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NCT03816358 · ClinicalTrials.gov registry record · Phase 1
Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer
A Phase 1 study of Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
- 20
- Study locations
NCT03816358: Active Phase 1 study of Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
NCT03816358 is a Phase 1 study of Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 74 participants, below the 99,464-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03816358, a Phase 1 study of Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of anetumab ravtansine when given together with nivolumab, ipilimumab and gemcitabine hydrochloride in treating patients with mesothelin positive pancreatic cancer that has spread to other places in the body (advanced). Anetumab ravtansine is a monoclonal antibody, called anetumab ravtansine, linked to a chemotherapy drug called DM4. Anetumab attaches to mesothelin positive cancer cells in a targeted way and delivers DM4 to kill them. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving anetumab ravtansine together with nivolumab, ipilimumab, and gemcitabine hydrochloride may work better in treating patients with pancreatic cancer.
Primary Outcome
This study will follow a 3+3 dose escalation design.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy Procedure
- BIOLOGICAL Ipilimumab
- DRUG Gemcitabine Hydrochloride
- BIOLOGICAL Anetumab Ravtansine
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- City of Hope at Irvine Lennar - Irvine
- Keck Medicine of USC Koreatown - Los Angeles
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- University of California Davis Comprehensive Cancer Center - Sacramento
Kansas
- University of Kansas Clinical Research Center - Fairway
- HaysMed - Hays
- University of Kansas Cancer Center - Kansas City
- Lawrence Memorial Hospital - Lawrence
- The University of Kansas Cancer Center - Olathe - Olathe
- University of Kansas Cancer Center-Overland Park - Overland Park
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Colorado
- UCHealth University of Colorado Hospital - Aurora
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2019-12-09 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 1 |
What the registry record for NCT03816358 still lists
NCT03816358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 99,464-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower).
The record links to 4 conditions, with Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03816358 names 20 study sites across 6 states, led by California, Kansas, Florida.
Frequently Asked Questions
What is clinical trial NCT03816358 about?
NCT03816358 is a clinical study titled "Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer". This phase I trial studies the side effects and best dose of anetumab ravtansine when given together with nivolumab, ipilimumab and gemcitabine hydrochloride in treating patients with mesothelin positive pancreatic cancer that has spread to other places in the body (advanced). Anetumab ravtansine is...
What is the current status of trial NCT03816358?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2019-12-09. Estimated completion is 2027-01-31.
What conditions does trial NCT03816358 study?
This clinical trial studies the following conditions: Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage II Pancreatic Cancer AJCC v8.
What interventions are being tested in trial NCT03816358?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy Procedure (PROCEDURE), Ipilimumab (BIOLOGICAL), Gemcitabine Hydrochloride (DRUG), Anetumab Ravtansine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03816358?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03816358 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03816358's enrollment target sits among peer trials
74 29th of 62 higher than 33 of 62 other Pancreatic Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic 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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