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 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
MonalizumabIPH2201Dose escalation
CetuximabDose escalation
Anti-PD(L)1Expansion cohort 3

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Dose escalationExperimentalDose escalation of monalizumab in combination with cetuximab
  • Monalizumab
  • Cetuximab
Expansion cohort 1Experimentalmonalizumab + cetuximab expansion cohort
  • Monalizumab
  • Cetuximab
Expansion cohort 2Experimentalmonalizumab + cetuximab expansion cohort in patients with prior exposure to PD-(L)1 blockers
  • Monalizumab
  • Cetuximab
Expansion cohort 3Experimentalmonalizumab + cetuximab + anti-PD(L)1
  • Monalizumab
  • Cetuximab
  • Anti-PD(L)1

Eligibility Criteria

        Main 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 with measurable disease as per Response Evaluation Criteria in
             Solid Tumors [RECIST] 1.1

        For phase II cohorts:

          -  Cohort #1: 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

          -  Cohort #2: Patients with R/M SCCHN not amenable to therapy of curative intent,who have
             received a maximum of two prior systemic regimens in the R/M setting and who have
             received prior PD-(L)1 blockers

          -  Cohort #3: Patients with R/M SCCHN who have not received prior systemic regimens in
             the R/M setting and who have not received prior PD-(L)1 inhibitors

        Main Exclusion Criteria:

          1. For phase II cohort #1 and cohort #2: 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 cohort #1 and cohort #2 : 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.
      
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) in the dose escalation part of the study
Time Frame:within 4 weeks after first administration
Safety Issue:
Description:To assess the occurrence of Drug Limited Toxicities (DLTs)

Secondary Outcome Measures

Measure:Objective Response Rate for dose escalation part of the study
Time Frame:up to 12 months
Safety Issue:
Description:rate of patients in complete or partial response according to RECIST 1.1
Measure:Duration of Response for expansion cohorts
Time Frame:From confirmed response until disease progression, up to 12 months
Safety Issue:
Description:Duration of complete and partial response
Measure:Progression Free Survival for expansion cohorts
Time Frame:Until disease progression or death, up to 2 years
Safety Issue:
Description:time between the start of treatment and the first documented progression or death
Measure:Overall Survival for expansion cohorts
Time Frame:Until death, up to 2 years
Safety Issue:
Description:time between the start of treatment and death

Details

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

Last Updated

April 26, 2019