Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial

This phase II trial studies how well low dose, reduced frequency nivolumab works in treating patients with cancer that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Nivolumab is a type of immune checkpoint inhibitor (ICI). ICIs have revolutionized the treatment of numerous cancers with remarkable improvement in participant outcomes. However, accessibility of ICIs is extremely poor on a global scale, mainly due to high costs. Previous research has suggested that these drugs can be given at lower doses and reduced frequency than their approved dosing regimens, with similar results. Giving nivolumab at a lower dose and less often may help reduce the cost of therapy, improve immunotherapy accessibility, and therefore improve survival outcomes globally.

NCT Number	NCT07576725
Lead Sponsor	Fred Hutchinson Cancer Center Collaborators: The Wayne D. Kuni and Joan E. Kuni Foundation
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, Hodgkin Lymphoma, Kaposi Sarcoma, Metastatic Acral Lentiginous Melanoma, Metastatic Basal Cell Carcinoma +35 more
Enrollment	50 participants
Start Date	2026-09-01
Primary Completion	2029-08-31 (estimated)
Study Completion	2029-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-08