RECRUITING

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

Conditions

Head and Neck Squamous Cell Carcinoma HNSCC PD-L1+Head and Neck cancer Petosemtamab Pembrolizumab Liger Oral Cavity Oropharynx Larynx Hypopharynx

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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+ head and neck squamous cell carcinoma.

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

Quick Facts

Study Start:2024-09-25

Study Completion:2030-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06525220

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 new tumor biopsy, unless the patient has an available archival tumor sample with sufficient material 8. Measurable disease per Investigator assessment 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. 13. 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	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 prior to randomization 2. Known leptomeningeal involvement 3. Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization 4. Requirement for immunosuppressive medication 5. Major surgery or radiotherapy within 3 weeks of randomization 6. 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 7. History of hypersensitivity reaction to any of the excipients of petosemtomab or pembrolizumab. 8. 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 9. History of prior malignancies within the last 5 years, with the exception of excised local cancer 10. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy 11. Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders 12. Patients with known infectious diseases as per protocol. 13. Pregnant or breastfeeding patients. 14. 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 15. 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 16. The patient has had an allogeneic tissue/solid organ transplant. 17. Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any histology)

Inclusion Criteria

Exclusion 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 new tumor biopsy, unless the patient has an available archival tumor sample with sufficient material
8. Measurable disease per Investigator assessment 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.
13. 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

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 prior to randomization
2. Known leptomeningeal involvement
3. Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization
4. Requirement for immunosuppressive medication
5. Major surgery or radiotherapy within 3 weeks of randomization
6. 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
7. History of hypersensitivity reaction to any of the excipients of petosemtomab or pembrolizumab.
8. 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
9. History of prior malignancies within the last 5 years, with the exception of excised local cancer
10. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy
11. Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
12. Patients with known infectious diseases as per protocol.
13. Pregnant or breastfeeding patients.
14. 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
15. 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
16. The patient has had an allogeneic tissue/solid organ transplant.
17. Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any histology)

Contacts and Locations

Study Contact

Head of Clinical Operations

CONTACT

+1 617 401 4499

USenquiries@merus.nl

Study Locations (Sites)

Site 36

La Jolla, California, 92037

United States

Site 27

Los Angeles, California, 90033

United States

Site 16

Palo Alto, California, 94304

United States

Site 19

Newark, Delaware, 19713

United States

Site 14

Fort Myers, Florida, 33901

United States

Site 48

Orlando, Florida, 32804

United States

Site 8

Orlando, Florida, 32827

United States

Site 21

Saint Petersburg, Florida, 33705

United States

Site 20

West Palm Beach, Florida, 33401

United States

Site 50

Chicago, Illinois, 60637

United States

Site 2

Louisville, Kentucky, 40202

United States

Site 94

Hackensack, New Jersey, 07601

United States

Site 6

Albuquerque, New Mexico, 87131

United States

Site 43

Philadelphia, Pennsylvania, 19104

United States

Site 89

Chattanooga, Tennessee, 37404

United States

Site 88

Nashville, Tennessee, 37203

United States

Site 22

Austin, Texas, 78745

United States

Site 1

Houston, Texas, 77030

United States

Site 18

Plano, Texas, 75075

United States

Site 17

Sugarland, Texas, 77479

United States

Site 15

Tyler, Texas, 75702

United States

Site 10

Salt Lake City, Utah, 84112

United States

Site 12

Blacksburg, Virginia, 24060

United States

Site 23

Norfolk, Virginia, 23502

United States

Collaborators and Investigators

Sponsor: Merus N.V.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-25

Study Completion Date2030-07

Study Record Updates

Study Start Date2024-09-25

Study Completion Date2030-07

Terms related to this study

Keywords Provided by Researchers

HNSCC
PD-L1+
Head and Neck cancer
Petosemtamab
Pembrolizumab
Liger
Oral Cavity
Oropharynx
Larynx
Hypopharynx

Additional Relevant MeSH Terms

Head and Neck Squamous Cell Carcinoma