Phase II Study of Pembrolizumab, Bevacizumab, and Cyclophosphamide for High-Grade Ovarian Cancer with Minimal Residual Disease After Initial Treatment

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06083844

Provider View

This clinical trial is exploring whether a combination of pembrolizumab, bevacizumab, and low-dose cyclophosphamide can help control high-grade ovarian cancer that remains after initial treatment. The study will also assess the safety of this treatment combination.

Patient Parameters

Program Overview

The aim of this study is to determine if combining the drugs pembrolizumab, bevacizumab (or a similar drug), and low-dose cyclophosphamide can help manage high-grade ovarian cancer that still has minimal residual disease (MRD) after initial treatment. Researchers will also evaluate the safety of this treatment combination.

Description

This study focuses on patients with high-grade ovarian cancer who have minimal residual disease after initial treatment. The primary goal is to see if the combination of pembrolizumab, bevacizumab, and low-dose cyclophosphamide can extend the time patients live without the cancer worsening by at least six months.

Secondary goals include assessing the safety of this treatment combination. Researchers will also explore how the treatment affects gene expression and immune profiles in tumor tissue, and whether changes in tumor DNA in the blood can indicate how well the treatment is working.

Participants will be women aged 18 or older with a confirmed diagnosis of high-grade non-mucinous epithelial ovarian cancer. They must have undergone standard initial treatment and a second-look surgery showing minimal residual disease. Participants must have specific genetic profiles and be willing to provide tissue samples for the study. They must also meet certain health criteria, including adequate organ function and recovery from surgery.

The study excludes those who have had certain prior treatments, active infections, or other health conditions that could interfere with the study. Women who are pregnant or breastfeeding, or who have certain genetic mutations, are also excluded.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older with a confirmed diagnosis of high-grade non-mucinous epithelial ovarian cancer.
  • Not pregnant or breastfeeding, and agree to use contraception if of childbearing potential.
  • Provide written informed consent.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Completed standard initial treatment and a second-look surgery showing minimal residual disease.
  • Have specific genetic profiles, including non-mutated BRCA1/2 and homologous recombination proficient tumors.
  • Willing to provide tissue samples from surgeries for the study.
  • Have adequate organ function based on specific blood tests.
  • Recovered from second-look surgery and able to start treatment within 28 to 49 days after surgery.
  • Negative pregnancy test before starting treatment, if applicable.

Exclusion Criteria

  • Previous treatment with certain immune therapies or recent radiotherapy.
  • Recent use of live vaccines or investigational drugs.
  • Immunodeficiency or use of high-dose steroids or immunosuppressive therapy.
  • Other active cancers or untreated brain metastases.
  • Active autoimmune diseases requiring treatment in the past two years.
  • History of lung disease requiring steroids or current lung disease.
  • Active infections or history of certain viral infections.
  • Conditions that could interfere with study results or participation.
  • Psychiatric or substance abuse disorders affecting cooperation.
  • Pregnant or breastfeeding women, or those planning to conceive during the study.
  • History of organ transplant or uncontrolled high blood pressure.
  • Certain types of ovarian cancer or genetic mutations.
  • History of blood clots or certain medical conditions increasing treatment risks.
  • Inability to comply with study requirements or concurrent use of other cancer treatments.

Get This Program In Your Inbox

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