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NCT03336216 · ClinicalTrials.gov registry record · Phase 2
A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
A Phase 2 study of Advanced Pancreatic Cancer, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 205
- Enrollment target
- 20
- Study locations
NCT03336216: Completed Phase 2 study of Advanced Pancreatic Cancer, sponsored by Bristol-Myers Squibb.
NCT03336216 is a Phase 2 study of Advanced Pancreatic Cancer that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 205 participants, above the 47-participant average among 7 other Advanced Pancreatic Cancer trials with a reported enrollment target (336% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03336216, a Phase 2 study of Advanced Pancreatic Cancer, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 205 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, with or without chemotherapy, is effective for the treatment of advanced pancreatic cancer.
Primary Outcome
PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline
Conditions Studied
Interventions
- DRUG Fluorouracil
- BIOLOGICAL Nivolumab
- DRUG Nab-paclitaxel
- DRUG Onivyde
- BIOLOGICAL Cabiralizumab
Study Locations (20)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Dana Farber Cancer Institute. - Boston
- Local Institution - 0010 - Boston
Arizona
- Mayo Clinic in Rochester, Minnesota - Phoenix
- HonorHealth Research Institute - Scottsdale
Florida
- Florida Cancer Specialists - South - Fort Myers
- Florida Cancer Specialists - North - St. Petersburg
New York
- Local Institution - 0012 - New York
- Local Institution - 0005 - New York
Pennsylvania
- Local Institution - 0006 - Philadelphia
- Local Institution - 0009 - Pittsburgh
Texas
- Local Institution - 0013 - Dallas
- Local Institution - 0011 - Houston
California
- Local Institution - 0007 - Los Angeles
Colorado
- University Of Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2017-12-18 |
| Est. Completion | 2023-06-01 |
| Phase | Phase 2 |
What the finished NCT03336216 record still lists
NCT03336216 is an interventional study that assigns participants to a tested intervention. The registered 205 participants enrollment target is mid-sized for trials with a published cap, above the 47-participant average among 7 other Advanced Pancreatic Cancer trials with a reported enrollment target (336% higher).
The record links to 1 condition, with Advanced Pancreatic Cancer appearing as the primary indexed condition, and to 5 interventions - of which Fluorouracil is the first listed.
NCT03336216 names 20 study sites across 13 states, led by Massachusetts, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT03336216 about?
NCT03336216 is a clinical study titled "A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer". The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, with or without chemotherapy, is effective for the treatment of advanced pancreatic cancer.
What is the current status of trial NCT03336216?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 205 participants. The study started on 2017-12-18. Estimated completion is 2023-06-01.
What conditions does trial NCT03336216 study?
This clinical trial studies the following conditions: Advanced Pancreatic Cancer.
What interventions are being tested in trial NCT03336216?
The interventions under investigation include: Fluorouracil (DRUG), Nivolumab (BIOLOGICAL), Nab-paclitaxel (DRUG), Onivyde (DRUG), Cabiralizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03336216?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03336216 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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