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

Part of paid clinical trials in La Jolla, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05896839
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

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 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

Eligibility Criteria

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

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Kidney Biopsy — PROCEDURE
    Undergo kidney biopsy
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Nivolumab — BIOLOGICAL
    Given IV
  • Prednisone — DRUG
    Given PO
  • Sirolimus — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jul 24, 2024
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nivolumab and ipilimumab)
    See detailed description

Primary Outcome Measure

Disease control without allograft loss [ Time Frame: At 14 weeks ]

Locations (26)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093
Site Public Contact
[email protected]
858-822-5354
Soo Park (PRINCIPAL_INVESTIGATOR)
Keck Medicine of USC KoreatownLos AngelesCalifornia90020
Site Public Contact
213-388-0908
Gino K. In (PRINCIPAL_INVESTIGATOR)
Los Angeles General Medical CenterLos AngelesCalifornia90033
Site Public Contact
[email protected]
323-865-0451
Gino K. In (PRINCIPAL_INVESTIGATOR)
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Site Public Contact
323-865-0451
Gino K. In (PRINCIPAL_INVESTIGATOR)
Sibley Memorial HospitalWashington D.C.District of Columbia20016
Site Public Contact
[email protected]
202-243-2373
Evan J. Lipson (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at AventuraAventuraFlorida33180
Site Public Contact
954-461-2180
Jose Lutzky (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral GablesFlorida33146
Site Public Contact
305-243-2647
Jose Lutzky (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield BeachFlorida33442
Site Public Contact
305-243-2647
Jose Lutzky (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at KendallMiamiFlorida33176
Site Public Contact
305-243-2647
Jose Lutzky (PRINCIPAL_INVESTIGATOR)
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136
Site Public Contact
305-243-2647
Jose Lutzky (PRINCIPAL_INVESTIGATOR)
University of Miami Sylvester Comprehensive Cancer Center at Sole MiaNorth MiamiFlorida33181
Site Public Contact
[email protected]
Jose Lutzky (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at PlantationPlantationFlorida33324
Site Public Contact
305-243-2647
Jose Lutzky (PRINCIPAL_INVESTIGATOR)
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611
Site Public Contact
[email protected]
312-695-1301
Sunandana Chandra (PRINCIPAL_INVESTIGATOR)
Memorial Hospital EastShilohIllinois62269
Site Public Contact
[email protected]
314-747-9912
George Ansstas (PRINCIPAL_INVESTIGATOR)
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536
Site Public Contact
859-257-3379
Ruta Arays (PRINCIPAL_INVESTIGATOR)
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287
Site Public Contact
[email protected]
410-955-8804
Evan J. Lipson (PRINCIPAL_INVESTIGATOR)
Siteman Cancer Center at Saint Peters HospitalCity of Saint PetersMissouri63376
Site Public Contact
[email protected]
800-600-3606
George Ansstas (PRINCIPAL_INVESTIGATOR)
Siteman Cancer Center at West County HospitalCreve CoeurMissouri63141
Site Public Contact
[email protected]
800-600-3606
George Ansstas (PRINCIPAL_INVESTIGATOR)
Siteman Cancer Center at Christian HospitalSt LouisMissouri63136
Site Public Contact
[email protected]
800-600-3606
George Ansstas (PRINCIPAL_INVESTIGATOR)
Siteman Cancer Center-South CountySt LouisMissouri63129
Site Public Contact
[email protected]
800-600-3606
George Ansstas (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
Site Public Contact
[email protected]
800-600-3606
George Ansstas (PRINCIPAL_INVESTIGATOR)
NYU Langone Hospital - Long IslandMineolaNew York11501
Site Public Contact
[email protected]
212-263-4432
Maya Dimitrova (PRINCIPAL_INVESTIGATOR)
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016
Site Public Contact
[email protected]
Maya Dimitrova (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232
Site Public Contact
412-647-8073
Diwakar Davar (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112
Site Public Contact
[email protected]
888-424-2100
Kathleen C. Kerrigan (PRINCIPAL_INVESTIGATOR)

Find similar trials in La Jolla, CA

By condition
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By specialty
OncologySkin cancerDermatology
By research site
UC San Diego Moores Cancer Center· La Jolla, CAKeck Medicine of USC Koreatown· Los Angeles, CALos Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CASibley Memorial Hospital· Washington D.C., DCUM Sylvester Comprehensive Cancer Center at Aventura· Aventura, FL

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