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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)

NCT06496178

RecruitingPhase 3

Sponsor: Merus B.V.

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Petosemtamab, Investigator's Choice, Investigator's Choice, Investigator's Choice

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Czechia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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).

Locations (218)

Mobile, Alabama, United States
Prescott, Arizona, United States
Scottsdale, Arizona, United States
Duarte, California, United States
La Jolla, California, United States
Orange, California, United States
Palo Alto, California, United States
Sacramento, California, United States
San Francisco, California, United States
Lone Tree, Colorado, United States
Washington D.C., District of Columbia, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
New Orleans, Louisiana, United States
Columbia, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Maple Grove, Minnesota, United States
Rochester, Minnesota, United States
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