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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)

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ClinicalTrials.gov Identifier: NCT04463771
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : February 9, 2021
Sponsor:
Collaborators:
GOG Foundation
European Network for Gynaecological Oncological Trial groups(ENGOT)
Information provided by (Responsible Party):
Incyte Corporation

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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 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 26, 2023
Estimated Study Completion Date : October 25, 2023

Arm Intervention/treatment
Experimental: Group A - retifanlimab
Select participants 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 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
Participants 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 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.




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. Groups B, C, and D - 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

  5. 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.



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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. 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 and B: 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.
  • 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 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 and D (combinations): limiting immune-related toxicity during prior checkpoint inhibitor 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.

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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United States, Oregon
Willamette Valley Cancer Institute Recruiting
Eugene, Oregon, United States, 97401-8122
Sponsors and Collaborators
Incyte Corporation
GOG Foundation
European Network for Gynaecological Oncological Trial groups(ENGOT)
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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: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
PODIUM
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases