RecruitingPhase 2NCT03991832

Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors

A Phase II Study of Olaparib and Durvalumab (MEDI 4736) in Patients With IDH-Mutated Solid Tumors


Sponsor

University Health Network, Toronto

Enrollment

58 participants

Start Date

Dec 31, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 2 study of the combination of drugs olaparib and durvalumab for the treatment of isocitrate dehydrogenase or (IDH) mutated solid tumors. The purpose of this study is to assess the efficacy of the drug combination via overall response rate and overall disease control rate. It is believed that giving olaparib and durvalumab together would be more useful when given to patients with IDH-mutated solid tumors than giving each drug alone.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests two drugs — olaparib (a PARP inhibitor) and durvalumab (an immunotherapy) — together in patients with tumors that have an IDH gene mutation. IDH mutations affect how cells use energy and are found in certain brain tumors and bile duct cancers. **You may be eligible if...** - You are 18 or older and weigh more than 30 kg - You have IDH-mutant diffuse brain tumor (astrocytic or oligodendroglial type) with no more than 2 prior treatment regimens after first relapse (Cohort A), OR - You have IDH-mutant bile duct cancer (cholangiocarcinoma) with no more than 2 prior regimens for advanced disease (Cohort B) - Your organ and bone marrow function are within normal range **You may NOT be eligible if...** - Your tumor does not have an IDH mutation - You have received more than 2 prior treatment regimens - Your organ function is not adequate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOlaparib

Olaparib is a drug that blocks a protein called poly (ADP-ribose) polymerase (PARP). PARP is important in the growth and spread of cancer cells. Because of this, blocking PARP from working is expected to stop the growth of or shrink cancer cells.

DRUGDurvalumab

Durvalumab is a drug that works by stopping a protein called Programmed Cell Death Ligand 1 (PD-L1) from working. PD-L1 is a protein that is thought to prevent the immune system (the body's defense against diseases) from killing cancer cells. Stopping PD-L1 from working is expected to allow the immune system to once again prevent or slow down cancer growth.


Locations(1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

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NCT03991832


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