Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-10 @ 12:41 PM
Study NCT ID:
NCT06525220
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2024-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2030-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2024-07-24', 'studyFirstSubmitQcDate': '2024-07-26', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review (BICR)', 'timeFrame': 'Up to approximately 2 years'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS) per RECIST v1.1 as assessed by BICR', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Duration of Response (DOR) per RECIST v1.1 as assessed by BICR', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Objective response rate per RECIST v1.1 as assessed by investigator review', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Progression-free survival per RECIST v1.1 as assessed by investigator review', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Duration of response per RECIST v1.1 as assessed by investigator review', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Clinical benefit rate per RECIST v1.1 as assessed by BICR', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Clinical benefit rate per RECIST v1.1 as assessed by investigator review', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Number of participants who experienced at least one treatment emergent adverse event (TEAE)', 'timeFrame': 'Up to 30 days post last dose'}, {'measure': 'Number of participants who experienced at least one serious TEAE', 'timeFrame': 'Up to 30 days post last dose'}, {'measure': 'Number of participants who discontinued study treatment due to TEAEs', 'timeFrame': 'Up to 30 days post last dose'}, {'measure': 'Number of participants who had dose modification due to TEAEs', 'timeFrame': 'Up to 30 days post last dose'}, {'measure': 'To evaluate patient reported outcomes for health-related quality of life', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Pharmacokinetic parameters', 'timeFrame': 'Up to first 6 cycles'}, {'measure': 'Incidence of anti-drug antibodies (ADAs)', 'timeFrame': 'Up to 30 days post last dose'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HNSCC', 'PD-L1+', 'Head and Neck cancer', 'Petosemtamab', 'Pembrolizumab', 'Liger', 'Oral Cavity', 'Oropharynx', 'Larynx', 'Hypopharynx'], 'conditions': ['Head and Neck Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '40511820', 'type': 'DERIVED', 'citation': 'Machiels JP, Fayette J, Haddad R, Adkins D, Gillison M, Harrington KJ, Kim SB, Le Tourneau C, Psyrri A, Rosenberg A, Siu LL, Tahara M, William WN Jr, Ford J, Jauhari S, Pyle R, Shen YM, Yao D, Zohren F, Vokes E. LiGeR-HN phase III trials of petosemtamab + pembrolizumab and petosemtamab monotherapy in recurrent or metastatic HNSCC. Future Oncol. 2025 Jul;21(16):2007-2016. doi: 10.1080/14796694.2025.2511470. Epub 2025 Jun 13.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed ICF before initiation of any study procedures\n2. Age ≥ 18 years at signing of ICF\n3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent.\n4. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.\n5. HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1.\n6. HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting\n7. A new tumor biopsy, unless the patient has an available archival tumor sample with sufficient material\n8. Measurable disease per Investigator assessment as defined by RECIST v1.1 by radiologic methods\n9. ECOG Performance Status (PS) of 0-1\n10. Life expectancy ≥ 12 weeks, as per investigator assessment.\n11. Left ventricular ejection fraction (LVEF) ≥50% or ≥ institutional normal limit, whichever is higher, by echocardiogram (ECHO) or multigated acquisition (MUGA) scan\n12. Adequate organ function as defined per protocol.\n13. 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\n\nExclusion Criteria:\n\n1. 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\n2. Known leptomeningeal involvement\n3. Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization\n4. Requirement for immunosuppressive medication\n5. Major surgery or radiotherapy within 3 weeks of randomization\n6. 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\n7. History of hypersensitivity reaction to any of the excipients of petosemtomab or pembrolizumab.\n8. 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\n9. History of prior malignancies within the last 5 years, with the exception of excised local cancer\n10. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy\n11. Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders\n12. Patients with known infectious diseases as per protocol.\n13. Pregnant or breastfeeding patients.\n14. 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\n15. 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\n16. The patient has had an allogeneic tissue/solid organ transplant.\n17. Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any histology)\n\nOther protocol defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06525220', 'briefTitle': 'A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merus N.V.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MCLA-158-CL03'}, 'secondaryIdInfos': [{'id': '2023-510323-30-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Petosemtamab + Pembrolizumab', 'description': 'Combination Therapy', 'interventionNames': ['Drug: Petosemtamab', 'Drug: Pembrolizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pembrolizumab', 'description': 'Monotherapy', 'interventionNames': ['Drug: Pembrolizumab']}], 'interventions': [{'name': 'Petosemtamab', 'type': 'DRUG', 'description': 'MCLA-158', 'armGroupLabels': ['Petosemtamab + Pembrolizumab']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Humanized Antibody', 'armGroupLabels': ['Pembrolizumab', 'Petosemtamab + Pembrolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36607', 'city': 'Mobile', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site 164', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site 36', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site 27', 'geoPoint': {'lat': 34.05223, 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