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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06496178




Registration number
NCT06496178
Ethics application status
Date submitted
3/07/2024
Date registered
11/07/2024
Date last updated
14/11/2024

Titles & IDs
Public title
A Phase 3 Study to Evaluate Petosemtamab Compared with Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients
Scientific title
A Phase 3 Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared with Investigator's Choice Monotherapy Treatment in Previously Treated Patients with Incurable, Metastatic/recurrent Head and Neck Squamous Cell Carcinoma
Secondary ID [1] 0 0
2023-510322-32
Secondary ID [2] 0 0
MCLA-158-CL02
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 - Investigator's Choice
Treatment: Drugs - Investigator's Choice
Treatment: Drugs - Investigator's Choice

Experimental: MCLA-158 -

Active comparator: Investigator's Choice -


Treatment: Drugs: Petosemtamab
MCLA-158

Treatment: Drugs: Investigator's Choice
Cetuximab

Treatment: Drugs: Investigator's Choice
Methotrexate

Treatment: Drugs: Investigator's Choice
Docetaxel
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review
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) as Assessed by Blinded Independent Central Review
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
Duration of Response (DOR) as Assessed by Blinded Independent Central Review
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
Objective Response Rate (ORR) as Assessed by Investigator Review
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
Progression Free Survival (PFS) as Assessed by Investigator Review
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [5] 0 0
Duration of Response (DOR) as Assessed by Investigator Review
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Time to Response (TTR) as Assessed by Blinded Independent Central Review
Timepoint [6] 0 0
Up to approximately 2 years
Secondary outcome [7] 0 0
Time to Response (TTR) as Assessed by Investigator Review
Timepoint [7] 0 0
Up to approximately 2 years
Secondary outcome [8] 0 0
Clinical Benefit Rate (CBR) as Assessed by Blinded Independent Central Review
Timepoint [8] 0 0
Up to approximately 2 years
Secondary outcome [9] 0 0
Clinical Benefit Rate (CBR) as Assessed by Investigator Review
Timepoint [9] 0 0
Up to approximately 2 years
Secondary outcome [10] 0 0
Number of participants Who experienced At Least One Treatment Emergent Adverse Event (TEAE)
Timepoint [10] 0 0
Up to 30 days post-last dose
Secondary outcome [11] 0 0
Number of participants Who experienced At Least One Serious TEAE
Timepoint [11] 0 0
Up to 30 days post-last dose
Secondary outcome [12] 0 0
Number of participants Who Discontinued Study Treatment Due to TEAEs
Timepoint [12] 0 0
Up to 30 days post-last dose
Secondary outcome [13] 0 0
Number of participants Who Had Dose Modification Due to TEAEs
Timepoint [13] 0 0
Up to 30 days post-last dose
Secondary outcome [14] 0 0
Mean Change From Baseline in EORTC QLQ-C30
Timepoint [14] 0 0
Up to approximately 2 years
Secondary outcome [15] 0 0
Mean Change From Baseline in EORTC QLQ-H&N43
Timepoint [15] 0 0
Up to approximately 2 years
Secondary outcome [16] 0 0
Concentrations Predose And at End of Infusion
Timepoint [16] 0 0
Up to first 6 cycles
Secondary outcome [17] 0 0
Pharmacokinetic parameters
Timepoint [17] 0 0
Up to first 6 cycles
Secondary outcome [18] 0 0
Incidence of anti-drug antibody (ADA)
Timepoint [18] 0 0
Up to 30 days post-last dose

Eligibility
Key inclusion criteria
* Signed ICF before initiation of any study procedures.
* Age = 18 years at signing of ICF.
* Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.
* HNSCC patients progressed on or after anti-PD-1 therapy and platinum-containing therapy.
* The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
* Documentation of p16 status (positive or negative) by local laboratory IHC for patients with primary oropharyngeal cancer.
* A baseline new tumor sample unless the patient has an available tumor sample as an FFPE block with sufficient material.
* Measurable disease as defined by RECIST v1.1 by radiologic methods.
* ECOG PS of 0 or 1
* Life expectancy = 12 weeks, as per investigator
* Adequate organ function (as per protocol)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry.
* Known leptomeningeal involvement
* Any systemic anticancer therapy within 4 weeks of the first dose of study treatment.
* Major surgery or radiotherapy within 3 weeks of the first dose of study treatment.
* Persistent Grade >1 clinically significant toxicities related to prior antineoplastic therapies
* History of hypersensitivity reaction to any of the excipients of treatment required for this study.
* 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
* History of prior malignancies with the exception of excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease
* Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy
* Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
* Patients with known infectious diseases (as per protocol)
* Pregnant or breastfeeding patients
* Patient has a primary tumor site of nasopharynx (any histology).

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
25/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2029
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Site 30 - Nedlands
Recruitment hospital [2] 0 0
Site 3 - Darlinghurst
Recruitment hospital [3] 0 0
Site 11 - Saint Leonards
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
2065 - Saint 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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
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
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Argentina
State/province [15] 0 0
Buenos Aires
Country [16] 0 0
Chile
State/province [16] 0 0
Providencia
Country [17] 0 0
Chile
State/province [17] 0 0
Recoleta
Country [18] 0 0
Chile
State/province [18] 0 0
Santiago
Country [19] 0 0
Israel
State/province [19] 0 0
Haifa
Country [20] 0 0
Israel
State/province [20] 0 0
Jerusalem
Country [21] 0 0
Israel
State/province [21] 0 0
Tel Aviv
Country [22] 0 0
Israel
State/province [22] 0 0
Tel HaShomer
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Jeollanam-do
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Goyang-si
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Seoul
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Soeul
Country [27] 0 0
Taiwan
State/province [27] 0 0
Kaohsiung
Country [28] 0 0
Taiwan
State/province [28] 0 0
Taipei City

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.
Trial website
https://clinicaltrials.gov/study/NCT06496178
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
David Yao, MD
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06496178