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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
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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