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 : Completed
First Posted : July 24, 2018
Results First Posted : August 23, 2021
Last Update Posted : January 20, 2022
|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 8, 2020|
|Actual Study Completion Date :||November 10, 2021|
INCMGA00012 administered at the recommended Phase 2 dose by intravenous infusion once every 28 days.
- Overall Response Rate (ORR) [ Time Frame: Cycle 1 day 1, and every 4 weeks throughout the study, up to approximately 24 months. ]Defined as Complete Response (CR),- Disappearance of all target lesions; Partial Response (PR)->=30% decrease in the sum of the longest diameter (LD) of target lesions from baseline; Overall Response (OR) = CR + PR, as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by independent central radiographic review (ICR)
- Duration of Response [ Time Frame: Up to approximately 3 years ]The time measurement from initial objective response Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions), as per RECIST v1.0, until the first date that disease progression is determined by ICR or death.
- Disease Control Rate [ Time Frame: Up to approximately 3 years ]The number of participants with a confirmed overall response of CR, PR, or SD, as per RECIST 1.1, at any postbaseline visit until the first PD or start of new anticancer therapy.
- Progression-free Survival [ Time Frame: Up to approximately 3 years ]According to RECIST 1.1, PFS is defined as the length of time from initial infusion of study drug until the earliest date of disease progression, determined by ICR, or death due to any cause, if occurring sooner than progression.
- Overall Survival [ Time Frame: Up to approximately 3 years ]Overall survival is defined as the time in months between the first dose date (Day 1) and the date of 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: Preinfusion on Day 1 of Cycles 1, 2, 4, 6, and 7 and 10 minutes and 4 hrs post-infusion on D1C1 and D1C6 ]Maximum observed plasma concentration
- Tmax of INCMGA00012 [ Time Frame: Preinfusion, 10 minutes post-infusion D1C6 ]Time to maximum concentration.
- Cmin of INCMGA00012 [ Time Frame: Preinfusion on Day 1 of Cycles 1, 2, 4, 6, and 7 and 10 minutes and 4 hrs post-infusion on D1C1 and D1C6 ]Minimum observed plasma concentration over the dose interval.
- AUC0-t of INCMGA00012 [ Time Frame: Preinfusion on Day 1 of Cycles 1, 2, 4, 6, and 7 and 10 minutes post-infusion and 4 hrs post-infusion on D1C1 and D1C6 ]Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t. Cycle 1 and Cycle 6: Day 1 predose and 10 min and 4 h after infusion Cycles 2, 4, and 7: Day 1 predose
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|