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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04590963




Registration number
NCT04590963
Ethics application status
Date submitted
23/09/2020
Date registered
19/10/2020
Date last updated
19/04/2021

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
Scientific 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
Secondary ID [1] 0 0
D7310C00001
Universal Trial Number (UTN)
Trial acronym
INTERLINK-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of the Head and Neck 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Monalizumab
Treatment: Drugs - Cetuximab

Experimental: Arm A (monalizumab and cetuximab) - monalizumab in combination with cetuximab

Active Comparator: Arm B (placebo and cetuximab) - placebo in combination with cetuximab


Treatment: Drugs: Monalizumab
Monalizumab (intravenous)

Treatment: Drugs: Cetuximab
Cetuximab (intravenous)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - Overall survival, defined as the time from the date of randomization until date of death due to any cause.
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [1] 0 0
Progression Free Survival (PFS) - 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.
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [2] 0 0
Disease-related symptoms, functioning and quality of life measured by EORTC QLQ-C30 questionnaire - 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.
Timepoint [2] 0 0
Approximately 3 years
Secondary outcome [3] 0 0
Immunogenicity of monalizumab - Presence of ADAs for monalizumab (confirmatory results: positive or negative, titers).
Timepoint [3] 0 0
Approximately 3 years
Secondary outcome [4] 0 0
Association of NK cell-related protein markers with efficacy endpoints including OS, PFS, and ORR - The level of protein expression related to Natural Killer cell-mediated immune response will be evaluated in relation to OS, PFS, and ORR outcomes.
Timepoint [4] 0 0
Approximately 3 years
Secondary outcome [5] 0 0
Assessment of Adverse Events (AE) - 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.
Timepoint [5] 0 0
Approximately 3 years
Secondary outcome [6] 0 0
Objective Response Rate (ORR) - 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.
Timepoint [6] 0 0
Approximately 3 years
Secondary outcome [7] 0 0
Duration of Response (DoR) - 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.
Timepoint [7] 0 0
Approximately 3 years
Secondary outcome [8] 0 0
Disease-related symptoms, functioning and quality of life measured by EORTC QLQ-H&N35 questionnaire - 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.
Timepoint [8] 0 0
Approximately 3 years
Secondary outcome [9] 0 0
Pharmacokinetics (PK) analysis of monalizumab - Measurement of the monalizumab concentration in blood.
Timepoint [9] 0 0
Approximately 3 years

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
130 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Elizabeth Vale
Recruitment hospital [3] 0 0
Research Site - Heidelberg
Recruitment hospital [4] 0 0
Research Site - Melbourne
Recruitment hospital [5] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Illinois
Country [7] 0 0
United States of America
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Kansas
Country [8] 0 0
United States of America
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Kentucky
Country [9] 0 0
United States of America
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Louisiana
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Maryland
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Massachusetts
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Michigan
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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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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Caba
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Argentina
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Cordoba
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Austria
State/province [24] 0 0
Graz
Country [25] 0 0
Austria
State/province [25] 0 0
Linz
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Belgium
State/province [26] 0 0
Brussels
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Belgium
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Bruxelles
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Belgium
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Edegem
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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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Brazil
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Belo Horizonte
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Brazil
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Curitiba
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Porto Alegre
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Rio de Janeiro
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Salvador
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Sao Paulo
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Brazil
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São José do Rio Preto
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Bulgaria
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Panagyurishte
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Montreal
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France
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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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Marseille
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Montpellier Cedex 05
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Nice
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Poitiers
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France
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Saint Herblain
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Strasbourg
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France
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Toulouse Cedex 9
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France
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Villejuif Cedex
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Germany
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Berlin
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Germany
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Essen
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Germany
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Freiburg
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Germany
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Hannover
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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Ulm
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Germany
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Würzburg
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Greece
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Athens
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Greece
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Chaidari
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Greece
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Heraklion
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Greece
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Kaliftaki, N.Kifissia, Athens
Country [71] 0 0
Greece
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Thessaloniki
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Italy
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Brescia
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Italy
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Candiolo
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Italy
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Firenze
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Italy
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Milano
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Italy
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Modena
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Italy
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Napoli
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Italy
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Padova
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Japan
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Chuo-ku
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Japan
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Fukuoka-shi
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Japan
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Hiroshima-shi
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Japan
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Isehara-shi
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Japan
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Kashiwa
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Japan
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Kobe-shi
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Japan
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Koto-ku
Country [86] 0 0
Japan
State/province [86] 0 0
Okayama
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Japan
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Osakasayama
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Japan
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Sunto-gun
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Japan
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Yokohama-shi
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Korea, Republic of
State/province [90] 0 0
Busan
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Korea, Republic of
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Cheongju-si
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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Amsterdam
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Netherlands
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Leiden
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Netherlands
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Maastricht
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Netherlands
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Nijmegen
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Peru
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Lima
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Philippines
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Cebu City
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Philippines
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Makati
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Philippines
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Manila
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Pasig City
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Philippines
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Quezon City
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Poland
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Bialystok
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Bydgoszcz
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Poznan
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Warszawa
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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Vila Nova de Gaia
Country [114] 0 0
Romania
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Constanta
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Romania
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Suceava
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Russian Federation
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Moscow region
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Russian Federation
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Moscow
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Russian Federation
State/province [118] 0 0
Obninsk
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Russian Federation
State/province [119] 0 0
Saint-Petersburg
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Russian Federation
State/province [120] 0 0
St.Petersburg
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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Spain
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Zaragoza
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Lausanne
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Taiwan
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Changhua
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Taiwan
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Taichung
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Taiwan
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Tainan City
Country [131] 0 0
Taiwan
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Taipei
Country [132] 0 0
United Kingdom
State/province [132] 0 0
London
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United Kingdom
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Manchester
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United Kingdom
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Newcastle upon Tyne
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Innate Pharma
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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 patients with
recurrent or metastatic head and neck cancer.
Trial website
https://clinicaltrials.gov/show/NCT04590963
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Roger B Cohen, MD
Address 0 0
Abramson Cancer Center, Perelman Center for Advanced Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04590963