A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03075527|
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : January 19, 2018
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)|
|Estimated Enrollment :||40 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|
|Estimated Primary Completion Date :||September 30, 2020|
|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: 2 years ]The smallest measurement of tumor burden as defined per protocol
- Overall Survival [ Time Frame: 2 years ]The time from registration to death due to any cause
- Progression Free Survival [ Time Frame: 2 years ]The time from registration to disease progression or death due to any cause
- Duration of Response [ Time Frame: 2 years ]Time from documentation of tumor response to disease progression
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 years ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075527
|Contact: Mark M. Awad, MD, PhDemail@example.com|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Mark M. Awad, MD, PhD 617-632-3468 firstname.lastname@example.org|
|Principal Investigator: Mark M. Awad, MD, PhD|
|Principal Investigator:||Mark M. Awad, MD, PhD||Dana-Farber Cancer Institute|