[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"scc---squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:scc---squamous-cell-carcinoma":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,83,107,161,191],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100609626","phase-1-study-evaluating-18fnota-aby030-for-safety-and-tolerability-of-indeterminate-primary-andor-metastatic-disease-in-head-and-neck-squamous-cell-carcinoma-100609626",false,"NCT07217028","Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and\u002For Metastatic Disease in Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed.\n3. Must have evidence of indeterminate metastatic and\u002For primary SCC based on clinical imaging or Primary SCC with suspicious Lymph Nodes standard image modalities prior to surgical removal\n4. Have acceptable lab values, including the following clinical results (if values are considered clinically significant per investigator, participants must be asymptomatic):\n\n   1. Hemoglobin ≥ 9gm\u002FdL\n   2. White blood cell count \\> 3000\u002Fmm3\n   3. Platelet count ≥ 100,000\u002Fmm3\n   4. Serum creatinine ≤ 1.5 times upper reference range\n   5. Potassium\n   6. Magnesium\n   7. Phosphorus\n\nExclusion Criteria:\n\n1. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.\n2. Prior severe infusion reactions or hypersensitivity to other monoclonal antibody therapies.\n3. Pregnant (based on Screening serum or urine pregnancy test administered before infusions), or breastfeeding.\n4. Participants with known hypersensitivity to NOTA-ABY-030, cetuximab, murine, or any of the drug components used in this trial.\n5. Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.\n6. Severe renal disease or anuria.\n7. Participants presenting with a baseline QTcF interval \\> than 480 milliseconds.\n8. Those with an allergy to red meat, a history of tick bites, and alpha-gal syndrome will be given extra consideration.","ALL","18 Years",{"count":18,"type":19},25,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","This Phase I, single-institution, open-label study will evaluate the safety, tolerability, and diagnostic performance of \\[18F\\]NOTA-ABY030 PET\u002FCT in patients with head and neck squamous cell carcinoma (HNSCC) who present with indeterminate lesions on standard imaging. The investigational agent is a radiolabeled anti-EGFR affibody designed for rapid clearance and improved tumor-to-background contrast. All participants will receive a 50 mg cetuximab loading dose followed by a bolus of \\[18F\\]NOTA-ABY030, with PET\u002FCT imaging performed at defined intervals to assess biodistribution and lesion uptake. The primary objective is to determine safety and tolerability; secondary objectives include radiation dosimetry and comparison of sensitivity and specificity to conventional imaging modalities (MRI, CT, and \\[18F\\]FDG-PET\u002FCT). This approach aims to improve diagnostic accuracy, reduce unnecessary biopsies, and streamline treatment decisions for patients with HNSCC.",[25,26,27,28],"SCC - Squamous Cell Carcinoma","Radiotracer","Head and Neck Squamous Cell Carcinoma","Metastatic Head and Neck Squamous Cell Carcinoma",[30,31,32,33],"unknown primary","cancer","hnscc","scc","RECRUITING","2026-05-06",{"date":37,"type":38},"2026-05-11","ACTUAL",{"date":40,"type":38},"2026-04-24",{"date":42,"type":19},"2030-09",{"name":44,"class":45},"Vanderbilt-Ingram Cancer Center","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":20,"phases":56,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":46},"100586444","high-resolution-pet-ct-imaging-for-surgical-margin-visualization-100586444","NCT06915454","High-Resolution PET-CT Imaging for Surgical Margin Visualization","High-resolution Specimen PET-CT Imaging for the Intraoperative Visualization of Resection Margins: an Exploratory Study","Inclusion Criteria:\n\n* Biopsy confirmed diagnosis of any solid malignancy\n* Diagnosis of any T stage, any subsite that are scheduled to undergo definitive en bloc surgical resection. Patients with recurrent disease or a new primary will be allowed.