EDDOP Program Update with EDDOP Accrual P30 Supplement Awardees - PowerPoint Presentation

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EDDOP Program Update with EDDOP Accrual P30 Supplement Awardees

Jeff Moscow, M.D

Investigational Drug Branch, CTEP/DCTD/NCI

EDDOP: A P30 supplement program for NCI-CCs NOT in the ETCTN UM1 program

NCI CCs that are not affiliated with the CTEP ETCTN UM1 program could apply for administrative supplements in the

NCI Early Drug Development Opportunity Program (EDDOP)

ETCTN study leadership supplements

–

require CTEP PRC approved LOI

Competitive administrative supplements to fund participation in select ETCTN studies

Together,

these initiatives:

Provide CTEP with more proposals for studies, with the goal of having more studies open in the ETCTN

Provides UM1 site investigators a wider net for rare patient populations

ETCTN’s P30 EDDOP accrual supplements

NCI-CC’s selected for EDDOP funding:

Receive a P30 administrative supplement of $50,000 per year

15 EDDOP accrual supplements have been awarded to NCI-CC’s

EDDOP P30 administrative supplements intended to offset per-patient research study costs, not screening costs.

Announced supplement goal was a minimum of 3-5 accruals to ETCTN studies per site per year

EDDOP:ETCTN Phase 2 study accrual initiative - challenges

Very few EDDOP awardees have made significant progress toward the goals of the award

Program start-up challenges:

In the first year there were few ETCTN studies transitioned into the EDDOP accrual program

Since parent grants had different dates for annual reports, there were challenges in assessing progress, as different awardees had different time periods to make progress toward the goals of the award.

However, now the awards have been in effect for a significant duration, and many ETCTN studies have been transitioned into the EDDOP program

EDDOP site participation in EDDOP studies as of 9/26/2017

CTEP Organization Name

CTEP ID

Protocols -->

9855

9706

9930

10020

10015

8329

9925

10057

10017

9767

9979

9875

9775

Active

Pend-

ing

With-drawn

Total

University of Alabama at Birmingham Cancer Center

AL002

A

1

0

0

1

University of Arizona Medical Center

AZ017

P

0

1

0

1

Northwestern University

IL036

A

1

0

0

1

University of Chicago Comprehensive Cancer Center

IL057

W

A

P

A

2

1

1

4

University of Kansas Cancer Center

KS004

A

A

A

A

4

0

0

4

University of Michigan Comprehensive Cancer Center

MI014

A

1

0

0

1

University of Nebraska Medical Center

NE003

0

0

0

0

Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center

NH012

A

A

2

0

0

2

Laura and Isaac Perlmutter Cancer Center at NYU Langone

NY011

P

0

1

0

1

Montefiore Medical Center - Moses Campus

NY045

A

P

A

A

A

4

1

0

5

Roswell Park Cancer Institute

NY158

A

A

A

3

0

0

3

Fox Chase Cancer Center

PA086

0

0

0

0

UT Southwestern/Simmons Cancer Center

TX011

W

A

P

1

1

1

3

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

TX041

A

1

0

0

1

Huntsman Cancer Institute/University of Utah

UT003

A

A

P

A

P

3

2

0

5

Active EDDOP studies (n=12)

Study #

Document Title

ETCTN / Legacy

Agent Name(s) (NSC) (IND agents in bold)

Principal Investigator (CTEP ID)

Principal Investigator Email

Study Coordinators

Study Coordinators (Email)

Active Studies

9706

Randomized Phase II Study to Assess the Role of Nivolumab as Single Agent to Eliminate Minimal Residual Disease and Maintain Remission in Acute Myelogenous Leukemia Patients After Chemotherapy

ETCTN

BMS-936558

(Nivolumab, MDX-

1106) (748726) (125462)

Liu, Hongtao (42318)

hliu2@medicine.bsd.uchicago.edu

Gabriel Robert Pugel; Supriya Perambakam

gpugel@bsd.uchicago.edu;

speramb@bsd.uchicago.edu

9855

A Phase 2 Study of Glembatumumab Vedotin for Metastatic Uveal Melanoma**Re-opened to accrual**

ETCTN

CDX-011

(glembatumumab

vedotin) (763737) (126619)

Patel, Sapna Pradyuman (46800)

sppatel@mdanderson.org

Larae Eng

LMEng@mdanderson.org

9930

A Phase I Evaluation/Dose Escalation of MEDI-570 in Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) Follicular Variant and Angioimmunoblastic T-Cell Lymphoma (AITL)

