Head and Neck Neoplasms
Conditions
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
Interventions
BIOLOGICALMonalizumab
BIOLOGICALCetuximab
BIOLOGICALAnti-PD(L)1
Sponsors
AstraZeneca
Innate Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Duration of Response for expansion cohorts | From confirmed response until disease progression, up to 12 months | Duration of complete and partial response |
| 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 |
Countries
France, United States
Outcome results
None listed