\n* Planned standard of care oncologic surgery with curative intent\n* Male or female patients age ≥ 18 years\n* Have life expectancy of more than 12 weeks\n* Karnofsky performance status of at least 70% or ECOG\u002FZubrod level 1\n* Have acceptable glucose status (\\\u003C200 mg\u002FdL) at Day of Surgery prior to 18F-FDG injection\n\nExclusion Criteria:\n\n* General or local contraindications for resective surgery\n* Women who are pregnant or breast-feeding\n* Blood glucose level over 200 mg\u002FdL prior to 18F-FDG infusion\n* Any participation in other clinical trials or research study that involved a radiation exposure of more than 1 mSv in the past year. If the participant had radiation exposure greater than 1 mSv as SOC, they would not be excluded unless the Principal Investigator determines that patient could be at risk.",{"count":55,"type":19},50,[57],"NA","Imaging will be exploratory and be used intraoperatively. There have been no discovered risks associated with the device to be used in this study, and none are anticipated given the diagnostic and non-invasive, 'ex vivo' nature of device use. Of note, the surgical resection will proceed as per standard of care and will not be affected by the research protocol.\n\nPotential Benefit: Imaging intra-operatively will ensure surgeons to identify at risk resection margins.\n\nTime Commitment: There are no additional visits that will be asked of you to partake in this study.\n\nDrug is FDA approved and Exposure to Radiation is minimal.",[60,61,25,62,63],"Cancer","Solid Malignant Tumors","HNSCC","HNSCC,Larynx, Pharynx and Oral Cavity",[65,66,67,68,69,70,71,72,73,33,74,75,32],"undergoing surgery","Xeos","PET\u002FCT imaging","specimen scanner","cancer margins","oral cancer","mouth cancer","tongue cancer","gum cancer","head and neck cancer","pharynx",{"date":77,"type":38},"2026-05-08",{"date":79,"type":38},"2025-09-03",{"date":81,"type":19},"2027-07",{"name":44,"class":45},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":20,"phases":91,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":46},"100579048","early-phase-1-window-trial-of-fluorescently-labeled-panitumumab-panitumumab-irdye800-in-head-and-neck-cancer-100579048","NCT06819228","Window Trial of Fluorescently Labeled Panitumumab (Panitumumab-IRDye800) in Head and Neck Cancer","Inclusion Criteria:\n\n* Willing to review and sign written informed consent.\n* Male or female patients age \\> 18 years.\n* Tissue confirmation of head and neck squamous cell carcinoma.\n* Patients for whom a potentially curative resection is planned as standard of care.\n* ECOG performance status of 0 or 1\n* Adequate hematologic and end-organ function appropriate for surgery as determined by routine preoperative evaluation. If liver function, renal function and hematologic laboratory test results are acceptable for elective surgery, the patient is considered eligible for the study. Laboratory results that will need to be obtained within 30 days prior to initiation of study treatment: Magnesium, Phosphorus, serum pregnancy test (for females of childbearing age).\n* For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods as defined below:\n\n  • A woman is considered to be of childbearing potential if she is post-menarchal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of the uterus and\u002For both ovaries and\u002For both fallopian tubes). Post-menarchal is defined as either:\n  * age \\>55 years old\n  * age \\\u003C55 years or less and\n* at least 12 months since last menstrual period,\n* at least 6 months since last menstrual period and FSH \\> 40 IU\n\n  * Women of childbearing potential must have a negative pregnancy test result within 14 days prior to initiation of study treatment.\n  * Women must remain abstinent or use effective contraceptive methods during the treatment period and for 5 months after the final dose of panitumumab.\n  * Men must agree to remain abstinent or use a condom during the treatment period and for 5 months after the final dose of panitumumab\u002Fpan800 to avoid exposing the embryo. Men must agree to refrain from donating sperm during this same period.\n\nExclusion Criteria:\n\n* Patients not eligible for standard of care surgical resection\n* Patients with a history of infusion reactions or allergic reactions to panitumumab.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n\n  • History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis. Patients do NOT have to be screened for tuberculosis for this trial.\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.\n* Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. The following drugs are known to interact with panitumumab and therefore any patients taking these medications within 30 days will be ineligible for the trial.\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment.\n* Magnesium or phosphorus lower than normal institutional values, patient is symptomatic, and the values are unable to be corrected through standard repletion strategies.\n* Evidence of QT prolongation on pretreatment ECG.",{"count":90,"type":19},18,[92],"EARLY_PHASE1","This study is exploring the use of Panitumumab in Head and Neck Cancer. Panitumumab is an approved drug named Vectibix and is used as an anti-cancer agent in other cancers such as colorectal cancer. It works by attaching to the cancer cell in a unique way that allows the drug to get into the cancer tissue. In addition to the Panitumumab, participants will also receive a Panitumumab-IRDye800 (Pan800) or a fluorescently labeled Panitumumab infusion. IRDye800 is an investigational dye that, when tested in the lab, helps various characteristics of human tissue show up better when using a special camera during surgery. Panitumumab-IRDye800 is a combination of the drug and the dye that attaches to cancer cells and appears to make them visible to the doctor when he or she uses the special camera during surgery.\n\nThe goal of this study is to use a novel and possibly safer approach to identify an optimal dose for panitumumab to treat cancer patients by using a new light-based therapy. In this study, different drug levels will be analyzed using this approach to understand how much drug reaches the tumor at different administered doses, which may help us provide safer and\u002For more effective therapies in the future.\n\nThe goal is to identify the correct amount or dose of a drug that is needed for effective cancer therapies. Often, clinical studies look at how much of the drug can be tolerated before patients become sick, rather than how much of the drug is required to be effective.\n\nIRDye800 is an investigational dye that, when tested in the lab, helps various characteristics of human tissue show up better when using a special camera during surgery. Panitumumab-IRDye800 is a combination of the drug and the dye that attaches to cancer cells and appears to make them visible to the doctor when he or she uses the special camera during surgery. This will help the surgeon with clinical margins during surgery and will may have a clearer way to differentiate between cancer and healthy tissue.",[62,63,25],[96,97,98,70,71,72,73,99,74,75,62,100],"Pan800","Panitumumab","Fluorescent guided surgery","SCC","larynx",{"date":77,"type":38},{"date":103,"type":38},"2025-04-17",{"date":105,"type":19},"2029-03",{"name":44,"class":45},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":20,"phases":116,"briefSummary":117,"conditions":118,"keywords":130,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":46},"100572677","phase-1-intratumoral-delivery-of-viral-replicon-sarna-particles-expressing-il-12-in-head-and-neck-cancer-100572677","NCT06736379","Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer","Study of Intratumoral Injections of VLPONC-01 in Head and Neck Cancer","Inclusion Criteria:\n\n1. Cohort A - Unresectable or recurrent\u002Fmetastatic head and neck cancer with at least 1 injectable tumor not scheduled for tumor resection surgery. With one the following prior treatments:\n\n   Subjects must have received a platinum containing chemotherapy regimen, 5-Fluorouracil chemotherapy, taxane based chemotherapy, cetuximab or gemcitabine for treatment of primary tumor in locally advanced, or metastatic settings.\n\n   Subjects must have received an anti-PD-1\u002F PD-L1 as monotherapy or in combination with chemotherapy.\n\n   Subjects must have progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status).\n\n   Prior progression on a PD-1 or PD-L1 checkpoint inhibitor should be unequivocal; progression that occurs within the first 8 weeks of treatment on these agents should be confirmed with a second CT at least 4 weeks apart (to exclude pseudo-progression).\n\n   Patients with activating EGFR mutation or ALK rearrangement which is expected to be responsive to available tyrosine kinase inhibitor therapy, therefore these subjects must have been previously treated with an applicable tyrosine kinase inhibitor.\n\n   OR Cohort C - Patients with at least 1 measurable resectable lesion clinical stage I-IVb (cT1-4, N0-3) (AJCC, 8th Edition) (Amin, 2017), Histologically or cytologically confirmed HNSCC. Scheduled to undergo tumor surgical resection of the primary tumor.\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and adequate bone marrow and organ function.\n3. Primary tumors should be amenable to intratumoral (IT) injection \\>1 cm diameter. This will be determined by the Protocol Director, or the surgeon involved.\n4. Subjects with either a local recurrence or a new primary tumor will be allowed.\n5. Age ≥ 18 years.\n6. Have acceptable organ and marrow function defined as follows:\n\n   Absolute neutrophil count ≥ 1,500\u002FmcL Platelets ≥ 100,000\u002FmcL Hemoglobin ≥ 8.0 g\u002FdL (Note: use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002FdL is acceptable) Total bilirubin ≤2x institutional upper limit of normal (ULN) AST(SGOT) or ALT(SGPT) ≤ 3.0x institutional ULN\n7. Ability to understand and the willingness to provide written informed consent.\n8. Life expectancy \\> 12 weeks (about 3 months).\n9. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n1. Tumors which are not feasible for injections include high risk lesions that are near vital organs or important neurovascular structures, as determined by the Protocol Director or involved surgeon.\n2. Women of childbearing potential must have a negative serum β-hCG pregnancy test within 7 days prior to the administration of the first study treatment and\u002For urine pregnancy 48 hours prior to the administration of the first study treatment. Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use two methods of effective contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for at least 6 months after last dose of study drugs.\n3. Patients expected to receive other anti-cancer medication such as, chemotherapy, immunotherapy, biologic therapy, targeted therapy, monoclonal antibodies, hormonal therapy (other than leuprolide or other GnRH agonists) prior to surgery and where all acute toxicity of prior treatments have not resolved.\n4. Participation in another clinical study with an investigational product during the last 30 days.\n5. Uncontrolled intercurrent illness including, that do not respond to active medical intervention.\n6. Current or prior use of immunosuppressive medication within 28 days before the first dose of injection, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone or an equivalent corticosteroid.\n7. If applicable: Women who are breastfeeding.\n8. History of allogenic organ transplant that requires use of immunosuppressives.\n9. Subject has active or uncontrolled infection including known HIV infection or known chronic hepatitis B or C.\n10. Any condition that, in the investigator's opinion, would interfere with evaluation of study treatment or interpretation of patient safety or study results.\n11. Uncontrolled intercurrent illness including those that do not respond to active medical intervention.\n12. Any contraindication to the use of known history of hypersensitivity to any immune therapy's drugs.",{"count":115,"type":19},41,[22],"The goal of this clinical trial is to assess the safety and tolerability of a virus replicon particle (VRP) encapsulated saRNA encoding IL-12 when injected into in head and neck cancer patients. The main questions being addressed are:\n\nThe safety and tolerability of intratumoral (IT) injections of VRP-encapsulated saRNA encoding IL-12 (VLPONC-01)\n\nThe tumor response to IT injections of VLPONC-01\n\nThe tumor response due to the combination of IT injections of VLPONC-01 and system IV administration of neoadjuvant pembrolizumab (anti-PD-1) treatment\n\nResearchers will compare neoadjuvant pembrolizumab alone to the combination therapy to see if the combination enhances tumor responses.",[119,120,121,62,25,122,123,124,125,126,127,128,129],"Head and Neck Cancers- Squamous Cell","Head and Neck Cancer","Solid Tumors","SCCHN","Head Neck Cancer","Head and Neck Squamous Cell Cancer","Squamous Cell Carcinoma of the Head and Neck","Squamous Cell Carcinoma, Head And Neck","Squamous Cell Head and Neck Carcinoma","Oral Cavity","Oral Cavity Carcinoma",[131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150],"Virus-like particle","VLP","IL-12","Interleukin 12","Intratumoral","VRP","Viral Replicon Particle","saRNA","VRP-encapsulated","IT injection","pembrolizumab","anti-PD-1","tumor resection surgery","tumor resection","Self-amplifying RNA","Multiple inoculations directly into the tumor","Keytruda","viral particles per injection","viral particles","macrophage","2026-01-15",{"date":153,"type":38},"2026-01-20",{"date":155,"type":38},"2025-05-13",{"date":157,"type":19},"2027-12-30",{"name":159,"class":160},"VLP Therapeutics","INDUSTRY",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":20,"phases":171,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100552898","prognostic-value-of-measuring-ctdna-in-a-cohort-of-patients-with-stage-iii-and-iv-upper-aero-digestive-tract-uadt-cancer--treated-with-curative-radiotherapy-with-or-without-concomitant-treatment-100552898","NCT06479070","Prognostic Value of Measuring CtDNA in a Cohort of Patients With Stage III and IV Upper Aero-digestive Tract (UADT) Cancer , Treated With Curative RADiOtherapy With or Without Concomitant Treatment.","Prognostic Value of Measuring Circulating Tumor DNA in a Cohort of Patients With Stage III and IV UADT Cancer, Treated With Curative RADiOtherapy With or Without Concomitant Treatment.","CIRADOR","Inclusion Criteria\n\n* OMS 0 to 2;\n* Patient suffering from UADT squamous cell carcinoma, newly diagnosed and histologically proven, regardless of the p16 protein status, naïve to any treatment for this cancer;\n* Non-metastatic cancer of stages III (N1), IVa (N1 minimum) or IVb;\n* Cancer localized in the oral cavity, larynx, oropharynx, hypopharynx and maxillary sinus;\n* Patient for whom treatment with curative radiotherapy associated or not with concomitant treatment (Cisplatin or Cetuximab) has been validated in a multidisciplinary consultation meeting (RCP);\n* Patient capable and willing to follow all study procedures in accordance with the protocol;\n* Patient having understood, signed and dated the consent form communicated on the day of inclusion;\n* Patient affiliated to the social security system.\n\nExclusion Criteria:\n\n* Minor patient;\n* Cancer located in the cavum, ethmoidal sinus, salivary glands and skin (cutaneous squamous cell carcinoma);\n* Patient already treated for UADT tumor;\n* Patient treated with immunotherapy;\n* Patient who has already had cancer within 5 years (cancer other than in the UADT sphere);\n* OMS \\> 2;\n* Contraindication to radiotherapy treatment associated or not with concomitant treatment;\n* Patient already included in another therapeutic trial;\n* Metastatic disease (stage IVc);\n* Pregnant woman, who may be pregnant, or currently breastfeeding;\n* Persons deprived of liberty or under guardianship (including curatorship).",{"count":170,"type":19},188,[57],"Squamous cell carcinomas of the upper aero-digestive tract (SCC-UADT) represent the seventh cause of cancer and affect approximately 600,000 patients per year worldwide. The majority of UADT cancers are diagnosed at an advanced stage (70.3% at stage III and IV) and less than 60% of these patients are free of the disease at 3 years, despite aggressive multimodal local treatment by surgery and \u002For radiochemotherapy. The average progression-free survival (PFS) at 2 years varies between 45 and 60% depending on the studies. Tumor recurrence is most often incurable. To our knowledge, no study has demonstrated the benefit of early evaluation of the rate of decrease in ctDNA at 1 month after the end of radiotherapy alone or associated with concomitant treatment, as a predictive factor of PFS in UADT squamous cell carcinomas regardless of their HPV status. The main objective of this study is to evaluate the value of measuring the quantity of circulating tumor DNA (ctDNA) at 1 month post-treatment as a predictive factor for PFS at 24 months.",[25,174],"Upper Aero-digestive Tract (UADT) Neoplasm",[176,177,178,179,180],"Squamous Cell Carcinoma","upper aero-digestive trac tumor","Ct DNA","Radiotherapy","Head and neck cancer","2025-12-18",{"date":183,"type":38},"2025-12-24",{"date":185,"type":38},"2024-09-30",{"date":187,"type":19},"2029-09-30",{"name":189,"class":45},"Institut de Cancérologie de Lorraine",7,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":20,"phases":200,"briefSummary":201,"conditions":202,"keywords":219,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":190},"100505262","phase-1-a-study-of-mq710-with-and-without-pembrolizumab-in-people-with-solid-tumor-cancer-100505262","NCT05859074","A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer","A First-In-Human Phase I, Open Label, Safety and Tolerability Study of Escalating Multiple Doses of Intratumoral MQ710, a Multi-Transgene Expressing Modified Vaccinia Virus Ankara-Based Virotherapy, Alone and in Combination With the Systemic Checkpoint Inhibitor Pembrolizumab in Solid Tumors","Inclusion Criteria:\n\n* Age 18 or over\n* Histologically or cytologically documented advanced or metastatic cancer that has relapsed from or is refractory to standard treatment in two lines of prior therapy in the advanced setting unless there are fewer than two FDA approved lines of therapy for the particular disease, or for which no standard treatment is available\n* At least 2 tumors suitable for direct or ultrasound-guided injection defined as at least one cutaneous, subcutaneous, or nodal lesion or aggregate of lesions, ≥0.5 cm for any single lesion and cumulative lesion dimensions. One lesion must meet criteria for RECIST measurable disease if in Part 2. Note: One lesion will be biopsied (if possible)\n* Mandatory initial screening biopsy\n\n  a. For patients undergoing surgical excision\u002Fresection: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to biopsy and surgical procedure iii. Patient able to undergo surgical procedure and appropriate anesthesia b. For patients not undergoing surgical excision\u002Fresection to obtain mandatory screening biopsy: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to initial tumor biopsy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Patients with no curative treatment options available including surgery and\u002For definitive radiation or patients in which these modalities are associated with significant morbidity\n* Patients with advanced disease who have received and progressed on standard therapy or have disease for which there is no standard therapy or have contraindications to standard therapy\n\nPart 1a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. Any malignancy with superficial cutaneous or subcutaneous lesions or palpable lymph nodes may be eligible based on the discretion of the investigator.\n\n* Part 2a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. BCC will also be included, given that pembrolizumab has not been approved for this condition, although cemiplimab is approved.\n* Parts 1b and 2b: Patients must have cSCC, Merkel cell carcinoma, melanoma, or head and neck squamous cell carcinoma. These patients should be refractory to anti-PD-1 therapy, with the exception of patients with HNSCC with PD-L1 expression \\\u003C1.\n* Parts 1a, 2a and 2b: Patients with BRAF-mutated melanoma should have received BRAF-targeted therapy.\n* Predicted life expectancy of 3 months or more (in both Part 1 and Part 2)\n* Participant or their legally authorized representative (LAR able to provide written informed consent to participate\n* Ability to comply with study procedures in the Investigator's opinion\n* Adequate renal function as defined by Cr \\\u003C2 mg\u002FdL\n* Adequate hepatic function\n\n  1. Serum bilirubin ≤1.5 x ULN\n  2. AST and ALT ≤2.5 ULN (no liver mets)\n  3. AST and ALT ≤5.0 ULN (for patients with liver mets)\n* Adequate bone marrow and hematologic function\n\n  1. Coagulation function adequate (PT and aPTT within x1.5 ULN)\n  2. Platelets ≥ 75,000\u002Fmm\\^2\n  3. ANC ≥ 1000\u002FuL\n* Females of child-bearing potential must have a negative pregnancy test within 14 days prior to enrollment and on day of treatment. All patients must agree to use adequate contraception prior to study entry, for the duration of study participation, and up to 90 days after the last dose of MQ710\n* Part 2 only: at least one measurable site of disease according to RECIST criteria\n* Prior non-immunotherapy, anti-tumor treatment including endocrine, chemical\u002Fradiotherapy, targeted therapy, or major surgery (but not anti-PD1\u002F- L1 therapies) was discontinued for more than 4 weeks prior to enrollment\n* Patients who have failed prior anti-PD1\u002F-PDL1 may be included. Washout of anti-PD1\u002F-PDL1 at least 3 weeks prior to initiation of therapy in Part 1a and 2a. No washout period is required for Part 1b and 2b.\n\nExclusion Criteria:\n\n* Splenectomy\n* Active infections requiring antibiotics, physician monitoring or recurrent fevers (\\>38.0 ℃) associated with a clinical diagnosis of active infection\n* Acute or chronic active viral disease or positive test for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) with CD4 count \\\u003C100mg\u002Fm3, or received treatment with antivirals or nucleoside analogs such as those used in the treatment of hepatitis B (e.g. lamivudine, adefovir, tenofovir, telbivudine, entecavir), ribavirin, cidofovir, diaminopurine analogs, methyladenosine analogs, or interferon alpha within 4 weeks of initiation of study treatment .a. Patients with HIV are allowed on study if CD4 count is \\>100 cells\u002Fmm3.\n* Incomplete recovery from surgery, incomplete healing of an incision site\n* Any of the following in the 3 months before the first dose of study treatment: Grade 3 or 4 gastrointestinal bleeding\u002Fhaemorrhage (unless due to resected tumour), treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thrombo-embolic event, history or evidence of haemoptysis or menorrhagia\n* History of myocardial infarction, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classsification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia,or significant cardiovascular or cerebrovascular event in the 6 months before the first dose of study treatment\n* Uncontrolled infection within 6 months prior to study entry.\n* History of significant bleeding requiring hospitalization in the 12 months before the first dose of study treatment\n* Treatment with PD-1\u002Fprogrammed death ligand (PD-L1), cytotoxic T-lymphocyte associated protein 4 (CTLA-4), or any other (including experimental) immune checkpoint inhibitor or immune-stimulatory treatment in the 3 weeks before the first dose of study treatment\n* Prior chemotherapy, radiotherapy, biological cancer therapy (not including anti-PD1\u002F-L1 immunotherapies), targeted therapy, investigational drug, or major surgery 28 days prior to enrollment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment with the exception of grade 2 or better for alopecia and neuropathy.\n* Has known active CNS metastases and\u002For carcinomatous meningitis\n* Received live vaccine within 28 days prior to enrollment\n* Patient is pregnant or breast-feeding, or expecting to conceive or father children within the duration of the trial\n* Patients with tumor that directly contacts, encases or penetrates a major blood vessel, pericardium, gastrointestinal tract, or other hollow organs that may lead to perforation due to tumor necrosis\n* Patients at risk of airway compromise in the event of post-injection tumor swelling\u002Finflammation based on investigator judgement\n* History or evidence of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)\n* History of chronic liver disease or evidence of hepatic cirrhosis\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia, active interstitial lung disease (ILD) requiring treatment with systemic steroids\n* Baseline pulse oximetry less than 92% on room air\n* History of re-irradiation to a field which includes the carotid arteries\n* History of leukemia: ALL and CLL (patients with a history of aggressive lymphomas in remission or patients with a history of allogeneic stem cell transplants are eligible if no longer on immunosuppressive therapy and without evidence of GvHD)\n* Current use of steroids such as prednisone 10 mg\u002Fdaily or greater (or its equivalent) or immunosupressants within 2 weeks of initiation of study treatment\n* Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results\n* Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent\n* Known allergy to MQ710 transgene products or formulation.\n* Patient requires anticoagulation therapy, such as warfarin.",{"count":199,"type":19},56,[22],"Participants of this study will have a diagnosis of a solid tumor cancer that has come back to its original location or spread beyond its original location (advanced), came back (relapsed) or worsened (refractory) after standard treatments, or no standard treatments are available for the participants' cancer. The purpose of this study if to find the highest dose of MQ710 that causes few or mild side effects in participants with a solid tumor cancer diagnosis.",[203,25,204,205,206,207,208,209,210,211,27,62,212,213,214,215,216,217,218],"Cutaneous Squamous Cell Carcinoma","Basal Cell Carcinoma","BCC","BCC - Basal Cell Carcinoma","Melanoma","Merkel Cell Carcinoma","Sebaceous Carcinoma","Extramammary Paget Disease","Kaposi Sarcoma","Adnexal Carcinoma","Angiosarcoma","Cutaneous Neoplasm","Advanced Cancer","Metastatic Cancer","Refractory Cancer","Solid Tumor",[203,25,204,205,207,208,209,210,211,27,62,212,213,214,215,216,217,220,221,222,218],"MQ710","Memorial Sloan Kettering Cancer Center","22-278","2025-12-02",{"date":225,"type":38},"2025-12-03",{"date":227,"type":38},"2023-05-04",{"date":229,"type":19},"2028-05-04",{"name":221,"class":45}]