Clinical trial NCT02643550: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Head and Neck Neoplasms
Lead sponsor: Innate Pharma
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2015-12-31
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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


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.

Primary outcomes:
measure: Occurrence of Dose Limiting Toxicities (DLT) in the dose escalation part of the study
timeFrame: within 4 weeks after first administration
measure: Objective Response Rate for expansion cohorts
timeFrame: up to 12 months
Secondary outcomes:
measure: Objective Response Rate for dose escalation part of the study
timeFrame: up to 12 months
measure: Duration of Response for expansion cohorts
timeFrame: From confirmed response until disease progression, up to 12 months
measure: Progression Free Survival for expansion cohorts
timeFrame: Until disease progression or death, up to 2 years
measure: Overall Survival for expansion cohorts
timeFrame: Until death, up to 2 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, Moores Cancer Center
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland, Greenebaum Comprehensive Cancer Center
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinaï
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Hopital La Timone
city: Montpellier
country: France
facility: Institut Regional du Cancer de Montpellier
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Saint-Herblain
country: France
facility: ICO Rene Gauducheau
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: