Study on New Treatments for Newly Diagnosed Stage III/IV Ovarian Cancer Before and After Surgery

Sponsor: University of Alabama at Birmingham

Sponsor score: 0

ClinicalTrials ID:NCT05952453

Provider View

This clinical trial is testing a combination of chemotherapy and immunotherapy drugs for women with newly diagnosed advanced ovarian cancer. The study aims to see if these treatments, given before and after surgery, can improve outcomes for patients.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of a combination of chemotherapy drugs (carboplatin and paclitaxel) and an immunotherapy drug (pembrolizumab) in women with newly diagnosed Stage III or IV ovarian cancer. These treatments are given before surgery to remove the tumor and continue after surgery. The study also includes maintenance therapy with olaparib and pembrolizumab to help prevent the cancer from returning.

Description

This study involves women with advanced ovarian cancer who will receive a series of treatments before and after surgery. Initially, patients will receive a cycle of carboplatin, with or without paclitaxel, followed by three cycles of carboplatin, paclitaxel, and pembrolizumab before surgery. After surgery, they will receive three more cycles of the same combination, followed by maintenance therapy with olaparib and pembrolizumab. The study will be conducted at one site, and participants will need to provide tissue samples before treatment and during surgery for research purposes. These samples will help researchers understand how the treatment affects different types of cells and proteins in the tumor. The study aims to offer a comprehensive treatment approach by including a PARP inhibitor and pembrolizumab as maintenance therapy. Bevacizumab may also be added after surgery if needed, especially if the cancer does not completely respond to initial treatments.

Eligibility Criteria

Inclusion Criteria

  • Women diagnosed with advanced Stage III or IV ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
  • Eligible for chemotherapy with carboplatin and paclitaxel before surgery.
  • Have a specific blood test ratio (CA-125 to CEA) that meets study requirements.
  • At least 18 years old and in good overall health.
  • Not pregnant or breastfeeding and willing to use contraception during and after treatment.
  • Able to provide informed consent and willing to participate in the study.
  • Have adequate organ function based on specific blood test results.

Exclusion Criteria

  • Have certain types of ovarian tumors or other cancers that are not eligible for the study.
  • Have a history of lung inflammation or certain blood disorders.
  • Have another active cancer that requires treatment.
  • Have active brain metastases or certain immune system conditions.
  • Have active infections or other serious medical conditions that could interfere with the study.
  • Have had recent surgery for early-stage ovarian cancer.
  • Have a history of certain viral infections like HIV or hepatitis.
  • Have received previous treatments for advanced ovarian cancer.
  • Have severe allergies to any of the study drugs.
  • Have certain heart conditions or have had a recent organ transplant.
  • Are taking medications that interfere with the study drugs and cannot be stopped.

Locations

FACILITYZIPCITYSTATE
O'Neal Comprehensive Cancer Center at UAB35294BirminghamAlabama

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