Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 214 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03281369
The ClinicalTrials.gov registry entry for NCT03281369 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 214 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Atezolizumab is the first listed.
NCT03281369 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.