Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-03 @ 11:17 PM
Study NCT ID:
NCT06636734
Status:
RECRUITING
Last Update Posted:
2025-01-20
First Post:
2024-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lovastatin and Pembrolizumab for the Treatment of Patients with Recurrent or Metastatic Head and Neck Cancer, LAPP Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D007012', 'term': 'Hypopharyngeal Neoplasms'}, {'id': 'D007822', 'term': 'Laryngeal Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'C582435', 'term': 'pembrolizumab'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2024-10-08', 'studyFirstSubmitQcDate': '2024-10-08', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'Up to 1 year', 'description': 'ORR will be defined as the proportion of subjects with partial response or complete response. ORR will be evaluated using Response Evaluation Criteria in Solid Tumors version (RECIST) (v)1.1 response criteria. ORR will be calculated with 95% confidence interval by binomial distribution.'}], 'secondaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': 'From date of treatment start to the date of objectively documented progression or death due to any cause, whichever status is recorded first, assessed up to 1 year', 'description': 'PFS will be defined as the duration from the date of treatment start to the date of objectively documented progression or death due to any cause, whichever status is recorded first. PFS will be assessed using RECIST v1.1 response criteria. Median PFS will be estimated by Kaplan-Meier method along with 95% confidence interval.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 1 year', 'description': 'To evaluate the anti-tumor activity of the combination of by assessing overall survival (OS).'}, {'measure': 'Incidence of adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': 'Up to 30 days after last dose of study treatment', 'description': 'AEs and SAEs will be assessed and graded according to Common Terminology Criteria for Adverse Events v5.0. Frequency of AEs and SAEs will be summarized accordingly.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC V8', 'Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary', 'Metastatic Head and Neck Squamous Cell Carcinoma', 'Metastatic Hypopharyngeal Squamous Cell Carcinoma', 'Metastatic Laryngeal Squamous Cell Carcinoma', 'Metastatic Nasopharyngeal Squamous Cell Carcinoma', 'Metastatic Oral Cavity Squamous Cell Carcinoma', 'Metastatic Oropharyngeal Squamous Cell Carcinoma', 'Metastatic Paranasal Sinus Squamous Cell Carcinoma', 'Recurrent Head and Neck Squamous Cell Carcinoma', 'Recurrent Hypopharyngeal Squamous Cell Carcinoma', 'Recurrent Laryngeal Squamous Cell Carcinoma', 'Recurrent Nasopharyngeal Squamous Cell Carcinoma', 'Recurrent Oral Cavity Squamous Cell Carcinoma', 'Recurrent Oropharyngeal Squamous Cell Carcinoma', 'Recurrent Paranasal Sinus Squamous Cell Carcinoma', 'Stage IV Hypopharyngeal Carcinoma AJCC V8', 'Stage IV Laryngeal Cancer AJCC V8', 'Stage IV Lip and Oral Cavity Cancer AJCC V8', 'Stage IV Nasopharyngeal Carcinoma AJCC V8', 'Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC V8', 'Stage IV Sinonasal Cancer AJCC V8']}, 'descriptionModule': {'briefSummary': "This phase II trial tests how well lovastatin and pembrolizumab work in treating patients with head and neck cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Lovastatin is a drug used to lower the amount of cholesterol in the blood and may also cause tumor cell death. In addition, studies have shown that lovastatin may make the tumor cells more sensitive to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lovastatin and pembrolizumab may kill more tumor cells in patients with recurrent or metastatic head and neck cancer.", 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To evaluate anti-tumor activity of the combination of pembrolizumab and lovastatin by assessing the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n\nSECONDARY OBJECTIVE:\n\nI. To evaluate the anti-tumor activity of the combination of by assessing progression-free survival (PFS) and overall survival (OS).\n\nTERTIARY/EXPLORATORY OBJECTIVES:\n\nI. To assess the effects of the combination of lovastatin + pembrolizumab on immune cells in blood.\n\nII. To assess the association between efficacy measures and expression in tumors.\n\nIII. To assess the association between anti-tumor activity and immune cells in the blood.\n\nOUTLINE:\n\nPatients receive lovastatin orally (PO) once daily (QD) and pembrolizumab intravenously (IV) over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, and computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT throughout the study.