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NCT03395847 · ClinicalTrials.gov registry record · Early Phase 1
Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Adenocarcinoma
A Early Phase 1 study of Gastroesophageal Junction Adenocarcinoma and Clinical Stage IV Gastric Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT03395847: Completed Early Phase 1 study of Gastroesophageal Junction Adenocarcinoma and Clinical Stage IV Gastric Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT03395847 is a Early Phase 1 study of Gastroesophageal Junction Adenocarcinoma and Clinical Stage IV Gastric Cancer AJCC v8 that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 9 participants, below the 404-participant average among 40 other Gastroesophageal Junction Adenocarcinoma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03395847, a Early Phase 1 study of Gastroesophageal Junction Adenocarcinoma and Clinical Stage IV Gastric Cancer AJCC v8, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
This early phase I trial studies how well pembrolizumab works in treating patients with gastroesophageal adenocarcinoma that has spread to other places or cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
Defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). Responses are based on assessments by the blinded MD Anderson radiology per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Exact method based on binomial distribution (Clopper-Pearson method).
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2018-02-09 |
| Est. Completion | 2023-01-27 |
| Phase | Early Phase 1 |
What the finished NCT03395847 record still lists
NCT03395847 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 404-participant average among 40 other Gastroesophageal Junction Adenocarcinoma trials with a reported enrollment target (98% lower).
The record links to 10 conditions, with Gastroesophageal Junction Adenocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which Pembrolizumab is the first listed.
NCT03395847 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03395847 about?
NCT03395847 is a clinical study titled "Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Adenocarcinoma". This early phase I trial studies how well pembrolizumab works in treating patients with gastroesophageal adenocarcinoma that has spread to other places or cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cance...
What is the current status of trial NCT03395847?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 9 participants. The study started on 2018-02-09. Estimated completion is 2023-01-27.
What conditions does trial NCT03395847 study?
This clinical trial studies the following conditions: Gastroesophageal Junction Adenocarcinoma, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8.
What interventions are being tested in trial NCT03395847?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03395847?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03395847 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gastroesophageal Junction Adenocarcinoma
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Where NCT03395847's enrollment target sits among peer trials
9 40th of 40 higher than 1 of 40 other Gastroesophageal Junction Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroesophageal Junction 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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