Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC

StatusSuspended
PhasePhase 1/2
Started

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Record History

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  1. Stopped Recruitment suspended Sponsor's reason: PI requested
    • Eligibility criteria expanded, about 38 words
    • Site details revised
    • Study description expanded, about 4 words
  2. Minor Site contact updatedv17
  3. Minor 2 versions Re-verified since Apr 13, 2026, no change to tracked fieldsv15-v16
  4. Notable Primary completion date: Oct 30, 2025 to Oct 30, 2027v14
  5. Minor Re-verified, no change to tracked fieldsv13
Show 11 earlier versionsHide 11 earlier versions
  1. Minor Collaborators: 1 to 2v12
  2. Notable Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v11
  3. Minor Study Identification, Study Status, Oversight, IPDSharingv10
  4. Notable Phase: Phase 2 to Phase 1/2
    • Trial status: Suspended to Active, Not Recruiting
    v9
  5. Stopped Trial status: Recruiting to Suspended Sponsor's reason: PI Request
    • Site details revised
    v8
  6. Minor 4 versions Re-verified since Sep 11, 2023, no change to tracked fieldsv4-v7
  7. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 30, 2024 to Jun 30, 2023
    • Site details revised
    v3
  8. Notable Start date: May 30, 2023 to May 30, 2024v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).
Trial Details
NCT Number NCT05663710
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: Telix Pharmaceuticals (Innovations) Pty Limited, United States Department of Defense
Conditions
(from sponsor)
Advanced Cancer, Clear Cell Renal Cell Carcinoma
Related terms Carcinoma, Renal Cell
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov