Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Anus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Anal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and placebo on Day 1 of each 28 day cycle

Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and retifanlimab on Day 1 of each 28 day cycle

carboplatin will be administered intravenous on Day 1 of each 28 day cycle

carboplatin

paclitaxel will be administered intravenous on Days 1,8, and 15 of each 28 day cycle

paclitaxel

retifanlimab will be administered intravenous on Day 1 of each 28 day cycle

retifanlimab

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.

Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (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)

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Defined as the time from the date of randomization until disease progression according to RECIST v1.1 by BICR or death due to any cause.

Defined as the time from the date of randomization until death due to any cause.

Defined as the proportion of participants who have a confirmed complete response or partial response per RECIST v1.1 based on BICR.

Defined as the time from the earliest date of documented response until earliest date of disease progression (per RECIST v1.1 based on BICR) or death from any cause, whichever comes first.

Defined as the number of participants maintaining either an ORR or stable disease.

Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 90 days after last dose of study treatment.

Maximum observed plasma or serum concentration.

Minimum observed plasma or serum concentration over the dose interval

Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).	NCT04472429	Squamous Cell C...	carboplatin paclitaxel retifanlimab	18 Years -	Incyte Corporation
Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).	NCT04472429	Squamous Cell C...	carboplatin paclitaxel retifanlimab	18 Years -	Incyte Corporation
Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).	NCT04472429	Squamous Cell C...	carboplatin paclitaxel retifanlimab	18 Years -	Incyte Corporation

Spots Global Cancer Trial Database for scac

Every month we try and update this database with for scac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for scac

Every month we try and update this database with for scac cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for scac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.