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NCT05896839 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Metastatic Melanoma and Clinical Stage IV Cutaneous Melanoma AJCC v8, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 1
Development phase
16
Enrollment target
20
Study locations

NCT05896839: Recruiting Phase 1 study of Metastatic Melanoma and Clinical Stage IV Cutaneous Melanoma AJCC v8, sponsored by National Cancer Institute (NCI).

NCT05896839 is a Phase 1 study of Metastatic Melanoma and Clinical Stage IV Cutaneous Melanoma AJCC v8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 16 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05896839, a Phase 1 study of Metastatic Melanoma and Clinical Stage IV Cutaneous Melanoma AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
16 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Defined as complete or partial response (CR; PR) or stable disease (SD), at 14 weeks per response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The percent of kidney transplant recipients who experience CR/PR/SD at 14 weeks and do not experience allograft loss after administration of nivolumab, ipilimumab, sirolimus, and prednisone will be calculated, along with the corresponding exact 95% confidence interval (CI).

Conditions Studied

Metastatic Melanoma Clinical Stage IV Cutaneous Melanoma AJCC v8 Clinical Stage III Cutaneous Melanoma AJCC v8 Metastatic Skin Squamous Cell Carcinoma Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8 Metastatic Merkel Cell Carcinoma Metastatic Basal Cell Carcinoma Metastatic Carcinoma in the Skin Unresectable Basal Cell Carcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy Procedure
  • BIOLOGICAL Ipilimumab
  • PROCEDURE Kidney Biopsy

Study Locations (20)

Florida

  • UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
  • UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
  • University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
  • UM Sylvester Comprehensive Cancer Center at Kendall - Miami
  • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia - North Miami
  • UM Sylvester Comprehensive Cancer Center at Plantation - Plantation

California

  • UC San Diego Moores Cancer Center - La Jolla
  • Keck Medicine of USC Koreatown - Los Angeles
  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles

Missouri

  • Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters
  • Siteman Cancer Center at West County Hospital - Creve Coeur
  • Washington University School of Medicine - St Louis

Illinois

  • Northwestern University - Chicago
  • Memorial Hospital East - Shiloh

District of Columbia

  • Sibley Memorial Hospital - Washington D.C.

Georgia

  • Emory University Hospital/Winship Cancer Institute - Atlanta

Kentucky

  • University of Kentucky/Markey Cancer Center - Lexington

Maryland

  • Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2024-07-24
Est. Completion 2027-01-31
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What NCT05896839 shows while recruiting

NCT05896839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (81% lower).

The record links to 10 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT05896839 names 20 study sites across 8 states, led by Florida, California, Missouri.

Frequently Asked Questions

What is clinical trial NCT05896839 about?

NCT05896839 is a clinical study titled "Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer". 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 transpla...

What is the current status of trial NCT05896839?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2024-07-24. Estimated completion is 2027-01-31.

What conditions does trial NCT05896839 study?

This clinical trial studies the following conditions: Metastatic Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8, Metastatic Skin Squamous Cell Carcinoma, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8.

What interventions are being tested in trial NCT05896839?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Ipilimumab (BIOLOGICAL), Kidney Biopsy (PROCEDURE).

Who is sponsoring clinical trial NCT05896839?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05896839 being conducted?

This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Melanoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05896839's enrollment target sits among peer trials

16 76th of 91 higher than 14 of 91 other Metastatic Melanoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05896839

Source: ClinicalTrials.gov NCT05896839, the US trial registry maintained by the National Library of Medicine. NCT05896839 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.