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NCT04472429 · ClinicalTrials.gov registry record · Phase 3
Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
A Phase 3 study, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 308
- Enrollment target
NCT04472429: Completed Phase 3 study, sponsored by Incyte Corporation.
NCT04472429 is a Phase 3 study that has completed, run by Incyte Corporation. The registered enrollment target is 308 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04472429, a Phase 3 study, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 308 participants
- Enrollment target
Study Summary
This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy.
Primary Outcome
PFS was defined as the time from the date of randomization to the date of the first documented disease progression (PD), according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review committee (BICR), or death due to any cause, whichever occurred first. PD: progression of a target or non-target lesion or presence of a new lesion.
Interventions
- DRUG carboplatin
- DRUG paclitaxel
- DRUG retifanlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2021-01-12 |
| Est. Completion | 2025-09-26 |
| Phase | Phase 3 |
What the finished NCT04472429 record still lists
NCT04472429 is an interventional study that assigns participants to a tested intervention. The registered 308 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which carboplatin is the first listed.
NCT04472429 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04472429 about?
NCT04472429 is a clinical study titled "Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).". This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy.
What is the current status of trial NCT04472429?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 308 participants. The study started on 2021-01-12. Estimated completion is 2025-09-26.
What interventions are being tested in trial NCT04472429?
The interventions under investigation include: carboplatin (DRUG), paclitaxel (DRUG), retifanlimab (DRUG).
Who is sponsoring clinical trial NCT04472429?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04472429's enrollment target sits among peer trials
308 1112th of 2000 higher than 886 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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