We’re researching a potential treatment for MMR-proficient (pMMR)* endometrial cancer that is advanced, or has come back after treatment (recurrent), to see if it may work better than a current standard treatment.
*At cancer diagnosis, doctors may use a part of the tumor sample to test for cancer biomarkers. Biomarkers are specific proteins, genes, or other markers that can give you more information about your cancer and will help you and your healthcare team determine your best treatment options and next steps. For this clinical trial, biomarker testing must indicate proficient mismatch repair (pMMR or MMR-P). Most endometrial cancers are pMMR tumors.
Participants in this clinical trial will receive either a study medicine combined with chemotherapy, or pembrolizumab (an approved medicine) combined with chemotherapy. This clinical trial will help researchers learn which works better (study medication or pembrolizumab) with chemotherapy to treat advanced or recurrent endometrial cancer.
If you choose to take part in this clinical trial, you could help us continue to make progress in endometrial cancer research.
Who may participate
Joining a clinical trial is an important and personal decision.
You may be eligible to take part in this clinical trial if you are
a female, and:
- Are 18 years or older
- Have been diagnosed with endometrial cancer that is advanced (Stage III or Stage IV) or has come back (recurrent) after previous treatment
- Have not had treatment for endometrial cancer in its advanced or recurrent stage
- Have a type of endometrial cancer that is MMR proficient (pMMR)*
This is not a complete list of the eligibility criteria for this clinical trial. The study doctor will review all eligibility criteria with you.
*These cancer biomarkers are specific proteins, genes, or other markers that can give you more information about your cancer.
Condition
Endometrial cancer
Age
18+ years
Sex
Female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If this clinical trial is a good fit for you and you decide to participate, you will receive either the study medicine or pembrolizumab (an approved medicine), in combination with chemotherapy.
You will have a 50% (1 in 2) chance of receiving either the study medicine or pembrolizumab. All participants will also receive chemotherapy. There is no placebo (inactive treatment) in this study.
Participants will be assigned to treatment groups by a process called randomization. This is one way to help avoid bias in a study. As this is an open-label study, you and the study doctor will know which medicine you are receiving.
The treatment period of the study will last approximately 2 years, or until you or the study doctor decides you should stop the study treatment. You will have assessments at each visit, which may include physical exams, blood/urine tests, questionnaires, electrocardiograms, and tumor imaging scans. Your doctor can answer any questions you may have.
All participants will have an in-person follow-up visit or phone call every 12 weeks after the end-of-treatment visit, until the clinical trial ends.
Length of study treatment
Approximately 2 years
Follow-up
Follow up visits can be in-person visits or phone calls every 12 weeks (about 3 months) after the end-of-treatment visit until the study ends.
About the study treatments
The study medicine is a bispecific antibody designed to target two different proteins, PD-1 and VEGF, at the same time. These proteins can play a role in how cancer grows and how the immune system responds to it. It is thought that by binding (or connecting) to and blocking these two proteins, the study medicine may help the immune system find and attack the cancer cells while also potentially slowing down tumor growth, which may be more effective for treating endometrial cancer than targeting PD-1 alone.
Pembrolizumab combined with chemotherapy is a standard treatment for endometrial cancer. Pembrolizumab binds to PD-1 (cancer protein) on the surface of the cancer cells and helps your immune system to recognize and attack them.
Potential risks and benefits of taking part in the clinical trial
People who take part in clinical studies are key to advancing medical research. By taking part in this clinical trial, you will be helping to advance research which may help your and others with endometrial cancer in the future.
This clinical trial offers the opportunity to explore if the potential study medicine combination may work better than an approved standard treatment for people with advanced or recurrent endometrial cancer.
Participant safety is the top priority of this clinical trial. It is possible that your condition or health may improve, worsen, or stay the same. The study doctor will discuss all the possible risks and benefits of participating with you before you choose to enroll.
In addition:
-The study team will monitor your health closely during the clinical trial
-The study treatment and any clinical trial-related procedures will be provided at no cost
-Travel support may also be available
-You will help advance research for the future of endometrial cancer treatments
Frequently asked questions
This clinical trial is evaluating a potential treatment to see if it may work better than a standard treatment (pembrolizumab combined with chemotherapy) to treat MMR-proficient (pMMR) advanced or recurrent endometrial cancer. Despite recent advancements in treatment options, the prognosis for patients with endometrial cancer is very challenging. There is an urgent need to develop potential new targeted therapies.
The study treatment and any study-related procedures are generally covered at no cost. You may be paid back (reimbursed) for reasonable expenses that you and your caregiver have as a result of taking part in this study. This may include parking, meals, or other travel-related expenses. Please speak with the study doctor if you have any questions about costs resulting from being in this study.
Yes, this is an open-label clinical trial, which means that you and the study team will know whether you are receiving the study medicine or pembrolizumab. You will receive chemotherapy in combination with the study medicine or pembrolizumab. You will have a 50% (1 in 2) chance of receiving the study medicine and a 50% chance of receiving pembrolizumab.
As part of this study, we will analyze your blood samples and a small portion of your tissue sample to examine various biological indicators known as biomarkers. Cancer biomarkers are specific proteins, genes, or other markers that can give you more information about your cancer. This testing will help us understand how the study drug interacts with your body and what factors may influence its effectiveness. By studying these markers, we aim to identify which patients are most likely to benefit from this treatment in the future.
