Status:
COMPLETED
REirradiation and Programmed Cell Death Protein 1 (PD-1) Blockade On Recurrent Squamous Cell Head and Neck Tumors
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Each subject will participate in the trial until death, drop out, or loss-to follow-up from the time the subject signs the Informed Consent Form (ICF) through the final contact. After a screening phas...
Detailed Description
In this study, the aim is to release the brake on the immune response by use of nivolumab, an inhibitory antibody against Programmed cell death protein 1 (PD-1). Nivolumab has shown efficacy and mild ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03317327
Start Date
September 9 2017
End Date
November 28 2022
Last Update
June 3 2025
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway