[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yana Najjar\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":122},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,63,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100579959","evaluation-of-hypoxia-in-primary-melanoma-100579959",false,"NCT06831071","Evaluation of Hypoxia in Primary Melanoma","Prospective Evaluation of Hypoxia in Primary Melanoma","Inclusion Criteria:\n\n1. Must be willing and able to provide written informed consent for the study.\n2. Must have histologically confirmed melanoma for which a Sentinel Lymph Node Biopsy (SLNB) is indicated per the treating physician.\n3. Cutaneous or mucosal melanoma is permitted.\n4. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days from the time of pimonidazole administration.\n\n   1. Female subjects of childbearing potential must not be pregnant or breastfeeding. Female subjects will be considered of non-reproductive potential if they:\n\n      1. are postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women \\\u003C 45 years of age a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n      2. have had a hysterectomy and\u002For bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation\u002Focclusion, at least 6 weeks prior to screening.\n      3. have a congenital or acquired condition that prevents childbearing.\n   2. Female and male subjects of reproductive potential must agree to avoid becoming pregnant or impregnating a partner, respectively, while receiving study drug and 1 week after the dose of study drug for females and 2 weeks for males by complying with one of the following:\n\n      1. practice abstinence from heterosexual activity\n      2. use (or have their partner use) acceptable contraception during heterosexual activity.\n5. Adequate hematologic function: white blood cells (WBC) ≥ 2,500\u002FμL, platelet count ≥ 100,000\u002FμL, hemoglobin ≥ 8.0 g\u002FdL\n6. Adequate renal function: serum creatinine ≤ 2.0 mg\u002FdL\n7. Adequate hepatic function: serum alkaline phosphatase, bilirubin, and ALT ≤ twice the institutional upper limit of normal\n\nExclusion Criteria:\n\n1. Subjects with known chronic immunosuppression (such as biologic agents like infliximab, mycophenolate, methotrexate, prednisone \\> 20 mg daily).\n2. Severe septicemia or severe infection in the 4 weeks prior to study entry.\n3. History of previous neuropathy from chemotherapy or other causes not related to cancer.\n4. Pregnant subjects or breastfeeding subjects. (Note: A pregnancy test will be administered within 7 days prior to the administration of pimonidazole to female subjects of childbearing potential enrolled in the study.)\n5. Subjects with (ECOG) Performance scale of 4 - subjects unable to perform self-care.\n6. Subjects who have received an investigational new drug 6 half-lives or two weeks prior to enrollment in this study, whichever is shorter.","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","OBSERVATIONAL","When controlling for tumor present in the Sentinel lymph node (SLN), intranodal hypoxia, as measured by Carbonic Anhydrase IX (CAIX IHC), is associated with worse PFS. This suggests that melanoma tumors may be utilizing deregulated metabolism as a means of propagating themselves to the next station of metastasis. This study aims to prospectively validate previous findings. Patients who are to undergo WLE and SLNB per standard of care (SOC) will be evaluable. It is hypothesized that SLN(s) with increased hypoxia, as measured by pimonidazole staining, will be associated with worse Progression-free Survival (PFS).",[24],"Melanoma",[26,27,28],"Melanoma in-transit metastases (ITMs)","intra-nodal hypoxia","Tumor cell oxidative metabolism (OCR)","RECRUITING","2026-06-08",{"date":32,"type":33},"2026-06-10","ACTUAL",{"date":35,"type":33},"2025-04-09",{"date":37,"type":20},"2029-03-31",{"name":39,"class":40},"Yana Najjar","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":50,"conditions":51,"keywords":52,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":41},"100413033","evolution-of-metabolic-and-immune-dysfunction-in-in-transit-melanoma-100413033","NCT04658303","Evolution of Metabolic and Immune Dysfunction in In-transit Melanoma","Inclusion Criteria:\n\n1. Be willing and able to provide written informed consent for the trial.\n2. Be ≥ 18 years of age on day of signing informed consent.\n3. A histological diagnosis of melanoma and at least two in-transit lesions at distinct distances from the primary site. Patients may be enrolled on the basis of a diagnosis of in-transit disease by a treating melanoma oncologist.\n4. Cutaneous, mucosal or uveal melanoma are permitted.\n5. Patients may be on treatment or treatment naïve.\n6. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days from the time of pimonidazole administration.\n\nExclusion Criteria:\n\n1. Subjects with in-transit disease that is not amenable to biopsy per the treating physician are excluded.\n2. Subjects with known chronic immunosuppression (such as biologic agents like remicade, mycophenolate, methotrexate, prednisone \\>20 mg daily).\n3. Subjects who are known to be HIV+, Hep B or Hep C positive.",{"count":49,"type":20},20,"Melanoma in-transit metastases (ITMs) continue to represent a therapeutic dilemma, in that no standard method of treatment has been uniformly adopted. The complexity and heterogeneity of patient and disease characteristics, including the location and number of ITMs presents a barrier to a one size fits all treatment approach. Treatment of patients with limited regional disease remains challenging. Patients are typically treated with a combination of surgery, regional therapy, systemic therapy. Data on the management of ITMs is limited, even with the availability of immunotherapy (IMT). This study will use the unique etiology of ITMs to facilitate the understanding of how individual lesions metabolically and immunologically evolve as they move away from the primary tumor site. It is hypothesize that as ITMs move away from the primary melanoma site each will harbor progressively hypermetabolic tumor cells and a harsher microenvironment.",[24],[53,54,26,55],"immune dysfunction","metabolic dysfunction","tumor microenvironment (TME)",{"date":57,"type":33},"2026-06-11",{"date":59,"type":33},"2021-02-24",{"date":61,"type":20},"2029-08-31",{"name":39,"class":40},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":87,"locationsCount":41},"100532755","early-phase-1-rp1-in-primary-melanoma-to-reduce-the-risk-of-sentinel-lymph-node-metastasis-100532755","NCT06216938","RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis","Phase I Pilot Study of RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis","Inclusion Criteria:\n\n1. Be willing and able to provide written informed consent for the trial.\n2. Be ≥ 18 years of age on day of signing informed consent.\n3. Have a diagnosis of pT3b, T4a or T4b melanoma on biopsy. Patients must have grossly visible residual tumor, or a positive deep or lateral margin on initial biopsy. Patients with uveal melanoma are not eligible.\n4. Females of childbearing potential must have a negative beta-human chorionic gonadotropin (β-hCG) test with a minimum sensitivity of 25 IU\u002FL or equivalent units of β-hCG during screening, before the first dose, and a negative urine pregnancy test on days of treatment (Day 1, 15 and 21). For serum and urine pregnancy tests and instructions (see Section 12.2).\n5. Female patients of reproductive potential must agree to avoid becoming pregnant and adhere to a highly effective contraception method until 90 days after last dose of RP1 alone. For a definition of highly effective contraceptive methods and instructions of patients and partners (see Section 12.2).\n6. Male patients of reproductive potential must agree to avoid impregnating a partner and adhere to a highly effective contraception method until 90 days after last dose of RP1 study agent and refrain from donating sperm during this period. For a definition of highly effective contraceptive methods and instructions of patients and partners (see Section 12.2).\n\n   Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n7. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.\n8. Demonstrate adequate organ function. All screening labs should be performed within 30 days of treatment initiation. Baseline labs may be used as screening labs.\n\nExclusion Criteria:\n\n1. Prior treatment with an oncolytic virus therapy.\n2. Has acute or chronic active hepatitis B and C virus infection or known history of hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (HCV) (defined as HCV RNA \\[qualitative\\]) or HIV infection.\n\n   Note: No testing for Hepatitis B, Hepatitis C, or HIV is required unless mandated by local health authority or clinically indicated.\n3. Had systemic infection requiring IV antibiotics or other serious infection within 14 days prior to dosing.\n4. Have active significant herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis).\n5. Conditions requiring treatment with immunosuppressive doses (\\> 10 mg daily prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy within 14 days after enrollment. For the definition of replacement therapy (Section 11.0 Supportive Care and Management of Adverse Reactions\u002FEvents).\n6. Major surgery ≤ 1 week prior to starting study drug. Note: Patients who undergo major surgery must adequately recover prior to starting study treatment.\n7. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within four weeks prior to the first dose of study treatment.\n8. History of documented allergic reactions or acute hypersensitivity reactions attributed to RP1 or any of its excipients.\n9. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacille Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed, however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n\n   Note: Available COVID-19 vaccines do not contain live virus.\n10. Has a history or current evidence of any condition, therapy, or laboratory abnormality that will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs or interfere with the patient's participation for the full duration of the study or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n11. Has serious or uncontrolled medical disorders.\n12. Has known psychiatric, alcohol abuse, or substance abuse disorders that would interfere with cooperating with the requirements of the study.\n13. Is a person deprived of their liberty by a judicial or administrative decision, or an adult person subject to a legal protection measure.\n14. Is a solid organ transplant recipient.\n15. Has a concurrent malignancy requiring active systemic therapy or ongoing radiation.\n16. Patients with tumors that are located near critical structures, such as the carotid artery or portal vein, or scalp lesions presenting with moderate to extensive bone erosion and tumors that may have invaded the heart, great vessels, or other critical structures will not be eligible because these area should not be injected. Injection through an ulcerated area of a lesion should be avoided.",{"count":71,"type":20},25,"INTERVENTIONAL",[74],"EARLY_PHASE1","This early-phase study will examine Vusolimogene Oderparepvec, a genetically modified oncolytic viral strain of the herpes simplex type 1 (HSV-1) virus, with potential oncolytic, immunostimulating and antineoplastic activities. Upon administration, vusolimogene oderparepvec specifically targets, infects and replicates in tumor cells and does not infect healthy cells. This results in tumor cell lysis and the release of virus particles which infect and replicate within nearby tumor cells, resulting in tumor cel death. The immune system is activated by the released tumor-associated antigens (TAAs) from the tumor cells creating an anti-tumor immune response against the tumor cells, thereby further killing the tumor cells. The virus itself also elicits a tumor-specific systemic immune and cytotoxic T-lymphocyte (CTL) response, thereby killing nearby non-infected tumor cells.",[24],[78,79,80],"sentinel lymph node (SLN)","herpes simplex virus 1 (HSV1)","Granulocyte-macrophage colony stimulating factor (GM-CSF)","2026-04-07",{"date":83,"type":33},"2026-04-13",{"date":85,"type":33},"2024-03-07",{"date":37,"type":20},{"name":39,"class":40},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":72,"phases":96,"briefSummary":98,"conditions":99,"keywords":109,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"100406441","phase-1-safety-of-sbrt-with-anti-pd1-and-anti-il-8-for-the-treatment-of-multiple-metastases-in-advanced-solid-tumors-and-melanoma-100406441","NCT04572451","Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma","Phase I Study Investigating the Safety of Stereotactic Body Radiotherapy (SBRT) With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma","Inclusion Criteria:\n\n* SAFETY COHORT\n\n  1. Patients with advanced\u002Fmetastatic\u002Funresectable solid tumors progressed on standard therapies. Patients with melanoma and RCC will make up approximately 30% of total cohort.\n  2. Patients with 1-4 tumor sites that can be irradiated safely\n  3. Age \\> or equal 18 years\n  4. ECOG performance status 0 or 1\n  5. Patients must have normal organ and marrow function as defined below:\n\n     * Leukocytes ≥ 3000\u002FmcL;\n     * absolute neutrophil count ≥ 1500\u002FmcL;\n     * Platelets ≥ 100,000\u002FmcL;\n     * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) ;\n     * Total bilirubin ≤ 1.5 × ULN (except participants with Gilbert's Syndrome who must have normal direct bilirubin)\n     * Serum creatinine ≤ 1.5 × ULN Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non- nodal lesions and short axis for nodal lesions) as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam\n  6. Ability to understand and the willingness to sign a written informed consent document.\n  7. Reproductive status\n\n     * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study treatment.\n     * Women must not be breastfeeding.\n     * WOCBP must agree to follow instructions for method(s) of contraception (Appendix 5) for the duration of study treatment plus 5 half-lives of nivolumab plus 30 days (duration of ovulatory cycle), for a total of 155 days post treatment completion. Local laws and regulations may require use of alternative and\u002For additional contraception methods.\n     * WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, but should still undergo pregnancy testing as described in this section.\n     * Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (Appendix4) during combination treatment with study treatment BMS-986253 and nivolumab, plus 5 half-lives of nivolumab (∼125 days), plus 90 days (duration of sperm turnover), for a total of 215 days post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time.\n* EFFICACY COHORT\n\n  1. Patients with anti-PD1\u002FPDL1 refractory melanoma\n  2. Patients with 1-4 tumor sites that can be irradiated safely\n  3. Age ≥ 18 years\n  4. ECOG performance status 0 or 1\n  5. Patients must have normal organ and marrow function as defined above for safety cohort\n  6. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non- nodal lesions and short axis for nodal lesions) as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam\n  7. