Study on MEDI4736 and Olaparib Combination for Advanced Solid Tumors

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT02734004

Provider View

This clinical trial is testing the safety and effectiveness of combining the drugs MEDI4736 and olaparib, with or without bevacizumab, in treating advanced solid tumors. The study will also look at how these drugs work in the body and how well patients tolerate them.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well the combination of MEDI4736 and olaparib, and in some cases with bevacizumab, works in treating advanced solid tumors. Researchers aim to understand the safety, effectiveness, and how these drugs interact in the body. The study will include patients who have not previously been treated with similar drugs or therapies that target specific immune pathways.

Description

This study is divided into two phases, Phase I and Phase II, and involves multiple centers. It aims to assess the safety, tolerability, and effectiveness of the drug combination MEDI4736 and olaparib in patients with advanced solid tumors. Participants must not have been treated with PARP inhibitors or certain types of immunotherapy before.

The study includes different groups of patients based on their type of cancer:

  • Relapsed small cell lung cancer
  • HER2-negative breast cancer with a specific genetic mutation (gBRCAm)
  • Ovarian cancer with or without the gBRCAm mutation
  • Metastatic or relapsed gastric cancer

The study will track how long patients live without their cancer getting worse and overall survival rates. Participants will undergo regular health checks and scans to monitor their response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic solid tumor, such as:
    • Platinum-sensitive relapsed small cell lung cancer
    • HER2-negative breast cancer with a gBRCAm mutation
    • Ovarian cancer with or without a gBRCAm mutation
    • Metastatic or relapsed gastric cancer
  • Have at least one tumor that can be measured by scans
  • Be 18 years or older (19 years or older in South Korea)
  • Be in good overall health with a performance status of 0 or 1
  • Have a life expectancy of at least 12 weeks
  • Have adequate organ and bone marrow function
  • Be able to swallow pills without altering them
  • Understand and agree to sign a consent form
  • Women must not be pregnant and must agree to use contraception if they or their partner can have children

Exclusion Criteria

  • Have had chemotherapy or other cancer treatments recently, with some exceptions
  • Have had radiation therapy recently
  • Depend on IV nutrition or hydration
  • Use certain medications that affect how the study drugs work
  • Have had a bone marrow transplant recently
  • Have uncontrolled brain metastases
  • Have serious medical conditions or psychiatric disorders
  • Have had major surgery or injury recently
  • Have a weakened immune system
  • Have certain heart conditions
  • Be pregnant or breastfeeding
  • Be involved in the study's planning or conduct
  • Have participated in another clinical study recently

Locations

FACILITYZIPCITYSTATE
Research Site30265NewnanGeorgia
Research Site21204TowsonMaryland
Research Site02114BostonMassachusetts
Research Site48202DetroitMichigan
Research Site63110St LouisMissouri
Research Site43026HilliardOhio
Research Site19104PhiladelphiaPennsylvania

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