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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
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
Objective Response Rate (ORR) per RECIST v1.1 as assessed by BICR
Timepoint [1] 0 0
Up to approximately 2 years
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 3 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
Incidence and Severity of AEs and SAEs
Timepoint [3] 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 baseline new tumor sample unless the patient has an available tumor sample as an FFPE block with sufficient material.
8. Measurable disease 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.
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 of study entry.
2. Known leptomeningeal involvement
3. Any systemic anticancer therapy within 4 weeks of the first dose of study treatment
4. Major surgery or radiotherapy within 3 weeks of the first dose of study treatment
5. Persistent Grade >1 clinically significant toxicities related to prior cancer therapies (except for alopecia); stable sensory neuropathy Grade =2 National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 is allowed.
6. History of hypersensitivity reaction to any of the excipients of petosemtomab or pembrolizumab.
7. 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 of study entry
8. History of prior malignancies, with the exception of excised local cancer, or treated cancer deemed at low risk for recurrence with no evidence of disease for =3 years
9. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy
10. Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
11. Patients with known infectious diseases as per protocol.
12. Pregnant or breastfeeding patients.
13. The patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the first dose
14. 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.
15. 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 postcode(s) [1] 0 0
2148 - Blacktown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
New Mexico
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Utah
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Israel
State/province [7] 0 0
Haifa
Country [8] 0 0
Israel
State/province [8] 0 0
Jerusalem
Country [9] 0 0
Israel
State/province [9] 0 0
Ramat Gan
Country [10] 0 0
Israel
State/province [10] 0 0
Tel Aviv
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Gyeonggi-do
Country [12] 0 0
Taiwan
State/province [12] 0 0
Kaohsiung City

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
USenquiries@merus.nl
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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