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Checkpoint Inhibitor

Immunotherapy + Prednisone + Sirolimus for Skin Cancer

Phase 1 & 2
Recruiting
Led By Evan J Lipson
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For patients with Basal cell carcinoma, prior therapies include hedgehog pathway inhibitors
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests immunotherapy combo with immunosuppressants in kidney transplant recipients with skin cancer.

Who is the study for?
This trial is for adult kidney transplant recipients with a functioning graft, who have skin cancer that's either inoperable or has spread. They should not need dialysis and must have had certain prior treatments if they have specific types of skin cancer like Basal cell carcinoma or BRAF-mutant melanoma.
What is being tested?
The study tests nivolumab and ipilimumab (immunotherapies) combined with sirolimus and prednisone (immunosuppressants). This mix aims to fight the skin cancer while protecting the transplanted kidney from being rejected by the body.
What are the potential side effects?
Potential side effects include immune system changes leading to organ inflammation, increased risk of infection due to immunosuppression, possible adverse reactions at infusion sites, fatigue, and other symptoms related to how the body tolerates these medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had treatments targeting the hedgehog pathway for my basal cell carcinoma.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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I have a working kidney transplant and don't need dialysis.
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I have melanoma with a BRAF mutation and have been treated with BRAF/MEK inhibitors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease control without allograft loss
Secondary study objectives
Duration of response (DOR) among patients who experience CR or PR
Objective response rate (ORR)
Overall survival
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab and ipilimumab)Experimental Treatment9 Interventions
See detailed description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2500
Kidney Biopsy
2007
Completed Phase 4
~340
Biopsy
2014
Completed Phase 4
~1090
Sirolimus
2013
Completed Phase 4
~2750
Biospecimen Collection
2004
Completed Phase 3
~2020
Computed Tomography
2017
Completed Phase 2
~2740
Ipilimumab
2015
Completed Phase 3
~3420
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,927 Previous Clinical Trials
41,017,989 Total Patients Enrolled
5 Trials studying Cutaneous Melanoma
146 Patients Enrolled for Cutaneous Melanoma
Evan J LipsonPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO
1 Previous Clinical Trials
12 Total Patients Enrolled
~11 spots leftby Jan 2027
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