Study of Monalizumab Given With Cetuximab or Placebo Given with Cetuximab in Patients With Head and Neck Cancer that has come back or spread to other parts of the body

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 - INTERLINK-1

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004770-25-NL

Enrollment

624

Registered

2020-04-29

Start date

2020-07-10

Completion date

Unknown

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor MedDRA version: 21.1 Level: PT Classification code 10067821 Term: Head and neck cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: Monalizumab Product Code: IPH2201 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Monalizumab CAS Number: 1228763-95-8 Current Sponsor code: IP

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Are aged 18 years and over 2. Recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx) 3. Received treatment using a PD-(L)1 inhibitor 4. Prior platinum failure 5. Received 1 or 2 prior systemic regimens for recurrent or metastatic SCCHN 6. At least one measurable lesion at baseline that qualifies RECIST 1.1 7. A fresh or recently acquired tumor tissue for the purpose of biomarker testing 8. WHO/ECOG PS of 0 or 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 416 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 208

Exclusion criteria

Exclusion criteria: 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 2. Had prior cetuximab therapy (unless it was administered in curative LA setting with radiotherapy and no disease progression for at least 6 months following the last cetuximab dose) 3. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis 4. Any concurrent anticancer treatment, except for hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy)

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effect of monalizumab and cetuximab (Arm A) relative to placebo and cetuximab (Arm B) in terms of overall survival (OS) in HPV-unrelated participants.;Secondary Objective: To compare the effect of monalizumab and cetuximab (arm A) relative to placebo and cetuximab (arm B) by: 1. assessment of OS in all randomized participants; 2. assessment of PFS, ORR, DoR 3. assessment of disease-related symptoms, functioning and quality of life 4. characterization of the association between clinical outcome and protein expression in the tumor 5. assessment of safety and tolerability. To investigate PK and immunogenicity of monalizumab.;Primary end point(s): Overall survival, defined as the time from the date of randomization until date of death due to any cause.;Timepoint(s) of evaluation of this end point: Assessments of survival status must be made periodically from enrollment.	—

Measure

Time frame

Main Objective: To compare the effect of monalizumab and cetuximab (Arm A) relative to placebo and cetuximab (Arm B) in terms of overall survival (OS) in HPV-unrelated participants.;Secondary Objective: To compare the effect of monalizumab and cetuximab (arm A) relative to placebo and cetuximab (arm B) by: 1. assessment of OS in all randomized participants; 2. assessment of PFS, ORR, DoR 3. assessment of disease-related symptoms, functioning and quality of life 4. characterization of the association between clinical outcome and protein expression in the tumor 5. assessment of safety and tolerability. To investigate PK and immunogenicity of monalizumab.;Primary end point(s): Overall survival, defined as the time from the date of randomization until date of death due to any cause.;Timepoint(s) of evaluation of this end point: Assessments of survival status must be made periodically from enrollment.

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Secondary

Measure	Time frame
Secondary end point(s): - 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;Timepoint(s) of evaluation of this end point: Periodically from enrollment	—

Measure

Time frame

Secondary end point(s): - 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;Timepoint(s) of evaluation of this end point: Periodically from enrollment

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, France, Germany, Greece, Italy, Japan, Korea, Democratic People's Republic of, Netherlands, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Spain, Switzerland, Taiwan, United Kingdom, United States

Contacts

Public ContactEva de Hoijer

Fortrea Inc

ccmoggs@fortrea.com00310718080 400

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026