\n\nAfter completion of study treatment, patients are followed for up to 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients, male or female, aged ≥ 18, able to provide informed consent\n* Subjects with pathologically proven, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) involving the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, or paranasal sinuses; patients with unknown primary HNSCC involving the cervical lymph nodes can be included if human papillomavirus (HPV)-positive\n* PD-L1 combined positive score (CPS) ≥ 1 (i.e., must be a candidate for treatment with pembrolizumab alone)\n* Patients must not be under consideration for salvage surgery\n* Measurable disease by RECIST 1.1 criteria\n* Life expectancy of more than 3 months, as determined by the investigator\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Recovery to baseline or ≤ grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5.0 from toxicities related to any prior treatments, unless adverse events are clinically non-significant and/or stable on supportive therapy\n* For men or women of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 8 weeks after the end of lovastatin/pembrolizumab administration\n* Absolute neutrophil count (ANC) ≥ 1000/mm\\^3 without colony stimulating factor support\n* Platelets ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 9 g/dL\n* Bilirubin ≤ 1.5 x the upper limit of normal (ULN). For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg/dL\n* Serum albumin ≥ 2.8 g/dl\n* Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 x ULN\n* Serum phosphorus, calcium, magnesium and potassium ≥ lower limit of normal (LLN)\n\nExclusion Criteria:\n\n* Patients already taking a statin drug\n* Liver dysfunction precluding the use of statins\n* Radiation to the head and neck or other sites within 4 weeks prior to enrollment\n* Cytotoxic chemotherapy or any form of investigational therapy within 4 weeks prior to study treatment\n* Prior treatment with immune checkpoint blocking therapy\n* Current use of drugs that interact with lovastatin (cimetidine, spironolactone, ketoconazole, and others)\n* Pregnancy, lactation, or plan to become pregnant\n* Inability to swallow lovastatin tablets\n* Known allergy or prior adverse reaction to lovastatin, other statin drugs, or pembrolizumab"}, 'identificationModule': {'nctId': 'NCT06636734', 'briefTitle': 'Lovastatin and Pembrolizumab for the Treatment of Patients with Recurrent or Metastatic Head and Neck Cancer, LAPP Trial', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'A Phase II Trial of Lovastatin and Pembrolizumab in Patients with RM HNSCC (LAPP)', 'orgStudyIdInfo': {'id': 'STUDY00007740'}, 'secondaryIdInfos': [{'id': 'NCI-2024-06118', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'STUDY00007740', 'type': 'OTHER', 'domain': 'Emory University Hospital/Winship Cancer Institute'}, {'id': 'WINSHIP6229-24', 'type': 'OTHER', 'domain': 'Emory University Hospital/Winship Cancer Institute'}, {'id': 'P30CA138292', 'link': 'https://reporter.nih.gov/quickSearch/P30CA138292', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (lovastatin, pembrolizumab)', 'description': 'Patients receive lovastatin PO QD and pembrolizumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, and CT, MRI or PET/CT throughout the study.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Computed Tomography', 'Drug: Lovastatin', 'Procedure: Magnetic Resonance Imaging', 'Biological: Pembrolizumab', 'Procedure: Positron Emission Tomography']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Treatment (lovastatin, pembrolizumab)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized axial tomography (procedure)', 'Computerized Tomography', 'Computerized Tomography (CT) scan', 'CT', 'CT Scan', 'tomography'], 'description': 'Undergo CT or PET/CT', 'armGroupLabels': ['Treatment (lovastatin, pembrolizumab)']}, {'name': 'Lovastatin', 'type': 'DRUG', 'otherNames': ['Lovastatin Sodium', 'Mevacor', 'Mevinolin', 'Monacolin K'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (lovastatin, pembrolizumab)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance', 'Magnetic Resonance Imaging (MRI)', 'Magnetic resonance imaging (procedure)', 'Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR', 'MR Imaging', 'MRI', 'MRI Scan', 'MRIs', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging', 'sMRI', 'Structural MRI'], 'description': 'Undergo MRI', 'armGroupLabels': ['Treatment (lovastatin, pembrolizumab)']}, {'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['BCD-201', 'GME 751', 'GME751', 'Keytruda', 'Lambrolizumab', 'MK 3475', 'MK-3475', 'MK3475', 'Pembrolizumab Biosimilar BCD-201', 'Pembrolizumab Biosimilar GME751', 'Pembrolizumab Biosimilar QL2107', 'QL2107', 'SCH 900475', 'SCH-900475', 'SCH900475'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (lovastatin, pembrolizumab)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET Scan', 'Positron emission tomography (procedure)', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging', 'PT'], 'description': 'Undergo PET/CT', 'armGroupLabels': ['Treatment (lovastatin, pembrolizumab)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ardith C. Deshay', 'role': 'CONTACT', 'email': 'ardith.deshay.deshay@emory.edu', 'phone': '404-686-1858'}, {'name': 'Nicole C. Schmitt, MD, FACS', 'role': 'CONTACT'}], 'facility': 'Emory University Hospital/Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'centralContacts': [{'name': 'Nicole C. Schmitt, MD, FACS', 'role': 'CONTACT', 'email': 'nicole.cherie.schmitt@emory.edu', 'phone': '404-778-0278'}, {'name': 'Nabil F Saba, MD, FACP', 'role': 'CONTACT', 'email': 'nfsaba@emory.edu', 'phone': '404-778-1900'}], 'overallOfficials': [{'name': 'Nicole C Schmitt, D, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University Hospital/Winship Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nicole Schmitt', 'investigatorAffiliation': 'Emory University'}}}}