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Endometrial CancerPhase 2POD1UM-204NCT04463771

Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy.

A Phase 2 study testing retifanlimab, epacadostat and pemigatinib in people with Endometrial Cancer, run by Incyte Corporation at 65 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in participants who have advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
retifanlimab, epacadostat and pemigatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
65 sitesin 7 countries
Study dates
26 Jan 2021to 29 May 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

65 sites in 7 countries.

65 sites in 7 countries

United States29 sites

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87131

  • Alaska Womens Cancer Care Akwcc

    Anchorage, Alaska, 99508

  • Georgia Cancer Center

    Augusta, Georgia, 30912

  • Texas Oncology-Austin Center

    Austin, Texas, 78731

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • University of North Carolina At Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Minnesota Oncology-Maplewood

    Coon Rapids, Minnesota, 55433

  • Barbara Ann Karmanos Cancer Hospital

    Detroit, Michigan, 48201

  • Willamette Valley Cancer Institute

    Eugene, Oregon, 97401-8122

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Texas Oncology-Fort Worth South Henderson

    Fort Worth, Texas, 76104-3902

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89074

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

    Hilliard, Ohio, 43026

  • Midwest Cancer Care

    Kansas City, Missouri, 64132

  • UCLA Medical Hematology & Oncology

    Los Angeles, California, 90048

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Mount Sinai Medical Center Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Laura & Isaac Perlmutter Cancer Ctr

    New York, New York, 10016

  • Advent Health Medical Group-Orlando 2501

    Orlando, Florida, 32804

  • Honorhealth

    Phoenix, Arizona, 85016

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Texas Oncology San Antonio

    San Antonio, Texas, 78240

  • Texas Oncology the Woodlands

    Shenandoah, Texas, 77380

  • Texas Oncology-Tyler

    Sioux Falls, South Dakota, 57104

  • Washington University

    St Louis, Missouri, 63110

  • Olive View Med Ctr

    Sylmar, California, 91342

  • H. Lee Moffitt Cancer Center and Research Institute Hospital

    Tampa, Florida, 33612-9497

  • Arizona Oncology Associates

    Tucson, Arizona, 85711

Other trials in United States

Italy10 sites

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

    Bologna, 40138

  • Presidio Ospedaliero Di Summa Antonio Perrino

    Brindisi, 72100

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

    Meldola, 47014

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

    Milan, 20132

  • Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

    Milan, 20133

  • European Institute of Oncology

    Milan, 20141

  • Istituto Nazionale Tumori Irccs Fondazione Pascale

    Naples, 80131

  • Iov - Istituto Oncologico Veneto Irccs

    Padova, 35128

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs

    Roma, 00168

  • Ospedale Santa Maria Ca Foncello

    Treviso, 31100

Other trials in Italy

Belgium6 sites

  • O.L.V Ziekenhuis

    Aalst, 09300

  • Institut Jules Bordet

    Brussels, 01000

  • Ghent University Hospital

    Ghent, 09000

  • Universitaire Ziekenhuis Leuven - Gasthuisberg

    Leuven, 03000

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 04000

  • Chu Ucl Namur de Saint Elisabeth

    Namur, 05000

Other trials in Belgium

France6 sites

  • Chu Besancon Hospital Jean Minjoz

    Besançon, 25000

  • Institut Bergonie

    Bordeaux, 33076

  • Hospital Cochin Cancerologie

    Paris, 75006

  • Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie

    Plérin, 22190

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

    Saint-Herblain, 44800

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Georgia6 sites

  • High Technology Hospital Medcenter

    Batumi, 06000

  • Jsc Evex Hospitals

    Kutaisi, 04600

  • Todua Clinic, Llc

    Tbilisi, 00112

  • Caucasus Medical Centre Llc

    Tbilisi, 00186

  • INNOVA

    Tbilisi, 00186

  • Multiprofile Clinic Consilium Medulla Llc

    Tbilisi, 00186

Other trials in Georgia

Germany4 sites

  • Charite - Campus Virchow-Klinikum

    Berlin, 13353

  • University Clinic Carl Gustav Carus Technical University Dresden

    Dresden, 01307

  • Klinikum Kassel Gmbh

    Kassel, 34125

  • Universitarsfrauenklinik Ulm

    Ulm, 89075

Other trials in Germany

Greece4 sites

  • Alexandra General Hospital of Athens

    Athens, 11528

  • University Hospital of West Attica - Attikon

    Athens, 12462

  • Hygeia Hospital

    Marousi, 15123

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, 54645

Other trials in Greece

About this study

Official title: An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)

This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in participants who have advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy. retifanlimab will be administered as monotherapy or in combination with other immunotherapy or targeted agents.

Being tested
retifanlimab, epacadostat, pemigatinib, INCAGN02385, INCAGN02390
Keywords
Endometrial Carcinoma, Endometrium Cancer, Neoplasms Endometrial, Advanced, Metastatic, PD-1, PD-L1, retifanlimab, INCMGA0012, INCAGN02385, INCAGN02390, PODIUM, LAG-3, TIM-3
Medical subject headings
Endometrial Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • retifanlimabDrug

    Also called INCMGA00012

    INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.

  • epacadostatDrug

    epacadostat will be administered orally BID.

  • pemigatinibDrug

    pemigatinib will be administered orally QD.

  • INCAGN02385Drug

    INCAGN2385 will be administered every 2 weeks

  • INCAGN02390Drug

    INCAGN2390 will be administered every 2 weeks

Study groups in NCT04463771
Study groupRoleWhat they receive
Group A - retifanlimabExperimentalSelect participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
Receives: Drug: retifanlimab
Group B - retifanlimabExperimentalSelect participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
Receives: Drug: retifanlimab
Group C - retifanlimab + epacadostatExperimentalSelect participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat (IDO1 inhibitor)
Receives: Drug: retifanlimab; Drug: epacadostat
Group D - retifanlimab + pemigatinibExperimentalSelect participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral pemigatininb (FGFR 1,2,3 inhibitor)
Receives: Drug: retifanlimab; Drug: pemigatinib
Group E - retifanlimab + epacadostatExperimentalSelect participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat
Receives: Drug: retifanlimab; Drug: epacadostat
Group F - retifanlimab + INCAGN02385 and INCAGN02390ExperimentalSelect participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab in combination with INCAGN02385 and INCAGN02390 intravenously
Receives: Drug: INCAGN02385; Drug: INCAGN02390

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Group A - Objective Response Rate

    Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee

    Measured: up to 2.5 years

Secondary outcomes (11)

  1. Group A -Duration of Response

    Defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause.

    Measured: up to 2.5 years

  2. Group A - Disease Control Rate

    Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.

    Measured: up to 2.5 years

  3. Group A - Overall Survival

    Defined as the time from the first dose of study treatment until death due to any cause.

    Measured: up to 3.5 years

  4. Group A - Progression Free Survival

    Defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause.

    Measured: up to 3.5 years

  5. Group B -Duration of Response

    Defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause.

    Measured: up to 2.5 years

  6. Group B - Disease Control Rate

    Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.

    Measured: up to 2.5 years

  7. Group B - Overall Survival

    Defined as the time from the first dose of study treatment until death due to any cause.

    Measured: up to 3.5 years

  8. Groups B - Objective Response Rate

    Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee

    Measured: up to 2 years

  9. Group B - Progression Free Survival

    Defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause.

    Measured: up to 3.5 years

  10. Groups C, D, E and F - Objective Response Rate

    Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee

    Measured: up to 2 years

  11. Number of Treatment-Related Adverse Events

    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

    Measured: up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2020
  2. Study start26 Jan 2021
  3. Primary completion29 May 2026
  4. Study completion29 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04463771
Sponsor's protocol ID
INCMGA 0012-204
Other IDs
2022-502600-79-00, 2020-000496-20
Acronym
POD1UM-204
Status last verified
Jun 2026
First submitted
6 Jul 2020
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing retifanlimab, epacadostat and pemigatinib in people with Endometrial Cancer, run by Incyte Corporation at 65 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Italy, Belgium, France, Georgia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Group A - Objective Response Rate (time frame: up to 2.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04463771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

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