Pembrolizumab and Carboplatin for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
|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: NCT04387227|
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : July 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma||Drug: Carboplatin Biological: Pembrolizumab||Phase 2|
Patients receive carboplatin intravenously (IV) over 30 minutes on day -2 of cycle 1 only. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed up at 30 days, then every 3 months for year 1, and every 6 months for year 2.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Anti-PD-1 in Combination With Carboplatin to Prevent Progression After Serologic Detection of Recurrent Ovarian Cancer|
|Estimated Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||April 3, 2023|
|Estimated Study Completion Date :||April 3, 2024|
Experimental: Treatment (carboplatin, pembrolizumab)
Patients receive carboplatin IV over 30 minutes on day -2 of cycle 1 only. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
- Progression-free survival [ Time Frame: At 6 months ]
- Rate of radiographic recurrence [ Time Frame: At 6 months ]
- Programmed cell death ligand 1 (PD-L1) expression [ Time Frame: Up to 2 years ]Evaluated by immunohistochemistry staining in combined tumor and inflammatory cells in which positivity will be defined by > 1% staining.
- PD-L2 expression [ Time Frame: Up to 2 years ]Evaluated by immunohistochemistry staining in combined tumor and inflammatory cells in which positivity will be defined by > 1% staining.
- Changes in T cell activation [ Time Frame: Baseline and 2 years ]Flow cytometry will be performed on peripheral blood mononuclear cells
- Overall survival [ Time Frame: Up to 2 years ]
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): NCT04387227
|Contact: Kris Kaunofirstname.lastname@example.org|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Contact: Kris Kauno 206-543-3829 email@example.com|
|Principal Investigator: John B. Liao|
|Principal Investigator:||John B. Liao||Fred Hutch/University of Washington Cancer Consortium|