A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma
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|ClinicalTrials.gov Identifier: NCT03075527|
Recruitment Status : Suspended (Criteria not met for second stage at time of interim analysis)
First Posted : March 9, 2017
Results First Posted : November 12, 2019
Last Update Posted : April 3, 2020
This research study is studying a pair of immunotherapies as a possible treatment for malignant pleural mesothelioma.
The drugs involved in this study are:
|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma||Drug: Tremelimumab Drug: Durvalumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma|
|Actual Study Start Date :||April 10, 2017|
|Actual Primary Completion Date :||June 7, 2019|
|Estimated Study Completion Date :||September 30, 2024|
Experimental: Tremelimumab + Durvalumab
Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.
Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.
Other Name: CP-675,206
Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
Other Name: MEDI-4736
- Overall Response Rate [ Time Frame: ORR was assessed every 8 weeks from Cycle 1 Day 1 until date of documented disease progression or death. ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Overall Survival [ Time Frame: Overall survival is assessed from date of registration until date of death on-treatment or during follow-up. ]defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive.
- Progression Free Survival [ Time Frame: PFS is measured from time of registration to date of radiographic progression per RECIST1.1 or death. ]Progression-Free Survival (PFS) is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.
- Duration of Response [ Time Frame: Duration of response will be assessed at study completion, after all participants are off treatment. ]Time from documentation of tumor response to disease progression
- Adverse Events [ Time Frame: Toxicity is assessed from the time of first dose of study medication until the participant comes off study. Adverse event profile will be assessed at study completion. ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075527
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Mark M. Awad, MD, PhD||Dana-Farber Cancer Institute|