Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer

StatusRecruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 6 months later Jan 31, 2027 → Aug 2, 2027
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Record History

The 50 most recent of 136 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jan 31, 2027 to Aug 2, 2027 Show 4 more changesShow less
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Study description revised
    • Site details revised at 5 of 26 sites
  2. Re-verified, no change to tracked fieldsv135
  3. Study sites revised (26)v134
  4. Site details revised at 2 of 26 sitesv133
  5. Site details revised at 2 of 26 sitesv132
Show 45 earlier versionsHide 45 earlier versions
  1. Re-verified, no change to tracked fieldsv131
  2. Site details revised at 3 of 26 sitesv130
  3. 43 versions Re-verified since Feb 7, 2026, no change to tracked fieldsv87-v129
  • 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 II trial tests the combination of nivolumab and ipilimumab with sirolimus and prednisone for the treatment of skin (cutaneous) cancer that cannot be removed by surgery (unresectable) or that has spread from where it first started to other places in the body (metastatic) in kidney transplant recipients. Immunotherapy with nivolumab and ipilimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Sirolimus and prednisone are immunosuppressants that are given to keep the body from rejecting the transplanted kidney. Giving nivolumab and ipilimumab in combination with sirolimus and prednisone may kill more cancer cells, while also keeping the transplanted kidney healthy, in patients with unresectable or metastatic cutaneous cancer who have received a kidney transplant.
Trial Details
NCT Number NCT05896839
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 Carcinoma in the Skin, Metastatic Melanoma, Metastatic Merkel Cell Carcinoma +5 more
Related terms Basal Cell Carcinoma, Carcinoma, Merkel Cell, Melanoma
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov