Durvalumab + Tremelimumab for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAmir A. Jazaeri

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well durvalumab and tremelimumab work in treating participants with ovarian, primary peritoneal, or fallopian tube cancer that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether give durvalumab and tremelimumab in combination or sequential administration works better in treating participants with ovarian, primary peritoneal, or fallopian tube cancer.

Eligibility Criteria

This trial is for adults with recurrent or resistant ovarian, primary peritoneal, or fallopian tube cancer. Participants must be over 18 years old, have a good performance status (able to carry out daily activities), and have proper organ function. They should not be pregnant and must use effective birth control if of reproductive potential.

Inclusion Criteria

The informed consent must be written and signed by the subject prior to performing any protocol-related procedures, including screening evaluations.

My blood tests for organ function and bone marrow are within normal ranges.

I am willing and able to follow the study's requirements, including treatments, visits, and biopsies.

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Exclusion Criteria

I have or had inflammatory bowel disease.

Your heart's electrical activity, measured by ECG, shows a prolonged QT interval.

I do not have any uncontrolled illnesses.

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Treatment Details

Interventions

Durvalumab (Checkpoint Inhibitor)
Tremelimumab (Checkpoint Inhibitor)

Trial OverviewThe study tests durvalumab and tremelimumab, two immunotherapy drugs that may help the immune system fight cancer. It's unclear if giving these drugs together or one after the other is more effective for treating certain gynecological cancers.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Arm II (combination tremelimumab, durvalumab)Experimental Treatment2 Interventions

Patients receive tremelimumab IV and durvalumab IV over 60 minutes on day 1. Treatment repeats every 4 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 4 weeks for up to 9 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (sequential tremelimumab, durvalumab)Experimental Treatment2 Interventions

Patients receive tremelimumab IV over 60 minutes on day 1. Treatment repeats every 4 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Upon progression, patients then receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 4 weeks for up to 9 cycles in the absence of disease progression or unacceptable toxicity. This arm is closed to enrollment.

Durvalumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Imfinzi for: