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.

Conditions

• Endometrial Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• retifanlimab — DRUG
  INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
• epacadostat — DRUG
  epacadostat will be administered orally BID.
• pemigatinib — DRUG
  pemigatinib will be administered orally QD.
• INCAGN02385 — DRUG
  INCAGN2385 will be administered every 2 weeks
• INCAGN02390 — DRUG
  INCAGN2390 will be administered every 2 weeks

Study Details

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.

Key Dates

Start date

Jan 26, 2021

Status verified

Jun 2026

Primary completion

May 29, 2026

Completion

May 29, 2026

Study Design

Enrollment

206 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group A - retifanlimab
  Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
• Experimental: Group B - retifanlimab
  Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
• 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)
• 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)
• Experimental: Group E - retifanlimab + epacadostat
  Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat
• 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

Primary Outcome Measure

Group A - Objective Response Rate [ Time Frame: up to 2.5 years ]

Locations (29)

Find similar trials in Anchorage, AK

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