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
1 other identifier
interventional
143
2 countries
18
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2015
Longer than P75 for phase_1
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 17, 2015
CompletedFirst Posted
Study publicly available on registry
December 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2023
CompletedMay 12, 2023
May 1, 2023
7.3 years
December 17, 2015
May 11, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Objective Response Rate for dose escalation part of the study
up to 12 months
Duration of Response for expansion cohorts
From confirmed response until disease progression, up to 12 months
Progression Free Survival for expansion cohorts
Until disease progression or death, up to 2 years
Overall Survival for expansion cohorts
Until death, up to 2 years
Study Arms (4)
Dose escalation
EXPERIMENTALDose escalation of monalizumab in combination with cetuximab
Expansion cohort 1
EXPERIMENTALmonalizumab + cetuximab expansion cohort
Expansion cohort 2
EXPERIMENTALmonalizumab + cetuximab expansion cohort in patients with prior exposure to PD-(L)1 blockers
Expansion cohort 3
EXPERIMENTALmonalizumab + cetuximab + anti-PD(L)1
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Innate Pharmalead
- AstraZenecacollaborator
Study Sites (18)
University of California, Moores Cancer Center
La Jolla, California, United States
Stanford Cancer Center
Stanford, California, 94305, United States
University of Chicago
Chicago, Illinois, 60637, 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, 10029, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
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, France
Related Publications (1)
Hwang M, Fan C, Yue MS, Zhou D, Paturel C, Andre P, Cheng LY, Mitchell P, Kourtesis P, Ruscica D, Das M, Morsli N, Ren S, Gibbs M, Phipps A, Song X. Population Pharmacokinetics of Monalizumab in Patients With Advanced Solid Tumors. J Clin Pharmacol. 2023 Jul;63(7):817-829. doi: 10.1002/jcph.2220. Epub 2023 Apr 10.
PMID: 36852723DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2015
First Posted
December 31, 2015
Study Start
December 1, 2015
Primary Completion
March 28, 2023
Study Completion
March 28, 2023
Last Updated
May 12, 2023
Record last verified: 2023-05