Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers

Part of paid clinical trials in Tampa, Florida.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03816332
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • 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 Melanoma
  • Metastatic Merkel Cell Carcinoma
  • Metastatic Skin Squamous Cell Carcinoma
  • Pathologic Stage III Cutaneous Melanoma AJCC v8
  • Pathologic Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
  • Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
  • Pathologic Stage IIIA Cutaneous Merkel Cell Carcinoma AJCC v8
  • Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
  • Pathologic Stage IIIB Cutaneous Merkel Cell Carcinoma AJCC v8
  • Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
  • Pathologic Stage IIID Cutaneous Melanoma AJCC v8
  • Pathologic Stage IV Cutaneous Melanoma AJCC v8
  • Pathologic Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8
  • Unresectable Basal Cell Carcinoma
  • Unresectable Melanoma
  • Unresectable Merkel Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — BIOLOGICAL
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV
  • Prednisone — DRUG
    Given PO
  • Tacrolimus — DRUG
    Given PO

Study Details

This phase I trial studies how well tacrolimus, nivolumab, and ipilimumab work in treating kidney transplant recipients with cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Tacrolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tacrolimus, nivolumab, and ipilimumab may work better in treating kidney transplant recipients with cancer compared to chemotherapy, surgery, radiation therapy, or targeted therapies.

Key Dates

Start date
Nov 8, 2019
Status verified
Mar 2026
Primary completion
Oct 11, 2022
Completion
Sep 19, 2026

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (tacrolimus, prednisone, nivolumab, ipilimumab)
    Patients receive tacrolimus PO BID and prednisone PO QD. Within 28 days, patients then receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 4 weeks for up to 24 cycles (96 weeks) in the absence of disease progression or unacceptable toxicity. Patients who experience PD or patients who have experienced allograft loss at 16 weeks receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Patients also receive tacrolimus PO BID and prednisone PO QD. Cycles repeat every 3 weeks for 4 cycles (12 weeks) in the absence of disease progression or unacceptable toxicity. Starting 6 weeks later, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 21 cycles (84 weeks) in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number (and Percentage) of Outcome Responses After Receiving Nivolumab, Tacrolimus, and Prednisone [ Time Frame: At 16 weeks ]

Locations (7)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Moffitt Cancer Center - McKinley CampusTampaFlorida33612-
Northwestern UniversityChicagoIllinois60611-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-

Find similar trials in Tampa, FL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Moffitt Cancer Center· Tampa, FLMoffitt Cancer Center - McKinley Campus· Tampa, FLNorthwestern University· Chicago, ILJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDBrigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

Related Studies