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New hope for advanced endometrial cancer: immunotherapy combo trial shows promise

NCT ID NCT04463771

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 study tested a drug called retifanlimab, which helps the immune system attack cancer, either alone or combined with other targeted drugs. It enrolled 206 women with advanced or metastatic endometrial cancer that had worsened after platinum-based chemotherapy. The goal was to see if these treatments could shrink tumors or slow the disease.

What this could mean

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

Active substance
retifanlimab (a drug that helps the immune system fight cancer), sometimes combined with epacadostat, pemigatinib, INCAGN02385, or INCAGN02390
What this could lead to
If successful, this could point toward new treatment options for advanced endometrial cancer that has stopped responding to standard chemotherapy.
What could go wrong
This is a phase 2 study, so results are still early. The drug combinations may not work better than existing treatments, and side effects from immunotherapy can be serious.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

206 people

The number who actually took part.

Started

Jan 2021

Finished

May 2026

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

Female participants only

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: * Ability to comprehend and willingness to sign a written ICF for the study. Note for Germany: This excludes individuals who are housed in an institution due to official or court order Women 18 years of age or older (or as applicable per local country requirements). * Histologically confirmed diagnosis of advanced or metastatic endometrial cancer with disease progression on or after treatment with at least 1 platinum-containing regimen for advanced or metastatic disease. * Groups A, B, and E: Have not been previously treated with a PD-(L)1 inhibitor. * Group A only: Tumor tissue tested as MSI-High * Group B only: Tumor tissue tested as deficient MMR or an ultra-mutated POLE tumor. * Group D only: Tumor tissue tested as having an FGFR 1,2,3 mutation or alteration characterized as per protocol. * Group E: Tumor tissue tested as MSS and PD-L1 positive. * Group F: Radiological evidence of disease progression on or after prior PD (L)1 therapy and Tumor tissue tested as MSI-H * Must have at least 1 measurable tumor lesion per RECIST v1.1. * Willing to provide tumor tissue sample (fresh or archived). * ECOG performance status 0 to 1. * Willingness to avoid pregnancy. Exclusion Criteria: * Group A, B and E only: Histologically confirmed diagnosis of carcinosarcoma of the uterus. * Histologically confirmed diagnosis of sarcoma of the uterus. * Has disease eligible for potentially curative treatment. * Receipt of anticancer therapy within 28 days of the first administration of study treatment, with the exception of localized radiotherapy. * Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline unless approved by the medical monitor. * Groups C, D and F (combinations): limiting immune-related toxicity during prior checkpoint inhibitor therapy. * Group F only: Previous treatment with LAG-# or TIM-3 therapy or lenvatinib; multiple metastases that achieved mixed tumor response to prior anti-PD-(L)1 therapy * Has an active autoimmune disease requiring systemic immunosuppression with corticosteroids (\> 10 mg/day of prednisone or equivalent) or immunosuppressive drugs within 14 days before the first dose of study treatment. * Receiving chronic systemic steroids (\> 10 mg/day of prednisone or equivalent): * Known active CNS metastases and/or carcinomatous meningitis. * Has known active hepatitis B or C. * Has received a live vaccine within 28 days of the planned start of study treatment. * Evidence of interstitial lung disease or active, noninfectious pneumonitis. * Participants who are known to be HIV-positive with some protocol exceptions.

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrial carcinoma endometrium neoplasm Neoplasm Metastasis

As listed by the trial registrant

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

Endometrial cancer

Contacts and locations

Locations

  • Advent Health Medical Group-Orlando 2501

    Orlando, Florida, 32804, United States

  • Alaska Womens Cancer Care Akwcc

    Anchorage, Alaska, 99508, United States

  • Alexandra General Hospital of Athens

    Athens, 11528, Greece

  • Arizona Oncology Associates

    Tucson, Arizona, 85711, United States

  • Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi

    Bologna, 40138, Italy

  • Barbara Ann Karmanos Cancer Hospital

    Detroit, Michigan, 48201, United States

  • Billings Clinic Cancer Center

    Billings, Montana, 59101, United States

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316, United States

  • Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie

    Plérin, 22190, France

  • Caucasus Medical Centre Llc

    Tbilisi, 00186, Georgia

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 04000, Belgium

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

    Saint-Herblain, 44800, France

  • Charite - Campus Virchow-Klinikum

    Berlin, 13353, Germany

  • Chu Besancon Hospital Jean Minjoz

    Besançon, 25000, France

  • Chu Ucl Namur de Saint Elisabeth

    Namur, 05000, Belgium

  • Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

    Milan, 20133, Italy

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89074, United States

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, 54645, Greece

  • European Institute of Oncology

    Milan, 20141, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs

    Roma, 00168, Italy

  • Georgia Cancer Center

    Augusta, Georgia, 30912, United States

  • Ghent University Hospital

    Ghent, 09000, Belgium

  • H. Lee Moffitt Cancer Center and Research Institute Hospital

    Tampa, Florida, 33612-9497, United States

  • High Technology Hospital Medcenter

    Batumi, 06000, Georgia

  • Honorhealth

    Phoenix, Arizona, 85016, United States

  • Hospital Cochin Cancerologie

    Paris, 75006, France

  • Hygeia Hospital

    Marousi, 15123, Greece

  • INNOVA

    Tbilisi, 00186, Georgia

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut Jules Bordet

    Brussels, 01000, Belgium

  • Iov - Istituto Oncologico Veneto Irccs

    Padova, 35128, Italy

  • Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

    Milan, 20132, Italy

  • Istituto Nazionale Tumori Irccs Fondazione Pascale

    Naples, 80131, Italy

  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

    Meldola, 47014, Italy

  • Jsc Evex Hospitals

    Kutaisi, 04600, Georgia

  • Klinikum Kassel Gmbh

    Kassel, 34125, Germany

  • Laura & Isaac Perlmutter Cancer Ctr

    New York, New York, 10016, United States

  • Miami Cancer Institute

    Miami, Florida, 33176, United States

  • Midwest Cancer Care

    Kansas City, Missouri, 64132, United States

  • Minnesota Oncology-Maplewood

    Coon Rapids, Minnesota, 55433, United States

  • Mount Sinai Medical Center Comprehensive Cancer Center

    Miami Beach, Florida, 33140, United States

  • Multiprofile Clinic Consilium Medulla Llc

    Tbilisi, 00186, Georgia

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87131, United States

  • O.L.V Ziekenhuis

    Aalst, 09300, Belgium

  • Olive View Med Ctr

    Sylmar, California, 91342, United States

  • Ospedale Santa Maria Ca Foncello

    Treviso, 31100, Italy

  • Presidio Ospedaliero Di Summa Antonio Perrino

    Brindisi, 72100, Italy

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Texas Oncology San Antonio

    San Antonio, Texas, 78240, United States

  • Texas Oncology the Woodlands

    Shenandoah, Texas, 77380, United States

  • Texas Oncology-Austin Center

    Austin, Texas, 78731, United States

  • Texas Oncology-Fort Worth South Henderson

    Fort Worth, Texas, 76104-3902, United States

  • Texas Oncology-Tyler

    Sioux Falls, South Dakota, 57104, United States

  • The Ohio State University Wexner Medical Center Division of Gynecologic Oncology

    Hilliard, Ohio, 43026, United States

  • Todua Clinic, Llc

    Tbilisi, 00112, Georgia

  • UCLA Medical Hematology & Oncology

    Los Angeles, California, 90048, United States

  • Universitaire Ziekenhuis Leuven - Gasthuisberg

    Leuven, 03000, Belgium

  • Universitarsfrauenklinik Ulm

    Ulm, 89075, Germany

  • University Clinic Carl Gustav Carus Technical University Dresden

    Dresden, 01307, Germany

  • University Hospital of West Attica - Attikon

    Athens, 12462, Greece

  • University of North Carolina At Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Willamette Valley Cancer Institute

    Eugene, Oregon, 97401-8122, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.