Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)
This research study is investigating new combinations of medicines for people with advanced stomach, gullet, or gastroesophageal junction cancer. This is cancer that has either spread to other parts of the body (metastatic) or is too advanced to be removed by surgery, and has already been treated with one type of therapy. The study aims to find out if new drug combinations, like sacituzumab tirumotecan with paclitaxel, or HER3-DXd with ramucirumab, are safer and work better than a standard treatment of ramucirumab with paclitaxel. It's an important step in finding more effective ways to treat this kind of cancer.
At a glance
What is this study about?
This study is really important for people who have advanced cancer in their stomach (gastric), where the gullet meets the stomach (gastroesophageal junction), or in their gullet (oesophageal). This type of cancer has already been treated once, but it has either started to grow again or has spread to other parts of the body.
The main goal of this study is to test different combinations of medicines. Researchers want to see how safe these new combinations are and how well they work at shrinking the cancer or stopping it from growing, compared to a standard treatment already used for this condition. By trying out these different drug pairings, doctors hope to find better ways to help people with this type of cancer live longer and with a better quality of life.
This is a 'Phase 1/2' study, which means it's still in the early to middle stages of testing. It's designed to give doctors a good idea of which treatments might be most promising to investigate further in larger studies.
Key takeaways
- This study is for advanced stomach or gullet cancer that has already been treated once.
- It compares new drug combinations against a standard treatment.
- The aim is to find safer and more effective ways to treat this cancer.
- Participation involves regular hospital visits, tests, and taking study medication.
- You can withdraw from the study at any time without affecting your care.
Who may be eligible?
To join this study, you would typically need to have been diagnosed with advanced stomach, gastroesophageal junction, or gullet cancer that has previously been treated with one course of therapy. Your cancer shouldn't have specific HER2 markers, which doctors will check from a recent biopsy.
There are also general health requirements, such as your overall fitness level (doctors use a scale called ECOG, and you'd need to be a 0 or 1), and a life expectancy of at least 3 months. If you have conditions like Hepatitis B, Hepatitis C, or HIV, these would need to be well-managed and under control.
You wouldn't be able to join if your cancer is a specific type called squamous cell, or if you've had significant recent weight loss. Also, any side effects from your previous cancer treatments would need to have largely cleared up to a mild level.
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.
- Do you have advanced stomach, gastroesophageal junction, or gullet cancer?
- Have you already had one treatment for your cancer?
- Has your cancer been tested and confirmed as HER2 negative?
- Are you able to provide a recent biopsy sample?
- Is your overall health generally good, with most previous treatment side effects cleared up?
What does participation involve?
If you join this study, you will receive one of the experimental drug combinations or the standard treatment. You'll have regular hospital visits for assessments, which will likely include blood tests, scans (like CT scans), and physical examinations to check how you're responding to the treatment and for any side effects. You'll take the study medication as prescribed by the doctors. The duration of the treatment phase will depend on how your cancer responds and how you tolerate the medication. Even after you stop receiving the study drug, there will be follow-up appointments to monitor your health.
Potential risks and benefits
Locations (45)
- University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 8927)Verified postcodeTucson, United States· Recruiting
- UCLA Hematology/Oncology - Santa Monica ( Site 8905)Verified postcodeLos Angeles, United States· Recruiting
- Norton Cancer Institute - Downtown ( Site 8900)Verified postcodeLouisville, United States· Completed
- The Cancer and Hematology Centers ( Site 8912)Verified postcodeGrand Rapids, United States· Recruiting
- Hematology-Oncology Associates of Central NY, P.C. ( Site 8925)Verified postcodeEast Syracuse, United States· Recruiting
- Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 8907)Verified postcodeNew York, United States· Completed
- UPMC Hillman Cancer Center-UPMC ( Site 8904)Verified postcodePittsburgh, United States· Recruiting
- University of Texas MD Anderson Cancer Center ( Site 8920)Verified postcodeHouston, United States· Recruiting
- Liga Norte Riograndense Contra o Câncer ( Site 8303)Verified postcodeNatal, Brazil· Recruiting
- Hospital Nossa Senhora da Conceição ( Site 8301)Verified postcodePorto Alegre, Brazil· Recruiting
- IBCC - Instituto Brasileiro de Controle do Câncer ( Site 8304)Verified postcodeSão Paulo, Brazil· Recruiting
- Clínica Puerto Montt ( Site 8409)Verified postcodePort Montt, Chile· Recruiting
Common questions
What does 'advanced or metastatic' cancer mean?
This means the cancer has either spread to other parts of your body or is too far along to be removed by surgery.
Why is it called 'second line' treatment?
This means you have already received one course of treatment for your cancer, and the study is looking at the next step in treatment.
What is a 'biopsy'?
A biopsy is when a small sample of tissue is taken from your body to be examined under a microscope, helping doctors understand your cancer better.
What does 'HER2 negative' mean?
HER2 is a protein that some cancer cells have. Being 'HER2 negative' means your cancer cells don't have this protein, which helps doctors choose the right treatment.
What is an 'umbrella platform study'?
It's a type of study where several different treatments for the same disease are tested at the same time under one main research plan, making research more efficient.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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