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NCT04472429

PHASE3

Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).

Sponsor: Incyte Corporation

View on ClinicalTrials.gov

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.

Official 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

308

Start Date

2021-01-12

Completion Date

2025-09-26

Last Updated

2026-09-02

Healthy Volunteers

Conditions

Squamous Cell Carcinoma of the Anal Canal

Interventions

DRUG

carboplatin

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

DRUG

paclitaxel

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

DRUG

retifanlimab

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

Inclusion Criteria: * Able to comprehend and willing to sign a written ICF for the study. * Are 18 years of age or older (or as applicable per local country requirements). * Histologically or cytologically verified, inoperable locally recurrent or metastatic SCAC. * No prior systemic therapy other than the following: a. Chemotherapy administered concomitantly with radiotherapy as a radiosensitizing agent is permitted. b. Prior neoadjuvant or adjuvant therapy if completed ≥ 6 months before study entry. * Has measurable disease per RECIST v1.1 as determined by local site investigator/radiology assessment. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion. * Able and willing to provide adequate tissue sample and whole blood sample with central testing result prior to randomization. Biopsy for archival samples should have occurred within 9 months prior to randomization. * ECOG performance status 0 to 1. * If HIV-positive, then must be stable as defined by: a. CD4+ count ≥ 200/μL, b. Undetectable viral load per standard of care assay, c. Receiving antiretroviral therapy (ART/HAART) for at least 4 weeks prior to study enrollment, and have not experienced any HIV-related opportunistic infection for at least 4 weeks prior to study enrollment. * Willingness to avoid pregnancy or fathering children Exclusion Criteria: * Has received prior PD-(L)1 directed therapy * Has received prior radiotherapy with or without radiosensitizing chemotherapy within 28 days of Cycle 1 Day 1 except for palliative radiation (30 Gy or less) which is restricted for 14 days of Cycle 1 Day 1 (note: all toxicities associated should have resolved to Grade ≤ 1). * Participants with laboratory outside of the protocol defined ranges. * History of second malignancy within 3 years (with exceptions). * Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders. * Active bacterial, fungal, or viral infections, including hepatitis A, B, and C and IV antibiotic use within 7 days of Cycle 1 Day 1. * Receipt of a live vaccine within 28 days of planned start of study therapy. * History of organ transplant, including allogeneic stem cell transplantation. * Known active CNS metastases and/or carcinomatous meningitis. * Known hypersensitivity to platinum, paclitaxel, another monoclonal antibody, or any of the excipients that cannot be controlled with standard measures (eg, antihistamines, corticosteroids). * Participant is pregnant or breastfeeding. * Current use of protocol defined prohibited medication. * Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE v5. * Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements

Locations (84)

The University of Arizona Cancer Center

Tucson, Arizona, United States

City of Hope National Medical Center

Duarte, California, United States

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

Sansum Clinic

Santa Barbara, California, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Ochsner Clinic

New Orleans, Louisiana, United States

Maryland Oncology Hematology, P.A.

Columbia, Maryland, United States

Mayo Clinic

Rochester, Minnesota, United States

Texas Oncology

Austin, Texas, United States

Baylor Scott and White Research Institute

Dallas, Texas, United States

Renovatio Clinical Consultants Llc

The Woodlands, Texas, United States

Texas Oncology-Wichita Falls Texoma Cancer Center

Wichita Falls, Texas, United States

Virginia Cancer Specialists, Pc

Arlington, Virginia, United States

Blue Ridge Cancer Care

Roanoke, Virginia, United States

Princess Alexandra Hospital Australia

Woolloongabba, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Monash Medical Centre Clayton

Clayton, Victoria, Australia

Zna Middelheim

Antwerp, Belgium

Ulb Hospital Erasme

Brussels, Belgium

Herlev Og Gentofte Hospital

Herlev, Denmark

Vejle Hospital

Vejle, Denmark

Institut de Cancerologie de L Ouest - Site Paul Papin

Angers, France

Chu Besancon Hospital Jean Minjoz

Besançon, France

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France

Centre Leon Berard

Lyon, France

Chu Hopital de La Timone

Marseille, France

Institut Du Cancer de Montpellier

Montpellier, France

Centre Antoine Laccassagne

Nice, France

Hospital Universitaire Pitie-Salpetriere

Paris, France

Hospital de La Miletrie

Poitiers, France

Chu de Rennes - Hospital Pontchaillou

Rennes, France

Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume

Rouen, France

Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

Saint-Herblain, France

Institut de Cancerologie de Strasbourg

Strasbourg, France

Chu Toulouse Hopital Rangueil

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Universitatsklinikum Bonn Aoer

Bonn, Germany

University Clinic Carl Gustav Carus Technical University Dresden

Dresden, Germany

Asklepios Klinik Altona

Hamburg, Germany

Fondazione Irccs Ca Granda Ospedale Maggiore

Milan, Italy

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, Italy

Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

Milan, Italy

European Institute of Oncology

Milan, Italy

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, Italy

University Di Cagliari-Presidio Policlinico Monserrato

Monserrato, Italy

Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli

Naples, Italy

Iov - Istituto Oncologico Veneto Irccs

Padova, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Ospedale Degli Infermi

Rimini, Italy

I.R.C.C.S. Casa Sollievo Della Sofferenza

San Giovanni Rotondo, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti

Torrette, Italy

National Cancer Center Hospital

Chūōku, Japan

Kyushu University Hospital

Fukuoka, Japan

Saitama Medical University International Medical Center

Hidaka-shi, Japan

Aichi Cancer Center Hospital

Nagoya, Japan

Osaka International Cancer Institute

Osaka, Japan

Tohoku University Hospital

Sendai, Japan

Center Hospital of the National Center For Global Health and Medicine

Shinjuku-ku, Japan

Haukeland University Hospital

Bergen, Norway

Oslo Universitetssykehus

Oslo, Norway

Panoncology Trials Pan American Center For Oncology Trials, Llc

San Juan, Puerto Rico

Complejo Hospitalario Universitario A Coruna

A Coruña, Spain

Hospital General Universitario Vall D Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario de La Paz

Madrid, Spain

Son Espases University Hospital

Palma de Mallorca, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Sahlgrenska University Hospital

Gothenburg, Sweden

Skaenes Universitetssjukhus Lund

Lund, Sweden

Stockholm South General Hospital Sodersjukhuset

Stockholm, Sweden

Royal Sussex County Hospital

Brighton, United Kingdom

Addenbrooke'S Hospital

Cambridge, United Kingdom

Royal Surrey County Hospital

Guildford, United Kingdom

Castle Hill Hospital

Hull, United Kingdom

Leeds Teaching Hospital

Leeds, United Kingdom

Royal Free London Nhs Foundation Trust

London, United Kingdom

The Royal Marsden Nhs Foundation Trust - Chelsea

London, United Kingdom

The Christie Nhs Foundation Trust Uk

Manchester, United Kingdom

Churchill Hospital

Oxford, United Kingdom

Royal Preston Hospital

Preston, United Kingdom

The Royal Marsden Nhs Foundation Trust - Sutton

Sutton, United Kingdom

Royal Cornwall Hospital Truro Sunrise Centre

Truro, United Kingdom

Clinical Research Directory

Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (84)