2022 NCI Early Drug Development (Agenda)

Draft Agenda

Thursday, September 22, 2022

9:00 – 9:05 AM

John Wright, Investigational Drug Branch (IDB), Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI)

CTEP-Sponsored Early-Phase Immunotherapy Studies: Clinical Trial Session
Moderators: Elad Sharon and Howard Streicher, IDB, CTEP, NCI

9:05 – 9:20 AM

Protocol # 10214: Immune Checkpoint Blockade for Kidney Transplant Recipients with Selected Unresectable or Metastatic Cancers
Kara Schenk, Johns Hopkins University

9:20 – 9:35 AM

Protocol # 10089: A Randomized Phase 2 Study of CDX-1127 (Varlilumab) in Combination with Nivolumab in Patients with Relapsed or Refractory Aggressive B-cell Lymphomas
Jose Villasboas Bisneto, Mayo Clinic

9:35 – 9:50 AM

Protocol # S1801: A Phase 2 Randomized Study of Adjuvant Versus NeoAdjuvant Pembrolizumab (MK-3475) for Clinically Detectable Stage III-IV High-Risk Melanoma
Sapna Pradyuman Patel, SWOG

9:50 – 10:05 AM

Protocol # 10398:  A Phase 2 Study of Anti-PD-L1 Antibody (Atezolizumab) in Chondrosarcoma and Clear Cell Sarcoma
Brian Ko, National Cancer Institute

10:05 – 10:20 AM

Protocol # S1512: A Phase 2 and Pilot Trial of PD-1 Blockade with Pembrolizumab (MK-3475) in Patients with Resectable or Unresectable Desmoplastic Melanoma (DM)
Kari Kendra, SWOG

10:20 – 10:35 AM

Protocol # NRG-GY017: Anti PD-L1 (Atezolizumab) as an Immune Primer and Concurrently with Extended Field Chemoradiotherapy for Node Positive Locally Advanced Cervical Cancer
Jyoti Mayadev, NRG

10:35 – 11:00 AM

Panel Discussion

11:00-11:15 AM



11:15 -11:45 AM

NCI COVID-19 in Cancer Patients Study (NCCAPS) Presentation 
Larissa Korde, National Cancer Institute

11:45 AM – 12:30 PM

ETCTN Meeting (Closed Session) – additional webinar link sent to members

Epigenetics Session (Moderators: Steven Gore and John Wright, IDB, CTEP NCI)

12:30 – 12:50 PM

Topic Title: Epigenetic determinates of hematopoietic stem cell differentiation in MDS/AML
Aaron Viny, Columbia University

12:50 –1:10 PM

Topic Title: Histone Lysine Demethylases: More than Gene Regulators and Key Therapeutic Targets
Johnathan Whetstine, Fox Chase Cancer Center

1:10 - 1:30 PM

Topic Title: Polycomb heterochromatin and its dysregulation in human cancers
Siddhant Jain, Dana-Farber Cancer Institute/Harvard Cancer Center

1:30 – 1:45 PM

Panel Discussion

1:45 – 2:00 PM


CTEP-Sponsored Phase 1/PILOT: Clinical Trial Session
Moderators: Steven Gore, Rabih Said, and John Wright, IDB, CTEP, NCI

2:00 – 2:20 PM

Protocol #9938:  Phase 1 Clinical Trial of M6620 (VX-970, Berzosertib) in Combination with the Topoisomerase I Inhibitor Irinotecan in Patients with Advanced Solid Tumors
Liza Villaruz, University of Pittsburgh Medical Center

2:20– 2:40 PM

Protocol # 9948: Phase 1 Dose Escalation and Expansion Cohort of Carboplatin and Gemcitabine with or without M6620 (VX-970) in First or Second Recurrence Platinum-Sensitive Epithelial Ovarian, Peritoneal, and Fallopian Tube Cancer
Andrea Wahner Hendrickson, Mayo Clinic

2:40 – 3:00 PM

Protocol # 9950: A Phase 1 Study of M6620 (VX-970, Berzosertib) in Combination with Cisplatin and XRT in Patients with Locally Advanced Head and Neck Squamous Cell Carcinoma
Aarti Bhatia, Yale University

3:00 – 3:20 PM

Protocol # 9924: A Phase 1 Trial of the Combination of Lenalidomide and Blinatumomab in Patients with Relapsed or Refractory Non-Hodgkin’s Lymphoma (NHL)
Joseph Tuscano, University of California at Davis

3:20– 3:40 PM

Protocol # 9591: Phase I pharmacokinetic study of single agent trametinib in patients with advanced cancer and hepatic dysfunction (ETCTN ODWG)
Pei Jye Voon, on behalf of the North American Star Consortium

3:40 - 4:00 PM

Panel Discussion and DAY 1 Wrap-up

4:00 PM



Friday, September 23, 2022

CTEP-Sponsored Phase I/II or Phase II: Clinical Trial Session
Moderators:  Rabih Said and Helen Chen, IDB, CTEP, NCI

9:30 – 9:35 AM

John Wright, Investigational Drug Branch (IDB), Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI)

9:35 – 9:50 AM

Protocol # 10015: A Non-Randomized, Open-Label, Phase 2 Study of Trametinib in Patients with Unresectable or Metastatic Epithelioid Hemangioendothelioma
Scott Michael Schuetze, University of Michigan Comprehensive Cancer Center

9:50 – 10:05 AM

Protocol # 10222: A Phase II Study of Olaparib and AZD6738 in Isocitrate Dehydrogenase (IDH) Mutant Solid Tumors
Navid Hafez, Yale Cancer Center

10:05 -10:20 AM

Protocol #10268: Randomized Phase II Trial of Topotecan Plus M6620 (VX-970, Berzosertib) Vs. Topotecan Alone in Patients with Relapsed Small-Cell Lung Cancer
Anish Thomas, National Cancer Institute

10:20 -10:35 AM

Protocol #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
Ann Silk, Dana-Farber Cancer Institute

10:35 – 10:50 AM

Protocol #9446: A Phase 2 Study of Trametinib in Combination with Radioiodine (RAI) for RAS Mutant or RAS/RAF Wild-Type, RAI-Refractory Recurrent and/or Metastatic Thyroid Cancers
Alan Ho, Memorial Sloan Kettering Cancer Center

10:50 – 11:10 AM

Panel Discussion

11:10 – 11:20 AM


Sixteenth Annual Michaele C. Christian Oncology Drug Development Award & Lecture

11:20 – 11:25 AM

John Wright, Investigational Drug Branch, CTEP, NCI

11:25-11:30 AM

Presentation of Award
Michaele C. Christian and Jeff Moscow, IDB, CTEP, NCI

11:30 – 11:55 AM

Awardee Lecture

12:00 PM

(ClOSED IDSC MEETING from 1:00-4:00 PM ET)