Testing Nivolumab With or Without Ipilimumab in Patients with Recurrent Endometrial Cancer with DNA Repair Deficiency

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05112601

Provider View

This study is exploring whether combining two immunotherapy drugs, nivolumab and ipilimumab, is more effective than using nivolumab alone in treating endometrial cancer that has returned and has a specific DNA repair deficiency.

Patient Parameters

Program Overview

This phase II clinical trial is investigating if a combination of two immunotherapy drugs, nivolumab and ipilimumab, can better shrink tumors in patients with recurrent endometrial cancer that has a deficiency in DNA repair. This deficiency, known as mismatch repair deficiency, makes the cancer more sensitive to immunotherapy. The study aims to determine if using both drugs together is more effective than using nivolumab alone.

Description

The main goal of this study is to see if using both nivolumab and ipilimumab can help patients with recurrent endometrial cancer live longer without the disease getting worse, compared to using nivolumab alone. Researchers will also look at overall survival rates, how well the tumors respond to treatment, and any side effects experienced by patients.

Participants will be randomly assigned to one of two groups:

  • Group 1: Patients will receive nivolumab and ipilimumab through an IV. This treatment will be given every three weeks for up to eight cycles, and then nivolumab alone every four weeks if the cancer does not progress or cause severe side effects.

  • Group 2: Patients will receive nivolumab alone through an IV every three weeks for up to eight cycles, and then every four weeks if the cancer does not progress or cause severe side effects.

If patients achieve a complete response, they will continue receiving nivolumab for an additional 12 months.

Throughout the study, patients will have blood and tissue samples collected and undergo CT or MRI scans. Follow-up visits will occur every three months for two years, then every six months for three years.

Eligibility Criteria

Inclusion Criteria

  • Have recurrent endometrial cancer that can be measured or detected.
  • Cancer must have a deficiency in the DNA repair system, confirmed by specific tests.
  • Have received 1-2 prior treatments for endometrial cancer.
  • Be 18 years or older.
  • Have a good performance status, meaning able to carry out daily activities with minimal assistance.
  • Have adequate blood counts and organ function based on specific lab tests.
  • Women of childbearing potential must use effective birth control and have a negative pregnancy test before starting treatment.
  • Patients with other stable health conditions, such as controlled HIV or hepatitis, may be eligible.
  • Must provide informed consent to participate in the study.

Exclusion Criteria

  • Have a type of endometrial cancer called serous carcinoma or carcinosarcoma.
  • Have had severe side effects from previous similar treatments.
  • Be on chronic steroid or immunosuppressive therapy, except for certain low-dose or specific uses.
  • Have active autoimmune diseases or a history of severe autoimmune reactions.
  • Have uncontrolled health conditions, such as severe heart or lung disease.
  • Be pregnant or breastfeeding.
  • Have had allergic reactions to similar drugs used in the study.

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