Description:
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.
Title
- Brief Title: 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.
- 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)
Clinical Trial IDs
- ORG STUDY ID:
INCMGA 0012-204
- NCT ID:
NCT04463771
Conditions
Interventions
Drug | Synonyms | Arms |
---|
retifanlimab | INCMGA00012 | Group A - retifanlimab |
epacadostat | | Group C - retifanlimab + epacadostat |
pemigatinib | | Group D - retifanlimab + pemigatinib |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Group A - retifanlimab | Experimental | Select participants will be administered retifanlimab intravenously | |
Group B - retifanlimab | Experimental | Select participants will be administered retifanlimab intravenously | |
Group C - retifanlimab + epacadostat | Experimental | Participants will be administered retifanlimab intravenously in combination with oral epacadostat (IDO1 inhibitor) | |
Group D - retifanlimab + pemigatinib | Experimental | Select participants will be administered retifanlimab intravenously in combination with oral pemigatininb (FGFR 1,2,3 inhibitor) | |
Eligibility 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Group A - Objective Response Rate |
Time Frame: | up to 2.5 years |
Safety Issue: | |
Description: | 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
Measure: | Group A -Duration of Response |
Time Frame: | up to 2.5 years |
Safety Issue: | |
Description: | 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. |
Measure: | Group A - Disease Control Rate |
Time Frame: | up to 2.5 years |
Safety Issue: | |
Description: | Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response. |
Measure: | Group A - Overall Survival |
Time Frame: | up to 3.5 years |
Safety Issue: | |
Description: | Defined as the time from the first dose of study treatment until death due to any cause. |
Measure: | Groups B, C, and D - Objective Response Rate |
Time Frame: | up to 2 years |
Safety Issue: | |
Description: | Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee |
Measure: | Number of Treatment-Related Adverse Events |
Time Frame: | up to 4 years |
Safety Issue: | |
Description: | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Incyte Corporation |
Trial Keywords
- Endometrial Carcinoma
- Endometrium Cancer
- Neoplasms Endometrial
- Advanced
- Metastatic
- PD-1
- PD-L1
- retifanlimab
- INCMGA0012
- PODIUM
Last Updated
July 29, 2021