Pembrolizumab in Patients With Poor-Prognosis Carcinoma of Unknown Primary Site (CUP) (CUP)
|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: NCT03391973|
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : March 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma of Unknown Primary||Drug: Pembrolizumab Injection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a multi-centre, single arm phase 2 study of Pembrolizumab (Keytruda™ or MK-3475) in treatment naïve patients with poor prognosis carcinoma of unknown primary site (CUP).|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Centre, Single Arm, Phase 2 Trial of Pembrolizumab in Treatment Naïve Patients With Poor-Prognosis Carcinoma of Unknown Primary Site|
|Actual Study Start Date :||August 24, 2018|
|Estimated Primary Completion Date :||January 14, 2022|
|Estimated Study Completion Date :||January 14, 2023|
Experimental: Arm 1 - Pembrolizumab
Arm 1 - Pembrolizumab injection dosed at 200 mg given Q3 weeks by IV infusion on Day 1 of each 3 week cycle.
Drug: Pembrolizumab Injection
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W.
- Number of participants that develop an objective response to treatment. [ Time Frame: Within 3 years ]The objective response rate will be assessed by RECIST 1.1
- Number of participants that develop an adverse event to treatment. [ Time Frame: Within 3 years ]Treatment related adverse events will be assessed using CTCAE v4.0.
- The overall survival (OS) of participants. [ Time Frame: Within 4 years ]OS is the time from treatment initiation to death due to any cause
- The progression free survival (PFS) of participants. [ Time Frame: Within 4 years ]Progression will be assessed by RECIST 1.1
- The duration of response (DOR) of participants. [ Time Frame: Within 4 years ]Response will be assessed by RECIST 1.1
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): NCT03391973
|Contact: Jose Monzon, MD||(403)-5213688||Jose.Monzon@albertahealthservices.ca|
|Principal Investigator:||Jose Monzon, MD||Alberta Health Services|