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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04590963
Registration number
NCT04590963
Ethics application status
Date submitted
23/09/2020
Date registered
19/10/2020
Date last updated
4/06/2024
Titles & IDs
Public title
Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer
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Scientific 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
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Secondary ID [1]
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0
2019-004770-25
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Secondary ID [2]
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D7310C00001
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Universal Trial Number (UTN)
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Trial acronym
INTERLINK-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of the Head and Neck
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0
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Condition category
Condition code
Cancer
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0
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Non melanoma skin cancer
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Cancer
0
0
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0
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Kidney
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Cancer
0
0
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0
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Head and neck
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Monalizumab
Treatment: Drugs - Cetuximab
Other interventions - Placebo
Experimental: Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 - Participants will receive intravenous (IV) monalizumab 750 mg every two weeks (Q2W) and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 every one week (Q1W) until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Active Comparator: Placebo Q2W + Cetuximab 400 mg/m^2 - Participants will receieve IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Treatment: Drugs: Monalizumab
Participants will receive IV infusion of monalizumab as stated in arm description.
Treatment: Drugs: Cetuximab
Participants will receive IV infusion of cetuximab as stated in arm description.
Other interventions: Placebo
Participants will receive IV infusion of placebo as stated in arm description.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS) in Human Papillomavirus (HPV)-Unrelated Analysis Set
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Assessment method [1]
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The OS is defined as time from the date of randomization until death due to any cause regardless of whether the participant withdraws from randomized therapy or receives another anti-cancer therapy (i.e. date of death or censoring - date of randomization + 1). The OS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from a stratified log-rank test and hazard ratio (HR) and confidence intervals (CIs) from a stratified Cox proportional hazards model. Analyses were stratified on World Health Organization/ Eastern Cooperative Oncology Group performance status (WHO/ECOG PS) (0 or 1) and number of prior lines of therapy in recurrent or metastatic (R/M) setting (1 or 2).
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Timepoint [1]
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Baseline (-28 to -1) through 17.5 months (maximum observed duration)
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Secondary outcome [1]
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Overall Survival in Full Analysis Set (FAS)
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Assessment method [1]
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The OS is defined as time from the date of randomization until death due to any cause regardless of whether the participant withdraws from randomized therapy or receives another anti-cancer therapy (i.e. date of death or censoring - date of randomization + 1). The OS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from a stratified log-rank test and HR and CIs from a stratified Cox proportional hazards model. Analyses were stratified on HPV status (OPC HPV positive or HPV-unrelated), WHO/ECOG PS (0 or 1) and number of prior lines of therapy in R/M setting (1 or 2).
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Timepoint [1]
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Baseline (-28 to -1) through 17.5 months (maximum observed duration)
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Secondary outcome [2]
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Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment in HPV-unrelated Analysis Set
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Assessment method [2]
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PFS per RECIST 1.1 as assessed by the investigator is defined as time from randomization until date of RECIST 1.1-defined radiological progressive disease (PD) or death regardless of whether participant withdraws from therapy or received subsequent anticancer therapy prior to progression. PD: at least 20% increase in sum of diameters of target lesions (TLs), taking as reference the smallest sum on study (nadir) and sum must demonstrate an absolute increase of at least 5 mm from nadir or unequivocal progression of existing non-TLs (NTLs) or appearance of new lesions. PFS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from stratified log-rank test and HR and CIs from a stratified Cox proportional hazards model. Analyses were stratified on WHO/ECOG PS (0/1) and no. of prior lines of therapy in R/M setting.
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Timepoint [2]
0
0
Baseline (-28 to -1) through 17.5 months (maximum observed duration)
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Secondary outcome [3]
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Progression-Free Survival Per RECIST 1.1 by Investigator Assessment in FAS
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Assessment method [3]
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PFS per RECIST 1.1 as assessed by the investigator is defined as time from randomization until date of RECIST 1.1-defined radiological progressive disease (PD) or death regardless of whether participant withdraws from therapy or received subsequent anticancer therapy prior to progression. PD: at least 20% increase in sum of diameters of target lesions (TLs), taking as reference the smallest sum on study (nadir) and sum must demonstrate an absolute increase of at least 5 mm from nadir or unequivocal progression of existing NTLs or appearance of new lesions. PFS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from a stratified log-rank test and HR and CIs from a stratified Cox proportional hazards model. Analyses were stratified on HPV status, WHO/ECOG PS (0/1) and no. of prior lines of therapy in R/M setting.
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Timepoint [3]
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0
Baseline (-28 to -1) through 17.5 months (maximum observed duration)
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Secondary outcome [4]
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Percentage of Participants With Objective Response (OR) Per RECIST 1.1 in HPV-unrelated Analysis Set
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Assessment method [4]
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The OR is defined as the percentage of participants with at least one confirmed investigator-assessed response of complete response (CR) or partial response (PR) as assessed by RECIST 1.1 guidelines. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters (SoD) of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported. Participants who had measurable disease at baseline per the site investigator were analyzed for this outcome.
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Timepoint [4]
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0
Baseline (-28 to -1) through 17.5 months (maximum observed duration)
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Secondary outcome [5]
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Percentage of Participants With OR Per RECIST 1.1 in FAS
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Assessment method [5]
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The OR is defined as the percentage of participants with at least one confirmed investigator-assessed response of CR or PR as assessed by RECIST 1.1 guidelines. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported. Participants who had measurable disease at baseline per the site investigator were analyzed for this outcome.
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Timepoint [5]
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0
Baseline (-28 to -1) through 17.5 months (maximum observed duration)
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Secondary outcome [6]
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Duration of Response (DoR) Per RECIST 1.1 in HPV-unrelated Analysis Set
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Assessment method [6]
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The DoR is defined as the time from the date of first documented confirmed response until date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as at least a 30% decrease in the SoDs of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest previous SoDs (nadir) and the sum must demonstrate an absolute increase of at least 5 mm from nadir or unequivocal progression of existing NTLs or appearance of new lesions. The DoR was analyzed using Kaplan-Meier technique.
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Timepoint [6]
0
0
Baseline (-28 to -1) through 17.5 months (maximum observed duration)
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Secondary outcome [7]
0
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Duration of Response Per RECIST 1.1 in FAS
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Assessment method [7]
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The DoR is defined as the time from the date of first documented confirmed response until date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as at least a 30% decrease in the SoDs of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest previous SoDs (nadir) and the sum must demonstrate an absolute increase of at least 5 mm from nadir or unequivocal progression of existing NTLs or appearance of new lesions. The DoR was analyzed using Kaplan-Meier technique.
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Timepoint [7]
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Baseline (-28 to -1) through 17.5 months (maximum observed duration)
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Secondary outcome [8]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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Assessment method [8]
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An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first.
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Timepoint [8]
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Day 1 through 21.4 months (maximum observed duration)
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Secondary outcome [9]
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Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
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Assessment method [9]
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Participants with abnormal laboratory parameters reported as TEAEs are reported. Laboratory analysis included hematology and clinical chemistry. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first.
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Timepoint [9]
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Day 1 through 21.4 months (maximum observed duration)
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Secondary outcome [10]
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Number of Participants With Abnormal Vital Signs Reported as TEAEs
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Assessment method [10]
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Participants with abnormal vital signs (heart rate, blood pressure, temperature, and respiratory rate) reported as TEAEs are reported. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first.
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Timepoint [10]
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Day 1 through 21.4 months (maximum observed duration)
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Secondary outcome [11]
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Number of Participants With Electrocardiograms (ECGs) Reported as TEAEs
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Assessment method [11]
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Participants with Abnormal ECGs reported as TEAEs are reported. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first.
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Timepoint [11]
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Day 1 through 21.4 months (maximum observed duration)
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Eligibility
Key inclusion criteria
- Are aged 18 years and over
- Recurrent or metastatic squamous cell carcinoma of the 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 programmed cell death ligand-1 (PD-L1) 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
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/10/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/06/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
370
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Camperdown
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Recruitment hospital [2]
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Research Site - Elizabeth Vale
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Recruitment hospital [3]
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Research Site - Heidelberg
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Recruitment hospital [4]
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Research Site - Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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Arizona
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United States of America
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State/province [2]
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Illinois
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United States of America
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Kansas
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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Missouri
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Nevada
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New York
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North Carolina
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Ohio
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Pennsylvania
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Texas
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Argentina
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Caba
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Austria
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Linz
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Belgium
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Bruxelles
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Belgium
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Leuven
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Belgium
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Namur
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Belgium
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Roeselare
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Belo Horizonte
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Sao Paulo
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Bulgaria
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Panagyurishte
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Bulgaria
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Plovdiv
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Avignon
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Bordeaux
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Clermont Ferrand cedex 01
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Dijon
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Lyon Cedex 08
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Essen
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Ulm
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Yokohama-shi
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Busan
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Poland
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State/province [77]
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0
Bialystok
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Country [78]
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0
Poland
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State/province [78]
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0
Bydgoszcz
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Country [79]
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Poland
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State/province [79]
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0
Poznan
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Country [80]
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0
Portugal
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State/province [80]
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Coimbra
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Country [81]
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Portugal
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State/province [81]
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Porto
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Country [82]
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Portugal
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State/province [82]
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Vila Nova de Gaia
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Country [83]
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Russian Federation
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State/province [83]
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Moscow region
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Country [84]
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Russian Federation
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State/province [84]
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Moscow
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Country [85]
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Russian Federation
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State/province [85]
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Obninsk
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Country [86]
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Russian Federation
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State/province [86]
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0
Saint Petersburg
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Country [87]
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Russian Federation
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State/province [87]
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Saint-Petersburg
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Country [88]
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Russian Federation
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State/province [88]
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St.Petersburg
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Country [89]
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Spain
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Barcelona
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Country [90]
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Spain
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State/province [90]
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Madrid
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Country [91]
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Spain
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State/province [91]
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Valencia
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Country [92]
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Switzerland
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State/province [92]
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Basel
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Country [93]
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Switzerland
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State/province [93]
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Bern
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Country [94]
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Switzerland
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State/province [94]
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Lausanne
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Country [95]
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Taiwan
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State/province [95]
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Changhua
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Country [96]
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Taiwan
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State/province [96]
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Taichung
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Country [97]
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Taiwan
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State/province [97]
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Tainan City
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Country [98]
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Taiwan
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State/province [98]
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Taipei
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Country [99]
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United Kingdom
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State/province [99]
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London
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Country [100]
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United Kingdom
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State/province [100]
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Manchester
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Country [101]
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United Kingdom
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State/province [101]
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0
Newcastle upon Tyne
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Country [102]
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United Kingdom
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State/province [102]
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Other collaborator category [1]
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0
Commercial sector/Industry
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Innate Pharma
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Ethics approval
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Summary
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 Participants
with recurrent or metastatic head and neck cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04590963
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Roger B Cohen, MD
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Address
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Abramson Cancer Center, Perelman Center for Advanced Medicine
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04590963
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