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

Head and Neck Neoplasms Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT02643550
• Other study ID #: IPH2201-203
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2015
• Est. completion date: March 28, 2023

Study information

• Verified date: May 2023
• Source: Innate Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: March 28, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Intervention

Biological:
• Monalizumab

• Cetuximab

• Anti-PD(L)1

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre Oscar Lambret	Lille
France	Centre Leon Berard	Lyon
France	Hopital La Timone	Marseille
France	Institut Regional du Cancer de Montpellier	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Centre Eugene Marquis	Rennes
France	ICO Rene Gauducheau	Saint-Herblain
France	Institut Gustave Roussy	Villejuif
United States	University of Maryland, Greenebaum Comprehensive Cancer Center	Baltimore	Maryland
United States	University of Chicago	Chicago	Illinois
United States	University of California, Moores Cancer Center	La Jolla	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Icahn School of Medicine at Mount Sinaï	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Stanford Cancer Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Innate Pharma	AstraZeneca

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Objective Response Rate for expansion cohorts	rate of patients in complete or partial response according to RECIST 1.1.	up to 12 months
Secondary	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
Secondary	Duration of Response for expansion cohorts	Duration of complete and partial response	From confirmed response until disease progression, up to 12 months
Secondary	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
Secondary	Overall Survival for expansion cohorts	time between the start of treatment and death	Until death, up to 2 years