Neodjuvant Nivolumab and Lirilumab, Followed by Surgery, Followed by Adjuvant Nivolumab and Lirilumab, in SCCHN

NCT03341936 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: 17-411
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is studying a combination of two immunotherapy drugs, as a possible treatment for locoregionally recurrent squamous cell carcinoma of the head and neck. The immunotherapy drugs involved in this study are:

• Nivolumab (Opdivo™)
• Lirilumab

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 1-Year Disease-Free Survival Percentage

  The percentage of patients who were alive and disease free at one year past salvage surgery. Patients who were alive at last contact prior to the one year mark are censored. Data analysis conducted through Kaplan Meier methods.

  1 year since salvage surgery, up to 1 year and 23 days since treatment start

Secondary Outcomes (4)

• Response at Time of Salvage Surgery

  At the time of salvage surgery, up to 23 days from treatment start date.

• Median Disease-Free Survival Rate

  Up to 27.2 months post salvage surgery, up to 28 months total.

• 1-Year Overall Survival Percentage

  1 year post salvage surgery, up to 1 year and 23 days post treatment start.

• Median Change in Programmed Cell Death Ligand - 1 Combined Positive Score

  Measured at baseline and then at time of salvage surgery, up to 23 days.

Study Arms (1)

Nivolumab+Lirilumab

EXPERIMENTAL

* The drugs will be administered intravenously. A single dose of Nivolumab and Lirilumab will be administered prior Salvage surgical resection. * In Cycle 1-3: Nivolumab will be administered on Days 1 and 15 and lirilumab will be administered on Day 1 of each 28 day long cycle * In Cycle 4-6 and beyond: Nivolumab and lirilumab will be administered on Day 1 of each 28 day long cycle.

Drug: Nivolumab; Drug: Lirilumab

Interventions

Nivolumab DRUG

Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells

Nivolumab+Lirilumab

Lirilumab DRUG

Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells

Nivolumab+Lirilumab

Eligibility Criteria

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

You may qualify if:

• Subject must have histologically or cytologically confirmed locoregionally recurrent squamous cell carcinoma of the head and neck (including any primary site, such as oral cavity, oropharynx, larynx or hypopharynx, and nasopharyngeal carcinoma)
• Must be a candidate for salvage surgery
• Willing to provide blood and tissue from diagnostic biopsy and at the time of surgery
• Has documented disease-free interval (DFI) \> 8 weeks after completion of initial therapy; DFI is from the time of completion of initial treatment to the diagnosis of local or locoregional recurrence
• Any HPV status or smoking history is permitted. Oropharyngeal cancer patients are required to undergo HPV testing with p16 immunohistochemistry and/or confirmatory HPV PCR or ISH testing
• Age 18 years or older
• ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
• Participant must have normal organ and marrow function as defined below within 21 days prior to study registration:
• leukocytes ≥3,000/mcL
• absolute neutrophil count ≥1,500/mcL
• platelets ≥100,000/mcL
• total bilirubin ≤2.0 g/dL
• AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
• creatinine within normal institutional limits OR
• creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal

You may not qualify if:

• Existing significant autoimmune conditions. Patients with a history of Hashimoto thyroiditis who are stable on replacement hormone therapy are not excluded. Patients cannot be on long-term (\> 4 weeks) corticosteroids at doses exceeding prednisone 20 mg (or its equivalent) prior to enrollment. Short-term corticosteroid dosing is permitted as long as steroids are discontinued within 2 weeks of study enrollment.
• Subject who has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Subject who has been treated with immunotherapy. This includes prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
• Subject with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However, baseline brain imaging is not required prior to enrollment in the study if patients are asymptomatic.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Known human immunodeficiency virus carrier or a diagnosis of immunodeficiency. Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, eg, Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative).
• Known non-infectious pneumonitis or any history of interstitial lung disease.
• Receipt of a live vaccine within 30 days of start of study treatment

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Interventions

Nivolumab; lirilumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Glenn J. Hanna, MD
• Organization: Dana Farber Cancer Institute

GJHANNA@partners.org

6176326799

Study Officials

• Glenn J. Hanna, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 14, 2017
• Study Start: March 15, 2018
• Primary Completion: July 6, 2021
• Study Completion (Estimated): July 6, 2026
• Last Updated: June 18, 2025
• Results First Posted: June 16, 2022

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)