Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

268

Participants

Timeline

Start Date

June 29, 2015

Primary Completion Date

April 1, 2026

Study Completion Date

July 1, 2026

Conditions
Colorectal NeoplasmsBreast Neoplasms
Interventions
DRUG

Olaparib

Olaparib tablets will be given orally on a continuous dosing schedule. The DLT period will be one cycle, 28 days. MEDI4736 (3mg/kg or 10mg/kg IV) and Olaparib tablets (200 mg or 300 mg BID) Ph II - MEDI4736 + Olaparib at RP2D

DRUG

Cediranib

Cediranib will be given orally on a continuous dosing schedule. The DLT period will be one cycle, 28 days. MEDI4736 (10mg/kg IV) and Cediranib (15 mg or 20 mg or 30 mg daily) Ph II - MEDI4736 + Cediranib at RP2D

DRUG

Durvalumab

Ph I - Durvalumab will be administered once every 2 weeks for 12 months.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT02484404 - Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can... | Biotech Hunter | Biotech Hunter