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

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

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Biological: Cetuximab; Biological: Monalizumab; Biological: Anti-PD(L)1

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • Centre Jean Perrin
  • Lille, France
    • Centre Oscar Lambret
  • Lyon, France
    • Centre Leon Berard
  • Marseille, France
    • Hôpital La Timone
  • Montpellier, France
    • Institut régional du Cancer de Montpellier
  • Nice, France
    • Centre Antoine Lacassagne
  • Rennes, France
    • Centre Eugène Marquis
  • Saint-Herblain, France
    • Ico Rene Gauducheau
  • Villejuif, France
    • Institut Gustave Roussy
• United States
  • California
    • La Jolla, California, United States
      • University of California, Moores Cancer Center
    • Stanford, California, United States, 94305
      • Stanford Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Maryland
    • Baltimore, Maryland, United States
      • University of Maryland, Greenebaum Comprehensive Cancer Center
  • Missouri
    • Saint Louis, Missouri, United States
      • Washington University School of Medicine
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Tennessee
    • Nashville, Tennessee, United States
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation; Dose escalation of monalizumab in combination with cetuximab	Biological: Cetuximab; Biological: Monalizumab; Other Names: IPH2201
Experimental: Expansion cohort 1; monalizumab + cetuximab expansion cohort	Biological: Cetuximab; Biological: Monalizumab; Other Names: IPH2201
Experimental: Expansion cohort 2; monalizumab + cetuximab expansion cohort in patients with prior exposure to PD-(L)1 blockers	Biological: Cetuximab; Biological: Monalizumab; Other Names: IPH2201
Experimental: Expansion cohort 3; monalizumab + cetuximab + anti-PD(L)1	Biological: Cetuximab; Biological: Monalizumab; Other Names: IPH2201; Biological: Anti-PD(L)1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Dose Limiting Toxicities (DLT) in the dose escalation part of the study	To assess the occurrence of Drug Limited Toxicities (DLTs)	within 4 weeks after first administration
Objective Response Rate for expansion cohorts	rate of patients in complete or partial response according to RECIST 1.1.	up to 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Innate Pharma
• Collaborators: AstraZeneca

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): March 28, 2023
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: December 29, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab
• Other Study ID Numbers: IPH2201-203