ETCTN

MEDI-570 (783606) (128911)

Chavez, Julio C. (51649)

julio.c.chavez@moffitt.org

Tracy Wong

Tracy.Wong@uhn.ca

10020

A Phase II Multiple-Arm, Open-Label, Randomized Study of PARP Inhibition (Veliparib; ABT-888) and Anti-PD-L1 Therapy (Atezolizumab; MPDL3280A) Either Alone or in Combination in Homologous DNA Repair (HDR) Deficient Triple Negative Breast Cancer (TNBC)

ETCTN

Atezolizumab

(MPDL3280A) (783608) (77840); ABT-888

(Veliparib) (737664) (77840)

LoRusso, Patricia Mucci (18994)

patricia.lorusso@yale.edu

Jacqueline Rollin;

Scott Anthony Boerner

jacqueline.rollin@yale.edu;

scott.boerner@yale.edu

10015

A Non-Randomized, Open-Label, Phase 2 Study of Trametinib in Patients with Unresectable or Metastatic Epithelioid Hemangioendothelioma

ETCTN

Trametinib

(GSK1120212B) (763093) (120372)

Schuetze, Scott Michael (33818)

scotschu@med.umich.edu

Rachel Luchs

SARC033@sarctrials.org; RLuchs@sarctrials.org

8329

A Phase I/II Trial of ABT-888, an Inhibitor of Poly(ADP-ribose) Polymerase (PARP), and Topotecan (TPT) in Patients with Solid Tumors (Phase I) and Relapsed Ovarian Cancer or Primary Peritoneal Cancer (Phase II) After Prior Platinum Containing First-Line Chemotherapy

ETCTN

ABT-888

(

Veliparib

) (7376Topotecan (664) (77840); 09699)

Wahner Hendrickson, Andrea E. (49842)

wahnerhendrickson.andrea@mayo.edu

Sanna McKinzie

mckinzie.sanna@mayo.edu

9925

Phase II Trial of Nivolumab for HTLV-Associated Adult T Cell Leukemia/Lymphoma

ETCTN

BMS-936558

(Nivolumab

Ratner, Lee (25383)

lratner@dom.wustl.edu

Christy Arrowood; Nancy Garrett-Mead

Sarah Larson

christy.arrowood@duke.edu

;

nancy.garrett-mead@duke.edu

10057

A Phase II Study of Talimogene laherparepvec Followed by Talimogene laherparepvec + Nivolumab in Refractory T Cell and NK Cell Lymphomas, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, and Other Rare Skin Tumors

ETCTN

TVEC,

Nivolumab

Silk, Ann (Annie) Willman (54210)

ann.w.silk@rutgers.edu

Joanne Onyschak

joanne.onyschak@rutgers.edu

Active EDDOP studies (n=12)

9979

Phase 1 and Pharmacology Study of Oral 5-Iodo-2-Pyrimidinone-2-Deoxyribose (IPdR) as a Prodrug for IUdR-Mediated Tumor Radiosensitization in Brain Metastases

ETCTN

IPdR

Mohindra, Pranshu (54074)

pmohindra@som.umaryland.edu

Sanna McKinzie

mckinzie.sanna@mayo.edu

9875

Phase 2 Study of AT13387 (onalespib) in ALK+ ALCL, MCL, and BCL-6+ DLBCL

ETCTN

AT13387 (

Onalespib

)

Jacobson, Caron Alyce (50042)

cajacobson@partners.org

Grace Fairchild

Grace_Fairchild@DFCI.HARVARD.EDU

9775

A Phase 2 Study of MLN0128 (TAK-228) in Relapsed and/or Refractory Acute Lymphoblastic Leukemia (ALL)

ETCTN

MLN0128 (TAK-228)

Al-Kali, Aref (46829)

alkali.aref@mayo.edu

Sanna McKinzie

mckinzie.sanna@mayo.edu

9767

An Open Label, Multicenter, Single Arm Phase II Study to Evaluate the Activity and Tolerability of the Novel

mTOR

Inhibitor, MLN0128 (TAK-228), in Patients with Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract Whose Tumors Harbor a TSC1 and/or a

TSC2 Mutation

ETCTN

MLN0128 (TAK-

228)

Kim, Joseph Woong (48841)

joseph.w.kim@yale.edu

Matthew Piscatelli

matthew.piscatelli@yale.edu

10017

A Randomized Phase 2 Trial of

Atezolizumab

(MPDL3280A), SGI-110 and CDX-1401 Vaccine in Recurrent Ovarian Cancer

ETCTN

Atezolizumab (SGI-110

(Guadecitabine)

Odunsi

,

Kunle

(33598)

kunle.odunsi@roswellpark.org

Phase I: Francine

Siedlecki

;

Phase II:

Lise

Hernandez

Francine.Siedlecki@RoswellPark.org

;

Lise.Hernandez@RoswellPark.org

Upcoming Open EDDOP studies (n=2)

9377

A Sequential Safety and Biomarker Study of BRAF-MEK Inhibition on the Immune Response in the Context of Combined CTLA-4 Blockade and

PD-1 Blockade for BRAF Mutant Melanoma

Legacy

Dabrafenib Trametinib

Ipilimumab (Nivolumab,

Ott, Patrick Alexander (42962)

patrick_ott@dfci.harvard.edu

Jennifer Maattala

Jennifer_Maattala@dfci.harvard.edu

9598

A Phase II Therapeutic Trial of the Use of Dabrafenib and Trametinib in Patients with BRAF V600E Mutation Positive Lesions in Erdheim Chester Disease **Temporily closed to accrual**

Legacy

Dabrafenib (Trametinib

William A. Gahl

gahlw@mail.nih.gov

Kevin O’Brien

obrienke@nhgri.nih.gov

Upcoming pending EDDOP studies (n=3)

10060

Phase II Safety Study of

Trastuzumab

,

Pertuzumab

, and MEDI4736

ETCTN

MEDI4736

(

durvalumab

)

Pertuzumab

Trastuzumab

(

Nivolumab

,; MDX-

1106)

Poklepovic, Andrew (46317)

andrew.poklepovic@vcuhealth.org

10186

A Phase I/II Study

Hypofractionated

Radiation Therapy in Combination with

Nivolumab

and Ipilimumab for Recurrent High-Grade Radiation-Refractory Meningioma

ETCTN

BMS-936558

(748726);

Ipilimumab

(BMS-

MDX-010

Transfectomaderived

) (732442)

Huang, Jiayi (50415)

jiayi.huang@wustl.edu

Garrett-Mead, Nancy

nancy.garrett-mead@duke.edu

10104

Cabozantinib and Nivolumab in Advanced or Metastatic Endometrial Cancer

ETCTN

Caboantinib; Nivolumab

Stephanie Lheureux

Stephanie.Lheureux@uhn.ca

EDDOP accrual program award requirements - Starting NOW

Progress reports will have to show either

A minimum of 3 accruals to EDDOP studies have been achieved

OR

A minimum of 75% of available EDDOP studies are open (at the time of submission of your annual progress report) at your institution

Studies that collect 2 or more research biopsies will be given 1.5 accrual credits

EDDOP accrual program award requirements -Starting in 10/18

Progress reports will have to show either

A minimum of 3 accruals to EDDOP studies have been achieved

OR

A minimum of 75% of available EDDOP studies are open (at the time of submission of your annual progress report) at your institutions, AND convincing evidence that patients have been screened for EDDOP studies

EDDOP accrual awards not meeting progress goals

First time

–

the award will be placed on a No Cost Extension

Second time

–

the award will be ended, and the amount awarded will be used as an offset against the parent P30 grant in the next funded year of the grant

Steps to take to open ETCTN studies

Share ETCTN studies that are open to EDDOP sites with your disease specific clinics

Emphasize the importance of participation in the EDDOP program for your CCSG grant

Recognize that many of these studies have been chosen because they are open for rare populations, so they should not be rejected because of limited accrual potential

Help for activating EDDOP studies

For ETCTN studies:

Listed on CTSU website

–

see PDF

For Legacy Studies:

Directly contact the PI of the study and ask for your institution to join the study

–

requires an amendment to the face page

EDDOP: ETCTN Phase 2 study leadership initiative

Any investigator from any

clinical NCI-CC NOT

in the ETCTN could submit an Letter of Intent (LOI) to CTEP and, if approved by the Protocol Review Committee (PRC), the PI could receive:

Full ETCTN clinical trial support for the study – including CIRB, registration and data management support, and accrual from ETCTN sites

Funds for salary reimbursement (% effort)

Funds for accrual to the study at the PI’s home institution

LOIs must be approved and submitted by cancer center

Administered as a P30 administrative supplement after LOI approved by PRC

Funding doubled for FY18

–

from $62,500 over two years to $125,000 over two years.

Discussion