Study on Vismodegib and Atezolizumab for Platinum-Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Sponsor: Ronald Buckanovich

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05538091

Provider View

This clinical trial is testing a new treatment combination of vismodegib and atezolizumab for patients with ovarian, fallopian tube, or primary peritoneal cancer that has not responded to platinum-based chemotherapy. The study aims to find better treatment options for these patients, as current therapies have low success rates.

Patient Parameters

Program Overview

The trial is designed to see if combining vismodegib and atezolizumab can help control ovarian, fallopian tube, or primary peritoneal cancer that has become resistant to platinum-based treatments. These cancers often return or progress after initial treatment, and current options have limited effectiveness. The study will explore if this new combination can improve outcomes for patients with these challenging cancers.

Description

Ovarian, fallopian tube, and primary peritoneal cancers are often diagnosed at an advanced stage, leading to lower survival rates. While early-stage cancers have a 90% survival rate over five years, this drops to 30% for advanced stages. Many patients eventually develop resistance to treatments, including those with BRCA mutations. This trial will test a combination of vismodegib and atezolizumab, which may help by targeting specific cancer pathways. The goal is to find a treatment that can better manage these cancers, especially for those who have limited options after becoming resistant to platinum-based therapies.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • Cancer must be resistant to platinum-based chemotherapy, meaning it progressed within six months of the last treatment.
  • Must have measurable or evaluable disease.
  • Must provide a tumor sample for research purposes.
  • Must have a performance status score of 0 or 1, indicating good overall health.
  • Must have a life expectancy of at least three months.
  • Must have adequate blood counts and organ function based on specific lab tests.
  • Must test negative for HIV, unless stable on treatment with a controlled viral load.
  • Must test negative for hepatitis B.
  • Women of childbearing potential must agree to use effective contraception during and after the study for specified periods.

Exclusion Criteria

  • Cannot swallow capsules or comply with study procedures.
  • Have a history of certain diseases like leptomeningeal disease or uncontrolled fluid buildup in the body.
  • Have active or past autoimmune diseases, with some exceptions for controlled conditions.
  • Have certain lung diseases or active infections like tuberculosis.
  • Have significant heart disease or recent major surgery.
  • Have had other cancers within the past five years, with some exceptions.
  • Have had severe infections or are currently on certain medications that affect the immune system.
  • Have had a stem cell or organ transplant.
  • Are pregnant, breastfeeding, or planning to become pregnant during or after the study.
  • Have allergies to the study drugs or their components.
  • Must not donate blood during and after the study for specified periods.

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