Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers

StatusActive, Not Recruiting
PhasePhase 1
Started

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Record History

The 50 most recent of 65 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from Sep 19, 2026 to Sep 17, 2027 Show 4 more changesShow less
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Site details revised at 2 of 7 sites
    • Publications: details revised at 3 of 3 entries
  2. Study sites revised (7)v64
  3. 2 versions Re-verified since Apr 9, 2026, no change to tracked fieldsv62-v63
  4. Study completion date: Sep 22, 2025 to Sep 19, 2026v61
  5. Re-verified, no change to tracked fieldsv60
Show 44 earlier versionsHide 44 earlier versions
  1. Study completion date: Sep 22, 2024 to Sep 22, 2025v59
  2. 6 versions Re-verified since Oct 24, 2023, no change to tracked fieldsv53-v58
  3. Start date: Feb 1, 2019 to Nov 8, 2019
    • Study completion date: Mar 27, 2024 to Sep 22, 2024
    v52
  4. Re-verified, no change to tracked fieldsv51
  5. Results first posted: Jun 27, 2023
    • Primary endpoints: 2 to 1
    • Enrollment target: 10 to 12
    • Secondary endpoints: 5 to 6
    v50
  6. Re-verified, no change to tracked fieldsv49
  7. Enrollment target: estimated 16 to confirmed 10
    • Primary completion date changed from estimate of May 30, 2023 to Oct 11, 2022
    • Study completion date: May 30, 2023 to Mar 27, 2024
    v48
  8. Study sites: 8 to 7v47
  9. Trial status: Suspended to Active, Not Recruitingv46
  10. 2 versions Re-verified since Jun 7, 2022, no change to tracked fieldsv44-v45
  11. Primary and study completion dates: May 30, 2022 to May 30, 2023v43
  12. 3 versions Re-verified since Jan 21, 2022, no change to tracked fieldsv40-v42
  13. Trial status: Recruiting to Suspended Sponsor's reason: Other - Pending amendment to redesign treatment plan.
    • Site details revised at 8 of 8 sites
    v39
  14. Re-verified, no change to tracked fieldsv38
  15. Trial status: Suspended to Recruiting
    • Site details revised at 8 of 8 sites
    v37
  16. Re-verified, no change to tracked fieldsv36
  17. Primary and study completion dates: May 30, 2021 to May 30, 2022v35
  18. Trial status: Recruiting to Suspended Sponsor's reason: Scheduled Interim Monitoring
    • Site details revised at 8 of 8 sites
    v34
  19. Study sites: 7 to 8v33
  20. 3 versions Re-verified since Jan 19, 2021, no change to tracked fieldsv30-v32
  21. Site contacts updated at 2 of 7 sitesv29
  22. Study sites: 6 to 7v28
  23. Re-verified, no change to tracked fieldsv27
  24. Study description expanded, about 7 wordsv26
  25. Study sites: 5 to 6v25
  26. Re-verified, no change to tracked fieldsv24
  27. Study sites: 4 to 5v23
  28. Re-verified, no change to tracked fieldsv22
  29. Study sites: 3 to 4v21
  30. Re-verified, no change to tracked fieldsv20
  31. Site details revised at 1 of 3 sitesv19
  32. Site details revised at 1 of 3 sitesv18
  33. Re-verified, no change to tracked fieldsv17
  34. Study sites: 2 to 3v16
  • 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 phase I trial studies how well tacrolimus, nivolumab, and ipilimumab work in treating kidney transplant recipients with cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Tacrolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tacrolimus, nivolumab, and ipilimumab may work better in treating kidney transplant recipients with cancer compared to chemotherapy, surgery, radiation therapy, or targeted therapies.
Trial Details
NCT Number NCT03816332
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, Metastatic Basal Cell Carcinoma, Metastatic Melanoma, Metastatic Merkel Cell Carcinoma, Metastatic Skin Squamous Cell Carcinoma +13 more
Related terms Basal Cell Carcinoma, Carcinoma, Merkel Cell, Melanoma
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov