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Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer (INTERLINK-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04590963
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : January 19, 2022
Sponsor:
Collaborator:
Innate Pharma
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in patients with recurrent or metastatic head and neck cancer.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Drug: Monalizumab Drug: Cetuximab Phase 3

Detailed Description:
Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who had prior immune checkpoint inhibitor and platinum-based chemotherapy treatment will be randomized in a 2:1 ratio to monalizumab and cetuximab or placebo and cetuximab. Efficacy and safety assessments will be performed periodically from the time of enrollment and throughout the study. Patients in all arms will continue therapy until progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. All patients will be followed for survival after progression is confirmed.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 624 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel study. Patients will be randomized in a 2:1 ratio to monalizumab and cetuximab or placebo and cetuximab.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blinded study
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor
Actual Study Start Date : October 2, 2020
Estimated Primary Completion Date : March 28, 2024
Estimated Study Completion Date : March 28, 2024

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: Arm A (monalizumab and cetuximab)
monalizumab in combination with cetuximab
 Drug: Monalizumab
Monalizumab (intravenous)

Drug: Cetuximab
Cetuximab (intravenous)
Other Name: Erbitux
Active Comparator: Arm B (placebo and cetuximab)
placebo in combination with cetuximab
 Drug: Cetuximab
Cetuximab (intravenous)
Other Name: Erbitux


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Approximately 3 years ]
    Overall survival, defined as the time from the date of randomization until date of death due to any cause, in HPV-unrelated participants.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Approximately 3 years ]
    Overall survival, defined as the time from the date of randomization until date of death due to any cause, in all randomized participants

  2. Progression Free Survival (PFS) [ Time Frame: Approximately 3 years ]
    PFS is defined as time from randomization until disease progression, per RECIST 1.1 as assessed by the investigator at local site or death due to any cause, whichever occurs first.

  3. Disease-related symptoms, functioning and quality of life measured by EORTC QLQ-C30 questionnaire [ Time Frame: Approximately 3 years ]
    EORTC QLQ-C30 questionnaire to measure cancer patients' functioning (HRQoL) and symptoms. It consists of functional, symptom and a global measure of health status scales.

  4. Immunogenicity of monalizumab [ Time Frame: Approximately 3 years ]
    Presence of ADAs for monalizumab (confirmatory results: positive or negative, titers).

  5. Association of NK cell-related protein markers with efficacy endpoints including OS, PFS, and ORR [ Time Frame: Approximately 3 years ]
    The level of protein expression related to Natural Killer cell-mediated immune response will be evaluated in relation to OS, PFS, and ORR outcomes.

  6. Assessment of Adverse Events (AE) [ Time Frame: Approximately 3 years ]
    Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of monalizumab plus cetuximab as compared to placebo plus cetuximab.

  7. Objective Response Rate (ORR) [ Time Frame: Approximately 3 years ]
    ORR is defined as the proportion of participants with measurable disease who have a confirmed CR or PR, as determined by the investigator at local site per RECIST 1.1.

  8. Duration of Response (DoR) [ Time Frame: Approximately 3 years ]
    DoR is defined as the time from the date of first documented response until date of documented disease progression or death in the absence of disease progression.

  9. Disease-related symptoms, functioning and quality of life measured by EORTC QLQ-H&N35 questionnaire [ Time Frame: Approximately 3 years ]
    EORTC QLQ-H&N35 questionnaire to measure head and neck cancer patients' functioning (HRQoL) and symptoms. It consists of functional, symptom and a global measure of health status scales.

  10. Pharmacokinetics (PK) analysis of monalizumab [ Time Frame: Approximately 3 years ]
    Measurement of the monalizumab concentration in blood.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are aged 18 years and over
  • Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), (oral cavity, oropharynx, hypopharynx, or larynx) which has progressed on or after previous systemic cancer therapy and is not amenable to curative therapy
  • Received prior treatment using a PD-(L)1 inhibitor
  • Prior platinum failure
  • Received 1 or 2 prior systemic regimens for recurrent or metastatic SCCHN
  • Has measurable disease per RECIST 1.1
  • A fresh or recently acquired tumor tissue for the purpose of biomarker testing
  • World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

  • Head and neck cancer of any primary anatomic location in the head and neck not specified in the inclusion criteria, including participants with SCCHN of unknown primary or non-squamous histologies
  • Had prior cetuximab therapy (unless it was administered in curative locally advanced setting with radiotherapy and no disease progression for at least 6 months following the last cetuximab dose)
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis
  • Any concurrent anticancer treatment, except for hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy)
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): NCT04590963


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Sponsors and Collaborators
AstraZeneca
Innate Pharma
Investigators
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Principal Investigator: Roger B Cohen, MD Abramson Cancer Center, Perelman Center for Advanced Medicine
Principal Investigator: Jérôme Fayette, MD Centre Leon Berard
Study Director: Dario Ruscica, MD AstraZeneca, Cambridge, UK
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04590963    
Other Study ID Numbers: D7310C00001
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of the timelines, please refer to the disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
head and neck cancer
Squamous Cell Carcinoma of the Head and Neck
monalizumab
cetuximab
Erbitux
oral cavity
 larynx
pharynx
natural killer
oropharynx
hypopharynx
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents