BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
This research study is investigating a new medication called BI-1808 for people with advanced cancers, including certain ovarian cancers, T-cell lymphomas, and melanoma, where previous treatments have stopped working. The study aims to understand how safe BI-1808 is, whether it causes new side effects, and to find the most effective dose when given alone and in combination with an existing cancer drug, pembrolizumab (Keytruda®). Participants will receive BI-1808, either on its own or with pembrolizumab, through an intravenous drip every three weeks. This is a multi-stage study, starting with small groups to carefully monitor safety and dosage. The findings from this study will help determine if BI-1808 can move forward into larger studies and potentially offer a new treatment option in the future.
At a glance
What is this study about?
This clinical trial is looking into a new medication called BI-1808. It's being tested in people who have advanced cancer, meaning their cancer has spread or hasn't responded to standard treatments. The study focuses on advanced solid tumours, which can include conditions like ovarian cancer, and a specific type of blood cancer called T-cell lymphoma, as well as melanoma.
The main purpose of this early-stage study is to understand how safe BI-1808 is when given alone, and also when it's given together with an existing cancer drug called pembrolizumab (Keytruda®). Researchers also want to find out what dose of BI-1808 can be given safely while causing the fewest side effects. This is really important because it helps them decide on the best dose to use in future, larger studies.
This study is conducted in a careful step-by-step way. It starts by giving the new drug to a small number of people, gradually increasing the dose while closely watching for any problems. If the drug appears safe, the study will then look more closely at how well it works against the cancer, but the primary focus initially is on safety and finding the right dose.
Key takeaways
- This study is for adults (18+) with advanced cancers that have progressed after standard treatments.
- It tests a new drug, BI-1808, alone and with pembrolizumab (Keytruda®).
- The main goals are to check the new drug's safety, side effects, and find the right dose.
- Participation involves regular infusions (every 3 weeks) and medical checks.
- Eligible conditions include certain ovarian cancers, T-cell lymphoma, and melanoma.
- Patients can leave the study at any time without affecting their care.
Who may be eligible?
To join this study, you must be an adult aged 18 or over and be willing to sign a consent form. You need to have been diagnosed with an advanced cancer that has been confirmed by laboratory tests, and your cancer must have continued to grow despite standard treatments. Importantly, you should have at least one measurable tumour that doctors can track.
You also need to be well enough to take part, generally meaning you can look after yourself or manage most daily activities without significant help. Your major organs, like your kidneys and liver, need to be working properly, and your doctors will check this with blood tests.
Specific types of cancer are being looked at, such as recurrent ovarian, fallopian tube, or peritoneal cancer, and certain T-cell lymphomas. If you have T-cell lymphoma, there are additional requirements, for example, regarding previous treatments you might have had, and if you are taking steroids, the dose needs to be stable.
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 an advanced cancer that has been confirmed by doctors and for which standard treatments are no longer working?
- Do you have at least one tumour that doctors can measure?
- Are you generally well enough to manage most day-to-day activities?
- Are you able to have a small tissue sample (biopsy) taken if needed?
- Are your major organs (like liver and kidneys) working adequately, as shown by blood tests?
What does participation involve?
If you decide to join this study, you will receive the study medication, BI-1808, either on its own or in combination with pembrolizumab. Both medications are given as an infusion directly into your bloodstream, usually every three weeks. Throughout the study, you'll have regular hospital visits for assessments, which will include blood tests, physical examinations, and scans to monitor your health and how the treatment is affecting your cancer.
The study is divided into two main parts. The first part (Phase 1) focuses on finding the safest and most effective dose, starting with small groups of participants. The second part (Phase 2a) will then use these determined doses in larger groups of people with specific types of cancer to further assess safety and get an early idea of how well the treatment works. The total duration of your participation will depend on how you respond to the treatment and the stage of the study, but you will have ongoing follow-up.
Potential risks and benefits
Locations (25)
- City of Hope National Medical CenterVerified postcodeDuarte, United States· Recruiting
- Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States· Recruiting
- University of PennsylvaniaVerified postcodePhiladelphia, United States· Recruiting
- RigshospitaletVerified postcodeCopenhagen, Denmark· Recruiting
- Herlev HospitalVerified postcodeHerlev, Denmark· Recruiting
- PRA Health Sciences - HungaryVerified postcodeBudapest, Hungary· Active not recruiting
- Magyar Honvédség-Egészségügyi KözpontVerified postcodeBudapest, Hungary· Recruiting
- Debreceni Egyetem Klinikai KözpontVerified postcodeDebrecen, Hungary· Withdrawn
- Byudzhetnoye Uchrezhdeniye Zdravookhraneniya Omskoy Oblasti - Klinicheskiy Onkologicheskiy DispanserVerified postcodeOmsk, Russia· Terminated
- National Medical Research Center VA AlmazovVerified postcodeSaint Petersburg, Russia· Withdrawn
- N.N. Petrov National Medical Research Center of OncologyVerified postcodeSaint Petersburg, Russia· Withdrawn
- Institut Catala d'oncologia. Hospital Duran I ReynalsVerified postcodeBarcelona, Spain· Not yet recruiting
Common questions
What is 'advanced malignancy'?
It means your cancer has spread from where it started or it hasn't responded well to standard treatments. This study includes specific advanced solid tumours and T-cell lymphomas.
What is BI-1808?
BI-1808 is an investigational new drug being tested in this study. It's not yet approved for general use. Its full effects and safety are still being researched.
What is pembrolizumab (Keytruda®)?
Pembrolizumab (Keytruda®) is a type of immunotherapy that is already approved for treating several types of cancer. It works by helping your body's immune system fight cancer cells.
What does 'Phase 1/2a' mean?
This refers to the early stages of a clinical trial. Phase 1 focuses on finding a safe dose and understanding side effects. Phase 2a starts to look more closely at how well the drug works for specific cancers, while still monitoring safety.
Will I know if I'm getting BI-1808 alone or with Keytruda?
Yes, this is an 'open-label' study, which means both you and your study doctor will know which treatment you are receiving.
How to find out more
Susanne Gertsson
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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