POD1UM-204: 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.

Sponsor
Incyte Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04463771
Collaborator
GOG Foundation (Other), European Network of Gynaecological Oncological Trial Groups (ENGOT) (Other)
300
79
6
30.9
3.8
0.1

Study Details

Study Description

Brief 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. retifanlimab will be administered as monotherapy or in combination with other immunotherapy or targeted agents.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jan 26, 2021
Anticipated Primary Completion Date :
Aug 25, 2023
Anticipated Study Completion Date :
Aug 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A - retifanlimab

Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously

Drug: retifanlimab
INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
Other Names:
  • INCMGA00012
  • Experimental: Group B - retifanlimab

    Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously

    Drug: retifanlimab
    INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
    Other Names:
  • INCMGA00012
  • Experimental: Group C - retifanlimab + epacadostat

    Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat (IDO1 inhibitor)

    Drug: retifanlimab
    INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
    Other Names:
  • INCMGA00012
  • Drug: epacadostat
    epacadostat will be administered orally BID.

    Experimental: Group D - retifanlimab + pemigatinib

    Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral pemigatininb (FGFR 1,2,3 inhibitor)

    Drug: retifanlimab
    INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
    Other Names:
  • INCMGA00012
  • Drug: pemigatinib
    pemigatinib will be administered orally QD.

    Experimental: Group E - retifanlimab + epacadostat

    Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat

    Drug: retifanlimab
    INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
    Other Names:
  • INCMGA00012
  • Drug: epacadostat
    epacadostat will be administered orally BID.

    Experimental: Group F - retifanlimab + INCAGN02385 and INCAGN02390

    Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab in combination with INCAGN02385 and INCAGN02390 intravenously

    Drug: INCAGN02385
    INCAGN2385 will be administered every 2 weeks

    Drug: INCAGN02390
    INCAGN2390 will be administered every 2 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Group A - Objective Response Rate [up to 2.5 years]

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

    Secondary Outcome Measures

    1. Group A -Duration of Response [up to 2.5 years]

      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.

    2. Group A - Disease Control Rate [up to 2.5 years]

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

    3. Group A - Overall Survival [up to 3.5 years]

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

    4. Group A - Progression Free Survival [up to 3.5 years]

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

    5. Group B -Duration of Response [up to 2.5 years]

      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.

