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NOT YET RECRUITING
NCT07576725
PHASE2

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

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

Summary

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.

Official title: AFFORD IO: A Phase 2 Trial of Low Dose, Reduced Frequency Nivolumab (Anti-PD-1 Antibody) in Patients With Unresectable or Metastatic Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-12-01

Completion Date

2029-08-31

Last Updated

2026-09-17

Healthy Volunteers

No

Conditions

Clinical Stage III Cutaneous Melanoma AJCC v8Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8Hodgkin LymphomaKaposi SarcomaMetastatic Acral Lentiginous MelanomaMetastatic Basal Cell CarcinomaMetastatic Cervical CarcinomaMetastatic Clear Cell Renal Cell CarcinomaMetastatic Colorectal CarcinomaMetastatic Cutaneous MelanomaMetastatic Head and Neck Squamous Cell CarcinomaMetastatic Kaposi SarcomaMetastatic Lung Non-Small Cell CarcinomaMetastatic Malignant Solid NeoplasmMetastatic Merkel Cell CarcinomaMetastatic Mucosal MelanomaMetastatic Skin Squamous Cell CarcinomaMetastatic Urothelial CarcinomaStage III Cervical Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage III Lung Cancer AJCC v8Stage III Renal Cell Cancer AJCC v8Stage IV Cervical Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage IV Lung Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8Unresectable Acral Lentiginous MelanomaUnresectable Basal Cell CarcinomaUnresectable Cervical CarcinomaUnresectable Clear Cell Renal Cell CarcinomaUnresectable Colorectal CarcinomaUnresectable Cutaneous MelanomaUnresectable Head and Neck Squamous Cell CarcinomaUnresectable Lung Non-Small Cell CarcinomaUnresectable Malignant Solid NeoplasmUnresectable Merkel Cell CarcinomaUnresectable Mucosal MelanomaUnresectable Skin Squamous Cell CarcinomaUnresectable Urothelial Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of urine and/or blood samples

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Nivolumab

Given IV

Locations (1)

Uganda Cancer Institute

Kampala, Uganda