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NCT04117087 · ClinicalTrials.gov registry record · Phase 1
Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Resected Mismatch Repair Protein (MMR-p) Colorectal and Pancreatic Cancer
A Phase 1 study of Colorectal Cancer and Pancreatic Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Active
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT04117087: Active Phase 1 study of Colorectal Cancer and Pancreatic Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT04117087 is a Phase 1 study of Colorectal Cancer and Pancreatic Cancer that is active but no longer recruiting, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 27 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04117087, a Phase 1 study of Colorectal Cancer and Pancreatic Cancer, is active but no longer recruiting, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
Phase 1 study for patients with resected PDAC after neoadjuvant and/ or adjuvant chemotherapy and/or radiation, as well as patients with metastatic colorectal cancer who have exposure to 2 or more lines of chemotherapy, to evaluate safety and the immune response to pooled mutant-KRAS peptide vaccine (KRAS peptide vaccine) with poly-ICLC adjuvant in combination with nivolumab and ipilimumab.
Primary Outcome
Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG KRAS peptide vaccine
Study Locations (1)
Maryland
- Sidney Kimmel Comprehensive Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2020-05-28 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 1 |
What the registry record for NCT04117087 still lists
NCT04117087 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT04117087 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04117087 about?
NCT04117087 is a clinical study titled "Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Resected Mismatch Repair Protein (MMR-p) Colorectal and Pancreatic Cancer". Phase 1 study for patients with resected PDAC after neoadjuvant and/ or adjuvant chemotherapy and/or radiation, as well as patients with metastatic colorectal cancer who have exposure to 2 or more lines of chemotherapy, to evaluate safety and the immune response to pooled mutant-KRAS peptide vaccine...
What is the current status of trial NCT04117087?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2020-05-28. Estimated completion is 2027-06-01.
What conditions does trial NCT04117087 study?
This clinical trial studies the following conditions: Colorectal Cancer, Pancreatic Cancer.
What interventions are being tested in trial NCT04117087?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), KRAS peptide vaccine (DRUG).
Who is sponsoring clinical trial NCT04117087?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04117087 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04117087's enrollment target sits among peer trials
27 328th of 381 higher than 54 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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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