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NCT03193190 · ClinicalTrials.gov registry record · Phase 1
A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 341
- Enrollment target
NCT03193190: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT03193190 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 341 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (468% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03193190, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 341 participants
- Enrollment target
Study Summary
A Phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma (PDAC). Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of patients who have received no prior systemic therapy for metastatic PDAC, and Cohort 2 will consist of patients who have received one line of prior systemic therapy for PDAC. In each cohort, eligible patients will be assigned to one of several treatment arms.
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 lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of d
Interventions
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Nab-Paclitaxel
- DRUG Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 341 participants |
| Start Date | 2017-07-05 |
| Est. Completion | 2025-02-27 |
| Phase | Phase 1 |
What the finished NCT03193190 record still lists
NCT03193190 is an interventional study that assigns participants to a tested intervention. The registered 341 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 (468% higher).
The record links to 0 conditions, and to 5 interventions - of which Fluorouracil is the first listed.
NCT03193190 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03193190 about?
NCT03193190 is a clinical study titled "A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)". A Phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma (PDAC). Two cohorts will be enrol...
What is the current status of trial NCT03193190?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 341 participants. The study started on 2017-07-05. Estimated completion is 2025-02-27.
What interventions are being tested in trial NCT03193190?
The interventions under investigation include: Fluorouracil (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), Nab-Paclitaxel (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT03193190?
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 NCT03193190's enrollment target sits among peer trials
341 104th of 2000 higher than 1,897 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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