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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
143
University of California, Moores Cancer Center
La Jolla, California, United States
Stanford Cancer Center
Stanford, California, United States
Occurrence of Dose Limiting Toxicities (DLT) in the dose escalation part of the study
To assess the occurrence of Drug Limited Toxicities (DLTs)
Time frame: 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.
Time frame: up to 12 months
Objective Response Rate for dose escalation part of the study
rate of patients in complete or partial response according to RECIST 1.1
Time frame: up to 12 months
Duration of Response for expansion cohorts
Duration of complete and partial response
Time frame: 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
Time frame: Until disease progression or death, up to 2 years
Overall Survival for expansion cohorts
time between the start of treatment and death
Time frame: Until death, up to 2 years
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University of Chicago
Chicago, Illinois, United States
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinaï
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Centre Jean Perrin
Clermont-Ferrand, France
...and 8 more locations