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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04590963
Ethics application status
Date submitted
23/09/2020
Date registered
19/10/2020

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 Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor
Secondary ID [1] 0 0
2019-004770-25
Secondary ID [2] 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
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) in Human Papillomavirus (HPV)-Unrelated Analysis Set
Timepoint [1] 0 0
Baseline (-28 to -1) through 17.5 months (maximum observed duration)
Secondary outcome [1] 0 0
Overall Survival in Full Analysis Set (FAS)
Timepoint [1] 0 0
Baseline (-28 to -1) through 17.5 months (maximum observed duration)
Secondary outcome [2] 0 0
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment in HPV-unrelated Analysis Set
Timepoint [2] 0 0
Baseline (-28 to -1) through 17.5 months (maximum observed duration)
Secondary outcome [3] 0 0
Progression-Free Survival Per RECIST 1.1 by Investigator Assessment in FAS
Timepoint [3] 0 0
Baseline (-28 to -1) through 17.5 months (maximum observed duration)
Secondary outcome [4] 0 0
Percentage of Participants With Objective Response (OR) Per RECIST 1.1 in HPV-unrelated Analysis Set
Timepoint [4] 0 0
Baseline (-28 to -1) through 17.5 months (maximum observed duration)
Secondary outcome [5] 0 0
Percentage of Participants With OR Per RECIST 1.1 in FAS
Timepoint [5] 0 0
Baseline (-28 to -1) through 17.5 months (maximum observed duration)
Secondary outcome [6] 0 0
Duration of Response (DoR) Per RECIST 1.1 in HPV-unrelated Analysis Set
Timepoint [6] 0 0
Baseline (-28 to -1) through 17.5 months (maximum observed duration)
Secondary outcome [7] 0 0
Duration of Response Per RECIST 1.1 in FAS
Timepoint [7] 0 0
Baseline (-28 to -1) through 17.5 months (maximum observed duration)
Secondary outcome [8] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [8] 0 0
Day 1 through 21.4 months (maximum observed duration)
Secondary outcome [9] 0 0
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Timepoint [9] 0 0
Day 1 through 21.4 months (maximum observed duration)
Secondary outcome [10] 0 0
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Timepoint [10] 0 0
Day 1 through 21.4 months (maximum observed duration)
Secondary outcome [11] 0 0
Number of Participants With Electrocardiograms (ECGs) Reported as TEAEs
Timepoint [11] 0 0
Day 1 through 21.4 months (maximum observed duration)

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
Minimum age
18 Years
Maximum age
130 Years
Sex
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
Accrual to date
Final
370
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 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 outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
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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United States of America
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Missouri
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United States of America
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Nevada
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Texas
Country [14] 0 0
Argentina
State/province [14] 0 0
Caba
Country [15] 0 0
Austria
State/province [15] 0 0
Linz
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Belgium
State/province [16] 0 0
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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Brazil
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Belo Horizonte
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Brazil
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Porto Alegre
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Brazil
State/province [22] 0 0
Rio de Janeiro
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Brazil
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Sao Paulo
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Bulgaria
State/province [24] 0 0
Panagyurishte
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Bulgaria
State/province [25] 0 0
Plovdiv
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Bulgaria
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Sofia
Country [27] 0 0
Canada
State/province [27] 0 0
British Columbia
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Canada
State/province [28] 0 0
Ontario
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Canada
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Quebec
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France
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Avignon
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France
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Bordeaux
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France
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Clermont Ferrand cedex 01
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France
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Dijon
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France
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Lyon Cedex 08
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France
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Marseille
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France
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Montpellier Cedex 05
Country [37] 0 0
France
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Strasbourg
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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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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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Thessaloniki
Country [48] 0 0
Italy
State/province [48] 0 0
Brescia
Country [49] 0 0
Italy
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Candiolo
Country [50] 0 0
Italy
State/province [50] 0 0
Firenze
Country [51] 0 0
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
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Japan
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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
Country [66] 0 0
Korea, Republic of
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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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Seongnam-si
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Korea, Republic of
State/province [70] 0 0
Seoul
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Netherlands
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Amsterdam
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Netherlands
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Maastricht
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Netherlands
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Nijmegen
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Philippines
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Manila
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Philippines
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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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Poland
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Bydgoszcz
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Poland
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Poznan
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Portugal
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Coimbra
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Portugal
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Porto
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Portugal
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Vila Nova de Gaia
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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
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Obninsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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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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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 [98] 0 0
Taiwan
State/province [98] 0 0
Taipei
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United Kingdom
State/province [99] 0 0
London
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United Kingdom
State/province [100] 0 0
Manchester
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United Kingdom
State/province [101] 0 0
Newcastle upon Tyne
Country [102] 0 0
United Kingdom
State/province [102] 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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04590963