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Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

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ClinicalTrials.gov Identifier: NCT02643550
Recruitment Status : Active, not recruiting
First Posted : December 31, 2015
Last Update Posted : February 9, 2021
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Innate Pharma

Study Description
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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


Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Biological: Monalizumab Biological: Cetuximab Biological: Anti-PD(L)1 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2015
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose escalation
Dose escalation of monalizumab in combination with cetuximab
 Biological: Monalizumab
Other Name: IPH2201

Biological: Cetuximab
Experimental: Expansion cohort 1
monalizumab + cetuximab expansion cohort
 Biological: Monalizumab
Other Name: IPH2201

Biological: Cetuximab
Experimental: Expansion cohort 2
monalizumab + cetuximab expansion cohort in patients with prior exposure to PD-(L)1 blockers
 Biological: Monalizumab
Other Name: IPH2201

Biological: Cetuximab
Experimental: Expansion cohort 3
monalizumab + cetuximab + anti-PD(L)1
 Biological: Monalizumab
Other Name: IPH2201

Biological: Cetuximab
Biological: Anti-PD(L)1


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of Dose Limiting Toxicities (DLT) in the dose escalation part of the study [ Time Frame: within 4 weeks after first administration ]
    To assess the occurrence of Drug Limited Toxicities (DLTs)

  2. Objective Response Rate for expansion cohorts [ Time Frame: up to 12 months ]
    rate of patients in complete or partial response according to RECIST 1.1.


Secondary Outcome Measures :
  1. Objective Response Rate for dose escalation part of the study [ Time Frame: up to 12 months ]
    rate of patients in complete or partial response according to RECIST 1.1

  2. Duration of Response for expansion cohorts [ Time Frame: From confirmed response until disease progression, up to 12 months ]
    Duration of complete and partial response

  3. Progression Free Survival for expansion cohorts [ Time Frame: Until disease progression or death, up to 2 years ]
    time between the start of treatment and the first documented progression or death

  4. Overall Survival for expansion cohorts [ Time Frame: Until death, up to 2 years ]
    time between the start of treatment and death


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643550


Locations
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Sponsors and Collaborators
Innate Pharma
AstraZeneca
More Information
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Responsible Party: Innate Pharma
ClinicalTrials.gov Identifier: NCT02643550    
Other Study ID Numbers: IPH2201-203
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents