INCMGA 0012-303: A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)
This important study is investigating a new treatment approach for squamous cell carcinoma of the anal canal. Researchers are looking for people whose cancer has either spread to other parts of the body or has returned after previous treatments, and who haven't had chemotherapy for this stage of their cancer yet. The study will compare a new medicine called retifanlimab, given with standard chemotherapy (carboplatin and paclitaxel), against chemotherapy with a dummy medicine (placebo). The main goal is to see if patients taking retifanlimab plus chemotherapy live longer without their cancer progressing. They will also look at how long patients live overall, how many see their cancer shrink or disappear, and any side effects. This is a "Phase 3" study, which means it's a large trial designed to confirm if a new treatment is truly effective and safe.
At a glance
What is this study about?
This research study is about finding better ways to treat a type of cancer called squamous cell carcinoma of the anal canal. This is cancer that starts in the long tube that connects the end of your bowel to the outside of your body. Specifically, the study is for people whose cancer has either spread to other parts of their body (metastatic) or has come back in the same area after earlier treatments (locally recurrent), and who haven't had chemotherapy for this advanced stage of their cancer before.
The study aims to see if adding a new medicine called retifanlimab to standard chemotherapy (carboplatin and paclitaxel) works better than just the standard chemotherapy on its own. Retifanlimab is a type of medicine that helps your own immune system fight the cancer. By comparing these two approaches, researchers hope to discover if the new combination can help patients live longer without their cancer getting worse.
This is a 'Phase 3' study, which means it's one of the final and largest steps in testing a new treatment. If the results show that the new treatment is safe and effective, it could become a new standard treatment option for people with this type of anal canal cancer. This research could make a real difference to future patient care.
Key takeaways
- This study is for anal canal cancer that has spread or come back.
- It tests a new medicine, retifanlimab, with standard chemotherapy.
- Patients will either get retifanlimab or a dummy medicine, plus chemotherapy.
- The main goal is to see if patients live longer without their cancer getting worse.
- It's a large, important 'Phase 3' study to confirm treatment effectiveness.
- Your health will be closely monitored throughout.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.
The main thing is that your anal canal cancer must be a specific type, called squamous cell carcinoma. It also needs to be at a stage where it has either come back in the same general area after previous treatment, or it has spread to other parts of your body.
Critically, you must *not* have had chemotherapy for this advanced stage of your cancer previously. There will also be other health checks and tests to make sure the study treatment is safe for you.
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 18 years old or older?
- Do you have squamous cell carcinoma of the anal canal?
- Has your cancer spread or come back after previous treatment?
- Have you *not* had chemotherapy for this stage of your cancer before?
What does participation involve?
If you join this study, you will have regular hospital visits for assessments and to receive your treatment. Because this is a "double-blind" study, neither you nor your study doctor will know whether you are receiving the new medicine (retifanlimab) or the dummy medicine (placebo) along with your chemotherapy. This is important to ensure the study results are as fair and accurate as possible.
During the study, you'll have various tests, including scans, to check how your cancer is responding and to monitor any side effects. The treatment will continue as long as it's helping and you're not experiencing difficult side effects. After your treatment period, doctors will continue to follow up on your health and check-ups for a certain amount of time to understand the long-term effects.
Potential risks and benefits
Locations (8)
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Common questions
What is anal canal cancer?
Anal canal cancer is a type of cancer that starts in the cells lining the anal canal, which is the short tube at the end of your bowel.
What does 'metastatic' or 'locally recurrent' mean?
'Metastatic' means the cancer has spread from where it started to other parts of your body. 'Locally recurrent' means the cancer has come back in the same area after earlier treatments.
What is retifanlimab?
Retifanlimab is a new type of medicine that works with your body's immune system to help it find and fight cancer cells.
What is a 'placebo'?
A placebo is a dummy medicine that looks just like the real drug but doesn't contain any active ingredients. It's used in studies to compare the new medicine's effects accurately.
Why is this study 'double-blind'?
Being 'double-blind' means neither you nor your doctor knows if you're getting the new medicine or the placebo. This helps make sure the study results are fair and objective.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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