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NCT06564623 · ClinicalTrials.gov registry record · Phase 1
Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC)
A Phase 1 study of Biliary Tract Cancers, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT06564623: Recruiting Phase 1 study of Biliary Tract Cancers, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT06564623 is a Phase 1 study of Biliary Tract Cancers that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06564623, a Phase 1 study of Biliary Tract Cancers, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety and the immune response of personalized mutant peptide vaccine with poly-ICLC adjuvant (mBTCvax) in combination with durvalumab and tremelimumab following front-line treatment in patients with advanced stage BTC.
Primary Outcome
When calculating the incidence of Adverse Events (AE), each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject.
Conditions Studied
Interventions
- DRUG Durvalumab
- DRUG Tremelimumab
- DRUG mBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)]
Study Locations (1)
Maryland
- SKCCC Johns Hopkins Medical Institution - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2025-05-27 |
| Est. Completion | 2029-05 |
| Phase | Phase 1 |
What NCT06564623 shows while recruiting
NCT06564623 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Biliary Tract Cancers appearing as the primary indexed condition, and to 3 interventions - of which Durvalumab is the first listed.
NCT06564623 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06564623 about?
NCT06564623 is a clinical study titled "Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC)". The purpose of this study is to evaluate the safety and the immune response of personalized mutant peptide vaccine with poly-ICLC adjuvant (mBTCvax) in combination with durvalumab and tremelimumab following front-line treatment in patients with advanced stage BTC.
What is the current status of trial NCT06564623?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2025-05-27. Estimated completion is 2029-05.
What conditions does trial NCT06564623 study?
This clinical trial studies the following conditions: Biliary Tract Cancers.
What interventions are being tested in trial NCT06564623?
The interventions under investigation include: Durvalumab (DRUG), Tremelimumab (DRUG), mBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)] (DRUG).
Who is sponsoring clinical trial NCT06564623?
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 NCT06564623 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 Biliary Tract Cancers
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 NCT06564623's enrollment target sits among peer trials
25 1496th of 2000 higher than 481 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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