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

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Trial Identification

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

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)

Study ID: NCT04472429

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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, Antwerpen, , Belgium

Ulb Hospital Erasme, Bruxelles, , Belgium

Herlev Og Gentofte Hospital, Herlev, , Denmark

Vejle Hospital, Vejle, , Denmark

Institut de Cancerologie de L Ouest - Site Paul Papin, Angers Cedex 2, , France

Chu Besancon Hospital Jean Minjoz, Besançon, , France

Centre Hospitalier Universitaire de Bordeaux, Bordeaux Cedex, , France

Centre Leon Berard, Lyon, , France

Chu Hopital de La Timone, Marseille Cedex 5, , France

Institut Du Cancer de Montpellier, Montpellier, , France

Centre Antoine Laccassagne, Nice, , France

Hospital Universitaire Pitie-Salpetriere, Paris Cedex 13, , France

Hospital de La Miletrie, Poitiers Cedex, , France

Chu de Rennes - Hospital Pontchaillou, Rennes Cedex 09, , France

Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume, Rouen Cedex, , 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 Cedex 9, , France

Institut Gustave Roussy, Villejuif Cedex, , France

Universitatsklinikum Bonn Aoer, Bonn, , Germany

University Clinic Carl Gustav Carus Technical University Dresden, Dresden, , Germany

Asklepios Klinik Altona, Hamburg, , Germany

Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano, Milano, , Italy

European Institute of Oncology, Milano, , Italy

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milano, , Italy

Fondazione Irccs Ca Granda Ospedale Maggiore, 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, Napoli, , 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, Chuo-ku, , Japan

Kyushu University Hospital, Fukuoka-shi, , Japan

Saitama Medical University International Medical Center, Hidaka-shi, , Japan

Aichi Cancer Center Hospital, Nagoya-shi, , Japan

Osaka International Cancer Institute, Osaka-shi, , Japan

Tohoku University Hospital, Sendai-shi, , 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, Sevilla, , Spain

Hospital Universitario Miguel Servet, Zaragoza, , Spain

Sahlgrenska University Hospital, Goteborg, , 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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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