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Monoclonal Antibodies
Retifanlimab Combination Therapy for Endometrial Cancer (POD1UM-204 Trial)
Phase 2
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Group A only: Tumor tissue tested as MSI-High
Groups A, B, and E: Have not been previously treated with a PD-(L)1 inhibitor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3.5 years
Awards & highlights
POD1UM-204 Trial 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.
Who is the study for?
This trial is for women over 18 with advanced or metastatic endometrial cancer that worsened after platinum-based chemotherapy. They must have a good performance status, measurable tumor lesions, and specific genetic markers depending on the group they're assigned to. They can't join if they've had certain recent treatments, unresolved toxicity from past therapies, active hepatitis B or C, live vaccines recently, some immune conditions, known HIV with exceptions, CNS metastases or treatable disease.Check my eligibility
What is being tested?
The study tests retifanlimab alone or combined with other immunotherapies/targeted agents in patients whose endometrial cancer has progressed post-platinum chemotherapy. It's an open-label Phase 2 trial where everyone knows what treatment they're getting; it's not randomized.See study design
What are the potential side effects?
Retifanlimab and its combinations may cause immune-related reactions affecting various organs (like inflammation), potential infusion-related symptoms (such as fever and chills), fatigue, possible liver issues (hepatitis), skin problems (rash) and could increase infection risk.
POD1UM-204 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is MSI-High.
Select...
I have never been treated with a PD-(L)1 inhibitor.
Select...
My endometrial cancer has worsened after treatment with a platinum-based therapy.
Select...
My tumor is MSS and tests positive for PD-L1.
Select...
I can carry out all my daily activities without help.
POD1UM-204 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Group A - Objective Response Rate
Secondary outcome measures
Group A - Disease Control Rate
Group A - Overall Survival
Group A - Progression Free Survival
+8 morePOD1UM-204 Trial Design
6Treatment groups
Experimental Treatment
Group I: Group F - retifanlimab + INCAGN02385 and INCAGN02390Experimental Treatment2 Interventions
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab in combination with INCAGN02385 and INCAGN02390 intravenously
Group II: Group E - retifanlimab + epacadostatExperimental Treatment2 Interventions
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat
Group III: Group D - retifanlimab + pemigatinibExperimental Treatment2 Interventions
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral pemigatininb (FGFR 1,2,3 inhibitor)
Group IV: Group C - retifanlimab + epacadostatExperimental Treatment2 Interventions
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat (IDO1 inhibitor)
Group V: Group B - retifanlimabExperimental Treatment1 Intervention
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
Group VI: Group A - retifanlimabExperimental Treatment1 Intervention
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCAGN02385
2018
Completed Phase 1
~30
epacadostat
2018
Completed Phase 2
~20
pemigatinib
2017
Completed Phase 2
~270
INCAGN02390
2018
Completed Phase 1
~40
retifanlimab
2018
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
367 Previous Clinical Trials
55,107 Total Patients Enrolled
4 Trials studying Endometrial Cancer
953 Patients Enrolled for Endometrial Cancer
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
36 Previous Clinical Trials
16,565 Total Patients Enrolled
3 Trials studying Endometrial Cancer
566 Patients Enrolled for Endometrial Cancer
GOG FoundationNETWORK
42 Previous Clinical Trials
16,067 Total Patients Enrolled
3 Trials studying Endometrial Cancer
1,198 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 28 days.My tumor is MMR deficient or has a POLE mutation.My cancer has grown despite previous PD-1 or PD-L1 therapy and my tumor is MSI-H.My tumor is MSI-High.My side effects from previous treatments have mostly gone away.I have never been treated with a PD-(L)1 inhibitor.I am taking high doses of steroids or other drugs for an autoimmune disease.You are not planning to get pregnant during the study.My endometrial cancer has worsened after treatment with a platinum-based therapy.My tumor is MSS and tests positive for PD-L1.I can carry out all my daily activities without help.I understand the study and agree to participate.My condition may be treatable with the intent to cure.I haven't had cancer treatment in the last 28 days, except for targeted radiation.My cancer is a type of uterine sarcoma confirmed by tissue analysis.I've had LAG-3, TIM-3, or lenvatinib treatment and mixed results from anti-PD-(L)1 therapy for my multiple metastases.I am taking more than 10 mg/day of prednisone or its equivalent.I have active hepatitis B or C.I have lung scarring or inflammation not caused by an infection.My tumor has an FGFR 1,2,3 mutation.I have cancer that has spread to my brain or surrounding membranes.I experienced limited side effects from previous immune therapy.My diagnosis is carcinosarcoma of the uterus.
Research Study Groups:
This trial has the following groups:- Group 1: Group A - retifanlimab
- Group 2: Group B - retifanlimab
- Group 3: Group C - retifanlimab + epacadostat
- Group 4: Group D - retifanlimab + pemigatinib
- Group 5: Group E - retifanlimab + epacadostat
- Group 6: Group F - retifanlimab + INCAGN02385 and INCAGN02390
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unoccupied slots available for this clinical experiment?
"Affirmative. Clinicaltrials.gov's records attest to this ongoing medical trial, which was published on January 26th 2021 and most recently revised in November of 2022. The study needs around 300 participants from 27 different sites for completion."
Answered by AI
What are the primary indications for retifanlimab treatments?
"Retifanlimab can be implemented to treat unresectable, metastatic cholangiocarcinomas, advance directives and fgfr2 protein in human patients."
Answered by AI
Could you please elucidate the safety of retifanlimab for individuals?
"With some clinical evidence supporting its safety, retifanlimab earned a score of 2. It should be noted that no prior data exists in regards to the efficacy of this drug for humans."
Answered by AI
What is the current enrollment size of this medical experiment?
"Affirmative. The records published on clinicaltrials.gov illustrate that this research is actively recruiting participants, having first been made available to the public on January 26th 2021 and was last edited on November 11th 2022. Altogether 300 patients need to be enrolled across 27 sites."
Answered by AI
Has retifanlimab been the subject of other research experiments?
"Currently, there are 46 clinical trials investigating retifanlimab with 6 in the final phase of research. While Istanbul and California boast a majority of these studies, 1585 different locations across the world have opened their doors to this drug's investigation."
Answered by AI
How many sites are participating in the execution of this trial?
"Patients are currently being recruited from Advent Health Medical Group-Orlando 2501, Texas Oncology the Woodlands in Shenandoah and Tennessee Oncology in Nashville. Additionally, there are 27 other medical centres hosting this trial."
Answered by AI
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