Not recruiting

Study of Retifanlimab Alone and in Combination with Drug Therapy for Adults with Advanced or Metastatic Endometrial Cancer Who Have Not Responded to Platinum Chemotherapy

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with advanced endometrial cancer or metastatic endometrial cancer who have previously undergone platinum-based chemotherapy. The research evaluates several medications including Pemazyre (pemigatinib), INCAGN02385 (tuparstobart), INCAGN02390, and retifanlimab. The study aims to assess how well these treatments work, either alone or in combination, in treating this type of cancer that has spread or become advanced.

The medications will be administered in different ways - some as tablets taken by mouth, while others as solutions given through intravenous infusion (delivered directly into a vein). The treatment period may continue for up to 104 weeks, depending on how well patients respond to the therapy and any side effects they may experience.

This is known as an umbrella study, which means it includes several different groups of patients who will receive different combinations of treatments based on specific characteristics of their cancer. Some patients will receive a single medication, while others may receive a combination of treatments. The study will track how the cancer responds to these treatments and monitor the overall health of the participants throughout the treatment period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
Your tumor tissue will be tested to determine which treatment group you qualify for
A physical examination will be performed and your performance status will be evaluated
Your tumor will be measured using imaging scans to establish baseline measurements
Step 2
Treatment assignment
Based on your test results, you will be assigned to one of the following treatment groups:
Group A: If your tumor is MSI-H (a specific genetic characteristic), you will receive INCMGA00012 alone
Group B: If your tumor has specific DNA repair defects (dMMR) or POLE mutations, you will receive INCMGA00012 alone
Group D: If your tumor has specific FGFR gene changes, you will receive Pemazyre tablets
Group E: If your tumor is PD-L1 positive, you will receive specific treatment
Group F: If your tumor is MSI-H and you have previously received certain treatments, you will receive specific therapy
Step 3
Treatment administration
Depending on your assigned group, you will receive either:
Oral tablets (Pemazyre) that you will take by mouth
Intravenous infusions of study medications (INCMGA00012, INCAGN02385, or INCAGN02390)
Regular assessments will be performed to monitor your response to treatment
Step 4
Monitoring period
Your tumor will be measured regularly using imaging scans to assess treatment response
Blood tests will be performed to monitor your health
Side effects will be monitored and recorded
Treatment will continue until either your disease progresses or you experience unacceptable side effects
Step 5
Follow-up period
After treatment ends, you will be monitored for up to 6 months
Women who can become pregnant must continue pregnancy prevention measures for 6 months after the last treatment
Your survival status will be tracked until the study ends in May 2026

Who can join the trial?

13 criteria

Must be a woman aged 18 years or older
Must be able to understand and willing to sign an informed consent form
Must have confirmed advanced or metastatic endometrial cancer that has progressed after treatment with at least one platinum-based therapy
Must have at least one tumor that can be measured using standard imaging techniques
Must have an ECOG performance status of 0 or 1 (able to perform daily activities with minimal or no assistance)
Must be willing to provide a tumor tissue sample
Must agree to use highly effective birth control methods (99% effective) during the study and for 6 months after the last treatment, unless surgically sterile
For Group A: Must have tumors that are MSI-H (a specific genetic characteristic) confirmed by central testing
For Group B: Must have tumors with specific genetic characteristics (dMMR or POLE mutations) confirmed by testing
For Groups A, B and E: Must not have received previous treatment with PD-(L)1 inhibitors (a type of immunotherapy)
For Group D: Must have tumors with specific genetic changes called FGFR1-3 fusions or rearrangements
For Group E: Must have PD-L1 positive tumors (confirmed by specific testing) and no more than one previous treatment for advanced disease
For Group F: Must have received at least 2 doses of prior PD-(L)1 therapy with documented disease progression

Who cannot join the trial?

14 criteria

Prior treatment with any PD-1 or PD-L1 inhibitor (types of immunotherapy medications)
Active or untreated brain metastases (cancer that has spread to the brain)
History of autoimmune disease requiring systemic treatment (conditions where the immune system attacks healthy cells)
Current pregnancy or breastfeeding
Active infection requiring systemic therapy (infections needing medication that affects the whole body)
Known HIV infection or active hepatitis B or C
Other active cancer diagnosis within the last 2 years (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
Significant heart conditions or uncontrolled high blood pressure
History of organ transplant
Any condition that would interfere with the safety or interpretation of study results
Unable to give informed consent
Male patients (study is for female patients only)
Age under 18 years
Previous participation in this clinical trial

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

Trial locations

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Investigated drugs

INCMGA00012
is an investigational immunotherapy medication being studied for treating advanced or metastatic endometrial cancer. It belongs to a class of drugs that help the immune system fight cancer cells. This medication is being tested both as a standalone treatment and in combination with other cancer therapies in patients who have previously received platinum-based chemotherapy that is no longer working.
Platinum-based chemotherapy
is mentioned as a prior treatment that patients in this trial must have received before. This is a standard type of chemotherapy that contains platinum drugs, commonly used to treat various types of cancer including endometrial cancer.

What is already known about the treatment

INCMGA00012 – A novel investigational immunotherapy medication administered through intravenous infusion, currently being studied in clinical trials for the treatment of advanced or metastatic endometrial cancer in patients who have progressed after platinum-based chemotherapy. This drug belongs to the class of immune checkpoint inhibitors and works by enhancing the body's immune response against cancer cells by targeting specific molecular pathways involved in immune system regulation. The medication is being evaluated both as a monotherapy and in combination with other cancer treatments to assess its effectiveness in improving outcomes for patients with endometrial cancer who have limited treatment options.

Investigated diseases

Endometrial Cancer - A cancer that begins in the endometrium, which is the inner lining of the uterus. It typically develops when cells in the endometrium begin to grow out of control, forming a tumor. The condition most commonly occurs in women after menopause. Early signs often include abnormal vaginal bleeding or discharge. The cancer usually develops slowly over time, starting from changes in the endometrial cells. As the disease progresses, the abnormal cells can grow deeper into the uterine wall and potentially spread to nearby tissues.