What side effects are associated with this type of intervention?

Common treatments for endometrial cancer, particularly immune checkpoint inhibitors like Retifanlimab, pembrolizumab, and cemiplimab, can cause side effects such as fatigue, rash, diarrhea, and pruritus. Severe adverse events may include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Chemotherapy agents, often used in combination with immunotherapy, can lead to nausea, vomiting, alopecia, neutropenia, and increased risk of infections. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of endometrial cancer, particularly those targeting the PD-1/PD-L1 pathway. Pembrolizumab, an anti-PD-1 monoclonal antibody, is approved for use in patients with advanced endometrial cancer that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, pembrolizumab in combination with lenvatinib, a tyrosine kinase inhibitor, is approved for patients with advanced endometrial cancer who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. These treatments are similar to retifanlimab, which is also an anti-PD-1 monoclonal antibody being studied for advanced or metastatic endometrial cancer.

What other types of research exist?

Promising alternatives to Retifanlimab for endometrial cancer patients include Pembrolizumab (an anti-PD-1 monoclonal antibody) and Lenvatinib (a multi-kinase inhibitor), which have shown efficacy in combination therapy. Additionally, Dostarlimab (another anti-PD-1 monoclonal antibody) is emerging as a potential option based on recent clinical trial results.

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Monoclonal Antibodies

Retifanlimab Combination Therapy for Endometrial Cancer (POD1UM-204 Trial)

Phase 2

Waitlist Available

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.

Must not have

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.

Has disease eligible for potentially curative treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing retifanlimab, an immunotherapy drug, in patients with advanced endometrial cancer that has not improved with standard chemotherapy. The drug helps the immune system better identify and destroy cancer cells. It can be used alone or with other treatments.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is MSI-High.

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I have never been treated with a PD-(L)1 inhibitor.

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My endometrial cancer has worsened after treatment with a platinum-based therapy.

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My tumor is MSS and tests positive for PD-L1.

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I can carry out all my daily activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking high doses of steroids or other drugs for an autoimmune disease.

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My condition may be treatable with the intent to cure.

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I haven't had cancer treatment in the last 28 days, except for targeted radiation.

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My cancer is a type of uterine sarcoma confirmed by tissue analysis.

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I am taking more than 10 mg/day of prednisone or its equivalent.

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I have active hepatitis B or C.

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I have lung scarring or inflammation not caused by an infection.

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I have cancer that has spread to my brain or surrounding membranes.

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My diagnosis is carcinosarcoma of the uterus.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Group A - Objective Response Rate

Secondary study objectives

Group A - Disease Control Rate

Group A - Overall Survival

Group A - Progression Free Survival

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~350

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for endometrial cancer include targeted therapies and immunotherapies. Targeted therapies focus on specific molecular pathways that drive cancer cell growth and survival, such as inhibitors of angiogenesis and signal transduction pathways. Immunotherapies, like Retifanlimab (an anti-PD-1 monoclonal antibody), work by blocking the PD-1 pathway, which cancer cells exploit to evade the immune system. By inhibiting this pathway, these drugs enhance the body's immune response against cancer cells. This approach is particularly important for patients with tumors that have high mutational burdens or specific genetic deficiencies, as it can lead to more effective and personalized treatment options.

Developments in the systemic treatment of endometrial cancer.