A Phase 2 Study of Nivolumab and Ipilimumab in Combination With Sirolimus and Prednisone in Kidney Transplant Recipients With Selected Unresectable or Metastatic Cutaneous Cancers

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Procedure, Biological, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Patients must have histologically or cytologically confirmed non-uveal melanoma, basal cell carcinoma, Merkel cell carcinoma, or cutaneous squamous cell carcinoma for which standard non-immunological medical, surgical, or radiation therapy would be insufficient (i.e., patients who are not surgical candidates). Patients with cutaneous squamous cell carcinoma or Merkel cell carcinoma may enroll without prior medical therapy (e.g., cetuximab or chemotherapy respectively). Non-immunologic standard therapies that patients must have received, refused or for which patients were ineligible include:

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

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

• Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, i.e., at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm by chest x-ray or as \>= 10 mm with CT scan, magnetic resonance imaging (MRI), or calipers by clinical exam is preferred, but not required

• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) performance status criteria

• Leukocytes \>= 2,000/mcL

• Absolute neutrophil count \>= 1,500/mcL

• Platelets \>= 50,000/mcL

• Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 x institutional ULN

• Serum creatinine =\< 3 x ULN

• dd-cfDNA =\< 1.0% and =\< 61% increase

• The effects of nivolumab and ipilimumab on the developing human fetus are unknown. For this reason, and because other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential (WOCBP) receiving nivolumab must continue contraception for a period of 5 months after the last dose of nivolumab. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception.

∙ WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin \[B-HCG\]) during the screening period. Follow-up evaluations will include interval sexual/menstrual histories as needed.

∙ Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately.

∙ WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. Women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL to be considered postmenopausal.

• Human immunodeficiency virus (HIV)-infected patients will be eligible for this trial if they are on effective antiretroviral regimens utilizing non-CYP-interactive agents and have an undetectable viral load. If there is evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy, if indicated. If there is history of hepatitis C virus (HCV) infection, the patient must have been treated and have undetectable HCV viral load.

• Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants

Locations
United States
California
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
Keck Medicine of USC Koreatown
RECRUITING
Los Angeles
Los Angeles General Medical Center
RECRUITING
Los Angeles
USC / Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Washington, D.c.
Sibley Memorial Hospital
RECRUITING
Washington D.c.
Florida
UM Sylvester Comprehensive Cancer Center at Aventura
RECRUITING
Aventura
UM Sylvester Comprehensive Cancer Center at Coral Gables
RECRUITING
Coral Gables
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
RECRUITING
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Kendall
RECRUITING
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITING
Miami
UM Sylvester Comprehensive Cancer Center at Plantation
RECRUITING
Plantation
Georgia
Emory University Hospital/Winship Cancer Institute
RECRUITING
Atlanta
Illinois
Northwestern University
RECRUITING
Chicago
Memorial Hospital East
RECRUITING
Shiloh
Kentucky
University of Kentucky/Markey Cancer Center
RECRUITING
Lexington
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
RECRUITING
Baltimore
Missouri
Siteman Cancer Center at Saint Peters Hospital
RECRUITING
City Of Saint Peters
Siteman Cancer Center at West County Hospital
RECRUITING
Creve Coeur
Siteman Cancer Center at Christian Hospital
RECRUITING
St Louis
Siteman Cancer Center-South County
RECRUITING
St Louis
Washington University School of Medicine
RECRUITING
St Louis
New York
NYU Langone Hospital - Long Island
RECRUITING
Mineola
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITING
New York
Pennsylvania
University of Pittsburgh Cancer Institute (UPCI)
RECRUITING
Pittsburgh
Utah
Huntsman Cancer Institute/University of Utah
RECRUITING
Salt Lake City
Time Frame
Start Date: 2024-07-24
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 16
Treatments
Experimental: Treatment (nivolumab and ipilimumab)
See detailed description
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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