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

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.

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
• Metastatic Cervical Carcinoma
• Metastatic Clear Cell Renal Cell Carcinoma
• Metastatic Colorectal Carcinoma
• Metastatic Cutaneous Melanoma
• Metastatic Head and Neck Squamous Cell Carcinoma
• Metastatic Kaposi Sarcoma
• Metastatic Lung Non-Small Cell Carcinoma
• Metastatic Malignant Solid Neoplasm
• Metastatic Merkel Cell Carcinoma
• Metastatic Mucosal Melanoma
• Metastatic Skin Squamous Cell Carcinoma
• Metastatic Urothelial Carcinoma
• Stage III Cervical Cancer AJCC v8
• Stage III Colorectal Cancer AJCC v8
• Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
• Stage III Lung Cancer AJCC v8
• Stage III Renal Cell Cancer AJCC v8
• Stage IV Cervical Cancer AJCC v8
• Stage IV Colorectal Cancer AJCC v8
• Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8
• Unresectable Acral Lentiginous Melanoma
• Unresectable Basal Cell Carcinoma
• Unresectable Cervical Carcinoma
• Unresectable Clear Cell Renal Cell Carcinoma
• Unresectable Colorectal Carcinoma
• Unresectable Cutaneous Melanoma
• Unresectable Head and Neck Squamous Cell Carcinoma
• Unresectable Lung Non-Small Cell Carcinoma
• Unresectable Malignant Solid Neoplasm
• Unresectable Merkel Cell Carcinoma
• Unresectable Mucosal Melanoma
• Unresectable Skin Squamous Cell Carcinoma
• Unresectable 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

Sponsors & Collaborators

• The Wayne D. Kuni and Joan E. Kuni Foundation

  collaborator OTHER

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Shailender Bhatia, MD · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2029-08-31

Completion

2029-08-31

Countries

• Uganda

Study Locations