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NCT05764395 · ClinicalTrials.gov registry record · Phase 2
Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors
A Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT05764395: Active Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT05764395 is a Phase 2 study that is active but no longer recruiting, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05764395, a Phase 2 study, is active but no longer recruiting, sponsored by Vanderbilt-Ingram Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This phase II clinical trial tests how well rigosertib plus pembrolizumab workings in treating patients with melanoma which cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic), and that has not responded to previous treatment with PD-1 or PD-L1 inhibitors (refractory). Rigosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may change the immune system to make immunotherapy more effective. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving rigosertib in combination with pembrolizumab may be more effective in treating patients with unresectable metastatic melanoma that has not responded to previous treatment with PD-1 or PD-L1 inhibitors than giving either drug alone.
Primary Outcome
Progression will be assessed as defined by Immune-Modified Response Evaluation Criteria in Solid Tumors criteria. PFS will be assessed using the Kaplan-Meier method. Median PFS and PFS at one year will be reported with 95% confidence intervals
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy
- PROCEDURE Magnetic Resonance Imaging
- DRUG Rigosertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2023-05-09 |
| Est. Completion | 2029-05-01 |
| Phase | Phase 2 |
What the registry record for NCT05764395 still lists
NCT05764395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT05764395 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05764395 about?
NCT05764395 is a clinical study titled "Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors". This phase II clinical trial tests how well rigosertib plus pembrolizumab workings in treating patients with melanoma which cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic), and that has not responded t...
What is the current status of trial NCT05764395?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2023-05-09. Estimated completion is 2029-05-01.
What interventions are being tested in trial NCT05764395?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Biopsy (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Rigosertib (DRUG).
Who is sponsoring clinical trial NCT05764395?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05764395's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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