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...

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02484404
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    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
  • Cediranib — DRUG
    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
  • Durvalumab — DRUG
    Ph I - Durvalumab will be administered once every 2 weeks for 12 months.

Study Details

Background: \- Durvalumab is a drug that may help people s immune systems respond to and kill cancer cells. Olaparib is a drug that may inhibit repairing DNA damage of cancer cells. Cediranib is a drug that may stop the blood vessel growth of cancer cells. This study has two components. In the phase 1 component of the study, researchers want to investigate how well participants tolerate the combination of these drugs in treating advanced solid tumors, and in the phase 2 part of this study, researchers want to study if the combination treatments are effective in ovarian cancer. Objectives: \- Phase 2 part of the study: To determine how effective this combination is in treating ovarian cancer. Eligibility: \- Phase 2 part of the study: Adults age 18 or older with advanced or recurrent ovarian cancer that has no standard treatment. Design: * Participants will be screened with medical history, physical exam, and blood and urine tests. They will have CT or MRI scans. For these, they will lie in a machine that takes pictures of their bodies. * Phase 2 part of the study requests the participants to have tumor samples removed. * Participants will get Durvalumab through an IV. A small plastic tube will be inserted into a vein. The drug will be given every 4 weeks until disease progression. * Participants will take olaparib or cediranib by mouth every day. * Every 28 days will be 1 cycle. For cycle 1, participants will have 2 study visits. All other cycles, they will have 1 visit. At these visits, they will repeat the screening procedures. * Patients will keep a drug and diarrhea diary. * Patients on cediranib will monitor their blood pressure and keep a blood pressure diary. * Participants who can become pregnant, or have a partner who can become pregnant, must practice an effective form of birth control. * After 12 cycles, participants will have 1-3 months of follow-up.

Key Dates

Start date
Jun 29, 2015
Status verified
May 2026
Primary completion
Oct 30, 2027
Completion
Oct 30, 2027

Study Design

Enrollment
268 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: P1 Durvalumab+C
    Ph I Durvalumab + cediranib dose escalation
  • Experimental: P1 Durvalumab+O
    Ph I Durvalumab + olaparib dose escalation
  • Experimental: P1 Durvalumab+O+C
    Ph I Durvalumab + olaparib + cediranib dose escalation
  • Experimental: P2 Durvalumab+C
    Ph II Durvalumab + cediranib at RP2D
  • Experimental: P2 Durvalumab+O
    Ph II Durvalumab + olaparib at RP2D
  • Experimental: P2 Durvalumab+O+C
    Ph II Durvalumab + olaparib + cediranib at RP2D

Primary Outcome Measure

Ph II Determine overall response rate of Durvalumab-O and Durvalumab-C in patients with recurrent ovarian cancer [ Time Frame: every 4 wks for toxicity and every 8 wks for response ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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By condition
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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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