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NCT04495257 · ClinicalTrials.gov registry record · Phase 1
A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (RCC)
A Phase 1 study of Renal Cell Carcinoma and Advanced Melanoma, sponsored by Yale University.
- Active
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 2
- Study locations
NCT04495257: Active Phase 1 study of Renal Cell Carcinoma and Advanced Melanoma, sponsored by Yale University.
NCT04495257 is a Phase 1 study of Renal Cell Carcinoma and Advanced Melanoma that is active but no longer recruiting, run by Yale University. The registered enrollment target is 26 participants, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04495257, a Phase 1 study of Renal Cell Carcinoma and Advanced Melanoma, is active but no longer recruiting, sponsored by Yale University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study is a Phase 1, open-label, single institution, dose escalation and dose expansion study to evaluate the efficacy, safety, and tolerability of APX005M in combination with nivolumab and ipilimumab in patients with advanced melanoma and RCC.
Primary Outcome
The safety and tolerability of APX005M in combination with nivolumab and ipilimumab will be assessed by monitoring the of dose-limiting toxicities (DLTs) . This will be defined by both DLTs and any of the following AEs (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0) which occur during the first 9 weeks of ipilimumab + nivolumab + APX005M administration that is not clearly due to a cause other than study medication. DLTs in this stud
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG APX005M
Study Locations (2)
Connecticut
- Yale Cancer Center - New Haven
- Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-09-14 |
| Est. Completion | 2026-08-28 |
| Phase | Phase 1 |
What the registry record for NCT04495257 still lists
NCT04495257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT04495257 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04495257 about?
NCT04495257 is a clinical study titled "A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (RCC)". This study is a Phase 1, open-label, single institution, dose escalation and dose expansion study to evaluate the efficacy, safety, and tolerability of APX005M in combination with nivolumab and ipilimumab in patients with advanced melanoma and RCC.
What is the current status of trial NCT04495257?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2020-09-14. Estimated completion is 2026-08-28.
What conditions does trial NCT04495257 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma, Advanced Melanoma.
What interventions are being tested in trial NCT04495257?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), APX005M (DRUG).
Who is sponsoring clinical trial NCT04495257?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04495257 being conducted?
This trial has 2 study locations across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04495257's enrollment target sits among peer trials
26 99th of 121 higher than 22 of 121 other Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Cell Carcinoma 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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