retifanlimab for Endometrial Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Endometrial Cancerretifanlimab - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, retifanlimab, for endometrial cancer that has progressed after platinum-based chemotherapy. It will be given as monotherapy or in combination with other immunotherapy or targeted agents.

Eligible Conditions
  • Endometrial Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: up to 3.5 years

up to 2 years
Groups B - Objective Response Rate
Groups B, C, and D - Objective Response Rate
Groups C, D and E - Objective Response Rate
Groups C, D, E and F - Objective Response Rate
up to 2.5 years
Group A - Disease Control Rate
Group A - Objective Response Rate
Group A -Duration of Response
Group B - Disease Control Rate
Group B -Duration of Response
up to 3.5 years
Group A - Overall Survival
Group A - Progression Free Survival
Group B - Overall Survival
Group B - Progression Free Survival
up to 4 years
Number of Treatment-Related Adverse Events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

6 Treatment Groups

Group A - retifanlimab
1 of 6
Group D - retifanlimab + pemigatinib
1 of 6
Group F - retifanlimab + INCAGN02385 and INCAGN02390
1 of 6
Group B - retifanlimab
1 of 6
Group C - retifanlimab + epacadostat
1 of 6
Group E - retifanlimab + epacadostat
1 of 6

Experimental Treatment

300 Total Participants · 6 Treatment Groups

Primary Treatment: retifanlimab · No Placebo Group · Phase 2

Group A - retifanlimab
Drug
Experimental Group · 1 Intervention: retifanlimab · Intervention Types: Drug
Group D - retifanlimab + pemigatinibExperimental Group · 2 Interventions: retifanlimab, pemigatinib · Intervention Types: Drug, Drug
Group F - retifanlimab + INCAGN02385 and INCAGN02390Experimental Group · 2 Interventions: INCAGN02390, INCAGN02385 · Intervention Types: Drug, Drug
Group B - retifanlimab
Drug
Experimental Group · 1 Intervention: retifanlimab · Intervention Types: Drug
Group C - retifanlimab + epacadostatExperimental Group · 2 Interventions: retifanlimab, epacadostat · Intervention Types: Drug, Drug
Group E - retifanlimab + epacadostatExperimental Group · 2 Interventions: retifanlimab, epacadostat · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Retifanlimab
Not yet FDA approved
INCAGN02390
2018
Completed Phase 1
~40
INCAGN02385
2018
Completed Phase 1
~30
Epacadostat
Not yet FDA approved
Pemigatinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3.5 years

Who is running the clinical trial?

GOG FoundationNETWORK
29 Previous Clinical Trials
11,724 Total Patients Enrolled
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
28 Previous Clinical Trials
14,515 Total Patients Enrolled
1 Trials studying Endometrial Cancer
78 Patients Enrolled for Endometrial Cancer
Incyte CorporationLead Sponsor
315 Previous Clinical Trials
46,275 Total Patients Enrolled
4 Trials studying Endometrial Cancer
953 Patients Enrolled for Endometrial Cancer
Mark CornfieldStudy DirectorIncyte Corporation
1 Previous Clinical Trials
600 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have histologically confirmed advanced or metastatic endometrial cancer with disease progression on or after treatment with at least 1 platinum-containing regimen for advanced or metastatic disease.
You have a tumor tissue tested as MSI-High.
You have a tumor that is deficient in MMR or an ultra-mutated POLE tumor.
Tumor tissue tested as having an FGFR 1,2,3 mutation or alteration characterized as per protocol.
Tumor tissue tested as MSS and PD-L1 positive.
You have had prior PD (L)1 therapy and tumor tissue tested as MSI-H.
You have at least one tumor lesion per RECIST v1.1.