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NCT03680521 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma
A Phase 2 study, sponsored by Mirati Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT03680521: Completed Phase 2 study, sponsored by Mirati Therapeutics.
NCT03680521 is a Phase 2 study that has completed, run by Mirati Therapeutics. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03680521, a Phase 2 study, has completed, sponsored by Mirati Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
The study will evaluate the clinical activity of sitravatinib in combination with nivolumab in patients with locally-advanced clear cell renal cell carcinoma (ccRCC) in the neoadjuvant setting prior to nephrectomy.
Primary Outcome
Objective response is defined as the percent of participants documented by investigator assessment to have Complete Response (CR) or Partial Response (PR) in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR is defined as complete disappearance of all baseline target and non-target lesions with the exception of nodal disease; PR is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions.
Interventions
- DRUG Nivolumab
- DRUG Sitravatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-10-10 |
| Est. Completion | 2023-05-18 |
| Phase | Phase 2 |
What the finished NCT03680521 record still lists
NCT03680521 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT03680521 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03680521 about?
NCT03680521 is a clinical study titled "Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma". The study will evaluate the clinical activity of sitravatinib in combination with nivolumab in patients with locally-advanced clear cell renal cell carcinoma (ccRCC) in the neoadjuvant setting prior to nephrectomy.
What is the current status of trial NCT03680521?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2018-10-10. Estimated completion is 2023-05-18.
What interventions are being tested in trial NCT03680521?
The interventions under investigation include: Nivolumab (DRUG), Sitravatinib (DRUG).
Who is sponsoring clinical trial NCT03680521?
This trial is sponsored by Mirati Therapeutics, which has 49 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03680521's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 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
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