Single Agent Pembrolizumab in Subjects With Advanced Adrenocortical Carcinoma
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|ClinicalTrials.gov Identifier: NCT02673333|
Recruitment Status : Active, not recruiting
First Posted : February 3, 2016
Last Update Posted : February 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Adrenocortical Carcinoma||Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical Trial of Single Agent Pembrolizumab in Subjects With Advanced Adrenocortical Carcinoma|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W.
- objective response rate (ORR) [ Time Frame: 2 years ]using RECIST v1.1 A Simon two stage minimax design will be employed to carry out this objective. In the first stage, 21 patients will be enrolled. If at least 3 out of 21 patients respond (partial response - PR or complete response - CR), we will enroll an additional 18 patients for a total of 39 patients. At the end of the study, 8 of 39 patients will need to respond to consider the therapy promising. The study will be complete when all subjects have either completed 24 months of drug therapy, progressed, or discontinued from the study for other reasons.
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): NCT02673333
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Diane Reidy-Lagunes, MD||Memorial Sloan Kettering Cancer Center|