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NCT06794645 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab and Pemetrexed for Progressive Chordoma
A Phase 2 study of Chordoma and Chordomas, sponsored by Saint John's Cancer Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT06794645: Recruiting Phase 2 study of Chordoma and Chordomas, sponsored by Saint John's Cancer Institute.
NCT06794645 is a Phase 2 study of Chordoma and Chordomas that is actively recruiting participants, run by Saint John's Cancer Institute. The registered enrollment target is 21 participants, below the 86-participant average among 15 other Chordoma trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06794645, a Phase 2 study of Chordoma and Chordomas, is actively recruiting participants, sponsored by Saint John's Cancer Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective: 1\. To determine objective response rate (ORR) according to RECIST v1.1 of pembrolizumab and high-dose pemetrexed in the treatment of patients with chordoma until disease progression. The OOR will be investigator assessed. Secondary Objectives: 1. To describe the adverse events associated with administering pembrolizumab and high-dose pemetrexed combination treatment. 2. To determine disease control rate based on imaging and overall survival. 3. To determine median PFS and PFS rates at 6, 9, 12, and 18 months. 4. To evaluate changes in volumetric tumor measurements based on imaging. 5. To determine the effects of combination treatment on quality of life, assessed by the EORTC-QLQ-C30 questionnaire. 6. To assess tumor evolution over time in patients with chordoma based on imaging, and molecular profiling. 7. To assess the pharmacodynamic effects of treatment in blood. Exploratory Objective: 1\. To explore the relationship between molecular phenotype and patient response.
Primary Outcome
1\. To determine objective response rate (ORR) according to RECIST v1.1 of pembrolizumab and high-dose pemetrexed in the treatment of patients with chordoma. The OOR will be investigator assessed.
Interventions
- DRUG Pembrolizumab
- DRUG Pemetrexed Phase 2
Study Locations (1)
California
- Providence Saint John's Health Center - Santa Monica
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2025-01 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 2 |
What NCT06794645 shows while recruiting
NCT06794645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 86-participant average among 15 other Chordoma trials with a reported enrollment target (76% lower).
The record links to 2 conditions, with Chordoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT06794645 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06794645 about?
NCT06794645 is a clinical study titled "Pembrolizumab and Pemetrexed for Progressive Chordoma". Primary Objective: 1\. To determine objective response rate (ORR) according to RECIST v1.1 of pembrolizumab and high-dose pemetrexed in the treatment of patients with chordoma until disease progression. The OOR will be investigator assessed. Secondary Objectives: 1. To describe the adverse events...
What is the current status of trial NCT06794645?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2025-01. Estimated completion is 2026-11-30.
What conditions does trial NCT06794645 study?
This clinical trial studies the following conditions: Chordoma, Chordomas.
What interventions are being tested in trial NCT06794645?
The interventions under investigation include: Pembrolizumab (DRUG), Pemetrexed Phase 2 (DRUG).
Who is sponsoring clinical trial NCT06794645?
This trial is sponsored by Saint John's Cancer Institute, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06794645 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06794645's enrollment target sits among peer trials
21 13th of 15 higher than 2 of 15 other Chordoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chordoma 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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