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 : Active, not recruiting
First Posted : October 19, 2020
Last Update Posted : May 18, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of the Head and Neck||Drug: Monalizumab Drug: Cetuximab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||370 participants|
|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|
|Official Title:||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|
|Actual Study Start Date :||October 2, 2020|
|Actual Primary Completion Date :||May 11, 2022|
|Estimated Study Completion Date :||December 1, 2023|
Experimental: Arm A (monalizumab and cetuximab)
monalizumab in combination with cetuximab
Other Name: Erbitux
Active Comparator: Arm B (placebo and cetuximab)
placebo in combination with cetuximab
Other Name: Erbitux
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 130 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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)
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
|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|
|Other Study ID Numbers:||
2019-004770-25 ( EudraCT Number )
|First Posted:||October 19, 2020 Key Record Dates|
|Last Update Posted:||May 18, 2023|
|Last Verified:||May 2023|
|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.|
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.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
head and neck cancer
Squamous Cell Carcinoma of the Head and Neck
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents, Immunological