Health Trials

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

ConditionsClinical Stage III Cutaneous Melanoma AJCC v8Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8Metastatic Basal Cell CarcinomaMetastatic Carcinoma in the SkinMetastatic MelanomaMetastatic Merkel Cell CarcinomaMetastatic Skin Squamous Cell CarcinomaUnresectable Basal Cell CarcinomaUnresectable MelanomaUnresectable Merkel Cell CarcinomaUnresectable Skin Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

Qualifiers

Patients must be kidney transplant recipients with a functioning allograft who do not currently require dialysis

Patient's age must be >= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of nivolumab and ipilimumab in kidney transplant recipients <18 years of age, children are excluded from this study, but may be eligible for future pediatric trials

For patients with BRAF-mutant melanoma, prior therapies include BRAF/MEK inhibitors

For patients with Basal cell carcinoma, prior therapies include hedgehog pathway inhibitors

Disqualifiers

Patients who have received a liver, lung, heart, or pancreas transplant; or allogeneic stem cell transplant; or any kind of bone marrow transplant

Patients unwilling or unable to undergo dialysis in the event of allograft failure

Patients with prior evidence of human leukocyte antigen (HLA) or non-HLA donor-specific antibodies (DSA)

Patients with a history of antibody- or cell-mediated allograft rejection within 3 months of study entry

Trial design

Treatments tested in this trial

  • Biopsy Procedure
  • Biospecimen Collection
  • Computed Tomography
  • Ipilimumab
  • Kidney Biopsy
  • Magnetic Resonance Imaging
  • Nivolumab
  • Prednisone
  • Sirolimus

Treatment groups

16 Participants
are divided into 1 treatment group

Locations

26
California
UC San Diego Moores Cancer Center92093, La Jolla United States
Keck Medicine of USC Koreatown90020, Los Angeles United States
Los Angeles General Medical Center90033, Los Angeles United States
USC / Norris Comprehensive Cancer Center90033, Los Angeles United States

Sponsors and collaborators

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov