Study on Durvalumab and Tremelimumab for Treating Recurrent or Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03026062

Provider View

This clinical trial is exploring how well the combination of two immunotherapy drugs, durvalumab and tremelimumab, works in treating ovarian, primary peritoneal, or fallopian tube cancer that has returned or is not responding to treatment.

Patient Parameters

Program Overview

The purpose of this study is to see if using the immunotherapy drugs durvalumab and tremelimumab can help the body's immune system fight ovarian, primary peritoneal, or fallopian tube cancer that has come back or is resistant to treatment. These drugs are monoclonal antibodies that may help the immune system attack cancer cells and stop them from growing and spreading. The study will compare two ways of giving these drugs: either together or one after the other, to find out which method works better.

Description

The study has two main parts, called arms, where participants are randomly assigned to one of the two treatment methods.

ARM I (SEQUENTIAL):

  • Participants receive tremelimumab through an IV drip over 60 minutes on the first day of each cycle. This treatment is repeated every 4 weeks for up to 4 cycles, as long as the cancer does not progress and side effects are manageable.
  • If the cancer progresses, participants then receive durvalumab through an IV drip over 60 minutes on the first day of each cycle. This treatment is repeated every 4 weeks for up to 9 cycles, as long as the cancer does not progress and side effects are manageable.

ARM II (COMBINATION):

  • Participants receive both tremelimumab and durvalumab through an IV drip over 60 minutes (for each drug) on the first day of each cycle. This treatment is repeated every 4 weeks for up to 4 cycles, as long as the cancer does not progress and side effects are manageable.
  • After the initial cycles, participants continue to receive durvalumab alone through an IV drip over 60 minutes on the first day of each cycle. This treatment is repeated every 4 weeks for up to 9 cycles, as long as the cancer does not progress and side effects are manageable.

After completing the study treatment, participants will have follow-up visits 30 days after treatment and then every 2 months to monitor their health and any changes in their condition.

Eligibility Criteria

Inclusion Criteria

  • Must provide written informed consent before participating.
  • Must be 18 years or older.
  • Must have a good performance status, meaning they are fully active or have some restrictions but can still carry out light work.
  • Must have normal organ and bone marrow function based on specific blood tests.
  • Women must not be pregnant and must agree to use effective birth control during the study.
  • Must be willing to follow the study protocol, including attending scheduled visits and undergoing tests and treatments.
  • Must have a confirmed diagnosis of recurrent high-grade ovarian, peritoneal, or fallopian tube cancer, or uterine serous carcinoma with specific genetic mutations.
  • Must have cancer that is resistant to or has returned after platinum-based chemotherapy.
  • Must have measurable cancer that can be tracked using standard criteria.

Exclusion Criteria

  • Cannot be involved in planning or conducting the study.
  • Cannot have participated in another clinical study within the last 28 days.
  • Cannot have received certain previous cancer treatments, including specific immunotherapies.
  • Cannot have another active cancer, except for certain non-threatening types.
  • Cannot have unresolved side effects from previous cancer treatments.
  • Cannot have certain autoimmune diseases or a history of organ transplant.
  • Cannot have uncontrolled illnesses, such as infections or heart conditions.
  • Cannot have received a live vaccine within 30 days before starting the study.
  • Cannot be pregnant, breastfeeding, or not using effective birth control if of reproductive potential.
  • Cannot have any condition that would interfere with the study or its results.
  • Cannot have uncontrolled seizures.
  • Non-English speakers cannot participate in the patient-reported outcomes part of the study.

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