REirradiation and Programmed Cell Death Protein 1 (PD-1) Blockade On Recurrent Squamous Cell Head and Neck Tumors

NCT03317327 | Completed Phase 1

• 1 other identifier: CA209-686_REPORT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 phase of up to 28 days, each eligible subject will receive nivolumab. Two weeks after start of nivolumab the patients will receive radiotherapy (RT) to a total dose of 60 Gy, given as 1.5 Gy fractions twice daily for a total period of 4 weeks. Treatment with nivolumab will continue until disease progression, unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, Investigator's decision to withdraw the subject, noncompliance with trial treatment or procedures requirements, subject receives nivolumab for 12 months, pregnancy, or administrative reasons. After the end of treatment, each subject will be followed for 30 days for adverse event monitoring serious adverse events (SAEs) will be collected for 90 days after the end of treatment. Patients without disease progression will have follow-up visits for 4 years after end of study therapy.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

HNSCC; Nivolumab; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Incidence, nature, and severity of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

  18 months (6 months after end of treatment)

Secondary Outcomes (5)

• Progression-free survival (PFS)

  After 12 months

• Objective response rate (ORR)

  3 years

• Overall survival (OS)

  5 years

• Duration of response (DOR)

  3 years

• Durable response rate (DRR)

  3 years

Other Outcomes (2)

• Immunological response

  3 years

• tumor evolution

  3 years

Study Arms (1)

Nivolumab

EXPERIMENTAL

Nivolumab, intravenous every 2nd week (1 cycle = 2 weeks), dose escalation schedule (1.0, 3.0 mg/kg), for a maximum of 12 months or until disease progression.

Drug: Nivolumab; Radiation: Radiotherapy (RT)

Interventions

Nivolumab DRUG

Nivolumab is a humanized antibody used in cancer immunotherapy.

Also known as: Opdivo

Nivolumab

Radiotherapy (RT) RADIATION

Radiotherapy (RT) will be given to a total dose of 60 Gy (1,5 Gy fractions twice daily) for a total period of 4 weeks

Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Nivolumab; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Åse Bratland, m

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Exploratory

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 23, 2017
• Study Start: September 9, 2017
• Primary Completion: November 28, 2022
• Study Completion: November 28, 2022
• Last Updated: June 3, 2025

Record last verified: 2025-06

Locations

NO (1)