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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. (POD1UM-204)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04463771
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : June 2, 2023
Sponsor:
Collaborators:
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: retifanlimab Drug: epacadostat Drug: pemigatinib Drug: INCAGN02385 Drug: INCAGN02390 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 26, 2021
Estimated Primary Completion Date : August 25, 2023
Estimated Study Completion Date : June 22, 2025
Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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
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Primary Outcome Measures :
  1. Group A - Objective Response Rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04463771


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com

Locations
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Sponsors and Collaborators
Incyte Corporation
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Investigators
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Study Director: Mark Cornfield Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04463771    
Other Study ID Numbers: INCMGA 0012-204
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: June 2, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Endometrial Carcinoma
Endometrium Cancer
Neoplasms Endometrial
Advanced
Metastatic
PD-1
PD-L1
 retifanlimab
INCMGA0012
INCAGN02385
INCAGN02390
PODIUM
LAG-3
TIM-3
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases