Pembrolizumab in Treating Participants With Recurrent Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT03732950|
Recruitment Status : Not yet recruiting
First Posted : November 7, 2018
Last Update Posted : November 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma||Biological: Pembrolizumab||Phase 2|
I. To evaluate clinical anti-tumor activity of pembrolizumab monotherapy based on objective response rate (ORR) as assessed by the investigator per immune related Response Evaluation Criteria in Solid Tumors (irRECIST) in patients with recurrent ovarian cancer (ROC) whose tumors show an immunoreactive gene expression signature.
I. To evaluate clinical anti-tumor activity of pembrolizumab monotherapy based on progression-free survival (PFS) as assessed by the investigator per irRECIST in patients with ROC whose tumors show an immunoreactive gene expression signature.
II. To evaluate clinical anti-tumor activity of pembrolizumab monotherapy based on PFS rate at 6, 12 and 18 months as assessed by the investigator per irRECIST in patients with ROC whose tumors show an immunoreactive gene expression signature.
III. To evaluate and characterize the tolerability and safety profile of the study population after being treated with pembrolizumab as monotherapy.
I. To assess correlations of the immunoreactive gene signature with the validated a PD-L1 immunohistochemistry (IHC) assay using Merck's proprietary 22C3 antibody and the clinical activity observed in the study population.
Participants receive pembrolizumab intravenously (IV) on day 1. Courses repeat every 3 weeks for up to 35 courses (2 years) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 30 and then every 9 and 12 weeks thereafter.
|Study Type :||Interventional|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pembrolizumab Monotherapy in Recurrent Ovarian Cancer of the Immunoreactive Subtype Determined by NanoString Gene Expression Profiling|
|Estimated Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2020|
Experimental: Treatment (pembrolizumab)
Participants receive pembrolizumab intravenously IV on day 1. Courses repeat every 3 weeks for up to 35 courses (2 years) in the absence of disease progression or unacceptable toxicity.
- Overall response rate (ORR) assessed per immune related Response Evaluation Criteria in Solid Tumors (irRECIST) [ Time Frame: Up to 2 years ]ORR will be calculated with corresponding 95% unadjusted exact binomial confidence interval (CI).
- Progression-free survival (PFS) assessed per irRECIST [ Time Frame: At 6, 12, and 18 months ]The Kaplan?Meier method will be used to summarize PFS and PFS at 6 months.
- Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ 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): NCT03732950
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center||Not yet recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Gottfried E. Konecny 310-825-6194 firstname.lastname@example.org|
|Principal Investigator: Gottfried E. Konecny|
|United States, Minnesota|
|University of Minnesota/Masonic Cancer Center||Not yet recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Erin E. Zielinski 612-625-5000 email@example.com|
|Principal Investigator: Erin E. Zielinski|
|Mayo Clinic||Not yet recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Andrea E. Wahner Hendrickson 507-284-2511 Heinrichs.Lori@mayo.edu|
|Principal Investigator: Andrea E. Wahner Hendrickson|
|Principal Investigator:||Gottfried Konecny||UCLA / Jonsson Comprehensive Cancer Center|