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NCT03597295 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Incyte Corporation.

Completed
Registry status
Phase 2
Development phase
94
Enrollment target

NCT03597295: Completed Phase 2 study, sponsored by Incyte Corporation.

NCT03597295 is a Phase 2 study that has completed, run by Incyte Corporation. The registered enrollment target is 94 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03597295, a Phase 2 study, has completed, sponsored by Incyte Corporation.

COMPLETED
Registry status
Phase 2
Development phase
94 participants
Enrollment target

Study Summary

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.

Primary Outcome

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as assessed by independent central radiographic (ICR) review, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or n

Interventions

  • DRUG Retifanlimab

Trial Details

FieldValue
Enrollment Target 94 participants
Start Date 2018-10-08
Est. Completion 2021-11-10
Phase Phase 2
Incyte Corporation

239 total trials

What the finished NCT03597295 record still lists

NCT03597295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).

The record links to 0 conditions, and to 1 intervention - of which Retifanlimab is the first listed.

NCT03597295 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03597295 about?

NCT03597295 is a clinical study titled "A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)". 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.

What is the current status of trial NCT03597295?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2018-10-08. Estimated completion is 2021-11-10.

What interventions are being tested in trial NCT03597295?

The interventions under investigation include: Retifanlimab (DRUG).

Who is sponsoring clinical trial NCT03597295?

This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03597295's enrollment target sits among peer trials

94 764th of 2000 higher than 1,235 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03597295, the US trial registry maintained by the National Library of Medicine. NCT03597295 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.