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Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary completion date: Apr 6, 2026 to Nov 6, 2026
    • Study completion date: Oct 6, 2026 to Apr 6, 2027
    v15
  2. Primary completion date: Apr 6, 2025 to Apr 6, 2026
    • Study completion date: Oct 6, 2025 to Oct 6, 2026
    v14
  3. Primary completion date: Oct 6, 2024 to Apr 6, 2025
    • Study completion date: Apr 6, 2025 to Oct 6, 2025
    v13
  4. Primary completion date: Apr 6, 2024 to Oct 6, 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 4 of 4 sites
    v12
  5. Primary completion date: Apr 6, 2023 to Apr 6, 2024
    • Study completion date: Apr 6, 2024 to Apr 6, 2025
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. 2 versions Re-verified since Nov 16, 2021, no change to tracked fieldsv9-v10
  2. Study sites: 3 to 4
    • Eligibility criteria expanded, about 17 words
    v8
  3. Re-verified, no change to tracked fieldsv7
  4. Study sites: 1 to 3v6
  5. Primary completion date: Apr 2019 to Apr 6, 2023
    • Study completion date: Apr 2019 to Apr 6, 2024
    • Eligibility criteria expanded, about 6 words
    v5
  6. Re-verified, no change to tracked fieldsv4
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2017 to Jun 12, 2017
    • Site details revised
    v3
  8. Start date: May 2017 to Jul 2017v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03172754
Lead Sponsor Fox Chase Cancer Center
Conditions
(from sponsor)		 Renal Cell Carcinoma
Related terms Carcinoma, Renal Cell
Enrollment 98 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov