OncRef

Clinical Trial: NCT03816332

Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-10-14

Study Overview

Brief Summary

This phase I trial studies how well tacrolimus, nivolumab, and ipilimumab work in treating kidney transplant recipients with cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Tacrolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tacrolimus, nivolumab, and ipilimumab may work better in treating kidney transplant recipients with cancer compared to chemotherapy, surgery, radiation therapy, or targeted therapies.

Official Title

Immune Checkpoint Blockade for Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers

Conditions

Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, Metastatic Basal Cell Carcinoma, Metastatic Melanoma, Metastatic Merkel Cell Carcinoma, Metastatic Skin Squamous Cell Carcinoma, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIIA Cutaneous Merkel Cell Carcinoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Merkel Cell Carcinoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, Unresectable Basal Cell Carcinoma, Unresectable Melanoma, Unresectable Merkel Cell Carcinoma

Intervention / Treatment

  • Biological: Ipilimumab
  • Biological: Nivolumab
  • Drug: Prednisone
  • Drug: Tacrolimus

Other Study ID Numbers

  • NCI-2019-00239
  • NCI-2019-00239
  • ETCTN10214
  • 10214
  • 10214
  • UM1CA186691

Start Date (Actual)

2019-11-08

Primary Completion Date (Actual)

2022-10-11

Study Completion Date (Estimated)

2027-09-17

Enrollment (Actual)

12

Study Type

Interventional

Phase

Phase 1