Nivolumab and Ipilimumab for Skin Cancer in Kidney Transplants

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

Recruiting Phase 1 Phase 2 Interventional Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
16 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for kidney transplant recipients with skin cancer that cannot be removed by surgery or has spread to other parts of the body. Participants will receive a combination of immunotherapy drugs along with medications to help protect their transplanted kidney.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have a functioning kidney transplant and do not need dialysis.
  • I have been diagnosed with a type of skin cancer that cannot be treated with standard therapies.
  • I have measurable cancer that can be evaluated.
  • I have a specific performance status that shows I can engage in daily activities.
  • I have good blood cell counts and liver function.
  • I understand the study and can provide informed consent.

You may not be able to join if

  • I have received a transplant of any other organ.
  • I am unable to undergo dialysis if needed.
  • I have had issues with my previous kidney transplant within the last 3 months.
  • I have received certain cancer treatments in the past year.
  • I have serious allergic reactions to monoclonal antibodies.
  • I have untreated brain metastases or severe CNS symptoms.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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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 syst…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 transpla…
Contacts

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