. Mals. CRC

S1609 HSC: 140807 PI: Al-Rajabi SC: Ben Nivolumab and Ipili-mumab in Treating Patients With Rare Tumors CRC

Urothelial

PCYC-1128-CA HSC: 04055 PI: Wil-liamson SC: Emily K. Ibrutinib Combo Therapy in Pts. w/ Se-lected GI & GU Tumors CRC, WW

ASG-22CE-13-2 HSC: 0907 PI: Baranda SC: Xuan

Renal In-sufficiency

Safety & PKs of AGS-22M6E in pts. W/ Malignant Solid Tu-mors

CRC

TCD14678 HSC: 141226 PI: William-son SC: Stacy

SAR439459 Monothera-py & Com-bo of SAR439459 & REG-N2810 in Pts With Adv. Solid Tumors

CRC, WW Consent

NKTR 16-214-02 HSC: 141187 PI: Williamson SC: Santana CD122-Biased Cytokine (NKTR-214) in combo W/ Anti-PD-1 Antibody (Nivolumab) in Pts With Select Adv. or Met. Solid Tumors (PIVOT-02) CRC

TP-0184-101 HSC: tba PI: Baranda SC: tba Status: ERC approved 5.21 First-in-human Study of Oral TP 0184 in Pts w/ Adv. Solid Tumors CRC

FN-1501-UP1 HSC: 141902 PI: Wil-liamson SC: Stacy FN-1501 monother-apy in patients with adv. solid tu-mors CRC

S1602 HSC: 140931 PI: Lee SC: Chris-tina Different Strains of BCG w/ or w/o Vac-cine in High Grade Non- Mus-cle Inva-sive Blad-der Can-cer WW

CA-ALT-803-01-06 HSC: 142077 PI: Lee SC: tba Status: 6.22 SP ICF revi-sions Intravesical BCG in Com-bo with ALT-803 in PPts. w/ BCG Unre-sponsive High Grade Non-Muscle Inva-sive Bladder Cancer tba

SGN22E-002 HSC: 141807 PI: William-son SC: Xuan Enfortumab Vedotin + Immune Checkpoint Inhibitor Therapy for Pts. W/ Urothelial Bladder Cancer (EV-103) CRC

9767 HSC: 142112 PI: Parikh SC: Xuan MLN0128 (TAK-228), in Pts W/ Locally Adv. or Met. TCC of the Urothelial Tract Whose Tumors Har-bor a TSC1 and/or a TSC2 Muta-tion CRC, WW Consent

TCC

Localized

EA8143 HSC: 141860 PI: Wulff-Burchfield SC: Chris-tina Nivolumab in Treating Patients With Local-ized Kid-ney Can-cer Under-going Ne-phrectomy (PROSPER)

WW, Hos, CCP

GBR 1302-101 HSC: 141283 PI: Khan SC: San-tana GBR 1302 in Sub-jects With HER2+ Cancers (GBR 1302-101) CRC, Hos

4010-01-001 HSC: 141177 PI: Jewell SC: Stacy

MSI-H solid tumor

TSR-042 an Anti-PD-1 Monoclo-nal Anti-body -GARNET

CRC (WW Consent)

Study Contact Pager Phone

Stacy Anderson 4453 5-7543

Ashlee Curtis 5376 8-7566

Santana Fortney 4451 8-4769

Christina Hopkins 5457 8-2566

Emily Kelly 0844 8-2545

Xuan Lam 4655 5-7551

Benjamin Roberts 5178 8-0545

A031501 HSC: 142042 PI: Parikh SC: Christi-na Pembroli-zumab in muscle invasive and locally adv. urothelial carcinoma (AMBASSADOR) VS observation WW, CCP, MCA

8374-CL-0101 HSC: 142212 PI: William-son SC: pending Status: 6.5 IRB apprvd. ASP8374, an Immune Checkpoint Inhibitor, in Subjects With Adv. Solid Tumors CRC

Adv/Met.

PCYC-1128-CA HSC: 04055 PI: Wil-liamson SC: Emi-ly K. Ibrutinib Combi-nation Therapy in Pa-tients With Selected GI & GU Tumors CRC, WW

17403 (FORT-1) HSC: 142427 PI: Parikh SC: tba Status: to RSC 7.25 Rogaratinib -BAY1163877- vs Chemo in Patients With FGFR -Positive Lo-cally Adv. or Met. Urothe-lial Carcino-ma tba

TAS 120-101 HSC: 142341 PI: Al-Rajabi SC: tba Status: 7.2 IC comments to SP TAS-120 in Pts With Adv. Solid Tumors Har-boring FGF/FGFR Aber-rations CRC

UCa-001 HSC: 142686 PI: Parikh SC: tba Status: ERC approved 6.15 INO-5401 + INO-9012 in Combo W/ Atezolizumab in Locally Adv. Unre-sectable or Met/ Recur-rent Urotheli-al Carcinoma tba

8

Updated 7/5/2018 Page 1 of 2 GYN Project Director: Jessica Schwent Clinical Trial Nurse Navigator Early Phase Project Director: Jecinta Scott Phone: 913-945-7552 CTNurseNav@kumc.edu

Hold Pending CCP IIT

GYN Cancers: Endometrial & Multi Diseases on pg 2

Ovarian/ Peritoneal/ Fallopian Cervical / Vaginal

Recurrent

Study Contact (SC) Pager Phone

Stacy Anderson 4453 5-7543

Santana Fortney 4451 8-4769

Reshma Jaseja 5994 8-5576

Xuan Lam 4655 5-7551

Rituja Patil n/a 8-0512

Benjamin Roberts 5178 8-0545

Jessica Schwent 2515 8-4254

Kayra Thompson 2840 8-1886

Supportive

GOG– 0225 HSC: 13490 PI: Jewell SC: Reshma Can Diet & Physi-cal Activi-ty Trial?

High tumors

grade only

WW

2nd

line +

No trials Platinum Resistant

D8488C00001 (CONCERTO) HSC: 140100 PI: Chapman SC: Reshma

Cediranib (VEGFRi) in Combo With Olaparib (PARPi)

- High grade serous, endo-metriod, clear cell

- Resistant only, NOT re-fractory

- ≥3 prior lines, only 2 non-pltm

- Measurable dx required

- Needs hx of Bev

- HGB ≥10.0g/dL

- NO transfusions w/in 4wks

WW, CRC

1st line

IIT-2017-HIPEC-Ovarian HSC: 141468 PI: Jewell SC: Reshma Heated Intraperi-toneal Chemo in primary ovarian cancer patients

WW, CRC consent

8329 HSC: 141223 PI: Wil-liamson SC: Stacy

Veliparib (PARPi) & Topotecan Hydrochlo-ride Treat-ing Solid Tumors, R/R Ovari-an CA, or Primary Peritoneal CA

CRC, WW Consent

EMR200647-001 HSC: 140009 PI: William-son SC: Stacy

MSB001135 9C [M7824] (anti-PDL1 + anti- TGFB) in Met. or Locally Adv. Solid Tumors

*Refractory Ovarian co-hort pending CRC

Plat. Sensitive

No trials

3000-02-004 HSC: 141867 PI: Jewell SC: Reshma Niraparib combined w/ Bevaci-zumab as maintenance treatment following Bevaci-zumab + frontline plat-inum-based chemo

WW, CRC Consent

10017 HSC: 141975 PI: Jewell SC: Stacy Atezoli-zumab (MPDL3280A), SGI-110 and CDX-1401 Vac-cine in Recurrent Ovarian Cancer CRC, WW

