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A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma

NCT03075527•Dana-Farber Cancer Institute

View on ClinicalTrials.gov

Summary

This research study is studying a pair of immunotherapies as a possible treatment for malignant pleural mesothelioma. The drugs involved in this study are: * Durvalumab * Tremelimumab

Detailed Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved durvalumab or tremelimumab as a treatment for any disease. In this research study, the investigators are studying if the study drug can help your cancer compared to the usual approach to treating malignant pleural mesothelioma . Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells. Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack. These two study drugs have been used alone for mesothelioma but the combination has not yet been tested for mesothelioma. These two drugs have been used for cancers such as melanoma and have been effective than using either drug alone.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent obtained prior to any study-specific procedures not considered part of routine medical care
•Histologically or cytologically confirmed unresectable or medically inoperable malignant pleural mesothelioma
•Disease progression after treatment with at least one line of chemotherapy that included a first-line platinum agent in combination with an anti-folate
•Participants must have measurable disease according to modified RECIST for pleural malignant mesothelioma. (Bone metastases are not considered measurable.) Prior radiation to the only site of measurable disease will make the participant ineligible unless the lesion has been demonstrated to grow after completion of radiation therapy.
•Participants must be willing and able to undergo a biopsy at the start of this study and an on-treatment biopsy if safe and feasible.
•Participants must have be at least 28 days from any major surgery.
•ECOG performance status of 0 or 1.
•Subjects must have adequate hematologic, renal, and organ and marrow function
•Age 18 years or older
•Female subjects of childbearing potential who are sexually active with a non sterilized male partner must agree to use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions for 180 days after the last dose of investigational product. Male partners of a female subject must also agree to use male condom plus spermicide throughout this period. Cessation of birth control after this point should be discussed with a responsible physician. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however, occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Female patients should refrain from breastfeeding throughout this period.
+4 more criteria

Exclusion Criteria

•Previous treatment with an immune check-point inhibitors, CTLA-4, PD-1, or PD-L1, including prior treatment with either durvalumab or tremelimumab
•Known central nervous system metastasis. Patients with known brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease may be enrolled if they have been treated, are no longer taking corticosteroids, and have been stable on imaging for at least 3 weeks
•Subjects currently receiving systemic corticosteroids above 10 mg per day for more than 14 days; subjects receiving other systemic immunosuppressive drugs for more than 14 days. Exceptions include: inhaled, intranasal, ophthalmic, and topical corticosteroids, local corticosteroid injections (e.g., intra-articular injections), and subjects requiring corticosteroid pre-medication for hypersensitivity reactions (e.g. CT scan premedication)
•Subjects with medical conditions that require the chronic use of systemic corticosteroids. Exceptions include: inhaled, intranasal, ophthalmic, and topical corticosteroids, local corticosteroid injections (e.g., intra-articular injections), and subjects requiring corticosteroid pre-medication for hypersensitivity reactions (e.g. CT scan premedication)
•Active or prior documented autoimmune disease within the past 2 years, including but not limited to systemic lupus erythematosus, sarcoidosis syndrome, or Wegener's granulomatosis. NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment within the past 2 years are not excluded.
•Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, celiac disease, diverticulitis), or any other chronic, serious gastrointestinal condition associated with diarrhea. NOTE: Subjects with known diverticulosis are permitted to enroll.
•History of interstitial lung disease or pneumonitis that has required steroid administration.
•History of primary immunodeficiency
•History of allogeneic organ transplant
•History of hypersensitivity to tremelimumab, durvalumab, or any excipient
+22 more criteria

Locations (1)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

April 10, 2017

Primary Completion Date

June 7, 2019

Completion Date

December 16, 2024

Last Updated

January 8, 2026

Enrollment

ACTUAL participants

Conditions

Mesothelioma

Interventions

Tremelimumab

DRUG

Durvalumab

DRUG

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RECRUITINGPHASE1

Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

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