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

  • Interventional
  • Recruiting
  • NCT02643550
Eligibility Details Visit Clinicaltrials.gov

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

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

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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.

At a Glance

National Government IDNCT02643550

IRB#IRB16-1718

Lead SponsorInnate Pharma

Lead PhysicianAlexander Pearson

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting