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.
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
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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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