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Checkpoint Inhibitor

Durvalumab + Tremelimumab for Ovarian Cancer

Phase 2
Recruiting
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My cancer got worse or came back within 6 months after platinum-based treatment.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Immune-related progression-free survival (irPFS)

Side effects data

From 2019 Phase 2 trial • 33 Patients • NCT03007407
38%
Fatigue
21%
Diarrhea
17%
Pruritus
17%
Maculopapular rash
17%
Anorexia
17%
Nausea
17%
Fever
14%
Rash maculo-papular
14%
Constipation
10%
Itching
10%
Anemia
10%
Abdominal pain
7%
Cough
7%
Dry Skin
7%
Dehydration
7%
Hypothyroidism
7%
Non-cardiac chest pain
7%
Weight loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab and Tremelimumab

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
~3870
Tremelimumab
2017
Completed Phase 2
~3380

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,245 Total Patients Enrolled
4 Trials studying Fallopian Tube Carcinoma
600 Patients Enrolled for Fallopian Tube Carcinoma
Amir A JazaeriPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
166 Total Patients Enrolled

Media Library

Durvalumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03026062 — Phase 2
Fallopian Tube Carcinoma Research Study Groups: Arm II (combination tremelimumab, durvalumab), Arm I (sequential tremelimumab, durvalumab)
Fallopian Tube Carcinoma Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT03026062 — Phase 2
Durvalumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03026062 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any additional precedents of research with Tremelimumab?

"Currently, there are 340 active clinical trials exploring the efficacy of Tremelimumab. Out of these investigations, 52 have reached Phase 3 and are based primarily in Cordoba Texas. Additionally, over 13 thousand locations across our planet are conducting research with this medication."

Answered by AI

What medical issues has Tremelimumab been prescribed to address?

"For most cases of stage III non-small cell lung cancer that are not operable, tremelimumab is usually prescribed. Furthermore, this medication has been found to be beneficial for metastatic urothelial carcinoma and other advanced directives."

Answered by AI

How many individuals are the maximum capacity for this experimental endeavor?

"Affirmative, clinicaltrials.gov affirms that this experimental study is actively seeking participants. It first made its debut on the 18th of May 2017 and was updated most recently on July 19th 2022, with a need for 175 individuals to be recruited from one site alone."

Answered by AI

Are there still opportunities to join this trial as a participant?

"Clinicaltrials.gov evidences that this experiment has been recruiting since May 18th, 2017 and their most recent alteration occured on July 19th, 2022."

Answered by AI

Is this trial unique in its approach to treating the condition?

"Records show that there are 340 active trials for tremelimumab, available in 58 different countries and 1327 cities. The first trial involving this drug was conducted by AstraZeneca back in 2007 with 37 participants; 123 studies have been completed since then. This particular study has progressed to the second phase of its approval process."

Answered by AI

Has Tremelimumab been given the green light by regulatory bodies?

"Tremelimumab was ranked as a 2 on our safety scale due to the Phase 2 trial data, which provides evidence for its security but not efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
Illinois
How old are they?
18 - 65
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
~11 spots leftby Dec 2024