Recruiting NCT06525220

A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)

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, Pembrolizumab.
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 +23
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 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

Overview

Detailed description

This is 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+ HNSCC. HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting, although previous systemic therapy as part of multimodal treatment for locally advanced disease is allowed if PD was ≥6 months after the last platinum-containing therapy dose. Previous treatments with anti PD-(L)1 or anti-EGFR therapies are not allowed. In the case of cetuximab, patients who have received cetuximab with radiotherapy as a local treatment and PD was \>1 year after the last dose of cetuximab are eligible.

Interventions

Drug Petosemtamab
MCLA-158
Drug Pembrolizumab
Humanized Antibody

Primary outcome measures

Overall Survival (OS) [Time frame: Up to approximately 3 years]
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review (BICR) [Time frame: Up to approximately 2 years]

Secondary outcome measures (12)

Progression Free Survival (PFS) per RECIST v1.1 as assessed by BICR [Time frame: Up to approximately 2 years]
Duration of Response (DOR) per RECIST v1.1 as assessed by BICR [Time frame: Up to approximately 2 years]
Clinical benefit rate per RECIST v1.1 as assessed by BICR [Time frame: Up to approximately 2 years]
Time to response (TTR) per RECIST v1.1 as assessed by BICR [Time frame: Time Frame: Up to approximately 2 years]
Objective response rate per RECIST v1.1 as assessed by investigator review [Time frame: Up to approximately 2 years]
Progression-free survival per RECIST v1.1 as assessed by investigator review [Time frame: Up to approximately 2 years]
Duration of response per RECIST v1.1 as assessed by investigator review [Time frame: Up to approximately 2 years]
Time to response (TTR) per RECIST v1.1 as assessed by Investigator [Time frame: Time Frame: Up to approximately 2 years]
Clinical benefit rate per RECIST v1.1 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]
Number of participants who discontinued study treatment due to TEAEs [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 confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent.
The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1.
HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting
A new tumor biopsy, unless the patient has an available archival tumor sample with sufficient material
Measurable disease per Investigator assessment as defined by RECIST v1.1 by radiologic methods
ECOG Performance Status (PS) of 0-1
Life expectancy ≥ 12 weeks, as per investigator assessment.
Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
Adequate organ function as defined per protocol.
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

Exclusion criteria

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
Known leptomeningeal involvement
Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization
Requirement for immunosuppressive medication
Major surgery or radiotherapy within 3 weeks of randomization
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
History of hypersensitivity reaction to any of the excipients of petosemtamab or pembrolizumab.
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
History of prior malignancies within the last 5 years, with the exception of excised local 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
Patients with known infectious diseases as per protocol.
Pregnant or breastfeeding patients.
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
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
The patient has had an allogeneic tissue/solid organ transplant.
Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any histology)

Other protocol defined inclusion/exclusion criteria may apply.

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

Study locations

United States · 37 centers

Site 164 — Mobile
Site 36 — La Jolla
Site 27 — Los Angeles
Site 16 — Palo Alto
Site 19 — Newark
Site 108 — Washington D.C.
Site 14 — Fort Myers
Site 48 — Orlando
… and 29 more centers

France · 14 centers

Site 56 — Bordeaux
Site 101 — Le Mans
… and 12 more centers

Germany · 13 centers