Recruiting NCT06496178

A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2)

Phase III Interventional Head and Neck Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Petosemtamab, Investigator's Choice, Investigator's Choice, Investigator's Choice.
Who it may be relevant to: Registry conditions: Head and Neck Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Belgium, Brazil +19
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

Detailed description

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. HNSCC patients must have progressive disease (PD) on or after anti-PD-1 therapy and platinum-containing therapy. Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease, should have PD within 6 months of the last dose of platinum-containing therapy.

Interventions

Drug Petosemtamab
MCLA-158
Drug Investigator's Choice
Cetuximab
Drug Investigator's Choice
Methotrexate
Drug Investigator's Choice
Docetaxel

Primary outcome measures

Overall Survival (OS) [Time frame: Up to approximately 3 years]

Secondary outcome measures (12)

Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review [Time frame: Up to approximately 2 years]
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review [Time frame: Up to approximately 2 years]
Duration of Response (DOR) as Assessed by Blinded Independent Central Review [Time frame: Up to approximately 2 years]
Objective Response Rate (ORR) as Assessed by Investigator Review [Time frame: Up to approximately 2 years]
Progression Free Survival (PFS) as Assessed by Investigator Review [Time frame: Up to approximately 2 years]
Duration of Response (DOR) as Assessed by Investigator Review [Time frame: Up to approximately 2 years]
Time to Response (TTR) as Assessed by Blinded Independent Central Review [Time frame: Up to approximately 2 years]
Time to Response (TTR) as Assessed by Investigator Review [Time frame: Up to approximately 2 years]
Clinical Benefit Rate (CBR) as Assessed by Blinded Independent Central Review [Time frame: Up to approximately 2 years]
Clinical Benefit Rate (CBR) as Assessed by Investigator Review [Time frame: Up to approximately 2 years]
Number of Participants who Experienced At Least One Treatment Emergent Adverse Event (TEAE) [Time frame: Up to 30 days post-last dose]
Number of Participants who Experienced At Least One Serious TEAE [Time frame: Up to 30 days post-last dose]

Eligibility criteria

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 participants 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 participants with primary oropharyngeal cancer.
A baseline new tumor sample unless the participant 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)

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 prior to randomization.
Known leptomeningeal involvement
Any systemic anticancer therapy within 4 weeks prior to randomization.
Major surgery within 3 weeks or palliative radiotherapy within 2 weeks prior to randomization.
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 localized cancer with curative resection (e.g. cervical intraepithelial neoplasia or nonmelanoma skin cancer)
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
Participants with known infectious diseases (as per protocol)
Pregnant or breastfeeding participants
Participant has a primary tumor site of nasopharynx (any histology).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment