Clinical Trials /

Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

NCT02643550

Description:

The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses of Monalizumab given IV in combination with cetuximab in patients who have received prior systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Cohorts expansion will evaluate antitumor activity of monalizumab and cetuximab with or without anti-PD(L)1

Related Conditions:
  • Hypopharyngeal Squamous Cell Carcinoma
  • Laryngeal Squamous Cell Carcinoma
  • Nasopharyngeal Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of IPH2201 (Monalizumab) and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
  • Official Title: Phase 1b/2 Trial of IPH2201 And Cetuximab in Patients With Human Papillomavirus (HPV) (+) and HPV (-) Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Clinical Trial IDs

  • ORG STUDY ID: IPH2201-203
  • NCT ID: NCT02643550

Conditions

  • Head and Neck Neoplasms

Interventions

DrugSynonymsArms
IPH2201MONALIZUMABIPH2201 (MONALIZUMAB) +CETUXIMAB
CETUXIMABIPH2201 (MONALIZUMAB) +CETUXIMAB

Purpose

The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses of IPH2201 given IV in combination with cetuximab in patients who have received prior systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). A cohort expansion will evaluate antitumor activity of the combination.

Trial Arms

NameTypeDescriptionInterventions
IPH2201 (MONALIZUMAB) +CETUXIMABExperimentalDose escalation of IPH2201 (MONALIZUMAB) + CETUXIMAB

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Age ≥ 18 years
    
              2. Histologically or cytologically-confirmed, HPV (+) or HPV (-) squamous cell carcinoma
                 of the nasopharynx (WHO Type 1), oropharynx, hypopharynx, larynx (supraglottis,
                 glottis, subglottis) or oral cavity,
    
              3. Recurrent or metastatic disease, documented by imaging (CT scan, MRI, X-ray) and/or
                 physical examination. In phase II, measurable disease as per Response Evaluation
                 Criteria in Solid Tumors [RECIST] 1.1 is mandated. In phase Ib, patients with or
                 without measurable disease are eligible.
    
              4. Progression after platinum-based chemotherapy
    
              5. For phase Ib only: Pretreated patients, and not amenable to further therapy with
                 curative intent. This part is open to pretreated patients regardless of the number of
                 previous treatment lines.
    
                 For phase II only: Patients who received a maximum of two prior systemic regimens for
                 recurrent and/or metastatic disease and not amenable to further therapy with curative
                 intent.
    
              6. No prior treatment by cetuximab except if given for primary treatment (locally
                 advanced disease) with no progressive disease for at least 4 months following the end
                 of prior cetuximab treatment.
    
              7. Recovery from prior surgery and recovery from adverse events to grade 1 or less
                 (except alopecia) due to prior radiation therapy and any systemic therapy.
    
              8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
    
              9. Life expectancy of ≥ 3 months
    
             10. Patients with treated brain metastases are eligible if they are > 4 weeks from therapy
                 completion (including radiation and/or surgery), are clinically stable at the time of
                 study entry and are not receiving corticosteroid therapy at the time of study entry
    
             11. Adequate hematologic, immunologic, liver and renal function, defined as
    
                   -  hemoglobin ≥ 9.0 g/dL,
    
                   -  absolute neutrophil count ≥ 1,500/mm3,
    
                   -  platelets ≥ 100,000/mm3,
    
                   -  total bilirubin ≤ 1.5 X institutional upper normal limit (UNL),
    
                   -  aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 X
                      institutional UNL,
    
                   -  serum creatinine ≤1.5 X institutional UNL or estimated (Cockcroft-Gault formula)
                      or measured creatinine clearance ≥ 50 mL/min
    
             12. Negative serum pregnancy test within 72 hours before starting study treatment for
                 women of childbearing potential. Women of childbearing potential and all men must
                 agree to use adequate contraception (hormonal or barrier method of birth control;
                 abstinence) prior to study entry, for the duration of monalizumab administration and
                 for up to 5 months after the last dose of monalizumab.
    
             13. Ability to understand a written informed consent document
    
             14. Signed informed consent prior to any protocol-specific procedures
    
            Exclusion Criteria:
    
              1. For phase II only: Patients who received more than 2 prior systemic regimens for
                 recurrent and/or metastatic disease (no restriction in the phase Ib part of the
                 trial).
    
              2. For phase II only: Patients who received cetuximab or another inhibitor of epidermal
                 growth factor receptor are excluded from the phase II of the trial, except if
                 cetuximab was given as part of a primary treatment approach, with no progressive
                 disease for at least 4 months following the end of prior cetuximab treatment.
    
              3. History of allergic reactions attributed to compounds of similar chemical or biologic
                 composition to cetuximab.
    
              4. Patients with known untreated and uncontrolled brain metastases are excluded. However,
                 brain-imaging studies are not required for eligibility if the patient has no
                 neurological signs or symptoms.
    
              5. Serious concurrent uncontrolled medical disorder.
    
              6. Auto-immune disease, which:
    
                   1. currently or previously required systemic immunosuppressive or immunomodulatory
                      therapy (including corticosteroids administered by systemic route) and/or
    
                   2. has a substantial probability to cause an irreversible injury to any tissue
                      and/or
    
                   3. has been diagnosed less than 3 months before study entry and/or
    
                   4. is clinically unstable and/or
    
                   5. has a substantial risk to progress and cause severe complications.
    
              7. Abnormal cardiac status with any of the following:
    
                   1. Unstable angina
    
                   2. Arrhythmia requiring treatment which is not stabilized by the treatment
    
                   3. QTc > 450 ms (M) or 470 ms (F) (Bazett formula -QT Interval / √ (RR interval)
                      where RR Interval = 60/HR).
    
              8. History of cardiac dysfunction including any of the following:
    
                   1. Myocardial infarction within the last 6 months
    
                   2. History of documented congestive heart failure (New York Heart Association
                      functional classification III-IV).
    
              9. Known interstitial lung disease.
    
             10. Pregnant women are excluded from this study; breastfeeding must be discontinued.
    
             11. Other active invasive malignancy (except for treated basal or squamous cell skin
                 carcinoma, or in situ cervix carcinoma).
    
             12. Treatment with other investigational agents less than 14 days prior to study entry.
    
             13. Systemic treatment with steroids or other immunosuppressive agents within 30 days
                 prior to entry. Physiological replacement with hydrocortisone or equivalent is
                 acceptable.
    
             14. Current active infectious disease.
    
             15. Positive serology for HIV.
    
             16. Positive HBs Ag or positive HBV viremia, Positive HCV viremia.
    
             17. Psychological, familial, sociological, or geographical conditions that do not permit
                 medical follow-up and compliance with study protocol.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Occurrence of Dose Limiting Toxicities (DLT)
    Time Frame:within 4 weeks after first administration
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Objective Response Rate
    Time Frame:every 8 weeks until progression. Patients study participation will be 1 year from first dose of treatment
    Safety Issue:
    Description:

    Details

    Phase:Phase 1/Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Innate Pharma

    Last Updated

    November 24, 2016