Study on Pembrolizumab and Carboplatin for Treating Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04387227

Provider View

This clinical trial is exploring how well the combination of pembrolizumab, an immunotherapy drug, and carboplatin, a chemotherapy drug, works in treating ovarian, fallopian tube, or primary peritoneal cancer that has returned after previous treatment.

Patient Parameters

Program Overview

This study is testing a combination of two drugs, pembrolizumab and carboplatin, to see if they can effectively treat ovarian, fallopian tube, or primary peritoneal cancer that has come back. Pembrolizumab is an immunotherapy drug that helps the immune system attack cancer cells, while carboplatin is a chemotherapy drug that stops cancer cells from growing and spreading. The goal is to find out if using these drugs together works better than using them separately.

Description

In this study, patients will receive carboplatin through an IV for 30 minutes on the second day of the first cycle only. Pembrolizumab will be given through an IV for 30 minutes on the first day of each cycle. Each cycle lasts 6 weeks, and treatment can continue for up to 2 years unless the cancer progresses or side effects become too severe. Throughout the trial, patients will have CT or MRI scans and provide blood samples to monitor their health and the treatment's effects.

After finishing the study treatment, patients will have follow-up visits 30 days later, then every 3 months for the first year, and every 6 months for the second year.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with ovarian, fallopian tube, or primary peritoneal cancer and have received chemotherapy, including platinum-based drugs.
  • Cancer marker CA-125 must have returned to normal after initial treatment but increased significantly after recent treatments.
  • No measurable disease based on specific medical criteria, except for non-symptomatic fluid buildup.
  • Must agree to use contraception if sexually active.
  • Expected to live at least 3 more months.
  • Willing to provide written consent to participate.
  • Aged 18 or older.
  • Good overall health with a performance status of 0 or 1.
  • Meet specific blood count and organ function requirements based on recent tests.

Exclusion Criteria

  • Currently in another study or received experimental treatment within the last 4 weeks.
  • Have an immune deficiency or are taking high-dose steroids or other immune-suppressing drugs.
  • Have symptomatic fluid buildup in the abdomen or chest.
  • History of certain types of ovarian cancer with low malignancy.
  • Allergic to pembrolizumab or its ingredients.
  • Received certain cancer treatments recently and haven't recovered from side effects.
  • Have another progressing cancer needing treatment, except for certain skin cancers or in situ cervical cancer.
  • Have active brain cancer or meningitis, unless previously treated and stable.
  • Have an autoimmune disease needing treatment in the past 2 years.
  • Have lung disease needing steroids or current lung disease.
  • Have an active infection needing treatment.
  • Have a condition or treatment that could interfere with the study.
  • Have psychiatric or substance abuse issues affecting participation.
  • Pregnant or breastfeeding, or planning to conceive during the study.
  • Have significant heart disease.
  • Severe allergies to monoclonal antibodies or carboplatin.
  • Previously treated with pembrolizumab.
  • Have HIV, active hepatitis B or C.
  • Received a live vaccine recently, except for certain flu vaccines.

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