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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06525220




Registration number
NCT06525220
Ethics application status
Date submitted
24/07/2024
Date registered
29/07/2024

Titles & IDs
Public title
A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)
Scientific title
A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Recurrent or Metastatic PD-L1+ Head and Neck Squamous Cell Carcinoma
Secondary ID [1] 0 0
2023-510323-30-00
Secondary ID [2] 0 0
MCLA-158-CL03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma 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 - Petosemtamab
Treatment: Drugs - Pembrolizumab

Experimental: Petosemtamab + Pembrolizumab - Combination Therapy

Active comparator: Pembrolizumab - Monotherapy


Treatment: Drugs: Petosemtamab
MCLA-158

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

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 3 years
Primary outcome [2] 0 0
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review (BICR)
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Progression Free Survival (PFS) per RECIST v1.1 as assessed by BICR
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
Duration of Response (DOR) per RECIST v1.1 as assessed by BICR
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
Objective response rate per RECIST v1.1 as assessed by investigator review
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
Progression-free survival per RECIST v1.1 as assessed by investigator review
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [5] 0 0
Duration of response per RECIST v1.1 as assessed by investigator review
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Clinical benefit rate per RECIST v1.1 as assessed by BICR
Timepoint [6] 0 0
Up to approximately 2 years
Secondary outcome [7] 0 0
Clinical benefit rate per RECIST v1.1 as assessed by investigator review
Timepoint [7] 0 0
Up to approximately 2 years
Secondary outcome [8] 0 0
Number of participants who experienced at least one treatment emergent adverse event (TEAE)
Timepoint [8] 0 0
Up to 30 days post last dose
Secondary outcome [9] 0 0
Number of participants who experienced at least one serious TEAE
Timepoint [9] 0 0
Up to 30 days post last dose
Secondary outcome [10] 0 0
Number of participants who discontinued study treatment due to TEAEs
Timepoint [10] 0 0
Up to 30 days post last dose
Secondary outcome [11] 0 0
Number of participants who had dose modification due to TEAEs
Timepoint [11] 0 0
Up to 30 days post last dose
Secondary outcome [12] 0 0
To evaluate patient reported outcomes for health-related quality of life
Timepoint [12] 0 0
Up to approximately 2 years
Secondary outcome [13] 0 0
Pharmacokinetic parameters
Timepoint [13] 0 0
Up to first 6 cycles
Secondary outcome [14] 0 0
Incidence of anti-drug antibodies (ADAs)
Timepoint [14] 0 0
Up to 30 days post last dose

Eligibility
Key inclusion criteria
1. Signed ICF before initiation of any study procedures
2. Age = 18 years at signing of ICF
3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent.
4. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
5. HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS =1.
6. HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting
7. A new tumor biopsy, unless the patient has an available archival tumor sample with sufficient material
8. Measurable disease per Investigator assessment as defined by RECIST v1.1 by radiologic methods
9. ECOG Performance Status (PS) of 0-1
10. Life expectancy = 12 weeks, as per investigator assessment.
11. Left ventricular ejection fraction (LVEF) =50% or = institutional normal limit, whichever is higher, by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
12. Adequate organ function as defined per protocol.
13. HIV-positive patients are eligible only if the cluster of differentiation 4 (CD4+) count is = 300/µl, viral load is undetectable, and the patient is currently receiving highly active antiretroviral therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Central nervous system metastases that are untreated or already treated but symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 21 days prior to randomization
2. Known leptomeningeal involvement
3. Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization
4. Requirement for immunosuppressive medication
5. Major surgery or radiotherapy within 3 weeks of randomization
6. Clinically significant toxicities related to prior anticancer therapies that have not returned to = Grade 1 or baseline except for Grade =2- myalgia, neuropathy, alopecia, and any prior therapy related endocrinopathies
7. History of hypersensitivity reaction to any of the excipients of petosemtomab or pembrolizumab.
8. Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment; or history of myocardial infarction within 6 months prior to randomization
9. History of prior malignancies within the last 5 years, with the exception of excised local cancer
10. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy
11. Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
12. Patients with known infectious diseases as per protocol.
13. Pregnant or breastfeeding patients.
14. The patient has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy of prednisone >10 mg/day or equivalent, or any other form of immunosuppressive therapy
15. The patient has an active autoimmune disease that has required systemic immune suppressive treatment in the past 2 years; replacement therapy is not considered immune suppressive treatment
16. The patient has had an allogeneic tissue/solid organ transplant.
17. Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any histology)

Other protocol defined inclusion/exclusion criteria may apply.

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
Open (masking not used)
Who is / are masked / blinded?



