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New treatment option for Clinical Stage III Cutaneous Melanoma AJCC v8
Official title Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
ClinicalTrials.gov ID: NCT05896839
What this study is testing
What is Ipilimumab?
Ipilimumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for clinical stage iii cutaneous melanoma ajcc v8.
Also referred to as Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patients must have histologically or cytologically confirmed non-uveal melanoma, basal cell carcinoma, Merkel cell carcinoma, or cutaneous squamous...
- For patients with BRAF-mutant melanoma, prior therapies include BRAF/MEK inhibitors
- For patients with Basal cell carcinoma, prior therapies include hedgehog pathway inhibitors
You likely can't join if
- Patients who have received a liver, lung, heart, or pancreas transplant; or allogeneic stem cell transplant; or any kind of bone marrow transplant
- Patients unwilling or unable to undergo dialysis in the event of allograft failure
- Patients with prior evidence of human leukocyte antigen (HLA) or non-HLA donor-specific antibodies (DSA)
- Patients with a history of antibody- or cell-mediated allograft rejection within 3 months of study entry
- Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to...
- Patients may have received prior anti-PD-(L)1 therapy; however, patients must not have any other checkpoint antibody targeting T-cell co-stimulation...
See the full eligibility 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 transplant recipients \<18 years of age, children are excluded...
- 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...
- 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...
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =\ = 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...
- 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...
- 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
- Patients who have received a liver, lung, heart, or pancreas transplant; or allogeneic stem cell transplant; or any kind of bone marrow transplant
- Patients unwilling or unable to undergo dialysis in the event of allograft failure
- Patients with prior evidence of human leukocyte antigen (HLA) or non-HLA donor-specific antibodies (DSA)
- Patients with a history of antibody- or cell-mediated allograft rejection within 3 months of study entry
- Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment
- Patients may have received prior anti-PD-(L)1 therapy; however, patients must not have any other checkpoint antibody targeting T-cell co-stimulation within 1 year of study enrollment. Prior history of adjuvant therapy...
- Patients must not be receiving any other investigational agents
- Patients with leptomeningeal metastases, more than 3 untreated central nervous system (CNS) metastases, untreated brain metastases measuring \>1cm, or requiring treatment-dose steroids (\> 10 mg/day prednisone...
- Patients must not have a history of severe hypersensitivity reaction to any monoclonal antibody
- Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to other agents used in the study
- Patients must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any other...
- Pregnant women are excluded from this study because nivolumab and ipilimumab have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants...
- Patients with autoimmune disease that is active or might recur and affect vital organ function will be eligible only after consultation with the study PI. Guillain-Barre (GB) syndrome, bullous skin disease, Stevens...
- Patients must not have had evidence of active or acute diverticulitis, intra-abdominal abscess, GI obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the...
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- Aventura, Florida, United States
- Coral Gables, Florida, United States
- Deerfield Beach, Florida, United States
- Miami, Florida, United States
- North Miami, Florida, United States
- Plantation, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Shiloh, Illinois, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- City of Saint Peters, Missouri, United States
- Creve Coeur, Missouri, United States
- St Louis, Missouri, United States
- Mineola, New York, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Los Angeles, California, United States; Washington D.C., District of Columbia, United States; Aventura, Florida, United States; Coral Gables, Florida, United States; Deerfield Beach, Florida, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.