Durvalumab + Chemotherapy for Mesothelioma
(DREAM3R Trial)

Recruiting in Palo Alto (17 mi)

+56 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: PrECOG, LLC.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

Patients with pleural mesothelioma (PM) that cannot be surgically removed will receive standard chemotherapy (cisplatin or carboplatin and pemetrexed) given with durvalumab, a type of immunotherapy, or a treatment chosen by the study doctor, which is either standard chemotherapy or immunotherapy combination (ipilimumab and nivolumab). Durvalumab is an antibody (a type of human protein) that works by blocking a body substance called Programmed Death-Ligand 1 (PD-L1). Blocking PD-L1 helps the body's immune system attack cancer cells. Research has shown that durvalumab can slow tumor growth and shrink tumors in some people with cancer. Previous studies of combining durvalumab and chemotherapy showed that this combination is active in advanced mesothelioma. The purpose of this study is to see whether adding durvalumab to standard chemotherapy will improve overall survival (OS) in patients with PM.

Research Team

Patrick Forde, MD

Principal Investigator

Johns Hopkins University

Anna Nowak, MD

Principal Investigator

Faculty of Health and Medical Sciences University of Western Australia

Eligibility Criteria

Adults over 18 with epithelioid pleural mesothelioma that can't be removed by surgery. They should have a good performance status, weigh more than 30 kg, and have acceptable blood test results. Women must not be pregnant and use contraception; men also need to follow certain contraceptive guidelines.

Inclusion Criteria

Life expectancy of at least 12 weeks.

Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.

I am an adult diagnosed with a type of cancer called epithelioid pleural mesothelioma that cannot be removed by surgery.

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Exclusion Criteria

My diagnosis was confirmed with a fine needle biopsy.

I have hearing loss or nerve issues that prevent me from taking certain medications.

I do not have active brain cancer symptoms or uncontrolled brain metastases.

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Treatment Details

Interventions

Durvalumab (Monoclonal Antibodies)
Ipilimumab and Nivolumab (Monoclonal Antibodies)
Standard Chemotherapy (Anti-tumor antibiotic)

Trial OverviewThe trial is testing if adding durvalumab (an immunotherapy drug) to standard chemotherapy improves survival in patients with advanced pleural mesothelioma compared to standard chemotherapy alone or combined with other immunotherapies like ipilimumab and nivolumab.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Arm: Durvalumab + Chemotherapy, then Durvalumab MaintenanceExperimental Treatment1 Intervention

Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab

Group II: Control Arm: Chemotherapy, then ObservationActive Control1 Intervention

Standard Chemotherapy for 4 to 6 cycles, followed by Observation

Group III: Control Arm: Ipilimumab and NivolumabActive Control1 Intervention

Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years.

Durvalumab is already approved in Japan for the following indications: