Study on Chemotherapy with Pembrolizumab Followed by Maintenance with Olaparib for First-Line Treatment of Women with Advanced Ovarian Cancer Without BRCA Mutation

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03740165

Provider View

This clinical trial is testing a combination of chemotherapy and immunotherapy drugs, followed by maintenance therapy, to see if it can improve outcomes for women with advanced ovarian cancer that does not have a BRCA mutation.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness and safety of combining chemotherapy drugs carboplatin and paclitaxel with the immunotherapy drug pembrolizumab, followed by maintenance therapy with olaparib, in women with advanced ovarian, fallopian tube, or primary peritoneal cancer. Researchers want to see if this combination can help patients live longer without their cancer getting worse, especially in those with PD-L1 positive tumors.

Description

Participants will first receive a single cycle of chemotherapy with carboplatin and paclitaxel. After this, they will be randomly assigned to one of three groups:

  • Group 1: Receives pembrolizumab and olaparib.
  • Group 2: Receives pembrolizumab and a placebo instead of olaparib.
  • Group 3: Receives placebos instead of both pembrolizumab and olaparib.

The chemotherapy regimen may vary slightly based on the doctor's decision, and an alternative drug, docetaxel, may be used if there are severe reactions to paclitaxel. The study will monitor how well the cancer responds to these treatments and how long patients remain free of disease progression.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer at Stage III or IV.
  • Recently had or is eligible for surgery to remove the tumor.
  • Suitable for chemotherapy with carboplatin and paclitaxel.
  • Able to provide a tumor sample for testing specific cancer markers.
  • In good overall health with an ECOG performance status of 0 or 1.
  • Women must not be pregnant or breastfeeding and must agree to use effective birth control during the study and for a specified period after treatment.
  • Have adequate organ function as determined by medical tests.

Exclusion Criteria

  • Have a type of ovarian cancer not included in the study, such as mucinous or germ cell tumors.
  • Have a known BRCA mutation.
  • Have a history of lung inflammation requiring steroids or current lung issues.
  • Have certain blood disorders or other active cancers requiring treatment in the last 3 years.
  • Have active brain metastases or certain autoimmune diseases.
  • Have active infections or uncontrolled medical conditions.
  • Have had recent surgery or certain treatments for other cancers.
  • Are unable to swallow pills or have digestive issues affecting medication absorption.
  • Have uncontrolled high blood pressure or recent significant bleeding issues.
  • Are currently pregnant or planning to become pregnant during the study.
  • Have received certain prior cancer treatments or medications that could interfere with the study drugs.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.