Clinical Trials /

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

NCT03341936

Description:

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

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Neodjuvant Nivolumab and Lirilumab, Followed by Surgery, Followed by Adjuvant Nivolumab and Lirilumab, in SCCHN
  • Official Title: Neodjuvant Nivolumab and Lirilumab, Followed by Surgery, Followed by Adjuvant Nivolumab and Lirilumab, in Patients With Relapsed, Resectable Squamous Cell Carcinoma of the Head and Neck

Clinical Trial IDs

  • ORG STUDY ID: 17-411
  • NCT ID: NCT03341936

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DrugSynonymsArms
NivolumabNivolumab+Lirilumab
LirilumabNivolumab+Lirilumab

Purpose

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

Detailed Description

      This research study is a Phase II clinical trial. Phase II clinical trials test the safety
      and effectiveness of an investigational drug or combination of drugs to learn whether it
      works in treating a specific disease. "Investigational" means that the drug/s is being
      studied.

      The purpose of this study is to evaluate effectiveness (how well the drug/s work) of
      nivolumab in combination with lirilumab in participants with SCCHN.

      Nivolumab and lirilumab are types of immunotherapy. Immunotherapy works by encouraging the
      body's own immune system to attack cancer cells. Both nivolumab and lirilumab have been
      demonstrated to activate the immune system to attack cancer cells in participants with
      different types of cancers.

      In November, 2016, the Food and Drug Administration (FDA) approved nivolumab for the
      treatment of participants with recurrent or metastatic squamous cell carcinoma of the head
      and neck (SCCHN). Lirilumab is not FDA approved as of now.
    

Trial Arms

NameTypeDescriptionInterventions
Nivolumab+LirilumabExperimentalThe 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.
  • Nivolumab
  • Lirilumab

Eligibility Criteria

        Inclusion Criteria:

          -  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

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Women of childbearing potential (WOCBP) must agree to use appropriate method(s) of
             contraception. WOCBP should plan to use an adequate method to avoid pregnancy for 5
             months (30 days plus the time required for nivolumab to undergo five half-lives) after
             the last dose of investigational drug

          -  Women of childbearing potential 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 nivolumab

          -  "Women of childbearing potential (WOCBP)" is defined as any female who has experienced
             menarche and who has not undergone surgical sterilization (hysterectomy or bilateral
             oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12
             months of amenorrhea in a woman over 45 in the absence of other biological or
             physiological causes. In addition, women under the age of 55 must have a documented
             serum follicle stimulating hormone (FSH) level less than 40 mIU/mL

          -  Men who are sexually active with WOCBP must agree to use any contraceptive method with
             a failure rate of less than 1% per year. Men who are sexually active with WOCBP will
             be instructed to adhere to contraception for a period of 7 months after the last dose
             of investigational product. Women who are not of childbearing potential (ie, who are
             postmenopausal or surgically sterile as well as azoospermic men) do not require
             contraception

        Exclusion Criteria:

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease-free survival
Time Frame:1 year
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Best overall Response Rate
Time Frame:at the time of salvage surgery
Safety Issue:
Description:
Measure:Disease-free survival
Time Frame:2 years
Safety Issue:
Description:
Measure:Overall Survival Rate
Time Frame:3 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Dana-Farber Cancer Institute

Trial Keywords

  • Squamous Cell Carcinoma

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