1st

line

NRG-GY006 HSC: 140110 PI: Hoover SC: Reshma Radiation Therapy and Cisplatin w/ or w/o Triapine in Treating pts With New-ly DX Stage IB2, II, or IIIB-IVA aCervical Cancer or Stage II-IVA Vaginal Can-cer

WW

GCT1015-05 HSC: 142678 PI: Jewell SC: tba Status: 6.21 assigned to regulatory Tisotumab Vedotin (HuMax-TF-ADC) alone or in Combo in 1st Line Recurrent or Stage IVB Cervical Ca. tba

NRG-GY009 HSC: tba PI: Jewell SC: tba Status: ERC ap-proved 7.2 Pegylated Liposomal Doxorubicin Hydro-chloride w/ Atezoli-zumab and/or Bevacizumab in Treating pts w/ Re-current Ovarian, Fal-lopian Tube, or Pri-mary Peritoneal CA

tba

GOG-3020 ATHENA HSC: 142720 PI: Jewell SC: tba Status: ERC approved 6.25 Ovarian Ca. Pts Evaluating Rucaparib & Nivolumab as Maintenance Treatment Fol-lowing Re-sponse to Front-Line Platinum-Based Chemo tba

9

Updated 7/5/2018 Page 2 of 2 GYN Project Director: Jessica Schwent Clinical Trial Nurse Navigator Early Phase Project Director: Jecinta Scott Phone: 913-945-7552 CTNurseNav@kumc.edu

Hold Pending CCP IIT GYN Cancers:

Ovarian/Peritoneal/Fallopian, Cervical on Pg 1

Multi Diseases

S1316 HSC: 03516 PI: Al-Kass-pooles SC: Kayra Prospec-tive Com-parative Effective-ness Trial for Malig-nant Bowel Obstruc-tion. WW

Endometrial

1st line

No trials

2nd line + S1609 DART HSC: 140807 PI: Al-Rajabi SC: Ben Nivolumab and Ipili-mumab in Treat-ing Pa-tients With Ra-re Tu-mors CRC

C31004 HSC: 04525 PI: Jewell SC: Stacy

Ph. 2 Study of MLN0128, Combo of MLN0128 w/ MLN1117, Paclitaxel & Combo of MLN0128 W/ Paclitaxel in Wom-en W/ Endometrial Cancer

- No HGB guidance

- ALL uterine types

- H2 allowable

- At least 1 pltm but ≤2

prior regimens

- CrCl >50

CRC, WW

4010-01-001 HSC:141177 PI: Jewell SC: Stacy

Study of TSR-042, an Anti-PD-1 Monoclo-nal Antibody, in Patients With Advanced Solid Tumors (GARNET)

Only endome-trial cancer pts (MSS or MSI) & NSCLC co-horts enrolling currently

CRC (WW Consent)

TCD14678 HSC: 141226 PI: William-son SC: Stacy A Ph. 1/1b ...study to eval. anti-tumor activity of SAR439459 intravenously as monother-apy & in com-bo w/ REG-N2810 in pts. w/ adv. solid tumors

CRC, WW Consent

TP-0184-101 HSC: tba PI: Baranda SC: tba Status: ERC ap-proved 5.21 First-in-human Study of Oral TP 0184 in Patients With Adv. Solid Tu-mors CRC

IIT-2016-Epaca-dostat +SIROAdv HSC: 141107 PI: Huang SC: Xuan Epaca-dostat (INCB24360) in combina-tion with sirolimus in adv. Malignan-cies CRC

FN-1501-UP1 HSC: 141902 PI: William-son SC: Stacy Safety, tolerability, PK and anti-tumor ac-tivity of FN-1501 mono-therapy in patients with adv. solid tu-mors CRC

GBR 1302-101 HSC: 141283 PI: Khan SC: Santana GBR 1302 in Subjects With HER2+ Cancers (GBR 1302-101) CRC, Hos

Study Contact (SC) Pager Phone

Stacy Anderson 4453 5-7543

Santana Fortney 4451 8-4769

Reshma Jaseja 5994 8-5576

Xuan Lam 4655 5-7551

Rituja Patil n/a 8-0512

Benjamin Roberts 5178 8-0545

Jessica Schwent 2515 8-4254

Kayra Thompson 2840 8-1886

TAS 120-101 HSC: 142341 PI: Al-Rajabi SC: tba Status: 7.2 IC com-ments to SP Ph. 1/2 Study of TAS-120 in Pts With Adv. Solid Tumors Harboring FGF/FGFR Aberrations CRC

10104 HSC: 142208 PI: Jewell SC: tba Cabozan-tinib & Nivolumab in Treating Patients With Adv., Recurrent or Meta-static En-dometrial Cancer CRC

10

Updated 7/5/2018 Page 1 of 1 Head and Neck Project Director: Jessica Schwent Clinical Trial Nurse Navigator Early Phase Project Director: Jecinta Scott Phone: 913-945-7552 CTNurseNav@kumc.edu

Pending Hold CCP IIT Head & Neck Cancer

Study Contact Pager Phone

Stacy Anderson 4453 5-7543

Chris Baierl 0361 8-3058

Santana Fortney 4451 8-4769

Xuan Lam 4655 5-7551

Benjamin Roberts 5178 8-0545

Jessica Schwent 2515 8-4254

Metastatic Adjuvant

Multi diseases

201404139 HSC: 04159 PI: Neupane SC: Stacy Phase II is 2nd line + PD 0332991 and Cetuxi-mab in Patients With Incur-able SCCHN CRC

RTOG-1216 HSC: 13868 PI: Kumar SC: Jessica and Chris Radiation Therapy With Cispla-tin, Docet-axel, or Ce-tuximab After Surgery in Treating Pts. W/ Stage III-IV Squa-mous Cell H&N Cancer

WW, CCP, MCA

IIT-2016-Epacadostat +SIROAdv HSC: 141107 PI: Huang SC: Xuan Status: Hold– lab contract pending Epacadostat (INCB24360) in combo with sirolimus in adv. Malig-nancies

CRC

S1609 HSC: 140807 PI: Al-Rajabi SC: Ben

Nivolumab and Ipili-mumab in Treat-ing Pts. With Rare Tumors

CRC

TCD14678 HSC: 141226 PI: William-son SC: Stacy

Eval. anti-tumor activity of SAR439459 intravenously as monother-apy and in combo w/ REGN2810 in pts. with adv. solid tumors

CRC, WW Consent

TP-0184-101 HSC: tba PI: Baranda SC: tba Status: ERC approved 5.21

First-in-human Study of Oral TP 0184 in Pa-tients With Adv. Solid Tumors

CRC

Local. Adv.

The APA Trial 15-x255 HSC: 04258 PI: Neupane SC: Jessica Nab-Paclitaxel and Cispla-tin or Nab-paclitaxel as Induction Therapy for Locally Ad-vanced HNSCC WW, CCP

MK3475-629 HSC: 141299 PI: Neupane SC: Jessica

Study to Evaluate the Safety and Effica-cy of Pem-brolizumab in Partici-pants with R/M cSCC

WW, CRC Consent

Thyroid

No trials

Localized

No trials NRG-HN003 HSC: 140777 PI: Neupane SC: Jessica Cisplatin, In-tensity-Modulated Radiation Therapy, and Pembroli-zumab in Treating Pa-tients With Stage III-IV H&N Squa-mous Cell Carcinoma

WW, CCP

FN-1501-UP1 HSC: 141902 PI: William-son SC: Stacy

Evaluate... anti-tumor activity of FN-1501 monothera-py in pa-tients with adv. solid tumors

CRC

CA209-9TM HSC: 142061 PI: Neupane SC: tba Status: 5.31 re-submit to HSC Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiothera-py in Patients With Cisplatin-ineligible or Eligi-ble Locally Adv. Squamous Cell H&N Cancer

tba

4010-01-001

HSC:

141177

PI: Jewell

SC: Stacy

MSI-H solid

tumor

TSR-042 an Anti-PD-1 Monoclonal Antibody

-GARNET

CRC

GBR 1302-101 HSC: 141283 PI: Khan SC: San-tana

GBR 1302 in Subjects With HER2+ Cancers

CRC, Hos

8374-CL-0101 HSC: 142212 PI: William-son SC: pending Status: 6.5 IRB submis-sion

ASP8374, an Immune Checkpoint Inhibitor, in Subjects With Adv. Solid Tumors

CRC

TAS 120-101 HSC: 142341 PI: Al-Rajabi SC: tba Status: 7.2 IC comments to SP TAS-120 in Patients With Adv. Solid Tumors Har-boring FGF/FGFR Aberrations

CRC

NRG-HN004 HSC: 142590 PI: Lominska SC: tba Status: 6.27 pending OIS an-cillary review Radiation Thera-py With Durval-umab or Cetuxi-mab in Treating Patients With Stage III-IVB H&N Cancer Who Cannot Take Cisplatin

tba

MK3475-689 HSC: 142548 PI: Neupane SC: tba Status: 6.20 pend-ing submission to legal Pembrolizumab as Neoadjuvant Ther-apy and in Combo With SOC as Adju-vant Therapy for Stage III-IVA Re-sectable Locore-gionally Adv. H&N SCC (LA HNSCC)

tba

SGNTV-001 HSC: 142260 PI: Saeed SC: tba Status: 6.28 SP still has ICF Efficacy and Safety Study of Tiso-tumab Ve-dotin for Pts With Solid Tumors

tba

C-145-03 HSC: pending PI: Neupane SC: 142714 Status: ERC approved 6.25 Study of LN-145 Autolo-gous Tumor Infiltrating Lymphocytes in the Treat-ment of Squa-mous Cell Carcinoma of the H&N

pending

11

Updated 7/5/2018 Page 1 of 2 Melanoma Project Director: Sherri Miller Clinical Trial Nurse Navigator Early Phase Project Director: Michelle Cairns Phone: 913-945-7552 CTNurseNav@kumc.edu

Pending Hold CCP IIT

Advanced/Metastatic

Melanoma & Sarcoma (Sarcoma Next page)

Study Contact Pager Phone

Stacy Anderson 4453 5-7543

Ashlee Curtis 5376 8-7566

Santana Fortney 44514 8-4769

Valerie Francis Na 4-2672

Xuan Lam 4655 5-7551

Rhonda May 1976 5-7523

Sasha Moores 0811 8-5520

Benjamin Roberts 5178 8-0545

Jessica Schwent 2515 8-4254

Mel-2012-01-01 MARVSmALo– IIT HSC: 02217 PI: Doolittle SC: Sasha

Ages 18-66

Vaccine En-riched, Autolo-gous, Activat-ed T-Cells Directed to Tumor in Pa-tients With R/R Melano-ma

CRC, WW

Observational

No trials S1320 HSC: 02735 PI: Doolittle SC: Rhonda Dabrafenib and Tramet-inib in Treating Patients With Stage III-IV BRAF Mutant Mel-anoma That Cannot Be Removed by Surgery WW, CCP, MCA

Surgery

IIT-2016-JM-MEL-T2Margins HSC: 140148 PI: Mam-men SC: Rhonda Pilot Study of 1cm ver-sus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma WW

MK3475-629 HSC: 141299 PI: Neupane SC: Jessi-ca

R/M cSCC

Pembroli-zumab in Partici-pants with Recurrent or Meta-static cSCC WW, CRC Consent

Adjuvant

No trials

Multi Diseases

IIT-2016-Epacadostat +SIROAdv HSC: 141107

PI: Huang SC: Xuan Status: hold– lab contract pending

Epacadostat (INCB24360) in combo w/ sirolimus in adv. Mals

CRC

S1609 HSC: 140807 PI: Al-Rajabi SC: Ben Nivolumab & Ipili-mumab in Treating pts. With Rare Tu-mors

CRC

R3767-ONC-1613 HSC: 141280 PI: William-son SC: Xuan Status: 5.9 activation pending REGN3767 (Anti-LAG-3) w/ or w/o REGN2810 (Anti-PD1) in Adv. Cancers

CRC

NKTR 16-214-02 HSC: 141187 PI: William-son SC: Santana

Melanoma

NKTR-214 & Nivolumab in Pts With Select Lo-cally Adv. or Met. Solid Tumor Ma-lignancies

CRC

TCD14678 HSC: 141226 PI: William-son SC: Stacy

SAR439459 intrave-nously as monothera-py and in combo w/ REGN2810 in pts. with adv. solid tumors

CRC, WW Consent

TP-0184-101 HSC: tba PI: Baranda SC: tba Status: ERC approved 5.21 First-in-human Study of Oral TP 0184 in Pa-tients With Adv. Solid Tumors

CRC

PL3397-A-U126 HSC: 141309 PI: William-son SC: Ben

Pexidartinib Effects on How the Body Pro-cesses Midazolam and S-warfarin (PKs)

CRC, WW Consent

FN-1501-UP1 HSC: 141902 PI: William-son SC: Stacy

Evaluate the safety, tolerability, PK and anti-tumor activity of FN-1501 monotherapy in patients with adv. solid tumors

CRC

10057 HSC: 141974 PI: Powers SC: Santana

Talimogene La-herparepvec & Nivolumab in Pts With` Refractory Lym. or Adv. or Refracto-ry Non-melanoma Skin Can-cers

CRC WW Consent

S1607 HSC: 141870 PI: Doolittle SC: Rhonda Talimogene La-herparepvec and Pem-brolizumab in Patients With Stage III-IV Mel. WW

Desmoplastic

S1512 HSC: 140911 PI: Doolittle SC: Rhonda Pembroli-zumab in Treating Patients With Desmo-plastic Mela-noma That Can or Can-not Be Re-moved by Surgery WW, CCP, MCA

Idera 2125-204 HSC: 142078 PI: Doolittle SC: tba Status: 7.3 revise CF to finance Intratumoral IMO-2125 in Combo w/ Ipilimumab or Pembroli-zumab in Patients w/ Met. Mel tba

TAS 120-101 HSC: 142341 PI: Al-Rajabi SC: tba Status: 7.2 IC com-ments to SP TAS-120 in Patients With Adv. Solid Tu-mors Har-boring FGF/FGFR Aberrations

CRC

S1616 HSC: 141869 PI: Doolittle SC: Ashlee Ipilimumab w/ or w/o Nivolumab in Treating pts/ With Mel. That is Stage III or IV & Cannot Be Re-moved by Surgery WW, CCP, MCA

12

Updated 7/5/2018 Page 2 of 2 Melanoma Project Director: Sherri Miller Clinical Trial Nurse Navigator Early Phase Project Director: Michelle Cairns Phone: 913-945-7552 CTNurseNav@kumc.edu

Pending Hold CCP IIT

Observational

No trials

Melanoma & Sarcoma (Melanoma Previous page)

Adjuvant/Neo Adj.

ARST1321 HSC: 01758 PI: Mammen SC: Rhonda

Pazopanib Neo-adjuvant Trial in Non-rhabdomyosar-coma Soft Tissue Sarcomas (PAZNTIS): A Ph. II/III Randomized Trial of Preopera-tive Chemoradia-tion or Preop. Radiation w/ or w/o Pazopanib WW, CCP, MCA

Hemangioendothelioma

EDDOP 10015 / SARC033 HSC: 141792 PI: Powers SC: Santana A Non-

Randomized, Open-Label, Phase 2 Study of Tramet-inib in Patients with Unresectable or Metastatic Epitheli-oid Hemangioen-dothelioma CRC, WW consent

Advanced/Metastatic

A091304 HSC: 141255 PI: Powers SC: Valerie A Phase I/Randomized Phase II Study Of MlLN0128 (Tak-228) Vs. Pazopanib In Patients With Locally Advanced/ Unresectable And/Or Metastatic Sarcoma CCP-OP

Study Contact Pager Phone

Stacy Anderson 4453 5-7543

Ashlee Curtis 5376 8-7566

Santana Fortney 44514 8-4769

Valerie Francis Na 4-2672

Xuan Lam 4655 5-7551

Rhonda May 1976 5-7523

Sasha Moores 0811 8-5520

Benjamin Roberts 5178 8-0545

Jessica Schwent 2515 8-4254

Multi Diseases

IIT-2016-Epacadostat +SIROAdv HSC: 141107

PI: Huang SC: Xuan Status: hold– lab contract pending

Epacadostat (INCB24360) in combo w/ sirolimus in adv. Mals

CRC

S1609 HSC: 140807 PI: Al-Rajabi SC: Ben Nivolumab & Ipili-mumab in Treating pts. With Rare Tu-mors

CRC

R3767-ONC-1613 HSC: 141280 PI: William-son SC: Xuan Status: 5.9 activation pending REGN3767 (Anti-LAG-3) w/ or w/o REGN2810 (Anti-PD1) in Adv. Cancers

CRC

NKTR 16-214-02 HSC: 141187 PI: William-son SC: Santana

Melanoma

NKTR-214 & Nivolumab in Pts With Select Lo-cally Adv. or Met. Solid Tumor Ma-lignancies

CRC

TCD14678 HSC: 141226 PI: William-son SC: Stacy

SAR439459 intrave-nously as monothera-py and in combo w/ REGN2810 in pts. with adv. solid tumors

CRC, WW Consent

TP-0184-101 HSC: tba PI: Baranda SC: tba Status: ERC approved 5.21 First-in-human Study of Oral TP 0184 in Pa-tients With Adv. Solid Tumors

CRC

PL3397-A-U126 HSC: 141309 PI: William-son SC: Ben

Pexidartinib Effects on How the Body Pro-cesses Midazolam and S-warfarin (PKs)

CRC, WW Consent

FN-1501-UP1 HSC: 141902 PI: William-son SC: Stacy

Evaluate the safety, tolerability, PK and anti-tumor activity of FN-1501 monotherapy in patients with adv. solid tumors

CRC

10057 HSC: 141974 PI: Powers SC: Santana

Talimogene La-herparepvec & Nivolumab in Pts With` Refractory Lym. or Adv. or Refracto-ry Non-melanoma Skin Can-cers

CRC WW Consent

TAS 120-101 HSC: 142341 PI: Al-Rajabi SC: tba Status: 7.2 IC com-ments to SP TAS-120 in Patients With Adv. Solid Tu-mors Har-boring FGF/FGFR Aberrations

CRC

13

Updated 7/5/2018 Page 1 of 1 Lung Project Director: Chris Baierl Clinical Trial Nurse Navigator Early Phase Project Director: Jecinta Scott Phone: 913-945-7552

CTNurseNav@kumc.edu

Pending Hold CCP IIT Thoracic Cancer

2nd line +

Study Contact Pager Phone

Stacy Anderson 4453 5-7543

Chris Baierl 0361 8-3058

Santana Fortney 4451 8-4769

Xuan Lam 4655 5-7551

Rhonda May 1976 5-7523

Benjamin Roberts 5178 8-0545

Small Cell Metastatic Localized

Resectable

Multi Diseases

ALCHEMIST: PI: Huang SC: Rhonda The Adjuvant

Lung Cancer Enrichment Marker Iden-tification & Sequencing Trials, set of 3 integrated, precision medicine trials testing targeted ther-apy in early stage lung cancer WW, CCP, MCA

Study # HSC#

A151216 02026

A081105 02048

E4512 02052

EA5142 04157

S1400 HSC: 01615 PI: Huang SC: Rhon-da

Lung-MAP: Biomarker-Targeted 2nd Line Therapy in Pts w/ Recurrent Stage IIIB-IV Squa-mous NSCLC

WW , CCP, MCA

JoLT-Ca-STABLE-MATES STU 022015-069 HSC: 04269 PI: Wang SC: Rhonda Study of SR VS SAbR in High Risk pts with Stage I NSCLC WW

CA018001 HSC: 04494 PI: Huang SC: Rhon-da Fast Real-time As-sessment of Combo Therapies in Immuno-Onc. Study in pts w/adv. NSCLC (FRACTION-Lung). WW

IIT-2016-Epaca-dostat +SIROAdv HSC: 141107 PI: Huang SC: Xuan Epaca-dostat (INCB24360) in combo with siroli-mus in adv. Mals.

CRC

BPI-2358-103 HSC: 04484 PI: Huang SC: Rhon-da Docetaxel + Plinabulin VS Docet-axel + Pla-cebo in pts. w/ adv. NSCLC W/ ≥ 1 Measur-able Lung Lesion DUBLIN-3 WW

R3767-ONC-1613 HSC: 141280 PI: Jewell SC: Xuan Status: 5.9 activation pending REGN3767 (Anti-LAG-3) w/ or w/o REGN2810 (Anti-PD1) in Adv. Cancers CRC

S1609 HSC: 140807 PI: Al-Rajabi SC: Ben Nivolumab and Ipili-mumab in Treating Patients With Rare Tumors CRC

INCB 59872-101 HSC: 04040 PI: Lin SC: Stacy Study of INCB059872 in Sub-jects w/ adv. malig-nancies CRC

M16-300 HSC: 140979 PI: Huang SC: Xuan Roval-pituzumab Tesirine in Combo W/ Nivolumab and w/ or w/o Ipili-mumab for Adults w/ Extensive-Stage SCLC

CRC (WW Consent)

NRG-CC003 HSC: 140216 PI: Wang SC: Rhonda Prophy-lactic Cranial Irradia-tion w/ or w/o Hip-pocampal Avoid-ance for SCLC

CCP

TCD14678 HSC: 141226 PI: William-son SC: Stacy SAR439459 intrave-nously as monothera-py & in combo w/ REGN2810 in pts. with adv. solid tumors CRC, WW Consent

NKTR 16-214-02 HSC: 141187 PI: William-son SC: Santana CD122-Biased Cy-tokine (NKTR-214) in combo With Anti-PD-1 Anti-body (Nivolumab) CRC

TP-0184-101 HSC: tba PI: Baranda SC: tba Status: ERC ap-proved 5.21 1st-in-human Study of Oral TP 0184 in Pts With Adv. Solid Tu-mors CRC

CPDR001C2101 HSC: 142114 PI: Huang SC: Xuan Status: 4.11 HSC ap-proved PDR001 in combo w/ platinum-doublet chemo in PD-L1 un-selected, met. NSCLC pts

CRC

FN-1501-UP1 HSC: 141902 PI: William-son SC: Stacy FN-1501 monother-apy in pts with adv. solid tu-mors CRC

Unresectable

No trials

Supportive

PCRC 17-11 HSC: 142040 PI: Spoozak SC: tba Status: 6.4 activation pending Early Inte-grated Tele-health VSI n-Person Palli-ative Care for Patients With Lung Cancer (REACH PC)

tba

GBR 1302-101 HSC: 141283 PI: Khan SC: San-tana GBR 1302 in Subjects With HER2+ Cancers CRC, Hos

4010-01-001 HSC: 141177 PI: Jewell SC: Stacy

MSI-H solid tumor

TSR-042 an Anti-PD-1 Mon-oclonal Antibody -GARNET CRC

8374-CL-0101 HSC: 142212 PI: William-son SC: pending Status: 6.5 IRB aproved ASP8374, an Immune Checkpoint Inhibitor, in Subjects W/ Adv. Solid Tumors CRC

TAS 120-101 HSC: 142341 PI: Al-Rajabi SC: tba Status: 7.2 IC com-ments to SP

TAS-120 in Pts With Adv. Solid Tumors Harboring FGF/FGFR Aberrations

CRC

1st line

NRG-LU002 HSC: 141360 PI: Wang SC: Rhon-da Mainte-nance Chemo w/ or w/o Ste-reotactic Body Radi-ation Ther-apy in pts. With Stage IV NSCLC

Hos. , WW CCP– OP

GO40290 HSC: 142578 PI: Huang SC: tba Status: 7.2 RSC submis-sion MTIG7192A, an anti-tigit antibody, in combo w atezolizumab in chemo naïve pts with locally adv. or met NSCLC

tba

SGNTV-001 HSC: 142260 PI: Saeed SC: tba Status: 6.28 SP still has CF Efficacy & Safety Study of Tisotumab Vedotin for Pts With Solid Tu-mors tba

14

Updated 7/2/2018 Page 1 of 2 Hematology Project Director: BJ Broome Clinical Trial Nurse Navigator Early Phase Project Director: Michelle Cairns Phone: 913-945-7552 CTNurseNav@kumc.edu

Pending Hold CCP IIT AML

AML: Newly Diagnosed

AML: Relapsed/refractory

18+ GS-US-339-1559 HSC: 03587 PI: Lin SC: Emi-ly L. En-tospletinib Mono-therapy & in combo W/Chemotherapy in AML CRC, WW

OX1222 HSC: 03368 PI: Lin SC: Emily L. Dose Es-calation OXi4503 as Single Agent & in Combo w/ Cytara-bine w/Subse-quent Ph 2 Cohorts for AML & MDS

CRC, WW

Age ≥ 60

CLTR0310-301 HSC: tba PI: Lin SC: tba Status: ERC ap-proved 5.7 CPX-351 VS 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) AML (301) tba

BP1001-201 HSC: 04217 PI: Lin SC: Emily L. BP1001 (Liposomal Grb2 Antisense Oligonu-cleotide) in Combo With LDAC in Pts With Untreated AML CRC, WW

INCB 59872-101 HSC: 04040 PI: Lin SC: Stacy A Ph. 1/2.. Study of INCB059872 in Subjects With Adv. Mals CRC

IIT-2016-RP-HEM-LD-DNR HSC: 04137 PI: Lin SC: Stacy A Pilot Study of Low-Dose Dauno-rubicin in Patients with R/R Acute Leuk. CRC

AML: Remission

9706 HSC: 140219 PI: Wil-liamson SC: Stacy Nivolumab in Elimi-nating Minimal Residual Disease & Prevent-ing Re-lapse in AML in Remis-sion After Chemo

CRC, WW

Samples

Beat AML HSC: 04570 PI: Lin: SC: Syd-ney The Aca-demic Medical Center Partner-ship “Beat AML” AML Sample Collec-tion WW

TPI-ALV-201 HSC: 140505 PI: Lin SC: Marc A Ph. 2, Random-ized, Bi-omarker-driven, Study in Pts. with R/R AML WW

ARO-013 HSC: 141919 PI: Abhyankar SC: tba Status: 6.11 SP protocol amend-ments released Study Investi-gating the Effi-cacy of Crenol-anib With Chemotherapy vs Chemothera-py Alone in R/R FLT3 Mutated AML

tba

ARO-021 HSC: 142174 PI: Ab-hyankar SC: tba Status: 6.11 SP protocol amendments released Crenolanib vs Midostaurin Following Induction Chemo & Consolidation Therapy in Newly Dx FLT3 Mutat-ed AML

tba

TROV-052 HSC: 141828 PI: Lin SC: Emily L. PCM-075 in Combi-nation With Ei-ther Low-dose Cy-tarabine or Decita-bine in Adult Pa-tients With AML

CRC, WW, HOS

PRAN-16-52 HSC: 141982 PI: Yacoub SC: Paul Status: SIV 5.1 Efficacy & Safety Study Of Pracino-stat In Combina-tion With Azacitidine In Adults With AML tba

Iomab-01 SIERRA HSC: 140528 PI: Ab-hyankar SC: Marc Iomab-B Prior to HCT vs. Conven-tional Care in Older pts w/ Active, R/R AML

WW

Study Contact Pager Phone

Stacy Anderson 4453 5-7543

Michelle Cairns n/a 5-7547

Melody Kabrey 5256 8-8694

Emily Kelly n/a 8-2545

Emily Laskowski 6059 8-4714

Marc Morrison 4457 8-7585

Chris Monse 3991 8-3701

Sara Pearson 4978 8-8279

Sydney Ravenscraft 5909 8-1408

PTX-200-AML-015 HSC: 140819 PI: Lin SC: Emi-ly L.

A Study of PTX-200 (Triciribine) Plus Cytara-bine in R/R Acute Leuk.

CRC (WW Consent)

AMG397 20170173 HSC: 142576 PI: Vallurupalli SC: tba Status: 6.18 CF in progress Safety, Tolera-bility, Pharma-cokinetics and Efficacy of AMG 397 in Subjects With Selected RR Hematological Malignancies

CRC

AML: Newly Dx or R/R

CPX351-102 HSC: 142684 PI: Male SC: tba Status: ERC approved 6.11 Eval. the Potential Impact of Renal Im-pairment on the PKs and Safety of CPX-351

tba

DS3032-A-U105 HSC: 142680 PI: Skikne SC: tba Status: 6.26 PRMC meeting DS-3032b Plus Quizar-tinib Combi-nation Study in FLT3-ITD Mutant AML

CRC

BEAT AML Mas-ter Trial HSC: tba PI: Lin SC: tba Status: ERC ap-prove 6.25 A Master Protocol for Bi-omarker-Based Treatment of AML CRC

15

Updated 7/2/2018 Page 2 of 2 Hematology Project Director: BJ Broome Clinical Trial Nurse Navigator Early Phase Project Director: Michelle Cairns Phone: 913-945-7552 CTNurseNav@kumc.edu

Pending Hold CCP IIT ALL, CLL, CML

CLL ALL

Newly Diagnosed

E1910 HSC: 01213 PI: Lin SC: Marc Combo Chemo. w/ or w/o Blina-tumomab in Treating Pts With Newly Dx BCR-ABL-Negative B Lineage ALL

WW

Relapsed Relapsed

IIT-2016-RP-HEM-LD-DNR HSC: 04137 PI: Lin SC: Stacy A Pilot Study of Low-Dose Dauno-rubicin in Patients with R/R Acute Leuk. CRC

All Leuks CML

PTX-200-AML-015 HSC: 140819 PI: Lin SC: Emily L. PTX-200 (Triciribine) Plus Cytar-abine in R/R Acute Leukemia

CRC (WW consent)

PTX-200-AML-015 HSC: 140819 PI: Lin SC: Emily L. PTX-200 (Triciribine) Plus Cytar-abine in R Acute Leukemia CRC (WW Consent)

ONO-7475-01 HSC: 141657 PI: Lin SC: Emily A Study of ONO-7475 in Patients With Acute Leukemias

CRC, WW, Hos.

UTX-TGR-204 HSC: 140935 PI: Hoff-mann SC: Melody Ublituximab in Combo With TGR-1202 for Pts Previ-ously on UTX-TGR-304 CCP, WW

DCL-16-001 HSC: 141421 PI: Vallurupalli SC: Marc CLR 131 in R/R Select B-Cell Malig-nancies WW, Hos.

9775 ED-DOP HSC: 141970 PI: Lin SC: Emily L. A Phase 2 Study of MLN0128 (TAK-228) in R/R ALL CRC , Hos (WW Consent)

XmAb14045-01 HSC: 142507 PI: Dias SC: tba Status: 6.25 PI to submit to HSC PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies CRC

Study Contact Pager Phone

Stacy Anderson 4453 5-7543

Michelle Cairns n/a 5-7547

Melody Kabrey 5256 8-8694

Emily Kelly n/a 8-2545

Emily Laskowski 6059 8-4714

Marc Morrison 4457 8-7585

Chris Monse 3991 8-3701

Sara Pearson 4978 8-8279

Sydney Ravenscraft 5909 8-1408

CPX351-102 HSC: 142684 PI: Male SC: tba Status: ERC approved 6.11 A Trial to Evaluate the Potential Impact of Renal Im-pairment on the Pharma-cokinetics and Safety of CPX-351

tba

Newly Dx

No trials

16

Updated 7/2/2018 Page 1 of 2 Hematology Project Director: BJ Broome Clinical Trial Nurse Navigator Early Phase Project Director: Michelle Cairns Phone: 913-945-7552 CTNurseNav@kumc.edu

Pending Hold CCP IIT Lymphoma

Mantle Cell (MCL) Follicular (FL) DLBCL

Previously Untreated

Relapsed/ Refractory

Relapsed/ Refractory

CC-5013-NHL-008 MAGNIFY HSC: 01123 PI: Yacoub SC: Sara Lenalido-mide + Rituximab Followed by Lenalid-omide VS. Rituximab Mainte-nance for R/R FL, Marginal Zone or MCL WW & CCP

Relapsed/ Refractory

CC-5013-NHL-008 MAGNIFY HSC: 01123 PI: Yacoub SC: Sara Lenalido-mide + Rituximab Followed by Lenalid-omide VS. Rituximab Mainte-nance for R/R FL, Marginal Zone or MCL

WW & CCP

CCT-L019A2205B HSC: 02856 PI: McGuirk SC: Marc CD19 CART Long Term Follow Up (LTFU) Study WW

Previously Untreated

No trials INCB 50465-102 CITADEL-102 HSC: 141110 PI: Val-lurupalli SC: Emily INCB050465 Com-bined With Ben-damustine & Obinutuzumab in R/R FL CRC, WW Consent

Previously Untreated

No trials A051301 HSC: 140665 PI: Gan-guly SC: Ramsey Ibrutinib Before and Af-ter SCT in Treat-ing Pa-tients With R/R DLBCL WW

EA4151 HSC: 141768 PI: Gangu-ly SC: Ram-sey Rituximab w/ or w/o SCT in Treating pts. w/ Minimal Residual Disease-Negative MCL in 1st Complete Remission WW

C34004 HSC: 141418 PI: Val-lurupalli SC: Melody TAK-659 in Partici-pants With Re-lapsed or Re-fractory DLBCL WW

PCYC-1143-CA HSC: 141977 PI: Val-lurupalli SC: Sara Status: 5.21 WIRB approved Ibrutinib Combined w/ Ve-netoclax in pts w/ MCL (SYMPATICO) tba

Zuma-9 HSC: 142214 PI: McGuirk SC: Marc Status: 6.18 legal & SP in contact Axi-cabtagene Ciloleucel Expanded Access Study

tba

Indolent

UTX-TGR-205 HSC: 141865 PI: Hoff-mann SC: Melody Ublituximab + TGR-1202 w/ or w/o Benda-mustine & TGR-1202 Alone in Pts W/ Prev. Treat-ed NHL (UNITY-NHL) WW, CCP

UTX-TGR-205 HSC: 141865 PI: Hoff-mann SC: Melody Ublituximab + TGR-1202 w/ or w/o Benda-mustine & TGR-1202 Alone in Pts W/ Prev. Treat-ed NHL (UNITY-NHL) WW, CCP

UTX-TGR-205 HSC: 141865 PI: Hoffmann SC: Melody Ublituximab + TGR-1202 w/ or w/o Benda-mustine and TGR-1202 Alone in Pa-tients With Previously Treated NHL (UNITY-NHL)

WW, CCP

CPDR001XUS01 HSC: 142139 PI: William-son SC: Emily K. PDR001 Plus LAG525 for Patients With R/R DLBCL

CRC, CCP

CCTL019J2101 HSC: 142547 PI: McGuirk SC: tba Status: 6.18 CF in progress Ph. 1b study of tisagen-lecleucel in combo with prembroli-zumab in r/r DLBCL

tba

ACE-LY-308 HSC: 141256 PI: Val-lurupalli SC: Melo-dy

Benda-mustine & Rituximab Alone VS in Combo w/ Acalabru-tinib in Subjects With Un-treated MCL WW & CCP

Zuma-7 HSC: 142151 PI: McGuirk SC: Marc Efficacy of Axi-cabtagene Ciloleucel VS to SOC Therapy in Pts With R/R DLBCL WW, Hos.

Study Contact Pager Phone

Ramsey Attaria n/a 5-9226

Michelle Cairns n/a 5-7547

Santana Fortney n/a 8-4769

Emily Kelly n/a 8-2545

Melody Kabrey 5256 8-8694

Chris Monse 3991 8-3701

Marc Morrison 4457 8-7585

Sara Pearson 4978 8/8279

17

Updated 7/2/2018 Page 2 of 2 Hematology Project Director: BJ Broome Clinical Trial Nurse Navigator Early Phase Project Director: Michelle Cairns Phone: 913-945-7552 CTNurseNav@kumc.edu

Pending Hold CCP IIT Lymphoma

T- Cell

Relapsed/

Refractory

FEN-T14 HSC: 140709 PI: Val-lurupalli SC: Sara Intrave-nous Fen-retinide Emulsion for Pa-tients With R/R Peripher-al T-cell Lympho-mas WW

Previously

Untreated

No trials

Multi Diseases

9930 HSC: 140966 PI: Wil-liamson SC: Emi-ly K.

MEDI-570 in Patients with R/R PTCL Follicular Variant & AITL

CRC (WW Consent)

R3767-ONC-1613 HSC: 141280 PI: Jewell SC: tba Status: 5.9 activation pending REGN3767 (Anti-LAG-3) w/ or w/o REG-N2810 (Anti-PD1) in Adv. Cancers CRC

Hodgkin

CA209-812 HSC: 141198 PI: Vallurupalli SC: Melody Nivolumab + Brentuximab Vedotin VS. Brentuximab Vedotin Alone in Patients With Adv. Stage Clas-sical Hodgkin Lymphoma, Who Are R/R or Who Are Not Eligible for ASCT (CheckMate 812) WW, CCP

B-Cell

DCL-16-001 HSC: 141421 PI: Val-lurupalli SC: Marc CLR 131 in R/R Select B-Cell Ma-lignancies WW, Hos.

10057 HSC: 141974 PI: Powers SC: Santa-na Tali-mogene La-herparepvec & Nivolumab in Treating pts. w/ Ref. lym-phomas CRC, WW Consent

VT3996-201 HSC: 141837 PI: Val-lurupalli SC: Emily K. Oral VRx-3996 & Val-ganciclovir in Subjects With EBV-Associated Lymphoid Mals CRC (WW Consent)

CAN3001 HSC: 142597 PI: Hoff-mann SC: Melody Status: 6.26 IRB clarifica-tions A Long-term Ex-tension Study of PCI-32765 (Ibrutinib) tba

IIT-2017-CAR-T Bi-omarker HSC: 142508 PI: Dunavin SC: tba Status: 6.20 submit IRB Biomarker Discovery in Pts Receiv-ing Chimeric Antigen Re-ceptor T Cell Therapies tba

AMG397 20170173 HSC: 142576 PI: Vallurupalli SC: tba Status: 6.18 CF in pro-gress Safety, Toler-ability, PKs & Efficacy of AMG 397 in Subjects With Selected RR Hem Mals CRC

Study Contact Pager Phone

Ramsey Attaria n/a 5-9226

Michelle Cairns n/a 5-7547

Santana Fortney n/a 8-4769

Emily Kelly n/a 8-2545

Melody Kabrey 5256 8-8694

Chris Monse 3991 8-3701

Marc Morrison 4457 8-7585

Sara Pearson 4978 8/8279

18

Updated 7/2/2018 Page 1 of 1 Hematology Project Director: BJ Broome Clinical Trial Nurse Navigator Early Phase Project Director: Michelle Cairns Phone: 913-945-7552 CTNurseNav@kumc.edu

Pending Hold CCP IIT

MDS

Study Contact (SC) Pager Phone

Michelle Cairns n/a 5-7547

Kendra Cruz 1002 8-2517

Emily Laskowski 6059 8-4714

Chris Monse 3991 8-3701

Untreated Prev. Treated

Low/ Intermediate

2012-407 RV-MDS-PI-0645 HSC: 02560 PI: Yacoub SC: Ken-dra Lenalido-mide and Eltrom-bopag in Low and Intermedi-ate Risk MDS WW

High Risk

CTN 1102 HSC: 00371 PI: McGuirk SC: Chris Allo vs. Hypometh-ylating/ Best Sup-portive Care in MDS WW

OX1222 HSC: 03368 PI: Lin SC: Emily L. Dose Esca-lation Study of OXi4503 as Single Agent and in Combination With Cytara-bine w/Subsequent Ph 2 Co-horts for AML & MDS WW, CRC

04-30 (INSPIRE) HSC: 03798 PI: Yacoub SC: Kendra Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Pts After Fail-ure of an HMA WW

INCB 59872-101 HSC: 04040 PI: Lin SC: Stacy An Open-Label, Dose-Escala-tion/Dose-Expansion Safety Study of INCB059872 in Subjects With Ad-vanced Ma-lignancies CRC

Multi Diseases

No trials VICC Hem 16146 HSC: 141671 PI: Skikne SC: Kendra Pevonedistat and Aza-citidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With DNA Methyl Transferase Inhibitors WW

ASTX727-03 HSC: 142575 PI: Yacoub SC: tba Status: 6.11 work-ing on IC Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Low-er Risk MDS CRC

CPX351-102 HSC: 142684 PI: Male SC: tba Status: ERC approved 6.11 A Trial to Evaluate the Potential Impact of Renal Impair-ment on the Pharmacoki-netics and Safety of CPX-351

tba

19

Updated 7/2/2018 Page 1 of 1 Hematology Project Director: BJ Broome Clinical Trial Nurse Navigator Early Phase Project Director: Michelle Cairns Phone: 913-945-7552 CTNurseNav@kumc.edu

Pending Hold CCP IIT

Study Contact (SC) Pager Phone

Michelle Cairns n/a 5-7547

Kendra Cruz 1002 8-2517

Kristin Holms n/a 8-1090

Emily Kelly 0844 8-2545

Emily Laskowski 6059 8-4714

Paul Washington 6611 8-2541

MPN

INCB 50465-201 HSC: 140515 PI: Yacoub SC: Paul A Study of INCB050465 in Com-bination With Rux-olitinib in Subjects With Myelofibro-sis WW

INCB-MA-MF-401 HSC: 140637 PI: Yacoub SC: Kristin Myelofibro-sis and Es-sential Thrombo-cythemia Observa-tional Study (MOST) WW

MF

STML-401-0314 HSC: 140410 PI: Yacoub SC: tba SL-401 in Patients with Ad-vanced, High Risk Myeloprolif-erative Neoplasms

WW, CRC

ET PV

2nd line 1st line

No trials INCB 18424-272 HSC: 141194 PI: Yacoub SC: Paul Phase 2 Study of Rux-olitinib Versus Anagrelide in Subjects With ET Who Are Resistant to or Intolerant of Hy-droxyurea (RESET-272) WW

2nd line

No trials

1st line 2nd line

NP39761 HSC: 141600 PI: Yacoub SC: Emily L. Idasanutlin Monothera-py in Pa-tients With Hy-droxyurea-Resistant/ Intolerant Polycythe-mia Vera CRC

1st line

No trials INCB-MA-MF-401 HSC: 140637 PI: Yacoub SC: Kristin Myelofibro-sis and Es-sential Thrombo-cythemia Observa-tional Study (MOST) WW

PAC203 HSC: 141532 PI: Yacoub SC: Kendra Dose-Finding Study of Pa-critinib in Pa-tients W/ Thrombocyto-penia & Pri-mary MF, Post-polycythemia Vera MF, or Post-ET MF Previously Treated With Ruxolitinib WW

IMG-7289-CTP-102 HSC: 142110 PI: Yacoub SC: Emily K. Status: 7.2 responding to IC SP comments IMG-7289 in Patients With Myelo-fibrosis

CRC, WW Consent

Hold

20

Updated 7/2/2018 Page 1 of 1 Hematology Project Director: BJ Broome Clinical Trial Nurse Navigator Early Phase Project Director: Michele Cairns Phone: 913-945-7552 CTNurseNav@kumc.edu

Pending Hold CCP IIT Myeloma

Study Contact Pager Phone

Ramsey Attaria n/a 5-9226

Michelle Cairns n/a 5-7547

Kendra Cruz 1002 8-2517

Emily Kelly 0844 8-2545

Marc Morrison 4557 8-7585

Paul Washington 6611 8-2541

CTN 07LT HSC: 02349 PI: Ganguly SC: Kendra Continued, Long-Term Follow-Up and Lenalid-omide Mainte-nance Ther-apy for Pa-tients on BMT CTN 0702 Proto-col WW

Maintenance BMT

2015-BMT-MM-AutoSCT HSC: 02857 PI: Ganguly SC: Ramsey Exploratory Trial to Esti-mate Propor-tion of Patients With Tumor Cell Contami-nated Leu-kapheresis Products w/ or w/o Bortezomib With In-vivo Purging - MM WW

Newly Dx

No trials

Relapsed

CA209-039 HSC: 140822 PI: Abdal-lah SC: Emily K.

