Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04401995 · ClinicalTrials.gov registry record · Phase 2
Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination With Nivolumab vs. Nivolumab
A Phase 2 study, sponsored by Diwakar Davar.
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT04401995: Completed Phase 2 study, sponsored by Diwakar Davar.
NCT04401995 is a Phase 2 study that has completed, run by Diwakar Davar. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04401995, a Phase 2 study, has completed, sponsored by Diwakar Davar.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
The main goal of this research study is to determine how nivolumab and nivolumab/Vidutolimod (CMP-001) combination affect the likelihood of destroying melanoma involving lymph node and/or in-transit/satellite areas. The main goal of the PET/CT scan with 18F\]F-AraG is to evaluate how \[18F\]F-AraG uptake changes before and after administration of either nivolumab or nivolumab/CMP-001 combination.
Primary Outcome
Percentage of patients who experience Pathologic CR (pCR), Partial PR (pPR), or Pathologic NR (pNR) per Immune-related Pathologic Response Criteria. pCR is defined as 0% RVT (residual tumor volume) remaining in post-therapy specimen. pPR is defined a 10%\<%RVT\< 50%. pNR is defined as %RVT\>50%.
Interventions
- BIOLOGICAL Nivolumab
- DRUG Vidutolimod (CMP-001)
- OTHER [18F]F-AraG PET/CT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-09-02 |
| Est. Completion | 2024-08-16 |
| Phase | Phase 2 |
What the finished NCT04401995 record still lists
NCT04401995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT04401995 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04401995 about?
NCT04401995 is a clinical study titled "Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination With Nivolumab vs. Nivolumab". The main goal of this research study is to determine how nivolumab and nivolumab/Vidutolimod (CMP-001) combination affect the likelihood of destroying melanoma involving lymph node and/or in-transit/satellite areas. The main goal of the PET/CT scan with 18F\]F-AraG is to evaluate how \[18F\]F-AraG ...
What is the current status of trial NCT04401995?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2020-09-02. Estimated completion is 2024-08-16.
What interventions are being tested in trial NCT04401995?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Vidutolimod (CMP-001) (DRUG), [18F]F-AraG PET/CT (OTHER).
Who is sponsoring clinical trial NCT04401995?
This trial is sponsored by Diwakar Davar, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04401995's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI