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

Conditions

Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor

Brief summary

Overall survival, defined as the time from the date of randomization until date of death due to any cause.

Detailed description

Overall survival, defined as the time from the date of randomization until date of death due to any cause, 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., 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., 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., Patient questionnaires regarding wellbeing and symptom change in baseline scores across visits, Concentration of monalizumab in the blood, Presence of antibodies to monalizumab in the blood, Measurement of specific biomarkers in the tumor sample(s), AEs, vital signs, clinical laboratory results, ECGs

Related papers

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Interventions

DRUGMonalizumab

DRUGIsotone Kochsalz-Lösung 0

DRUG9 % Braun Infusionslösung

DRUGCETUXIMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival, defined as the time from the date of randomization until date of death due to any cause.	—

Secondary

Measure	Time frame
Overall survival, defined as the time from the date of randomization until date of death due to any cause, 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., 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., 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., Patient questionnaires regarding wellbeing and symptom change in baseline scores across visits, Concentration of monalizumab in the blood, Presence of antibodies to monalizumab in the blood, Measurement of specific biomarkers in the tumor sample(s), AEs, vital signs, clinical laboratory results, ECGs	—

Measure

Time frame

Overall survival, defined as the time from the date of randomization until date of death due to any cause, 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., 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., 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., Patient questionnaires regarding wellbeing and symptom change in baseline scores across visits, Concentration of monalizumab in the blood, Presence of antibodies to monalizumab in the blood, Measurement of specific biomarkers in the tumor sample(s), AEs, vital signs, clinical laboratory results, ECGs

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Countries

Germany

Outcome results

None listed