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NCT02962063 · ClinicalTrials.gov registry record · Phase 1
Durvalumab, an Anti-PDLI Antibody, and Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation Before Surgery for Esophageal Cancer
A Phase 1 study of Esophageal Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 7
- Study locations
NCT02962063: Active Phase 1 study of Esophageal Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT02962063 is a Phase 1 study of Esophageal Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 64 participants, below the 307-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (79% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02962063, a Phase 1 study of Esophageal Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to test the safety of adding a new drug, durvalumab (also called MEDI4736), to chemoradiation with either FOLFOX/Capeox or carboplatin and paclitaxel, following initial chemotherapy with FOLFOX. The investigators want to find out what effects, good and/or bad, this combination has on the patient and cancer.
Primary Outcome
"Unacceptable toxicity" is defined as any of the following toxicities: \>1 episode of grade 3/4 neutropenia or thrombocytopenia \<75,000/μL (despite prior dose reduction) during chemoradiation any toxicity that results in \>2 week cumulative delay in chemoradiation any toxicity that is attributed to durvalumab which results in a delay of \>8 weeks in surgery, i.e. surgery \>16 weeks from the end of radiation, for a potentially operable patient any reason that is attributed to durvalumab which le
Conditions Studied
Interventions
- DRUG Tremelimumab
- BIOLOGICAL durvalumab
- DRUG carboplatin AUC 2/paclitaxel
- RADIATION External beam radiation (EBRT)
- PROCEDURE esophagogastrectomy
Study Locations (7)
New York
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Rockville Centre - Rockville Centre
- Memorial Sloan Kettering Nassau - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Bergen - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2016-11 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
What the registry record for NCT02962063 still lists
NCT02962063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 307-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (79% lower).
The record links to 2 conditions, with Esophageal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Tremelimumab is the first listed.
NCT02962063 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT02962063 about?
NCT02962063 is a clinical study titled "Durvalumab, an Anti-PDLI Antibody, and Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation Before Surgery for Esophageal Cancer". The purpose of this study is to test the safety of adding a new drug, durvalumab (also called MEDI4736), to chemoradiation with either FOLFOX/Capeox or carboplatin and paclitaxel, following initial chemotherapy with FOLFOX. The investigators want to find out what effects, good and/or bad, this combi...
What is the current status of trial NCT02962063?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2016-11. Estimated completion is 2026-11.
What conditions does trial NCT02962063 study?
This clinical trial studies the following conditions: Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma.
What interventions are being tested in trial NCT02962063?
The interventions under investigation include: Tremelimumab (DRUG), durvalumab (BIOLOGICAL), carboplatin AUC 2/paclitaxel (DRUG), External beam radiation (EBRT) (RADIATION), esophagogastrectomy (PROCEDURE).
Who is sponsoring clinical trial NCT02962063?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02962063 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02962063's enrollment target sits among peer trials
64 23rd of 43 higher than 21 of 43 other Esophageal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Esophageal Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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