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NCT04007744 · ClinicalTrials.gov registry record · Phase 1
Sonidegib and Pembrolizumab in Treating Patients With Advanced Solid Tumors
A Phase 1 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8, sponsored by Mayo Clinic.
- Active
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 3
- Study locations
NCT04007744: Active Phase 1 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8, sponsored by Mayo Clinic.
NCT04007744 is a Phase 1 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8 that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 36 participants, below the 151-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (76% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04007744, a Phase 1 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8, is active but no longer recruiting, sponsored by Mayo Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I trial studies the best dose of sonidegib when given together with pembrolizumab and to see how well they work in treating patients with solid tumor that has spread to other places in the body (advanced). Sonidegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 sonidegib and pembrolizumab may work better than standard treatment in treating patients with advanced solid tumors.
Primary Outcome
MTD is defined as the dose level below the lowest dose that induces dose- limiting toxicity (DLT) in at least one-third of patients. Three patients will be treated at a given dose level combination and observed for at least 21 days from start of treatment to assess toxicity.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Sonidegib
Study Locations (3)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-02-13 |
| Est. Completion | 2027-07-02 |
| Phase | Phase 1 |
What the registry record for NCT04007744 still lists
NCT04007744 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 151-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (76% lower).
The record links to 10 conditions, with Clinical Stage IV Cutaneous Melanoma AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04007744 reports a single indexed study location in Arizona, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT04007744 about?
NCT04007744 is a clinical study titled "Sonidegib and Pembrolizumab in Treating Patients With Advanced Solid Tumors". This phase I trial studies the best dose of sonidegib when given together with pembrolizumab and to see how well they work in treating patients with solid tumor that has spread to other places in the body (advanced). Sonidegib may stop the growth of tumor cells by blocking some of the enzymes needed...
What is the current status of trial NCT04007744?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2020-02-13. Estimated completion is 2027-07-02.
What conditions does trial NCT04007744 study?
This clinical trial studies the following conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage III Gastric Cancer AJCC v8.
What interventions are being tested in trial NCT04007744?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Sonidegib (DRUG).
Who is sponsoring clinical trial NCT04007744?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04007744 being conducted?
This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Clinical Stage IV Cutaneous Melanoma AJCC v8
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Where NCT04007744's enrollment target sits among peer trials
36 22nd of 32 higher than 10 of 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clinical Stage IV Cutaneous Melanoma AJCC v8 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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