Combining nivolumab with radiotherapy for recurrent head and neck cancer
REPORT; REirradiation and PD-1 Blockade On Recurrent Squamous Cell Head and Neck Tumors
This study is testing if combining a drug called nivolumab with radiation therapy can help people with recurrent head and neck cancer fight their tumors better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Drugs / interventions | nivolumab |
| Locations | 1 site (Oslo) |
| Trial ID | NCT03317327 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the combination of nivolumab, an immune checkpoint inhibitor, with radiotherapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC). Participants will receive nivolumab followed by radiotherapy after two weeks, with treatment continuing until disease progression or other specified criteria are met. The study aims to enhance the immune response against tumors by leveraging the inflammatory effects of radiotherapy, which may increase the effectiveness of nivolumab. Patients will be monitored for adverse events and treatment efficacy throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with recurrent or secondary primary squamous cell carcinoma of the head and neck who have previously received radiotherapy.
Not a fit: Patients with distant metastases or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with recurrent head and neck cancer.
How similar studies have performed: While the combination of PD-1 inhibitors and radiotherapy is promising, this specific approach in humans remains largely unexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Recurrent or secondary primary squamous cell carcinoma originating from the oral cavity, oro/hypo-pharynx or larynx * Prior radiotherapy (46-70Gy) * Adequate newly obtained core or excisional biopsy of a recurrent tumor lesion * Measurable disease * Lesion available for biopsy during study treatment * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of more than 12 months * A minimum of 6 months since prior radiotherapy in the same area or minimum 4 weeks (28 days) since previous other cancer treatment * Human papillomavirus positive and negative disease allowed * Distant metastases allowed * Adequate organ function based on clinical examination and lab values * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug * Women must not be breastfeeding * WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug * Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo five half-lives. The terminal half-life of nivolumab is up to 25 days Exclusion Criteria: * History of other prior malignancy, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, cervical cancer stage IB and stage I prostate cancer considered not necessary to treat * Disease suitable for curative salvage surgery * Treatment with any investigational medicinal product (IMP) that may interfere with the study treatment, within 4 weeks prior to first administration of study drug. * Significant cardiac, pulmonary or other medical illness that would limit activity or survival * Pregnancy or lactation. * Known hypersensitivity to any of the components of the investigational product * Patients who test positive for hepatitis B, C or HIV. * Diagnosis of immunodeficiency or medical condition requiring systemic steroids or other forms of immunosuppressive therapy * Autoimmune disease that has required systemic therapy within the past 2 years * Any reason why, in the opinion of the investigator, the patient should not participate
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Åse Bratland, m — Oslo University Hospital
- Study coordinator: Åse Bratland, M.D.-Ph.D.
- Email: BRT@ous-hf.no
- Phone: 4024 3735/2293 5942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.