MK-3475-06C
Substudy 06C: A Study of Investigational Agents With Pembrolizumab and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma
Recruiting
Trial Purpose
This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluate the safety and tolerability of investigational agents with pembrolizumab and fluoropyrimidine chemotherapy for the first-line (1L) treatment of participants with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma.
This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for investigational agents in combination with chemotherapy and immunotherapy. There is no formal hypothesis in this study.
View more trial information on ClinicalTrials.gov
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National Trial Reference NumberNational Trial Reference NumberA unique identification code given to each clinical trial record registered on ClinicalTrials.gov. Also called the ClinicalTrials.gov identifier. | NCT06469944 |
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MSD Protocol ID |
MK-3475-06C |
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Conditions |
Esophageal Cancer, Esophageal Neoplasms, Gastroesophageal Adenocarcinoma, Gastroesophageal Junction |
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Age Range |
18+ |
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SexSexSex assigned at birth. Sex is distinct from gender-based eligibility. | ALL |
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Trial PhaseTrial PhaseThe stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the trial’s objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions. | 1, 2 |
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Start Date End Date |
2024-09-20 2029-09-12 |
Study Details
Patient Participation
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial.
Conditions
Esophageal Cancer, Esophageal Neoplasms, Gastroesophageal Adenocarcinoma, Gastroesophageal Junction
Trial Phase 1
Investigational medication is tested for safety on a relatively small group of 20 to 100 volunteers who are usually healthy, but not always. Phase 1 trials may happen in a doctor’s office or a hospital.
Trial Phase 2
In Phase 2 trials, researchers try to find out if a treatment works in about 100 to 500 participantsResearch participantIn clinical research, a person who qualifies and agrees to participate in a study. Also called volunteer, trial participant. – usually people who have the health condition the treatment is intended to treat. In vaccine trials, the participants are usually healthy. Phase 2 trials may happen in a doctor’s office, a clinic, or a hospital.
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.
Discuss with your doctor or care team
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