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Known or suspected CNS metastases, with the following exceptions:\n\n   a) Subjects with controlled brain metastases will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least 4 weeks following 18 radiation and\u002For surgical treatment at the time of randomization. b) Subjects must be off steroids for at least 2 weeks prior to initiation of investigational therapy c) Subjects with signs or symptoms of brain metastases are not eligible unless brain metastases are ruled out by computed tomography or magnetic resonance imaging.\n2. Medical History and Concurrent Diseases\n\n   * Patients who are receiving any other investigational agents.\n   * History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab and BMS-986253\n   * Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n   * Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:\n\n     i. Myocardial infarction (MI) or stroke\u002Ftransient ischemic attack (TIA) within the 6 months prior to consent ii. Uncontrolled angina within the 3 months prior to consent iii. Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes, or poorly controlled atrial fibrillation) within a month prior to consent iv. QTc prolongation \\> 480 msec v. History of other clinically significant cardiovascular disease (i.e., cardiomyopathy, congestive heart failure with New York Heart Association \\[NYHA\\] functional classification III-IV, pericarditis, significant pericardial effusion, significant coronary stent occlusion, poorly controlled deep venous thrombosis, etc) vi. Cardiovascular disease-related requirement for daily supplemental oxygen vii. History of two or more coronary revascularization procedures within the 3 months prior to consent viii. Subjects with history of myocarditis, regardless of etiology\n   * A confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent\n   * Subjects with history of life-threatening toxicity related to prior immune therapy (eg. anti-CTLA-4 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hormone replacement after endocrinopathy).\n   * Subject has been administered prior chemotherapy or immunotherapy at any time, and any with radiation therapy within 4 weeks prior to time of consent or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to previously administered agent.\n\n     1. Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.\n     2. Subjects with endocrinopathy which is adequately controlled with hormone replacement therapy are an exception to this criterion and may qualify for the study.\n   * If subject underwent major surgery, subject must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n   * Subject has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n   * A known or underlying medical condition that, in the opinion of the investigator could make the administration of study drug hazardous to the subject or could adversely affect the ability of the subject to comply with or tolerate study therapy.\n   * Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with the study drugs.\n   * Subjects who are unable to undergo venipuncture and\u002For tolerate venous access\n   * Evidence of active infection that requires systemic antibacterial, antiviral, or antifungal therapy ≤ 7 days prior to initiation of study drug therapy\n   * Subjects who are on immunosuppressive therapy (systemic steroids 10mg and more daily use)\n   * Prisoners or subjects who are involuntarily incarcerated\n   * Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness\n   * Inability to comply with restrictions and prohibited activities and treatments",{"count":19,"type":20},[97],"PHASE1","Nivolumab (and other agents affecting the anti-programmed death-1 \\[anti-PD-1\\] pathway) have demonstrated anti-tumor activity in multiple tumor types. Combinations of immune-oncology (IO) agents with complimentary mechanisms as well as radiation represent a promising strategy to improve response rates to immunotherapy and overcome resistance. In this phase I\u002FIb study, radiation will be used in combination with IO agents nivolumab and anti-IL-8 (BMS-986253) to assess toxicity by organ system and then assess the preliminary efficacy of the treatment regimen. In Part 1, the study will determine the safe doses of radiation by organ site in conjunction with nivolumab and BMS-986253. In Part 2, the treatment regimen will be investigated in melanoma, prioritizing acral melanoma, to describe the response rate to treatment as well as other clinical and safety outcomes. The study will also provide the opportunity to evaluate changes in the tumor microenvironment induced by the treatment.",[24,100,101,102,103,104,105,106,107,108],"Unresectable Solid Tumors","Neoplasms","Neoplasms by Histologic Type","Neoplasms by Site","Antineoplastic Agents, Immunological","Antineoplastic Agents","Immune Checkpoint Inhibitors","Molecular Mechanisms of Pharmacological Action","Nivolumab",[110,111,112],"Anti-PD-1 monoclonal antibody (mAb)","Anti-IL-8","Stereotactic Body Radiotherapy (SBRT)","2025-07-29",{"date":115,"type":33},"2025-08-01",{"date":117,"type":33},"2021-11-29",{"date":119,"type":20},"2027-05-31",{"name":39,"class":40},2,""]