A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
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|ClinicalTrials.gov Identifier: NCT03599713|
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Merkel Cell Carcinoma||Drug: Retifanlimab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma (POD1UM-201)|
|Actual Study Start Date :||February 25, 2019|
|Estimated Primary Completion Date :||August 25, 2021|
|Estimated Study Completion Date :||March 28, 2023|
INCMGA00012 administered at the recommended Phase 2 dose by IV infusion once every 28 days.
- Overall Response Rate (ORR) [ Time Frame: Baseline up to approximately 8 months ]Defined as the percentage of participants with an objective response (complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by independent central radiographic review (ICR).
- Duration of Response (DOR) [ Time Frame: Up to approximately 2 years ]Defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until disease progression as determined by ICR or death due to any cause.
- Disease Control Rate (DCR) [ Time Frame: Up to approximately 2 years ]Defined as the proportion of participants with either an objective response or stable disease lasting at least 6 months.
- Progression Free Survival (PFS) [ Time Frame: Up to approximately 2 years ]Defined as the time from the start of therapy until disease progression as determined by the ICR or death due to any cause.
- Overall survival (OS) [ Time Frame: Up to approximately 2 years ]Defined as the time from the start of therapy until death due to any cause.
- Number of Treatment-Emergent Adverse Events (TEAE) [ Time Frame: Up to approximately 2 years ]Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.
- Cmax of INCMGA00012 [ Time Frame: Up to approximately 6 months ]Maximum observed serum concentration.
- tmax of INCMGA00012 [ Time Frame: Up to approximately 6 months ]Time to maximum concentration.
- Cmin of INCMGA00012 [ Time Frame: Up to approximately 6 months ]Minimum observed serum concentration over the dose interval.
- AUCt of INCMGA00012 [ Time Frame: Up to approximately 6 months ]Area under the serum concentration-time curve.
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): NCT03599713
|Contact: Incyte Corporation Call Center (US)||firstname.lastname@example.org|
|Contact: Incyte Corporation Call Center (ex-US)||+800 email@example.com|
|Study Director:||Incyte Medical Monitor||Incyte Corporation|