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Checkpoint Inhibitor

Durvalumab + Tremelimumab for Ovarian Cancer

Phase 2

Waitlist Available

Led By Amir A Jazaeri

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate normal organ and marrow function as defined by specific criteria for hemoglobin, absolute neutrophil count, platelet count, serum bilirubin, AST and ALT levels, and serum creatinine clearance

Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including biopsies and follow up.

Must not have

Active or prior documented inflammatory bowel disease

Uncontrolled intercurrent illness including specific conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well two immunotherapies, durvalumab and tremelimumab, work in treating ovarian, primary peritoneal, or fallopian tube cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include immune-related reactions affecting different organs, infusion reactions similar to allergic responses during drug administration, fatigue, digestive issues like diarrhea or colitis, skin rash, hormone gland problems (like thyroid dysfunction), and liver inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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

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I am fully active or can carry out light work.

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I am 18 years old or older.

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

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I am 18 years old or older.

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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

You may be eligible for the trial if you check “No” for criteria below:

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I have or had inflammatory bowel disease.

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I do not have any uncontrolled illnesses.

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I have had severe side effects from previous immunotherapy.

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I have an ongoing blockage in my intestines.

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

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

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

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

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I have been diagnosed with tuberculosis in the past.

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I have seizures that are not controlled by medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2019 Phase 2 trial • 33 Patients • NCT03007407

38%

Fatigue

21%

Diarrhea

17%

Nausea

17%

Fever

17%

Anorexia

17%

Maculopapular rash

17%

Pruritus

14%

Constipation

14%

Rash maculo-papular

10%

Anemia

10%

Abdominal pain

10%

Itching

Hypothyroidism

Non-cardiac chest pain

Weight loss

Cough

Dry Skin

Dehydration

100%

80%

60%

40%

20%

Study treatment Arm

Durvalumab and Tremelimumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3750

Tremelimumab

2017

Completed Phase 2

~3070