Description:
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
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
IPH2201-203
- NCT ID:
NCT02643550
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Monalizumab | IPH2201 | Dose escalation |
Cetuximab | | Dose escalation |
Anti-PD(L)1 | | Expansion cohort 3 |
Purpose
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 Arms
Name | Type | Description | Interventions |
---|
Dose escalation | Experimental | Dose escalation of monalizumab in combination with cetuximab | |
Expansion cohort 1 | Experimental | monalizumab + cetuximab expansion cohort | |
Expansion cohort 2 | Experimental | monalizumab + cetuximab expansion cohort in patients with prior exposure to PD-(L)1 blockers | |
Expansion cohort 3 | Experimental | monalizumab + cetuximab + anti-PD(L)1 | - Monalizumab
- Cetuximab
- 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Occurrence of Dose Limiting Toxicities (DLT) in the dose escalation part of the study |
Time Frame: | within 4 weeks after first administration |
Safety Issue: | |
Description: | To assess the occurrence of Drug Limited Toxicities (DLTs) |
Secondary Outcome Measures
Measure: | Objective Response Rate for dose escalation part of the study |
Time Frame: | up to 12 months |
Safety Issue: | |
Description: | rate of patients in complete or partial response according to RECIST 1.1 |
Measure: | Duration of Response for expansion cohorts |
Time Frame: | From confirmed response until disease progression, up to 12 months |
Safety Issue: | |
Description: | Duration of complete and partial response |
Measure: | Progression Free Survival for expansion cohorts |
Time Frame: | Until disease progression or death, up to 2 years |
Safety Issue: | |
Description: | time between the start of treatment and the first documented progression or death |
Measure: | Overall Survival for expansion cohorts |
Time Frame: | Until death, up to 2 years |
Safety Issue: | |
Description: | time between the start of treatment and death |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Innate Pharma |
Last Updated
February 9, 2021