Durvalumab + Tremelimumab for Ovarian Cancer

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

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.

My cancer is a specific type of ovarian, peritoneal, or fallopian tube cancer, or I have uterine serous carcinoma with certain mutations.

I am fully active or restricted in physically strenuous activity but can do light work.

I am fully active or can carry out light work.

I am 18 years old or older.

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

I am 18 years old or older.

Your blood and organ function must be at certain levels: Hemoglobin should be at least 9.0 g/dL, ANC should be at least 1.5 x 10^9/L, Platelet count should be at least 100 x 10^9/L, Bilirubin should be below a certain level, and liver and kidney function should also be within specific ranges.

Exclusion Criteria

I have or had inflammatory bowel disease.

I do not have any uncontrolled illnesses.

I have had severe side effects from previous immunotherapy.

I have an ongoing blockage in my intestines.

I have no lasting side effects from cancer treatment, except for hair loss.

I am not able to participate in the study's surveys because I do not speak English.

I have had cancer spread to my brain or its coverings.

I have had an autoimmune disease in the last 2 years.

I have been diagnosed with tuberculosis in the past.

I have seizures that are not controlled by medication.

Treatment Details

The 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.

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: