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 : March 17, 2021
|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)|
|Estimated Enrollment :||600 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 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|
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.
- 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.
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
|Contact: AstraZeneca Clinical Study Information Centerfirstname.lastname@example.org|
|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|