Back to resultsAssessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer (INTERLINK-1)
Primary Purpose
Squamous Cell Carcinoma of the Head and Neck
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Monalizumab
Cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck focused on measuring head and neck cancer, Squamous Cell Carcinoma of the Head and Neck, monalizumab, cetuximab, Erbitux, oral cavity, larynx, pharynx, natural killer, oropharynx, hypopharynx
Eligibility Criteria
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
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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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A (monalizumab and cetuximab)
Arm B (placebo and cetuximab)
Arm Description
monalizumab in combination with cetuximab
placebo in combination with cetuximab
Outcomes
Primary Outcome Measures
Overall Survival (OS)
Overall survival, defined as the time from the date of randomization until date of death due to any cause, in HPV-unrelated participants.
Secondary Outcome Measures
Overall Survival (OS)
Overall survival, defined as the time from the date of randomization until date of death due to any cause, in all randomized participants
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.
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.
Immunogenicity of monalizumab
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
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)
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)
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)
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
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
Measurement of the monalizumab concentration in blood.
Full Information
NCT ID
NCT04590963
First Posted
September 23, 2020
Last Updated
August 1, 2023
Sponsor
AstraZeneca
Collaborators
Innate Pharma
1. Study Identification
Unique Protocol Identification Number
NCT04590963
Brief Title
Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer
Acronym
INTERLINK-1
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
May 11, 2022 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Innate Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who had prior immune checkpoint inhibitor and platinum-based chemotherapy treatment will be randomized in a 2:1 ratio to monalizumab and cetuximab or placebo and cetuximab. Efficacy and safety assessments will be performed periodically from the time of enrollment and throughout the study. Patients in all arms will continue therapy until progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. All patients will be followed for survival after progression is confirmed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck
Keywords
head and neck cancer, Squamous Cell Carcinoma of the Head and Neck, monalizumab, cetuximab, Erbitux, oral cavity, larynx, pharynx, natural killer, oropharynx, hypopharynx
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel study. Patients will be randomized in a 2:1 ratio to monalizumab and cetuximab or placebo and cetuximab.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blinded study
Allocation
Randomized
Enrollment
370 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A (monalizumab and cetuximab)
Arm Type
Experimental
Arm Description
monalizumab in combination with cetuximab
Arm Title
Arm B (placebo and cetuximab)
Arm Type
Active Comparator
Arm Description
placebo in combination with cetuximab
Intervention Type
Drug
Intervention Name(s)
Monalizumab
Intervention Description
Monalizumab (intravenous)
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
Cetuximab (intravenous)
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival, defined as the time from the date of randomization until date of death due to any cause, in HPV-unrelated participants.
Time Frame
Approximately 3 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival, defined as the time from the date of randomization until date of death due to any cause, in all randomized participants
Time Frame
Approximately 3 years
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Approximately 3 years
Title
Disease-related symptoms, functioning and quality of life measured by EORTC QLQ-C30 questionnaire
Description
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.
Time Frame
Approximately 3 years
Title
Immunogenicity of monalizumab
Description
Presence of ADAs for monalizumab (confirmatory results: positive or negative, titers).
Time Frame
Approximately 3 years
Title
Association of NK cell-related protein markers with efficacy endpoints including OS, PFS, and ORR
Description
The level of protein expression related to Natural Killer cell-mediated immune response will be evaluated in relation to OS, PFS, and ORR outcomes.
Time Frame
Approximately 3 years
Title
Assessment of Adverse Events (AE)
Description
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.
Time Frame
Approximately 3 years
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
Approximately 3 years
Title
Duration of Response (DoR)
Description
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.
Time Frame
Approximately 3 years
Title
Disease-related symptoms, functioning and quality of life measured by EORTC QLQ-H&N35 questionnaire
Description
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.
Time Frame
Approximately 3 years
Title
Pharmacokinetics (PK) analysis of monalizumab
Description
Measurement of the monalizumab concentration in blood.
Time Frame
Approximately 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger B Cohen, MD
Organizational Affiliation
Abramson Cancer Center, Perelman Center for Advanced Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jérôme Fayette, MD
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dario Ruscica, MD
Organizational Affiliation
AstraZeneca, Cambridge, UK
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Research Site
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Research Site
City
Caba
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Research Site
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Research Site
City
Elizabeth Vale
ZIP/Postal Code
5112
Country
Australia
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Facility Name
Research Site
City
Melbourne
ZIP/Postal Code
3000
Country
Australia
Facility Name
Research Site
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Research Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Research Site
City
Belo Horizonte
ZIP/Postal Code
30110-022
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90560-030
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
22271-110
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01327-001
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
04543-000
Country
Brazil
Facility Name
Research Site
City
Panagyurishte
ZIP/Postal Code
4500
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Research Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Research Site
City
Avignon
ZIP/Postal Code
84918
Country
France
Facility Name
Research Site
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Research Site
City
Clermont Ferrand cedex 01
ZIP/Postal Code
63011
Country
France
Facility Name
Research Site
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Research Site
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Research Site
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Research Site
City
Montpellier Cedex 05
ZIP/Postal Code
34298
Country
France
Facility Name
Research Site
City
Strasbourg
ZIP/Postal Code
67033
Country
France
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Research Site
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Research Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Research Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Research Site
City
Würzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Research Site
City
Chaidari
ZIP/Postal Code
124 62
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Facility Name
Research Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Research Site
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Research Site
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Research Site
City
Hiroshima-shi
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Research Site
City
Isehara-shi
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Research Site
City
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Research Site
City
Kobe-shi
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Research Site
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Research Site
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Research Site
City
Osakasayama
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Research Site
City
Sunto-gun
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Research Site
City
Busan
ZIP/Postal Code
49267
Country
Korea, Republic of
Facility Name
Research Site
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Research Site
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Research Site
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Research Site
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Research Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Research Site
City
Pasig City
ZIP/Postal Code
1605
Country
Philippines
Facility Name
Research Site
City
Quezon City
ZIP/Postal Code
1112
Country
Philippines
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
Research Site
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Research Site
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Research Site
City
Moscow region
ZIP/Postal Code
143081
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Site
City
St.Petersburg
ZIP/Postal Code
191014
Country
Russian Federation
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Research Site
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Research Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Research Site
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Research Site
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Tainan City
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
235
Country
Taiwan
Facility Name
Research Site
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Research Site
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Research Site
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of the timelines, please refer to the disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
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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