A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)
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|ClinicalTrials.gov Identifier: NCT03597295|
Recruitment Status : Active, not recruiting
First Posted : July 24, 2018
Last Update Posted : April 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of Anal Canal||Drug: Retifanlimab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy (POD1UM-202)|
|Actual Study Start Date :||October 8, 2018|
|Actual Primary Completion Date :||June 6, 2020|
|Estimated Study Completion Date :||February 17, 2022|
INCMGA00012 administered at the recommended Phase 2 dose by intravenous infusion once every 28 days.
- Overall response rate (ORR) [ Time Frame: Up to approximately 6 months ]Defined as the percentage of participants having a 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 [ Time Frame: Up to approximately 3 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 [ Time Frame: Up to approximately 3 years ]Defined as the number of participants maintaining either an ORR or stable disease.
- Progression-free survival [ Time Frame: Up to approximately 3 years ]Defined as the time from the first dose of study treatment until disease progression by ICR or death due to any cause.
- Overall survival [ Time Frame: Up to approximately 3 years ]Defined as the time from the start of therapy until death due to any cause.
- Number of treatment-emergent adverse events [ Time Frame: Up to approximately 3 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 plasma 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 plasma concentration over the dose interval.
- AUC0-t of INCMGA00012 [ Time Frame: Up to approximately 6 months ]Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
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): NCT03597295
|Study Director:||Incyte Medical Monitor||Incyte Corporation|