Conditions
Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Gastroesophageal Junction Carcinoma
Trial Purpose
The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Overall Survival (OS) and Event-free Survival (EFS) in:
- participants with esophageal squamous cell carcinoma (ESCC),
- participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, and
- all participants.
The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to:
- OS in participants with ESCC,
- OS in participants whose tumors express PD-L1 CPS ≥10,
- OS in all participants,
- EFS in participants with ESCC,
- EFS in participants whose tumors express PD-L1 CPS ≥10, and
- EFS in all participants.
NATIONAL TRIAL REFERENCE NUMBER
NCT04210115
When you talk with your doctor or clinical trial team member, please have the trial identifier 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
All patients who enroll in the trial will receive medication while on the study.
50% will receive pembrolizumab plus chemotherapy and radiotherapy
50% will receive placebo plus chemotherapy and radiotherapy
*A computer will decide which group you are put in. You have an equal chance of being in either group. You, your trial doctor, and the trial staff will know what you are getting.
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 February 28, 2020
- Estimated primary completion date February 11, 2027
- Estimated trial completion date February 11, 2027
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