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Trial record 2 of 15 for:    monalizumab

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

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ClinicalTrials.gov Identifier: NCT04590963
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : May 19, 2022
Sponsor:
Collaborator:
Innate Pharma
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE September 23, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date May 19, 2022
Actual Study Start Date  ICMJE October 2, 2020
Estimated Primary Completion Date March 28, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 12, 2020)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2021)
  • 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
  • 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.
  • 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.
  • Immunogenicity of monalizumab [ Time Frame: Approximately 3 years ]
    Presence of ADAs for monalizumab (confirmatory results: positive or negative, titers).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Pharmacokinetics (PK) analysis of monalizumab [ Time Frame: Approximately 3 years ]
    Measurement of the monalizumab concentration in blood.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2020)
  • 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.
  • 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.
  • Immunogenicity of monalizumab [ Time Frame: Approximately 3 years ]
    Presence of ADAs for monalizumab (confirmatory results: positive or negative, titers).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Pharmacokinetics (PK) analysis of monalizumab [ Time Frame: Approximately 3 years ]
    Measurement of the monalizumab concentration in blood.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer
Official Title  ICMJE A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Squamous Cell Carcinoma of the Head and Neck
Intervention  ICMJE
  • Drug: Monalizumab
    Monalizumab (intravenous)
  • Drug: Cetuximab
    Cetuximab (intravenous)
    Other Name: Erbitux
Study Arms  ICMJE
  • Experimental: Arm A (monalizumab and cetuximab)
    monalizumab in combination with cetuximab
    Interventions:
    • Drug: Monalizumab
    • Drug: Cetuximab
  • Active Comparator: Arm B (placebo and cetuximab)
    placebo in combination with cetuximab
    Intervention: Drug: Cetuximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 26, 2021)
624
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2020)
600
Estimated Study Completion Date  ICMJE March 28, 2024
Estimated Primary Completion Date March 28, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   France,   Germany,   Greece,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Peru,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Spain,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04590963
Other Study ID Numbers  ICMJE D7310C00001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Innate Pharma
Investigators  ICMJE
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
PRS Account AstraZeneca
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP