MEDI4736 + Olaparib for Advanced Cancers (MEDIOLA Trial)

Palo Alto (17 mi)

Overseen bySusan Domcheck, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to look at the effectiveness, safety, and antitumor activity of study drugs MEDI4736 in combination with olaparib (modules 1, 2, 3, 4, 5 and 7) and MEDI4736 in combination with olaparib and bevacizumab (module 6). It will also examine what happens to the study drugs in the body and investigate how well the combination between MEDI4736, olaparib and bevacizumab is tolerated.

Eligibility Criteria

This trial is for adults with certain advanced solid tumors, including specific breast and ovarian cancers, stomach cancer, or small cell lung cancer. Participants must have a life expectancy of at least 12 weeks, measurable lesions for assessment, and be able to swallow pills without altering them. They should not have had recent chemotherapy or other treatments that might interfere with the study drugs.

Inclusion Criteria

My cancer is advanced or has spread, and this was confirmed by lab tests.

I am not pregnant and agree to use birth control during the study if I can have children.

I am fully active or can carry out light work.

My organs and bone marrow are working well.

Exclusion Criteria

I rely on IVs for nutrition or hydration.

I am not taking strong or moderate drugs that affect liver enzymes.

I am not on any other cancer treatments or long-term steroids.

I have brain metastases that are causing symptoms or are not under control.

I have had a bone marrow or double cord blood transplant.

Treatment Details

The trial is testing the combination of MEDI4736 with olaparib (and in one module also bevacizumab) to evaluate their effectiveness and safety in treating these cancers. It will also assess how these drugs interact within the body and determine how well patients tolerate this drug regimen.

3Treatment groups

Experimental Treatment

Group I: Arm 3Experimental Treatment3 Interventions

Includes 2nd stage cohort (module 6): Olaparib twice daily starting on week 1 day 1 / MEDI4736 every 4 weeks starting on week 1 day 1 / Bevacizumab every 2 weeks starting on week 1 day 1

Group II: Arm 2Experimental Treatment2 Interventions

Includes 2nd stage cohorts (modules 5 \& 7): Olaparib twice daily starting on week 1 day 1 and MEDI4736 every 4 weeks starting on week 1 day 1

Group III: Arm 1Experimental Treatment2 Interventions

Includes initial stage cohorts (modules 1 to 4): Olaparib twice daily starting on week 1 day 1 and MEDI4736 every 4 weeks starting on week 5 day 1