Study on Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Treating Platinum-resistant Recurrent Ovarian Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT05116189

This clinical trial is testing whether adding pembrolizumab to standard chemotherapy with paclitaxel, with or without bevacizumab, can improve outcomes for patients with ovarian cancer that has returned and is resistant to platinum-based treatments.

Patient Parameters

Program Overview

The main goal of this study is to see if adding pembrolizumab to the chemotherapy drug paclitaxel, with or without bevacizumab, can help control ovarian cancer that has come back and is resistant to platinum-based treatments. Researchers will compare this combination to a placebo with paclitaxel, with or without bevacizumab, to see which is more effective in slowing down the cancer's progression.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • Previously received 1 or 2 treatments for ovarian cancer, including at least one platinum-based therapy.
  • Cancer has progressed within 6 months after the last platinum-based treatment.
  • Eligible for treatment with paclitaxel (and bevacizumab, if applicable).
  • Good overall health with an ECOG performance status of 0 or 1.
  • Not pregnant or breastfeeding, and using effective birth control if of childbearing potential.
  • Cancer can be measured by scans or other methods.
  • Provided a tumor sample for testing.
  • Have adequate organ function as shown by medical tests.

Exclusion Criteria

  • Have certain types of ovarian cancer, such as nonepithelial or mucinous tumors.
  • Cancer did not respond to first-line platinum-based therapy.
  • Cancer progressed on weekly paclitaxel alone.
  • Received more than 2 previous treatments for ovarian cancer.
  • Had recent cancer treatments or surgery without full recovery.
  • Received certain medications or vaccines recently.
  • Have immune system issues or are on long-term steroid therapy.
  • Have another active cancer or brain metastases.
  • Allergic to pembrolizumab, paclitaxel, or bevacizumab.
  • Have autoimmune diseases needing treatment in the past 2 years.
  • Have lung disease or active infections.
  • Have HIV, Hepatitis B, or active Hepatitis C.
  • Have conditions that could affect study results.
  • Have mental health or substance abuse issues affecting study participation.
  • Have had a tissue or organ transplant.

For bevacizumab treatment:

  • Have uncontrolled high blood pressure.
  • Have bowel obstruction or related issues.
  • Have a history of blood clots, bleeding, or gastrointestinal bleeding recently.

Locations

FACILITYZIPCITYSTATE
HonorHealth ( Site 0041)85016PhoenixArizona
Marin Cancer Care ( Site 0055)94904GreenbraeCalifornia
Pacific Cancer Care ( Site 0028)93940MontereyCalifornia
Eisenhower Medical Center ( Site 0067)92270Rancho MirageCalifornia
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004)06511New HavenConnecticut
University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 005432610GainesvilleFlorida
Sarasota Memorial Hospital ( Site 0018)34239SarasotaFlorida
Moffitt Cancer Center ( Site 0033)33612TampaFlorida
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005)30060MariettaGeorgia
Advocate Medical Group-Oncology ( Site 0049)60068Park RidgeIllinois

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