    6. Group B - Disease Control Rate [up to 2.5 years]

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

    7. Group B - Overall Survival [up to 3.5 years]

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

    8. Groups B - Objective Response Rate [up to 2 years]

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

    9. Group B - Progression Free Survival [up to 3.5 years]

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

    10. Groups C, D, E and F - Objective Response Rate [up to 2 years]

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

    11. Number of Treatment-Related Adverse Events [up to 4 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alaska Womens Cancer Care Akwcc Anchorage Alaska United States 99508
    2 Honorhealth Phoenix Arizona United States 85016
    3 Arizona Oncology Associates Tucson Arizona United States 85711
    4 UCLA Medical Hematology & Oncology Los Angeles California United States 90048
    5 Broward Health Medical Center Fort Lauderdale Florida United States 33316
    6 Mount Sinai Medical Center Comprehensive Cancer Center Miami Beach Florida United States 33140
    7 Miami Cancer Institute Miami Florida United States 33176
    8 Advent Health Medical Group-Orlando 2501 Orlando Florida United States 32804
    9 H. Lee Moffitt Cancer Center and Research Institute Hospital Tampa Florida United States 33612-9497
    10 Georgia Cancer Center Augusta Georgia United States 30912
    11 Barbara Ann Karmanos Cancer Hospital Detroit Michigan United States 48201
    12 Minnesota Oncology - Maplewood Minneapolis Minnesota United States 55404
    13 Midwest Cancer Care Kansas City Missouri United States 64132
    14 Washington University Saint Louis Missouri United States 63110
    15 Billings Clinic Cancer Center Billings Montana United States 59101
    16 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
    17 New Mexico Cancer Care Alliance Albuquerque New Mexico United States 87131
    18 Nyu Clinical Cancer Center New York New York United States 10032
    19 University of North Carolina At Chapel Hill Chapel Hill North Carolina United States 27514
    20 The Ohio State University Wexner Medical Center Division of Gynecologic Oncology Hilliard Ohio United States 43026
    21 Willamette Valley Cancer Institute Eugene Oregon United States 97401-8122
    22 Texas Oncology - Tyler Sioux Falls South Dakota United States 57104
    23 Tennessee Oncology Nashville Tennessee United States 37203
    24 Texas Oncology-Austin Center Austin Texas United States 78731
    25 Texas Oncology Fort Worth Texas United States 76104-3902
    26 Memorial Hermann Cancer Center Houston Texas United States 77030
    27 Texas Oncology San Antonio San Antonio Texas United States 78240
    28 Texas Oncology the Woodlands Shenandoah Texas United States 77380
    29 Virginia Commonwealth University Richmond Virginia United States 23298
    30 O.L.V Ziekenhuis Aalst Belgium 09300
    31 Institut Jules Bordet Brussels Belgium 01000
    32 Ghent University Hospital Gent Belgium 09000
    33 Universitaire Ziekenhuis Leuven - Gasthuisberg Leuven Belgium 03000
    34 Centre Hospitalier Universitaire de Liege - Sart Tilman Liege Belgium 04000
    35 Chu Ucl Namur de Saint Elisabeth Namur Belgium 05000
    36 Beijing Cancer Hospital Beijing China 100142
    37 Xiangya Hospital Central South University Changsha China 410000
    38 Hunan Cancer Hospital Changsha China 410013
    39 West China Second University Hospital, Sichuan University Chengdu China 610066
    40 Chongqing University Cancer Hospital Chongqing China 400030
    41 Sun Yat-Sen Memorial Hospital Sun Yat-Sen University Guangzhou China 510000
    42 University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital) Hefei China 230001
    43 Qilu Hospital of Shandong University Jinan China 250000
    44 The Affiliated Drum Tower Hospital of Nanjing University Nanjing China 210000
    45 Tsingdao Central Hospital Qingdao China 266042
    46 Obstetrics and Gynecology Hospital of Fudan University Shanghai China 200011
    47 The Second Hospital of Shanxi Medical University Taiyuan China 30001
    48 The First Affiliated Hospital of Xian Jiaotong University Xi'an China 710061
    49 The First Affiliated Hospital of Xiamen University Xiamen China 361003
    50 Henan Cancer Hostipal Zhengzhou China 450003
    51 Chu Besancon Hospital Jean Minjoz Besancon France 25030
    52 Institut Bergonie Bordeaux Cedex France 33076
    53 Hospital Cochin Cancerologie Paris France 75006
    54 Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie Plerin France 22190
    55 Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau Saint Herblain France 44800
    56 High Technology Hospital Medcenter Llc Batumi Georgia 06000
    57 Jsc Evex Hospitals Kutaisi Georgia 04600
    58 Llc Todua Clinic Tbilisi Georgia 00112
    59 Caucasus Medical Centre Llc Tbilisi Georgia 00186
    60 Ltd Innova Tbilisi Georgia 00186
    61 Multiprofile Clinic Consilium Medulla Llc Tbilisi Georgia 00186
    62 Charite - Campus Virchow-Klinikum Berlin Germany 13353
    63 Universitatsklinikum Bonn Aoer Bonn Germany 53127
    64 University Clinic Carl Gustav Carus Technical University Dresden Dresden Germany 01307
    65 Universitarsfrauenklinik Ulm ULM Germany 89075
    66 Alexandra General Hospital of Athens Athens Greece 11528
    67 University Hospital of West Attica - Attikon Athens Greece 12462
    68 Hygeia Hospital Marousi Greece 15123
    69 Euromedica General Clinic of Thessaloniki Thessaloniki Greece 54645
    70 L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI Bologna Italy 40138
    71 Presidio Ospedaliero Di Summa Antonio Perrino Brindisi Italy 72100
    72 Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori Meldola Italy 47014
    73 Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele Milano Italy 20132
    74 Fondazione Irccs Istituto Nazionale Dei Tumori Milano Italy 20133
    75 European Institute of Oncology Milano Italy 20141
    76 Istituto Nazionale Tumori Irccs Fondazione Pascale Napoli Italy 80131
    77 Iov - Istituto Oncologico Veneto Irccs Padova Italy 35128
    78 Fondazione Policlinico Universitario Agostino Gemelli Irccs Roma Italy 00168
    79 Ospedale Santa Maria Ca Foncello Treviso Italy 31100

    Sponsors and Collaborators

    • Incyte Corporation
    • GOG Foundation
    • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    Investigators

    • Study Director: Mark Cornfield, Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT04463771
    Other Study ID Numbers:
    • INCMGA 0012-204
    First Posted:
    Jul 9, 2020
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Incyte Corporation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 27, 2022