Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
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)
3 other identifiers
interventional
308
13 countries
84
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2021
Longer than P75 for phase_3
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2020
CompletedFirst Posted
Study publicly available on registry
July 15, 2020
CompletedStudy Start
First participant enrolled
January 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2024
CompletedResults Posted
Study results publicly available
May 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2025
CompletedNovember 3, 2025
October 1, 2025
3.3 years
July 13, 2020
April 8, 2025
October 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
PFS was defined as the time from the date of randomization to the date of the first documented disease progression (PD), according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review committee (BICR), or death due to any cause, whichever occurred first. PD: progression of a target or non-target lesion or presence of a new lesion.
up to 33.9 months
Secondary Outcomes (12)
Overall Survival
up to 40.4 months
Objective Response Rate (ORR)
up to 445 days
Duration of Response (DOR)
up to 32.1 months
Disease Control Rate (DCR)
up to 445 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) During the Randomized Period
up to 535 days
- +7 more secondary outcomes
Study Arms (2)
Group A : carboplatin+paclitaxel+placebo
PLACEBO COMPARATORParticipants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and placebo on Day 1 of each 28 day cycle
Group B : carboplatin+paclitaxel+retifanlimab
EXPERIMENTALParticipants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and retifanlimab on Day 1 of each 28 day cycle
Interventions
carboplatin will be administered intravenous on Day 1 of each 28 day cycle
paclitaxel will be administered intravenous on Days 1,8, and 15 of each 28 day cycle
retifanlimab will be administered intravenous on Day 1 of each 28 day cycle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (84)
The University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Sansum Clinic
Santa Barbara, California, 93105, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
Ochsner Clinic
New Orleans, Louisiana, 70121, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Texas Oncology
Austin, Texas, 78745, United States
Baylor Scott and White Research Institute
Dallas, Texas, 75246, United States
Renovatio Clinical Consultants Llc
The Woodlands, Texas, 77380, United States
Texas Oncology-Wichita Falls Texoma Cancer Center
Wichita Falls, Texas, 76310, United States
Virginia Cancer Specialists, Pc
Arlington, Virginia, 22205, United States
Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Princess Alexandra Hospital Australia
Woolloongabba, Queensland, 04102, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Monash Medical Centre Clayton
Clayton, Victoria, 03168, Australia
Zna Middelheim
Antwerp, 02020, Belgium
Ulb Hospital Erasme
Brussels, 01070, Belgium
Herlev Og Gentofte Hospital
Herlev, 02730, Denmark
Vejle Hospital
Vejle, 07100, Denmark
Institut de Cancerologie de L Ouest - Site Paul Papin
Angers, 49055, France
Chu Besancon Hospital Jean Minjoz
Besançon, 25030, France
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33075, France
Centre Leon Berard
Lyon, 69008, France
Chu Hopital de La Timone
Marseille, 13385, France
Institut Du Cancer de Montpellier
Montpellier, 34298, France
Centre Antoine Laccassagne
Nice, 06200, France
Hospital Universitaire Pitie-Salpetriere
Paris, 75651, France
Hospital de La Miletrie
Poitiers, 86021, France
Chu de Rennes - Hospital Pontchaillou
Rennes, 35033, France
Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
Rouen, 76031, France
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
Saint-Herblain, 44800, France
Institut de Cancerologie de Strasbourg
Strasbourg, 67200, France
Chu Toulouse Hopital Rangueil
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94805, France
Universitatsklinikum Bonn Aoer
Bonn, 53127, Germany
University Clinic Carl Gustav Carus Technical University Dresden
Dresden, 01307, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, 20122, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
Milan, 20133, Italy
European Institute of Oncology
Milan, 20141, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
University Di Cagliari-Presidio Policlinico Monserrato
Monserrato, 09042, Italy
Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli
Napoli, 80131, Italy
Iov - Istituto Oncologico Veneto Irccs
Padua, 35128, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Ospedale Degli Infermi
Rimini, 47923, Italy
I.R.C.C.S. Casa Sollievo Della Sofferenza
San Giovanni Rotondo, 71013, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Torrette, 60020, Italy
National Cancer Center Hospital
Chūōku, 104-0045, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Saitama Medical University International Medical Center
Hidaka-shi, 350-1298, Japan
Aichi Cancer Center Hospital
Nagoya, 464-8681, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Tohoku University Hospital
Sendai, 980-8574, Japan
Center Hospital of the National Center For Global Health and Medicine
Shinjuku-ku, 162-8655, Japan
Haukeland University Hospital
Bergen, 05021, Norway
Oslo Universitetssykehus
Oslo, 00450, Norway
Panoncology Trials Pan American Center For Oncology Trials, Llc
San Juan, 00935, Puerto Rico
Complejo Hospitalario Universitario A Coruna
A Coruña, 15006, Spain
Hospital General Universitario Vall D Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario de La Paz
Madrid, 28046, Spain
Son Espases University Hospital
Palma de Mallorca, 07120, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
Skaenes Universitetssjukhus Lund
Lund, 22185, Sweden
Stockholm South General Hospital Sodersjukhuset
Stockholm, 118 83, Sweden
Royal Sussex County Hospital
Brighton, BN2 5BE, United Kingdom
Addenbrooke'S Hospital
Cambridge, CB2 0QQ, United Kingdom
Royal Surrey County Hospital
Guildford, GU2 7XX, United Kingdom
Castle Hill Hospital
Hull, HU16 5JQ, United Kingdom
Leeds Teaching Hospital
Leeds, LS 9 7TF, United Kingdom
Royal Free London Nhs Foundation Trust
London, NW3 2QG, United Kingdom
The Royal Marsden Nhs Foundation Trust - Chelsea
London, SW3 6JJ, United Kingdom
The Christie Nhs Foundation Trust Uk
Manchester, M20 4BV, United Kingdom
Churchill Hospital
Oxford, OX3 7LE, United Kingdom
Royal Preston Hospital
Preston, PR2 9HT, United Kingdom
The Royal Marsden Nhs Foundation Trust - Sutton
Sutton, SM2 5PT, United Kingdom
Royal Cornwall Hospital Truro Sunrise Centre
Truro, TR1 3LQ, United Kingdom
Related Publications (2)
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.
PMID: 40517007DERIVEDRao 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.
PMID: 36091159DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
July 13, 2020
First Posted
July 15, 2020
Study Start
January 12, 2021
Primary Completion
April 15, 2024
Study Completion
September 26, 2025
Last Updated
November 3, 2025
Results First Posted
May 23, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
- Access Criteria
- Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency