NCI Early Drug Development (Agenda)


Thursday, September 28, 2023

9:00 – 9:10 AM

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

CTEP-Sponsored Early-Phase Immunotherapy Studies: Clinical Trial Session
Moderators: Helen Chen and Cheryl Pickett-Gies, IDB, CTEP, NCI

09:10 AM – 9:30 AM

Protocol # 10030: A Phase 1 Study of Blinatumomab in Combination with Checkpoint Inhibitor(s) of PD-1 (Nivolumab) or Both PD-1 (Nivolumab) and CTLA-4 (Ipilimumab) in Patients with Poor-Risk, Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia
Jon Webster, Johns Hopkins University

9:30 AM – 9:50 AM

Protocol # 10107: Phase 1 Safety Run-In and Phase 2 Randomized Clinical Trial of Anetumab Ravtansine and Pembrolizumab (MK-3475) Compared to Pembrolizumab Alone for Mesothelin-Positive Malignant Pleural Mesothelioma
Aaron Mansfield, Mayo Clinic Rochester

9:50 AM – 10:10 AM

Protocol # 10005: A Phase 2 Study of Anti-PD-L1 Antibody (Atezolizumab) in Alveolar Soft Part Sarcoma
Brian Ko, National Cancer Institute

10:10 AM – 10:30 AM

Protocol # 10476:  A Randomized Phase 2 Study of Combination Atezolizumab and CDX-1127 (Varlilumab) with or Without Addition of Cobimetinib in Previously Treated Unresectable Biliary Tract Cancers
Thatcher Heumann, Vanderbilt University Medical Center

10:30 AM– 10:50 AM

Protocol # 10020: A Phase II Open-Label, Randomized Study of PARP Inhibition (Olaparib) Either Alone or in Combination with Anti-PD-L1 Therapy (Atezolizumab; MPDL3280A) in Homologous DNA Repair (HDR) Deficient, Locally Advanced or Metastatic Non-HER2-Positive Breast Cancer
Kristina Fanucci, Dana-Farber Cancer Institute

10:50 AM– 11:15 AM

Protocol # S1929: Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab in Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Nagla Abdel Karim, SWOG

11:15 AM-11:45 PM

Panel Discussion


11:45 AM – 1:30 PM

ETCTN Meeting (Closed Session) in Room Seminar 110, NCI Shady Grove (12:30 pm)

DNA Damage Educational Session
Moderators:  Percy Ivy and Steve Gore, IDB, CTEP, NCI

1:30 PM – 1:50 PM

Targeting replication stress in cancer therapeutics
Yves Pommier, National Cancer Institute

1:50 PM – 2:10 PM

Leveraging DDR defects in cancer therapeutics
Geoffrey Shapiro – Dana Farber Cancer Institute

2:10 PM – 2:30 PM

G-quadruplexes, RNA polymerases, and cancer therapeutics
Jay Schneekloth – National Cancer Institute Frederick

2:30 PM – 2:50 PM

Inducing synthetic lethality to BRCA inhibitors
Feyruz Rassool – University of Maryland School of Medicine

2:50 PM – 3:05 PM

Panel Discussion

3:05 PM – 3:15 PM


PI3K Trial Session
Moderator:  Rabih Said, IDB, CTEP, NCI

3:15 PM – 3:30 PM

Protocol # 10221: A Phase I/II Biomarker Driven Combination Trial of Copanlisib and Immune Checkpoint Inhibitors in Patients with Advanced Solid Tumors
Timothy Yap, MD Anderson Cancer Center

3:30 PM – 3:45 PM

Protocol # 10382: A Phase I/II Trial Evaluating the Safety and Efficacy of Eribulin in Combination with Copanlisib in Patients with Metastatic Triple Negative Breast Cancer
Nusayba Bagegni, Washington University Saint Louis

3:45 PM- 4:00 PM

Protocol # 10287:  A Randomized Phase I/II Trial of Fulvestrant and Abemaciclib in Combination with Copanlisib (FAC) Versus Fulvestrant and Abemaciclib Alone (FA) for Endocrine-Resistant, Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer (FAC vs FA)
Cynthia Ma, Washington University Saint Louis

4:00 PM – 4:15 PM

Protocol # 10347: A Phase I Study with an Expansion Cohort of Duvelisib and Nivolumab in Mycosis Fungoides (MF) and Sézary Syndrome (SS))
Neha Mehta-Shah, Washington University Saint Louis

4:15 PM- 4:30 PM

Panel Discussion and DAY 1 Wrap-up

4:30 PM



Friday, September 29, 2023

CTEP-Sponsored Phase I and Pilot: Clinical Trial Session
Moderator: John Wright, IDB, CTEP, NCI

9:00 AM – 9:10 AM

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

9:10 AM– 9:30 AM

Protocol # 10114: Phase I Trial of 5-Aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in Patients with Advanced Solid Tumor
Sarah Shin, National Cancer Institute

9:30 AM– 9:50 AM

Protocol # 10183: A Pilot Study of Tazemetostat and Pembrolizumab (MK-3475) in Advanced Urothelial Carcinoma
Maha Hussain, Northwestern University

9:50 AM -10:10 AM

Protocol # 9892: Phase I Dose-Escalation Bioavailability Study of Oral Triapine in Combination with Concurrent Chemoradiation for Locally Advanced Cervical Cancer (LACC) and Vaginal Cancer
Sarah Taylor, University of Pittsburgh Medical Center

10:10 AM -10:30 AM

Protocol # 10208: A Phase I Study of Anetumab Ravtansine in Combination with Either Anti-PD-1 Antibody, or Anti-CTLA4 and Anti-PD-1 Antibodies or Anti-PD-1 Antibody and Gemcitabine in Mesothelin-Positive Advanced Pancreatic Adenocarcinoma
Anna Spreafico, Princess Margaret Hospital

10:30 AM – 10:50 AM

Panel Discussion

10:50 AM – 11:10 AM


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

11:10 AM – 11:20 AM

John Wright, Investigational Drug Branch, CTEP, NCI

11:20 AM-11:30 AM

Presentation of Award
Michaele C. Christian, IDB, CTEP, NCI

11:30 AM – 12:00 PM

Awardee Lecture                     

12:00 PM