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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...

NCT02484404 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2026-05-06

No results posted yet for this study

Summary

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.

Conditions

  • Colorectal Neoplasms
  • Breast 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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Takeo Fujii, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-29
Primary Completion
2027-10-30
Completion
2027-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02484404 on ClinicalTrials.gov