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Immunotherapy combo shows promise in Tough-to-Treat anal cancer

NCT ID NCT04472429

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This Phase 3 trial tested whether adding the immunotherapy drug retifanlimab to standard chemotherapy (carboplatin and paclitaxel) helps people with advanced anal cancer that cannot be removed by surgery. The study enrolled 308 adults who had not received chemotherapy for their advanced disease. Researchers measured how long participants lived without their cancer worsening and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
retifanlimab (an immunotherapy drug) combined with chemotherapy (carboplatin and paclitaxel)
What this could lead to
If successful, this combination could become a new standard treatment for advanced anal cancer, potentially improving how long people live without their cancer getting worse.
What could go wrong
This is a completed Phase 3 trial, but results are not yet widely reported. Immunotherapy can cause immune-related side effects, and the benefit may be modest or not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

308 people

The number who actually took part.

Started

Jan 2021

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

anal canal squamous cell carcinoma anus neoplasm squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Squamous cell carcinoma of the anal canal

Contacts and locations

Locations

  • Addenbrooke'S Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Aichi Cancer Center Hospital

    Nagoya, 464-8681, Japan

  • Asklepios Klinik Altona

    Hamburg, 22763, Germany

  • Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli

    Naples, 80131, Italy

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Torrette, 60020, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126, Italy

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Baylor Scott and White Research Institute

    Dallas, Texas, 75246, United States

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014, United States

  • Castle Hill Hospital

    Hull, HU16 5JQ, United Kingdom

  • Center Hospital of the National Center For Global Health and Medicine

    Shinjuku-ku, 162-8655, Japan

  • Centre Antoine Laccassagne

    Nice, 06200, France

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, 33075, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

    Saint-Herblain, 44800, France

  • Chu Besancon Hospital Jean Minjoz

    Besançon, 25030, France

  • Chu Hopital de La Timone

    Marseille, 13385, France

  • Chu Toulouse Hopital Rangueil

    Toulouse, 31059, France

  • Chu de Rennes - Hospital Pontchaillou

    Rennes, 35033, France

  • Churchill Hospital

    Oxford, OX3 7LE, United Kingdom

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

    Milan, 20133, Italy

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006, Spain

  • European Institute of Oncology

    Milan, 20141, Italy

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milan, 20122, Italy

  • Haukeland University Hospital

    Bergen, 05021, Norway

  • Herlev Og Gentofte Hospital

    Herlev, 02730, Denmark

  • Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume

    Rouen, 76031, France

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital General Universitario Vall D Hebron

    Barcelona, 08035, Spain

  • Hospital Universitaire Pitie-Salpetriere

    Paris, 75651, France

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de La Paz

    Madrid, 28046, Spain

  • Hospital de La Miletrie

    Poitiers, 86021, France

  • I.R.C.C.S. Casa Sollievo Della Sofferenza

    San Giovanni Rotondo, 71013, Italy

  • Institut Du Cancer de Montpellier

    Montpellier, 34298, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut de Cancerologie de L Ouest - Site Paul Papin

    Angers, 49055, France

  • Institut de Cancerologie de Strasbourg

    Strasbourg, 67200, France

  • Iov - Istituto Oncologico Veneto Irccs

    Padova, 35128, Italy

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • Leeds Teaching Hospital

    Leeds, LS 9 7TF, United Kingdom

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Monash Medical Centre Clayton

    Clayton, Victoria, 03168, Australia

  • National Cancer Center Hospital

    Chūōku, 104-0045, Japan

  • Ochsner Clinic

    New Orleans, Louisiana, 70121, United States

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • Oslo Universitetssykehus

    Oslo, 00450, Norway

  • Ospedale Degli Infermi

    Rimini, 47923, Italy

  • Panoncology Trials Pan American Center For Oncology Trials, Llc

    San Juan, 00935, Puerto Rico

  • Princess Alexandra Hospital Australia

    Woolloongabba, Queensland, 04102, Australia

  • Renovatio Clinical Consultants Llc

    The Woodlands, Texas, 77380, United States

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218, United States

  • Royal Cornwall Hospital Truro Sunrise Centre

    Truro, TR1 3LQ, United Kingdom

  • Royal Free London Nhs Foundation Trust

    London, NW3 2QG, United Kingdom

  • Royal Preston Hospital

    Preston, PR2 9HT, United Kingdom

  • Royal Surrey County Hospital

    Guildford, GU2 7XX, United Kingdom

  • Royal Sussex County Hospital

    Brighton, BN2 5BE, United Kingdom

  • Sahlgrenska University Hospital

    Gothenburg, 413 45, Sweden

  • Saitama Medical University International Medical Center

    Hidaka-shi, 350-1298, Japan

  • Sansum Clinic

    Santa Barbara, California, 93105, United States

  • Skaenes Universitetssjukhus Lund

    Lund, 22185, Sweden

  • Son Espases University Hospital

    Palma de Mallorca, 07120, Spain

  • Stockholm South General Hospital Sodersjukhuset

    Stockholm, 118 83, Sweden

  • Texas Oncology

    Austin, Texas, 78745, United States

  • Texas Oncology-Wichita Falls Texoma Cancer Center

    Wichita Falls, Texas, 76310, United States

  • The Christie Nhs Foundation Trust Uk

    Manchester, M20 4BV, United Kingdom

  • The Royal Marsden Nhs Foundation Trust - Chelsea

    London, SW3 6JJ, United Kingdom

  • The Royal Marsden Nhs Foundation Trust - Sutton

    Sutton, SM2 5PT, United Kingdom

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724, United States

  • Tohoku University Hospital

    Sendai, 980-8574, Japan

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • Ulb Hospital Erasme

    Brussels, 01070, Belgium

  • Universitatsklinikum Bonn Aoer

    Bonn, 53127, Germany

  • University Clinic Carl Gustav Carus Technical University Dresden

    Dresden, 01307, Germany

  • University Di Cagliari-Presidio Policlinico Monserrato

    Monserrato, 09042, Italy

  • Vejle Hospital

    Vejle, 07100, Denmark

  • Virginia Cancer Specialists, Pc

    Arlington, Virginia, 22205, United States

  • Zna Middelheim

    Antwerp, 02020, Belgium

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