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NCT03281369 · ClinicalTrials.gov registry record · Phase 1
A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 214
- Enrollment target
NCT03281369: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT03281369 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 214 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (257% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03281369, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 214 participants
- Enrollment target
Study Summary
A Phase Ib/II, open label, multi-center, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with locally advanced unresectable or metastatic G/GEJ cancer (hereafter referred to as gastric cancer) and esophageal cancer. Two cohorts of patients with gastric cancer have been enrolled in parallel in this study: the second-line (2L) Gastric Cancer Cohort consists of patients with gastric cancer who have progressed after receiving a platinum-containing or fluoropyrimide-containing chemotherapy regimen in the first-line setting, and the first-line (1L) Gastric Cancer Cohort consists of patients with gastric cancer who have not received prior chemotherapy in this setting. In each cohort, eligible patients will be assigned to one of several treatment arms. Additionally, a cohort of patients with esophageal cancer who have not received prior systemic treatment for their disease will be enrolled in this study. Eligible patients will be randomized to chemotherapy or the combination of chemotherapy with checkpoint inhibitor immunotherapy.
Primary Outcome
OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart during Stage 1, as determined by the investigator using RECIST v.1.1. Objective response rate (ORR) was defined as the percentage of participants with OR. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% dec
Interventions
- DRUG Atezolizumab
- DRUG Leucovorin
- DRUG 5-Fluorouracil (5-FU)
- DRUG Oxaliplatin
- DRUG Cobimetinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2017-10-13 |
| Est. Completion | 2025-10-09 |
| Phase | Phase 1 |
What the finished NCT03281369 record still lists
NCT03281369 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (257% higher).
The record links to 0 conditions, and to 5 interventions - of which Atezolizumab is the first listed.
NCT03281369 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03281369 about?
NCT03281369 is a clinical study titled "A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)". A Phase Ib/II, open label, multi-center, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with locally advanced unresectable or metastatic G/GEJ cancer (hereafter referred to a...
What is the current status of trial NCT03281369?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 214 participants. The study started on 2017-10-13. Estimated completion is 2025-10-09.
What interventions are being tested in trial NCT03281369?
The interventions under investigation include: Atezolizumab (DRUG), Leucovorin (DRUG), 5-Fluorouracil (5-FU) (DRUG), Oxaliplatin (DRUG), Cobimetinib (DRUG).
Who is sponsoring clinical trial NCT03281369?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03281369's enrollment target sits among peer trials
214 244th of 2000 higher than 1,756 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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