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NCT04028245 · ClinicalTrials.gov registry record · Early Phase 1
A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma
A Early Phase 1 study of Carcinoma, Renal Cell, sponsored by Columbia University.
- Active
- Registry status
- Early Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT04028245: Active Early Phase 1 study of Carcinoma, Renal Cell, sponsored by Columbia University.
NCT04028245 is a Early Phase 1 study of Carcinoma, Renal Cell that is active but no longer recruiting, run by Columbia University. The registered enrollment target is 17 participants, below the 283-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04028245, a Early Phase 1 study of Carcinoma, Renal Cell, is active but no longer recruiting, sponsored by Columbia University.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective: * To confirm the safety and feasibility of canakinumab and spartalizumab (PDR-001) administered using a standard dose / schedule in the neo-adjuvant setting in renal cell carcinoma Secondary Objectives: * To assess the immune response to combination canakinumab and spartalizumab * To assess anti-tumor activity as measured by pathologic downstaging
Primary Outcome
Feasibility of spartalizumab and canakinumab will be met if \> 85% of patients proceed to radical nephrectomy (12 of 14).
Conditions Studied
Interventions
- DRUG Canakinumab
- DRUG Spartalizumab
Study Locations (1)
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-08-15 |
| Est. Completion | 2026-03 |
| Phase | Early Phase 1 |
What the registry record for NCT04028245 still lists
NCT04028245 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 283-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Carcinoma, Renal Cell appearing as the primary indexed condition, and to 2 interventions - of which Canakinumab is the first listed.
NCT04028245 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04028245 about?
NCT04028245 is a clinical study titled "A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma". Primary Objective: * To confirm the safety and feasibility of canakinumab and spartalizumab (PDR-001) administered using a standard dose / schedule in the neo-adjuvant setting in renal cell carcinoma Secondary Objectives: * To assess the immune response to combination canakinumab and spartalizuma...
What is the current status of trial NCT04028245?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 17 participants. The study started on 2019-08-15. Estimated completion is 2026-03.
What conditions does trial NCT04028245 study?
This clinical trial studies the following conditions: Carcinoma, Renal Cell.
What interventions are being tested in trial NCT04028245?
The interventions under investigation include: Canakinumab (DRUG), Spartalizumab (DRUG).
Who is sponsoring clinical trial NCT04028245?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04028245 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Carcinoma, Renal Cell
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04028245's enrollment target sits among peer trials
17 33rd of 34 higher than 2 of 34 other Carcinoma, Renal Cell trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Renal Cell 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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