POD1UM-303 / InterAACT 2 : A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Bowel<br/>CancersCancer LocationBowel
Cancers

Systemic therapy,Treatment | Bowel (colorectum)Anus

Trial Overview Read MoreRead more

This phase III trial will add a type of immunotherapy to chemotherapy treatment in patients with recurrent or metastatic squamous cell carcinoma of the anal canal, to see if it is more or less effective than using chemotherapy on its' own.
 

This trial is treating patients with squamous cell carcinoma of the anal canal.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)

Commercial Sponsor

Incyte Corporation

Summary

Eligible patients will be randomised into Group A or Group B. Depending on their allocation, patients will receive carboplatin on Day 1, paclitaxel on Days 1,8 and 15, and either a placebo or the experimental treatment, retifanlimab, on Day 1 of each 28 day cycle.

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
GI Research Study Coordinator
gi.oncresearch@monashhealth.org
0436386758

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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