Safety Study of Nivolumab by Itself or in Combi-nation in Patients With R/R Lymphoma or MM

CRC (WW consent only)

MGUS

No trials

Multi Diseases

No trials BL8040.SCM.301-GENESIS HSC: 142041 PI: Dias SC: Ramsey Status: 6.25 HSC provisos Combo Treatment of BL-8040 and G-GSF as Com-pared to Placebo and G-CSF for thE MobilizatioN of HSC for Auto Transplant in Subjects With MM tba

TCD14906 HSC: 142615 PI: Abdallah SC: tba Status: 6.27 provi-so submit-ted Isatuximab in Combi-nation With REG-N2810 in R/R MM Patients tba

Lin-AC225-MM01 HSC: 142081 PI: Abdal-lah SC: Emily Status: 6.15 IRB approved A Ph. I Study of Lintuzumab-Ac225 in Pts with Ref. MM tba

H125001 HSC: tba PI: Gangu-ly SC: Marc Status: 6.13 pend-ing RSC application Study Eval-uating the Safety and Efficacy of JCARH125 in Subjects With R/R MM tba

GSK205768 HSC: 142426 PI: Abdallah SC: Paul Status: 6.28 re-turned consents GSK2857916 in pts with MM Who Had 3+ Prior Lines of Tx, Are Refrac-tory to a Pro-teasome Inhibitor and an Immuno-modulatory Agent and Have Failed an Anti-CD38 Anti-body (DREAMM 2)

tba

HBO MM HSC: 142505 PI: Shune SC: tba Status: 7.2 ICF to finance HBO effects on blood count re-covery and post-transplant out-comes following high-dose therapy and autologous HSPC transplan-tation for multiple myeloma

tba

AMG397 20170173 HSC: 142576 PI: Val-lurupalli SC: tba Status: 6.18 CF in pro-gress Safety, Toler-ability, PKs & Efficacy of AMG 397 in Subjects With Selected RR Hem Mals CRC

BS001 HSC: 142568 PI: Abdallah SC: Paul Status: 6.15 HSC review pending Aggressive Smoldering Curative Approach Evaluating Novel Ther-apies and Transplant (ASCENT) tba

Smoldering

EDO-S101-1004 Titanium 1 HSC: 142685 PI: Shune SC: tba Status: 6.28 ICF to legal A Ph. 1/2 Open-Label Trial of Tinostamustine Conditioning and Auto SCT for Salvage Treatment in R/R MM

tba

M16-085 HSC: tba PI: Abdallah SC: tba Status: ERC approved 7.2 A Study of Venetoclax in Combination With Poma-lidomide and Dexame-thasone in Subjects With R/R MM tba

21

Updated 7/2/2018 Page 1 of 2 BMT Project Director: BJ Broome Clinical Trial Nurse Navigator Early Phase Project Director: Michelle Cairns Phone: 913-945-7552

CTNurseNav@kumc.edu

Pending Hold CCP IIT

CTN 07LT HSC: 02349 PI: Ganguly SC: Kendra Lenalido-mide Mainte-nance Therapy for Pts on BMT CTN 0702 WW

BL8040.SCM.301-GENESIS HSC: 142041 PI: Singh SC: Ramsey Status: 6.25 HSC approved Combo Treat-ment of BL-8040 and G-GSF VS Pla-cebo and G-CSF for thE MobilizatioN of HSC for Auto in SubjectS With MM tba

2015-BMT-MM-AutoSCT HSC: 02857 PI: Ganguly SC: Ramsey Estimate Proportion of Pts W/ Tu-mor Cell Contaminat-ed Leu-kapheresis Products w/ or w/o Borte-zomib W/ In-vivo Purging

WW

Transplant Related GVHD on pg 2

Transplant Related Autologous

10-CBA HSC: 12855 PI: McGuirk SC: tba A Multi-center Access & Distribu-tion Proto-col for Unli-censed Cryo-preserved CBUs WW

CTN 1102 HSC: 00371 PI: McGuirk SC: Chris Allo vs. Hypo-methylating/Best Support-ive Care in MDS WW

A051301 HSC: 140665 PI: Ganguly SC: Ramsey Ibrutinib Before and After SCT in Treating Patients With R/R Diffuse Large B-cell Lym-phoma WW

BP-008 HSC: 03466 PI: McGuirk SC: Ramsey Gene Modified Donor T Cell Infu-sion in pts W/ Recur-rent Dis-ease After Allo Trans. WW

Iomab-01 SIERRA HSC: 140528 PI: Abhyankar SC: Marc Study of Iomab-B Prior to HCT vs. Convention-al Care in Older Sub-jects With Active, R/R AML WW

PLX-R18-HCT-01 HSC: 141237 PI: McGuirk SC: Marc Intramuscu-lar Injec-tions of PLX-R18 in Subjects With Incom-plete Hem-atopoietic Recovery Following HCT WW

GC P #05.01.020 HSC: 141344 PI: McGuirk SC: Marc Transplanta-tion of Ex Vivo Expand-ed, UCB-derived, Stem & Pro-genitor Cells vs. Unmanip-ulated UCB for HM Pa-tients WW, Hos

Study Contact Pager Phone

Ramsey Attaria n/a 5-9226

Michelle Cairns n/a 5-7547

Kendra Cruz 1002 8-2517

Marc Morrison 4457 8-7585

Chris Monse 3991 8-3701

BMT CTN 1506 HSC: 141769 PI: Dias SC: Chris FLT3 Inhibi-tor Gilteritinib as Mainte-nance Thera-py Following Allo for Pts With FLT3/Internal Tan-dem Duplica-tion (ITD) AML KU, Hop.

HBO MM HSC: 142505 PI: Shune SC: tba Status: 7.2 ICF to finance HBO effects on blood count recovery and post-transplant outcomes fol-lowing high-dose therapy and autologous HSPC trans-plantation for MM tba

EA4151 HSC: 141768 PI: Ganguly SC: Ramsey Rituximab w/ or w/o SCT in Treating Pts W/Minimal Residual Disease- Neg. MCL in 1st Com-plete Re-mission WW

EDO-S101-1004 Titanium 1 HSC: 142685 PI: Shune SC: tba Status: 6.28 ICF to legal Ti-nostamustine Condition-ing and Auto SCT for Sal-vage Treat-ment in R/R MM tba

22

Updated 7/2/2018 Page 2 of 2 BMT Project Director: BJ Broome Clinical Trial Nurse Navigator Early Phase Project Director: Michelle Cairns Phone: 913-945-7552

CTNurseNav@kumc.edu

Pending Hold CCP IIT GVHD Transplant Related pg 1

UMCC2014.051 HSC: 140136 PI: Ab-hyankar SC: Chris Study Of Natalizumab + Standard Steroid Treatment For High Risk aGVHD

WW

IIT-2016-aGvHD-MSCTC-0010 HSC: 140995 PI: McGuirk SC: Marc Status: 6.13 IRB approved Umbilical Cord Wharton's Jelly MSCs for De No-vo High Risk Acute or Steroid Refractory aGVHD tba

INCB 39110-301 GRAVITAS-301 HSC: 141148 PI: Abhyankar SC: Chris A Randomized, Double-blind, placebo-controlled phase 3 study of Itac-itinib or Placebo in combination with Corticoster-oids for the treatment of First-line aGVHD. WW, Hos.

INCB 18424-365 HSC: 141334 PI: Abhyankar SC: Chris A Study of Rux-olitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Mar-row Transplanta-tion (REACH3) WW, Hos.

JZP963-201 HSC: 141976 PI: Abhyankar SC: Marc Status: 6.1 resubmit to IRB An Open-Label Study of Defibrotide for the Preven-tion of aGvHD tba

Study Contact Pager Phone

Ramsey Attaria n/a 5-9226

Michelle Cairns n/a 5-7547

Kendra Cruz 1002 8-2517

Marc Morrison 4457 8-7585

Chris Monse 3991 8-3701

23