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
25/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2030
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Site 11 - Blacktown
Recruitment hospital [2] 0 0
Site 24 - St Leonards
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Delaware
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New Mexico
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
Argentina
State/province [13] 0 0
Caba
Country [14] 0 0
Argentina
State/province [14] 0 0
Córdoba
Country [15] 0 0
Argentina
State/province [15] 0 0
La Rioja
Country [16] 0 0
Argentina
State/province [16] 0 0
Rosario
Country [17] 0 0
Argentina
State/province [17] 0 0
Viedma
Country [18] 0 0
Belgium
State/province [18] 0 0
Brussels
Country [19] 0 0
Belgium
State/province [19] 0 0
Edegem
Country [20] 0 0
Belgium
State/province [20] 0 0
Gent
Country [21] 0 0
Belgium
State/province [21] 0 0
Leuven
Country [22] 0 0
Belgium
State/province [22] 0 0
Namur
Country [23] 0 0
Canada
State/province [23] 0 0
Toronto
Country [24] 0 0
Chile
State/province [24] 0 0
Antofagasta
Country [25] 0 0
Chile
State/province [25] 0 0
Providencia
Country [26] 0 0
Chile
State/province [26] 0 0
Recoleta
Country [27] 0 0
Chile
State/province [27] 0 0
Santiago
Country [28] 0 0
Chile
State/province [28] 0 0
Temuco
Country [29] 0 0
France
State/province [29] 0 0
Bordeaux
Country [30] 0 0
France
State/province [30] 0 0
Le Mans
Country [31] 0 0
France
State/province [31] 0 0
Lille
Country [32] 0 0
France
State/province [32] 0 0
Lyon
Country [33] 0 0
France
State/province [33] 0 0
Marseille
Country [34] 0 0
France
State/province [34] 0 0
Montpellier
Country [35] 0 0
France
State/province [35] 0 0
Nice
Country [36] 0 0
France
State/province [36] 0 0
Paris
Country [37] 0 0
France
State/province [37] 0 0
Poitiers
Country [38] 0 0
France
State/province [38] 0 0
Rouen
Country [39] 0 0
France
State/province [39] 0 0
Toulouse
Country [40] 0 0
France
State/province [40] 0 0
Vandœuvre-lès-Nancy
Country [41] 0 0
Germany
State/province [41] 0 0
Dresden
Country [42] 0 0
Germany
State/province [42] 0 0
Greifswald
Country [43] 0 0
Germany
State/province [43] 0 0
Hamburg
Country [44] 0 0
Germany
State/province [44] 0 0
Hannover
Country [45] 0 0
Germany
State/province [45] 0 0
Tübingen
Country [46] 0 0
Greece
State/province [46] 0 0
Chaïdári
Country [47] 0 0
Greece
State/province [47] 0 0
Panórama
Country [48] 0 0
Israel
State/province [48] 0 0
Haifa
Country [49] 0 0
Israel
State/province [49] 0 0
Jerusalem
Country [50] 0 0
Israel
State/province [50] 0 0
Ramat Gan
Country [51] 0 0
Israel
State/province [51] 0 0
Tel Aviv
Country [52] 0 0
Italy
State/province [52] 0 0
Ancona
Country [53] 0 0
Italy
State/province [53] 0 0
Brescia
Country [54] 0 0
Italy
State/province [54] 0 0
Milan
Country [55] 0 0
Italy
State/province [55] 0 0
Naples
Country [56] 0 0
Italy
State/province [56] 0 0
Rozzano
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Goyang-si
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Gyeonggi-do
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Hwasun
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Seoul
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Suwon-si
Country [62] 0 0
Netherlands
State/province [62] 0 0
Amsterdam
Country [63] 0 0
Netherlands
State/province [63] 0 0
Nijmegen
Country [64] 0 0
Netherlands
State/province [64] 0 0
Utrecht
Country [65] 0 0
Spain
State/province [65] 0 0
Barcelona
Country [66] 0 0
Spain
State/province [66] 0 0
Madrid
Country [67] 0 0
Spain
State/province [67] 0 0
Marbella
Country [68] 0 0
Spain
State/province [68] 0 0
Pamplona
Country [69] 0 0
Spain
State/province [69] 0 0
Valencia
Country [70] 0 0
Taiwan
State/province [70] 0 0
Changhua
Country [71] 0 0
Taiwan
State/province [71] 0 0
Kaohsiung
Country [72] 0 0
Taiwan
State/province [72] 0 0
Taichung
Country [73] 0 0
Taiwan
State/province [73] 0 0
Taipei City
Country [74] 0 0
Taiwan
State/province [74] 0 0
Taoyuan City
Country [75] 0 0
Thailand
State/province [75] 0 0
Bangkok
Country [76] 0 0
Thailand
State/province [76] 0 0
Songkhla
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Cambridge
Country [78] 0 0
United Kingdom
State/province [78] 0 0
London
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Northwood
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merus N.V.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Head of Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
+1 617 401 4499
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06525220