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

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT07576725
Phase
PHASE2
Status
Not Yet Recruiting

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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of urine and/or blood samples
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Sep 1, 2026
Status verified
May 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (low dose, reduced frequency nivolumab)
    INDUCTION PHASE: Patients receive nivolumab IV over approximately 30 minutes on days 1 and 45 in the absence of disease progression or unacceptable toxicity. Patients who are benefitting after 45 days proceed to Maintenance Phase. MAINTENANCE PHASE: Patients receive nivolumab IV over approximately 30 minutes every 90 days (days 90, 180, 270 and 360) in the absence of disease progression or unacceptable toxicity. All patients also undergo CT/MRI and blood sample collection throughout the study. Patients may also undergo urine sample collection throughout the study.

Primary Outcome Measure

Objective response [ Time Frame: Up to 4 years after completion of study treatment ]

Central Contacts

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