Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- Conditions
- Head and Neck Neoplasms
- Interventions
- Biological: MonalizumabBiological: CetuximabBiological: Anti-PD(L)1
- Registration Number
- NCT02643550
- Lead Sponsor
- Innate Pharma
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 143
- Age ≥ 18 years
- 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.
- 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
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose escalation Cetuximab Dose escalation of monalizumab in combination with cetuximab Expansion cohort 3 Cetuximab monalizumab + cetuximab + anti-PD(L)1 Expansion cohort 3 Anti-PD(L)1 monalizumab + cetuximab + anti-PD(L)1 Expansion cohort 1 Monalizumab monalizumab + cetuximab expansion cohort Expansion cohort 1 Cetuximab monalizumab + cetuximab expansion cohort Expansion cohort 2 Cetuximab monalizumab + cetuximab expansion cohort in patients with prior exposure to PD-(L)1 blockers Expansion cohort 3 Monalizumab monalizumab + cetuximab + anti-PD(L)1 Dose escalation Monalizumab Dose escalation of monalizumab in combination with cetuximab Expansion cohort 2 Monalizumab monalizumab + cetuximab expansion cohort in patients with prior exposure to PD-(L)1 blockers
- Primary Outcome Measures
Name Time Method Occurrence of Dose Limiting Toxicities (DLT) in the dose escalation part of the study within 4 weeks after first administration To assess the occurrence of Drug Limited Toxicities (DLTs)
Objective Response Rate for expansion cohorts up to 12 months rate of patients in complete or partial response according to RECIST 1.1.
- Secondary Outcome Measures
Name Time Method Objective Response Rate for dose escalation part of the study up to 12 months rate of patients in complete or partial response according to RECIST 1.1
Progression Free Survival for expansion cohorts Until disease progression or death, up to 2 years time between the start of treatment and the first documented progression or death
Overall Survival for expansion cohorts Until death, up to 2 years time between the start of treatment and death
Duration of Response for expansion cohorts From confirmed response until disease progression, up to 12 months Duration of complete and partial response
Trial Locations
- Locations (18)
University of Maryland, Greenebaum Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Centre Oscar Lambret
🇫🇷Lille, France
Icahn School of Medicine at Mount Sinaï
🇺🇸New York, New York, United States
Hopital La Timone
🇫🇷Marseille, France
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Centre Antoine Lacassagne
🇫🇷Nice, France
Centre Eugene Marquis
🇫🇷Rennes, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Institut Regional du Cancer de Montpellier
🇫🇷Montpellier, France
ICO Rene Gauducheau
🇫🇷Saint-Herblain, France
University of California, Moores Cancer Center
🇺🇸La Jolla, California, United States
Stanford Cancer Center
🇺🇸Stanford, California, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Centre Leon Berard
🇫🇷Lyon, France