A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)

Part of paid clinical trials in Duarte, California.

Sponsor
Incyte Corporation
Study ID
NCT03597295
Phase
PHASE2
Status
Completed

Conditions

  • Squamous Cell Carcinoma of Anal Canal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Retifanlimab — DRUG
    Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).

Study Details

The purpose of this study is to assess the efficacy of INCMGA00012 in participants with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed after platinum-based chemotherapy.

Key Dates

Start date
Oct 8, 2018
Status verified
Aug 2025
Primary completion
Jun 8, 2020
Completion
Nov 10, 2021

Study Design

Enrollment
94 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Retifanlimab 500 mg
    Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
UC Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Ridley-Tree Cancer CenterSanta BarbaraCalifornia95817-
Maryland Oncology Hematology P.A.RockvilleMaryland20850-
Texas Oncology-Baylor Charles A. SammonsDallasTexas75246-
Texas Oncology-McKinneyMcKinneyTexas75071-
Renovatio ClinicalSpringTexas77380-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAUC Davis Comprehensive Cancer Center· Sacramento, CARidley-Tree Cancer Center· Santa Barbara, CAMaryland Oncology Hematology P.A.· Rockville, MDTexas Oncology-Baylor Charles A. Sammons· Dallas, TXTexas Oncology-McKinney· McKinney, TX

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