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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

308

Participants

Timeline

Start Date

January 12, 2021

Primary Completion Date

April 15, 2024

Study Completion Date

March 16, 2026

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

Trial Locations (84)

5042

Flinders Medical Centre, Bedford Park

13385

Chu Hopital de La Timone, Marseille

15006

Complejo Hospitalario Universitario A Coruna, A Coruña

20122

Fondazione Irccs Ca Granda Ospedale Maggiore, Milan

20133

Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano, Milan

20141

European Institute of Oncology, Milan

20162

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan

21044

Maryland Oncology Hematology, P.A., Columbia

22185

Skaenes Universitetssjukhus Lund, Lund

22205

Virginia Cancer Specialists, Pc, Arlington

22763

Asklepios Klinik Altona, Hamburg

24014

Blue Ridge Cancer Care, Roanoke

25030

Chu Besancon Hospital Jean Minjoz, Besançon

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario de La Paz, Madrid

31059

Chu Toulouse Hopital Rangueil, Toulouse

33075

Centre Hospitalier Universitaire de Bordeaux, Bordeaux

34298

Institut Du Cancer de Montpellier, Montpellier

35033

Chu de Rennes - Hospital Pontchaillou, Rennes

35128

Iov - Istituto Oncologico Veneto Irccs, Padua

41013

Hospital Universitario Virgen Del Rocio, Seville

44800

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

47923

Ospedale Degli Infermi, Rimini

49055

Institut de Cancerologie de L Ouest - Site Paul Papin, Angers

50009

Hospital Universitario Miguel Servet, Zaragoza

53127

Universitatsklinikum Bonn Aoer, Bonn

55905

Mayo Clinic, Rochester

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

60020

Azienda Ospedaliero Universitaria Ospedali Riuniti, Torrette

67200

Institut de Cancerologie de Strasbourg, Strasbourg

69008

Centre Leon Berard, Lyon

70121

Ochsner Clinic, New Orleans

71013

I.R.C.C.S. Casa Sollievo Della Sofferenza, San Giovanni Rotondo

75246

Baylor Scott and White Research Institute, Dallas

75651

Hospital Universitaire Pitie-Salpetriere, Paris

76031

Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume, Rouen

76310

Texas Oncology-Wichita Falls Texoma Cancer Center, Wichita Falls

77380

Renovatio Clinical Consultants Llc, The Woodlands

78745

Texas Oncology, Austin

80131

Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli, Napoli

80218

Rocky Mountain Cancer Center, Denver

85724

The University of Arizona Cancer Center, Tucson

86021

Hospital de La Miletrie, Poitiers

91010

City of Hope National Medical Center, Duarte

93105

Sansum Clinic, Santa Barbara

94805

Institut Gustave Roussy, Villejuif

95817

UC Davis Comprehensive Cancer Center, Sacramento

04102

Princess Alexandra Hospital Australia, Woolloongabba

03168

Monash Medical Centre Clayton, Clayton

02020

Zna Middelheim, Antwerp

01070

Ulb Hospital Erasme, Brussels

02730

Herlev Og Gentofte Hospital, Herlev

07100

Vejle Hospital, Vejle

06200

Centre Antoine Laccassagne, Nice

01307

University Clinic Carl Gustav Carus Technical University Dresden, Dresden

09042

University Di Cagliari-Presidio Policlinico Monserrato, Monserrato

104-0045

National Cancer Center Hospital, Chūōku

812-8582

Kyushu University Hospital, Fukuoka

350-1298

Saitama Medical University International Medical Center, Hidaka-shi

464-8681

Aichi Cancer Center Hospital, Nagoya

541-8567

Osaka International Cancer Institute, Osaka

980-8574

Tohoku University Hospital, Sendai

162-8655

Center Hospital of the National Center For Global Health and Medicine, Shinjuku-ku

05021

Haukeland University Hospital, Bergen

00450

Oslo Universitetssykehus, Oslo

00935

Panoncology Trials Pan American Center For Oncology Trials, Llc, San Juan

08035

Hospital General Universitario Vall D Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

07120

Son Espases University Hospital, Palma de Mallorca

413 45

Sahlgrenska University Hospital, Gothenburg

118 83

Stockholm South General Hospital Sodersjukhuset, Stockholm

BN2 5BE

Royal Sussex County Hospital, Brighton

CB2 0QQ

Addenbrooke'S Hospital, Cambridge

GU2 7XX

Royal Surrey County Hospital, Guildford

HU16 5JQ

Castle Hill Hospital, Hull

LS 9 7TF

Leeds Teaching Hospital, Leeds

NW3 2QG

Royal Free London Nhs Foundation Trust, London

SW3 6JJ

The Royal Marsden Nhs Foundation Trust - Chelsea, London

M20 4BV

The Christie Nhs Foundation Trust Uk, Manchester

OX3 7LE

Churchill Hospital, Oxford

PR2 9HT

Royal Preston Hospital, Preston

SM2 5PT

The Royal Marsden Nhs Foundation Trust - Sutton, Sutton

TR1 3LQ

Royal Cornwall Hospital Truro Sunrise Centre, Truro

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY