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Trial 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.

Acronym:

POD1UM-303/InterAACT 2

ACTRN/NCT /ethics:

NCT04472429

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)

Sponsor / Cooperative group:

Incyte Corporation

Trial & Patient Characteristics

Cancer TypeBowel and colon
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexAll
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced, Metastatic or Widespread
Anticipated Start Date2020-11-09
Anticipated End Date2024-10-24

Participating Hospitals

HospitalFlinders Medical Centre
Clinical Trial CoordinatorHannah Adelson
EmailHannah.adelson@sa.gov.au
Phone08 8206 4835
Principal InvestigatorDr Amitesh Roy
Recruitment StatusRecruiting