Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
NCT ID: NCT04472429
Last Updated: 2025-11-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
308 participants
INTERVENTIONAL
2021-01-12
2025-09-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
International Multicentre Study in Advanced Anal Cancer Comparing Cisplatin Plus 5 FU vs Carboplatin Plus Weekly Paclitaxel
NCT02051868
Clinical and Biological Interest of Taxanes in Advanced Squamous Cell Anal Carcinoma
NCT02402842
Efficacy Study of Chemoradiotherapy With or Without Paclitaxel in Squamous-cell Anal Carcinoma Patients
NCT02526953
Leucovorin, Fluorouracil, Cetuximab, and Oxaliplatin in Treating Patients With Stage IV Colorectal Cancer and Liver Metastases That Cannot Be Removed by Surgery
NCT00544349
Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer
NCT00056446
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A : carboplatin+paclitaxel+placebo
Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and placebo on Day 1 of each 28 day cycle
carboplatin
carboplatin will be administered intravenous on Day 1 of each 28 day cycle
paclitaxel
paclitaxel will be administered intravenous on Days 1,8, and 15 of each 28 day cycle
Group B : carboplatin+paclitaxel+retifanlimab
Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and retifanlimab on Day 1 of each 28 day cycle
carboplatin
carboplatin will be administered intravenous on Day 1 of each 28 day cycle
paclitaxel
paclitaxel will be administered intravenous on Days 1,8, and 15 of each 28 day cycle
retifanlimab
retifanlimab will be administered intravenous on Day 1 of each 28 day cycle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
carboplatin
carboplatin will be administered intravenous on Day 1 of each 28 day cycle
paclitaxel
paclitaxel will be administered intravenous on Days 1,8, and 15 of each 28 day cycle
retifanlimab
retifanlimab will be administered intravenous on Day 1 of each 28 day cycle
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Incyte Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Napoli, , Italy
Iov - Istituto Oncologico Veneto Irccs
Padua, , 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rao S, Samalin-Scalzi E, Evesque L, Ben Abdelghani M, Morano F, Roy A, Dahan L, Tamberi S, Dhadda AS, Saunders MP, Casanova N, Guimbaud R, Lievre A, Maurel J, Fakih M, Tian C, Harrison J, Jones MM, Cornfeld M, Spano JP, Rochefort P; POD1UM-303/InterAACT-2 study investigators. Retifanlimab with carboplatin and paclitaxel for locally recurrent or metastatic squamous cell carcinoma of the anal canal (POD1UM-303/InterAACT-2): a global, phase 3 randomised controlled trial. Lancet. 2025 Jun 14;405(10495):2144-2152. doi: 10.1016/S0140-6736(25)00631-2.
Rao S, Jones M, Bowman J, Tian C, Spano JP. POD1UM-303/InterAACT 2: A phase III, global, randomized, double-blind study of retifanlimab or placebo plus carboplatin-paclitaxel in patients with locally advanced or metastatic squamous cell anal carcinoma. Front Oncol. 2022 Aug 24;12:935383. doi: 10.3389/fonc.2022.935383. eCollection 2022.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-512331-72-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-000826-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCMGA 0012-303
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.