Trial Search Results

Study of Monalizumab and Cetuximab in Patients With 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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Innate Pharma

Collaborator: AstraZeneca

Stanford Investigator(s):


  • Biological: Monalizumab
  • Biological: Cetuximab
  • Biological: Anti-PD(L)1


Phase 1/Phase 2


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

   - 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Michelle Jun
Not Recruiting