OncoMatch/Clinical Trials/NCT05896839
Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
Is NCT05896839 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Ipilimumab and Nivolumab for clinical stage iii cutaneous melanoma ajcc v8.
Treatment: Ipilimumab · Nivolumab · Prednisone · Sirolimus — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Tumor Agnostic
Biomarker criteria
Allowed: BRAF mutation
Disease stage
Required: Stage III, IV (AJCC v8)
Metastatic disease required
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; Metastatic Skin Squamous Cell Carcinoma; Unresectable Basal Cell Carcinoma; Unresectable Melanoma; Unresectable Merkel Cell Carcinoma; Unresectable Skin Squamous Cell Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BRAF inhibitor — BRAF-mutant melanoma
For patients with BRAF-mutant melanoma, prior therapies include BRAF/MEK inhibitors
Must have received: MEK inhibitor — BRAF-mutant melanoma
For patients with BRAF-mutant melanoma, prior therapies include BRAF/MEK inhibitors
Must have received: hedgehog pathway inhibitor — basal cell carcinoma
For patients with Basal cell carcinoma, prior therapies include hedgehog pathway inhibitors
Cannot have received: checkpoint antibody targeting T-cell co-stimulation
Exception: anti-PD-(L)1 therapy allowed; no other checkpoint antibody targeting T-cell co-stimulation within 1 year of study enrollment
patients must not have any other checkpoint antibody targeting T-cell co-stimulation within 1 year of study enrollment. Prior anti-PD-(L)1 therapy allowed
Lab requirements
Blood counts
Leukocytes >= 2,000/mcL; Absolute neutrophil count >= 1,500/mcL; Platelets >= 50,000/mcL
Kidney function
Serum creatinine <= 3 x ULN
Liver function
Total bilirubin <= 1.5 x institutional ULN; AST/ALT <= 2.5 x institutional ULN
Leukocytes >= 2,000/mcL; Absolute neutrophil count >= 1,500/mcL; Platelets >= 50,000/mcL; Total bilirubin <= 1.5 x institutional ULN; AST/ALT <= 2.5 x institutional ULN; Serum creatinine <= 3 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UC San Diego Moores Cancer Center · La Jolla, California
- Keck Medicine of USC Koreatown · Los Angeles, California
- Los Angeles General Medical Center · Los Angeles, California
- USC / Norris Comprehensive Cancer Center · Los Angeles, California
- Sibley Memorial Hospital · Washington D.C., District of Columbia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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