BridgeMD
A trial to see if the combination of fianlimab with cemiplimab works better than pembrolizumab for preventing or delaying melanoma from coming back after it has been removed with surgery
EU CTIS ID: 2022-501576-25-00
What this study is testing
To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by relapse free survival (RFS)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- All patients must be either stage IIB, IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition according to cutaneous melanoma staging criteria and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol
- Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery
- All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol
You likely can't join if
- Uveal melanoma
- Any evidence of residual disease after surgery by imaging, pathology, or cytology
- Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required treatment
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol
- Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol
- Adolescent patients (≥12 to <18 years old) with body weight <40 kg
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Canada
- South Africa
- Israel
- Argentina
- United States
- Mexico
- United Kingdom
- Brazil
- Georgia
- Chile
- New Zealand
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Canada; South Africa; Israel; Argentina; United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.