Conditions
Carcinoma, Squamous Cell
Trial Purpose
This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).
CLINICALTRIALS.GOV IDENTIFIER
NCT03833167
EudraCT Number
2018-001974-76
When you talk with your doctor or clinical trial team member, please have the trial identifier number or the EudraCT number available.
Resources
Eligibility
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Age Range
18+
Sex
All
About the trial
Patients who enroll in the trial will be assigned to one of the following study groups.
50% will receive pembrolizumab.
50% will receive placebo.
*You will be assigned by chance (a process called randomization) to receive one of the above treatments. The study doctor will discuss with you what options you have if your cancer comes back while you are in the study.
Current trial phase
Trial Phase 3
In Phase 3 trials, researchers try to find out if a treatment works in a large number of people, usually about 1,000 to 5,000 participants who have the health condition the treatment is intended to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.
Trial start and end dates
- Trial start date April 1, 2019
- Estimated primary completion date May 5, 2025
- Estimated trial completion date September 29, 2028
Trial locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.
What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risks and possible benefits are for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about