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NCT03172754 · ClinicalTrials.gov registry record · Phase 1
Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma
A Phase 1 study of Renal Cell Carcinoma, sponsored by Fox Chase Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
- 4
- Study locations
NCT03172754: Active Phase 1 study of Renal Cell Carcinoma, sponsored by Fox Chase Cancer Center.
NCT03172754 is a Phase 1 study of Renal Cell Carcinoma that is active but no longer recruiting, run by Fox Chase Cancer Center. The registered enrollment target is 98 participants, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (60% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03172754, a Phase 1 study of Renal Cell Carcinoma, is active but no longer recruiting, sponsored by Fox Chase Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a Phase I/II, open-label, multi-center study of axitinib in combination with nivolumab in patients with previously treated and untreated advanced RCC. This clinical study will be composed of a dose finding phase (Phase I) and two parallel dose expansion phases (Phase II). The dose finding phase will assess the safety of the combination and establish a recommended phase II dose (RP2D, the highest tested dose that is declared safe and tolerable by the Investigators and the Sponsor Investigator) in patients with advanced RCC who have received prior systemic therapy for metastatic disease. Phase II will evaluate the efficacy of the combination at the RP2D in two parallel expansion cohorts in both previously treated and treatment naïve patients.
Primary Outcome
To be assessed by CTCAE v4.03. Will be used to establish recommended phase II dose (RP2D)
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Axitinib
Study Locations (4)
New York
- US Oncology and Hematology - Albany
- Cornell - New York
Maryland
- Johns Hopkins - Baltimore
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2017-06-12 |
| Est. Completion | 2026-10-06 |
| Phase | Phase 1 |
What the registry record for NCT03172754 still lists
NCT03172754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT03172754 reports a single indexed study location in New York, Maryland, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03172754 about?
NCT03172754 is a clinical study titled "Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma". This is a Phase I/II, open-label, multi-center study of axitinib in combination with nivolumab in patients with previously treated and untreated advanced RCC. This clinical study will be composed of a dose finding phase (Phase I) and two parallel dose expansion phases (Phase II). The dose finding ph...
What is the current status of trial NCT03172754?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2017-06-12. Estimated completion is 2026-10-06.
What conditions does trial NCT03172754 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma.
What interventions are being tested in trial NCT03172754?
The interventions under investigation include: Nivolumab (DRUG), Axitinib (DRUG).
Who is sponsoring clinical trial NCT03172754?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03172754 being conducted?
This trial has 4 study locations across Maryland, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Renal Cell Carcinoma
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 NCT03172754's enrollment target sits among peer trials
98 54th of 121 higher than 68 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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