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Checkpoint Inhibitor

Immunotherapy + Prednisone + Sirolimus for Skin Cancer

Q: Can individuals still enroll in this research endeavor?

<p>Confirmed. Clinicaltrials.gov reveals that this trial is seeking participants, with the initial submission of 8/11/2024 and most recent update being 12/1/2023.</p>

Q: What is the aggregate quantity of individuals enrolled in this experiment?

<p>Affirmative. Clinicaltrials.gov is displaying that this clinical trial, which was first added on August 11th 2024, is actively recruiting patients. 16 individuals from one centre are needed to join the study.</p>

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease control without allograft loss

Secondary outcome measures

Duration of response (DOR) among patients who experience CR or PR

Objective response rate (ORR)

Overall survival

+2 more

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

~2370

Kidney Biopsy

2007

Completed Phase 4

~340

Biopsy

2014

Completed Phase 4

~1090

Sirolimus

2013

Completed Phase 4

~2750

Biospecimen Collection

2004

Completed Phase 2

~1700

Computed Tomography

2017

Completed Phase 2

~2720

Ipilimumab

2014

Completed Phase 3

~2620

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Nivolumab

2014

Completed Phase 3

~4750

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,786 Total Patients Enrolled

4 Trials studying Cutaneous Melanoma

198 Patients Enrolled for Cutaneous Melanoma

Evan J LipsonPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO

1 Previous Clinical Trials

12 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals still enroll in this research endeavor?

"Confirmed. Clinicaltrials.gov reveals that this trial is seeking participants, with the initial submission of 8/11/2024 and most recent update being 12/1/2023."

Answered by AI

What is the aggregate quantity of individuals enrolled in this experiment?

"Affirmative. Clinicaltrials.gov is displaying that this clinical trial, which was first added on August 11th 2024, is actively recruiting patients. 16 individuals from one centre are needed to join the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05896839.

All > Merkel Cell Carcinoma