Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy.
This research study is looking at a new treatment called retifanlimab for women with womb cancer (endometrial cancer) that has spread or come back after standard chemotherapy. The study will see how safe this new drug is and how well it works. Some women will receive retifanlimab by itself, while others will get it alongside other experimental medicines. The aim is to find better ways to treat this type of cancer, especially when previous treatments haven't worked or have stopped working. This is a Phase 2 study, meaning it's still in the earlier stages of testing new treatments, but it builds on earlier safety information.
At a glance
What is this study about?
This study is focusing on women who have advanced or metastatic endometrial cancer, which is a type of cancer that starts in the lining of the womb. 'Advanced' means the cancer has spread beyond the womb, and 'metastatic' means it has spread to other parts of the body. The study is specifically for women whose cancer has either come back or worsened after they've already had chemotherapy treatment that included a platinum-based drug.
The main drug being tested is called retifanlimab. This drug is a type of immunotherapy, which means it works by helping your body's own immune system fight the cancer. Sometimes, retifanlimab will be given on its own. Other times, it will be combined with other new medicines like epacadostat, pemigatinib, INCAGN02385, or INCAGN02390. These other medicines are also being tested to see if they can help retifanlimab work even better.
The main goals of this study are to understand how safe these treatments are and how effective they are at shrinking tumors or stopping them from growing. By taking part, you could help doctors learn more about new ways to treat endometrial cancer and potentially help other patients in the future. This is a 'Phase 2' study, which means it's still an early stage of testing, but it's an important step in developing new treatments.
Key takeaways
- This study is for advanced womb cancer that has worsened after chemotherapy.
- It tests a new immunotherapy drug called retifanlimab, sometimes with other drugs.
- The main goals are to check safety and how well the treatment works.
- Participants will have regular clinic visits, blood tests, and scans.
- You can stop participating at any time.
- It's a Phase 2 study, meaning it's still in early development for these treatments.
Who may be eligible?
To join this study, you must be a woman aged 18 or older with endometrial cancer that has spread or returned. This must have happened after you've already had at least one course of chemotherapy that included a platinum-based drug.
You would generally not be able to join if your cancer could be cured by other existing treatments, or if you've recently had other cancer treatments. Also, if you have certain types of womb cancer like carcinosarcoma or sarcoma, you might not be able to join some groups. Your doctors will check if your previous treatment side effects have gone away and if your general health is good enough for the study.
Depending on which specific group you might join within the study, your tumour will be tested. For example, some groups require your tumour to have specific genetic features (like MSI-High, dMMR, ultra-mutated POLE, or FGFR mutations), or to not have been treated with certain types of immunotherapy before. If you've had immunotherapy before, you might still be able to join if your cancer has specific features.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a woman aged 18 or older?
- Do you have advanced or metastatic endometrial (womb) cancer?
- Has your cancer progressed or returned after platinum-based chemotherapy?
- Do you have at least one measurable tumour that can be tracked?
- Are you willing to provide a tumour tissue sample?
- Do you have a good general health status (ECOG 0-1)?
What does participation involve?
If you decide to take part in this study, you would start by signing a consent form after understanding all the details. Over the course of the study, you'll receive the study medication (retifanlimab, either alone or with another drug) on a regular schedule. This will involve regular visits to the clinic for treatments, blood tests, and scans (like CT scans or MRI scans) to check how the cancer is responding and to monitor for any side effects. You'll also need to provide a sample of your tumour tissue, which might be a new biopsy or an archived sample from a previous surgery.
Throughout the study, you'll be closely monitored by the study team. They will ask you about your general health and any side effects you might be experiencing. Women taking part must agree to prevent pregnancy during the study and for some time afterwards. The total length of your participation will depend on how you respond to the treatment and whether you have any side effects, but you will stop treatment if your cancer worsens significantly. Even if you stop treatment, the study team will usually want to keep in touch to understand your health in the long term.
Potential risks and benefits
Locations (65)
- Alaska Womens Cancer Care AkwccVerified postcodeAnchorage, United States
- HonorhealthVerified postcodePhoenix, United States
- Arizona Oncology AssociatesVerified postcodeTucson, United States
- UCLA Medical Hematology & OncologyVerified postcodeLos Angeles, United States
- Olive View Med CtrVerified postcodeSylmar, United States
- Broward Health Medical CenterVerified postcodeFort Lauderdale, United States
- Miami Cancer InstituteVerified postcodeMiami, United States
- Mount Sinai Medical Center Comprehensive Cancer CenterVerified postcodeMiami Beach, United States
- Advent Health Medical Group-Orlando 2501Verified postcodeOrlando, United States
- H. Lee Moffitt Cancer Center and Research Institute HospitalVerified postcodeTampa, United States
- Georgia Cancer CenterVerified postcodeAugusta, United States
- Barbara Ann Karmanos Cancer HospitalVerified postcodeDetroit, United States
Common questions
What is endometrial cancer?
Endometrial cancer is a type of cancer that starts in the lining of the womb (uterus). It's the most common type of gynaecological cancer in the UK.
What does 'platinum-based chemotherapy' mean?
This refers to standard chemotherapy drugs that contain platinum, which are commonly used to treat many cancers, including endometrial cancer.
What is immunotherapy?
Immunotherapy is a treatment that helps your body's immune system fight cancer. It's different from chemotherapy, which directly kills cancer cells.
What is a 'Phase 2' study?
Phase 2 studies are an early stage of clinical research. They aim to find out if a new treatment works for a specific type of cancer and to learn more about its safety and side effects.
Will I get the new treatment, or a placebo?
Everyone in this study will receive the active study medicine (retifanlimab alone or with another drug). There is no placebo group in this particular trial.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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