[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Peter Hosein, MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100636397","phase-2-lorigerlimab-mgd019-in-patients-with-pancreatic-adenocarcinoma-and-homologous-recombination-deficiency-100636397",false,"NCT07565155","Lorigerlimab (MGD019) in Patients With Pancreatic Adenocarcinoma and Homologous Recombination Deficiency","A Phase 2 Trial of Lorigerlimab (MGD019) in Patients With Pancreatic Adenocarcinoma and Homologous Recombination Deficiency","Inclusion Criteria:\n\n1. Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures.\n2. ≥ 18 years of age.\n3. Histologically confirmed pancreas carcinoma with metastatic disease. Neuroendocrine neoplasms are not eligible. Adenosquamous, squamous and acinar histologies are allowed provided criteria #5 is fulfilled, and these histologies comprise no more than 10% of the total accrual.\n4. Measurable disease on baseline imaging by CT (or MRI where CT is contraindicated) based on RECIST 1.1.\n5. Documented germline mutation in BRCA1, BRCA2, PALB2, radiation sensitive protein 51 C (RAD51C), or radiation sensitive protein 51 D (RAD51D) that is known or predicted to be detrimental or lead to loss of function on a chemiluminescence immunoassay (CLIA)-approved assay (e.g. Invitae, Ambry, Myriad, Tempus).\n6. Must have an accessible tumor amenable to a safe biopsy where the major complication rate is ≤ 1.5% in the judgement of the investigator.\n7. Must have prior exposure and disease progression after at least one line of platinum-based chemotherapy. Platinum-based chemotherapy given in the neo-adjuvant or adjuvant setting also satisfies this requirement if progression occurs within 1 year of the end of adjuvant therapy.\n8. Prior receipt of a poly (ADP-ribose) polymerase (PARP) inhibitor is allowed but not mandatory.\n9. Life expectancy of at least 3 months.\n10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n11. Adequate organ function defined as the following laboratory values within 14 days of Cycle 1 Day 1:\n\n    1. Neutrophils \\>1000\u002FμL (stable off any growth factor within 4 weeks of first study treatment administration).\n    2. Platelets \\> 100 × 103\u002FμL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration).\n    3. Hemoglobin \\> 8.0 g\u002FdL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration).\n    4. Serum creatinine \\\u003C 1.5 × upper limit of normal (ULN), or creatinine clearance ≥30 mL\u002Fmin (measured or calculated using Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi)).\n    5. Aspartate aminotransferase (AST)\u002F alanine aminotransferase (ALT) \\\u003C 3.0 × ULN or \\\u003C 5.0 x ULN if liver metastases are present.\n    6. Total bilirubin \\\u003C 1.5 × ULN (except patients with Gilbert syndrome who must have a total bilirubin level of \\\u003C 3.0 × ULN).\n    7. Albumin ≥ 3.0 g\u002FdL.\n12. Female patients of childbearing potential must have a negative urine or serum pregnancy test at screening (within 72 hours of first dose of study medication) with repeat urine or serum pregnancy test of Day 1 of each cycle and at the end of treatment visit. Nonchildbearing potential is defined as: a. ≥ 50 years of age and has not had menses for greater than 1 year. b. Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation. c. Status is post hysterectomy, bilateral oophorectomy, or tubal ligation. d. Female patients who are diagnosed with a tumor that is known to secrete human chorionic gonadotropin (HCG) must be certified not pregnant based on clinical evidence and investigator judgment.\n13. Female patients of child-bearing potential must agree to use highly effective contraceptive measures starting with the screening visit through 7 months after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.\n14. Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 7 months after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.\n15. Willing and able to comply with the requirements of the protocol.\n\nExclusion Criteria:\n\n1. Has received any prior therapy with an anti-PD-1\u002FPD-L1 antibody or an anti-cytotoxic T lymphocyte-associated (CTLA) protein 4 (anti-CTLA-4) antibody.\n2. Has clinically significant ascites defined as requiring 1 or more therapeutic paracenteses in the last 4 weeks prior to study entry.\n3. Grade 2 or higher peripheral neuropathy\n4. Clinically significant gastrointestinal disorders including:\n\n   1. Any history of gastrointestinal perforation unless the affected area has been deemed by the investigator to no longer be a risk for perforation.\n   2. History of clinically significant gastrointestinal bleeding within 4 weeks prior to initiation of study treatment.\n   3. History of acute pancreatitis within 4 weeks prior to the initiation of study treatment.\n   4. Diverticulitis that is clinically significant in the opinion of the investigator based on the extent or severity of known disease and\u002For the occurrence of clinically significant disease flares within 4 weeks prior to the initiation of study treatment administration.\n   5. Bowel obstruction or impending bowel obstruction within the past 3 months.\n5. Clinically significant (i.e. active) cardiovascular disease:\n\n   1. Cerebral vascular accident\u002Fstroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.\n   2. Pericarditis or clinically significant pericardial effusion.\n   3. Any history of myocarditis.\n6. Known central nervous system (CNS) involvement as follows: a. Untreated CNS metastases. b. Leptomeningeal metastases. c. NOTE: Patients may be eligible if CNS metastases have been treated and patients have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment).\n7. Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 1 year prior to the first dose of study treatment (i.e. patients with a history of prior malignancy are eligible if treatment was completed at least 1 year before the first dose of study treatment and the patient has no evidence of disease). Patients with history of prior early-stage basal\u002Fsquamous cell skin cancer or noninvasive or in situ cancers who have undergone definitive treatment at any time are also eligible.\n8. Washout period prior to Cycle 1 Day1: Participants must recover from clinically significant adverse events from their more recent therapy or intervention prior to study enrollment.\n\n   No specific time windows are given.\n9. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n10. Symptomatic interstitial lung disease (ILD) or ILD which may interfere with detection and management of new immune-related pulmonary toxicity.\n11. History of allogeneic solid organ or stem cell transplant.\n12. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n13. Patients with a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent), are permitted in the absence of active autoimmune disease.\n14. Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e. with use of disease modifying agents or immunosuppressive drugs). Replacement therapy with thyroxine, insulin or physiologic corticosteroid replacement therapy is not considered systemic treatment for autoimmune disease.\n15. History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, 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.\n16. Breastfeeding patients.\n17. Note: All patients diagnosed with disease known to secrete HCG will test positive for pregnancy. Therefore, a positive pregnancy test is not exclusion criteria for these patients.\n\n    However, pregnancy negative status must be otherwise reasonably ascertained by other objective means.\n18. Active infection requiring treatment within 2 weeks of Cycle 1 Day1.\n19. HIV positive, except cluster of differentiation 4 (CD4) \\>200 and HIV viral load undetectable.\n20. Active hepatitis B or C infection:\n21. Patients with hepatitis B virus (HBV) infection are eligible if hepatitis B surface antigen and HBV DNA are negative.\n22. Patients with hepatitis C virus (HCV) infection are eligible if HCV RNA is negative.\n23. Participants with impaired decision-making capacity","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to determine the objective response rate (ORR) to lorigerlimab in patients with refractory pancreatic ductal adenocarcinoma (PDAC) and pathogenic germline variants (PGVs) in breast cancer type 1 or 2 susceptibility protein (BRCA1\u002F2), Partner and Localizer of BRCA2 (PALB2) and radiation sensitive protein 51 C or D (RAD51C\u002FD).",[26,27],"Pancreatic Adenocarcinoma","Homologous Recombination Deficiency","NOT_YET_RECRUITING","2026-04-27",{"date":31,"type":32},"2026-05-04","ACTUAL",{"date":34,"type":20},"2026-06-01",{"date":36,"type":20},"2031-06-01",{"name":38,"class":39},"Peter Hosein, MD","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":40},"100584450","phase-1-svv-001-with-nivolumab-and-ipilimumab-in-patients-with-poorly-differentiated-neuroendocrine-carcinomas-nec-or-well-differentiated-high-grade-neuroendocrine-tumors-net-100584450","NCT06889493","SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Differentiated High-Grade Neuroendocrine Tumors (NET)","A Phase 1 Trial of the Oncolytic Virus SVV-001 in Combination With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas or Well-Differentiated High-Grade (Grade 3) Neuroendocrine Tumors","Inclusion Criteria:\n\n1. Male or female patients, 18 years of age or older at the time of consent.\n2. Life expectancy of 6 months or greater as assessed by the treating oncologist.\n3. Have advanced metastatic disease that has progressed on at least one line of available therapy.\n4. Histologically or cytologically confirmed diagnosis of Grade 3 well-differentiated neuroendocrine tumor (NET) or poorly differentiated neuroendocrine carcinoma (NEC; large-cell neuroendocrine carcinoma, small-cell carcinoma, mixed neuroendocrine non neuroendocrine carcinoma). Note: if an archival tissue sample collected ≤ 2 years from enrollment is unavailable at Screening for diagnostic confirmation, at the Principal Investigator's (PI's) discretion, a screening biopsy will be ordered.\n5. For patients in Part 1A, in addition to histological or cytological confirmation of NEC or NET (see Inclusion #4), radiological confirmation of tumor is required.\n6. Parts 1B and 2 only: Measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or immune-related Response Evaluation Criteria in Solid Tumors (iRECIST). At least one lesion must be suitable for multiple injections (up to 6 injections every 2 weeks) with SVV-001. Lesions for injection must be ≥10 mm in longest diameter and deemed safe and suitable for injection by the Investigator.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. Recovered to Grade 1 or baseline from any clinically significant toxicity associated with prior treatments (excluding alopecia) prior to initiation of investigational medicinal product (IMP) administration.\n9. Adequate hematological, renal, and liver function defined as follows:\n\n   * a. Hepatic:\n\n     * i. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) (≤5 × ULN if liver metastases are present)\n     * ii. Serum bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis)\n   * b. Renal:\n\n     * i. Creatinine clearance ≥50 mL\u002Fminute using Cockcroft Gault equation\n   * c. Hematologic:\n\n     * i. Absolute neutrophil count ≥1500 cells\u002FµL\n     * ii. Platelet count ≥100,000 platelets\u002FµL\n     * iii. Hemoglobin ≥9.0 g\u002FdL\n     * iv. International normalization ratio (INR) within the institutional normal range\n     * v. Normal prothrombin time (PT) and partial thromboplastin time (PTT)\n10. For Part 2 Expansion Cohort patients only, patients will submit archival tissue at Screening and undergo a post-treatment biopsy according to the treating institution's guidelines with the following exceptions:\n\n    * a. If an archival tissue sample collected ≤ 2 years from enrollment is unavailable at Screening, at the PI's discretion, a screening biopsy will be ordered.\n    * b. Participants will not undergo a biopsy procedure for collection of the post-treatment biopsy if, in the discretion of their treating physician, the participant's condition has deteriorated to the point where performance of a biopsy procedure would place the participant at an increased risk for complications beyond what is reasonably expected for a biopsy collected as part of the participant's standard medical care.\n11. Women of childbearing potential must agree to use a reliable form of contraceptive during the trial treatment period and for at least 7 months following the last dose of IMP.\n12. Male patients must agree to use an adequate method of contraception during the trial treatment period and for at least 7 months following the last dose of IMP.\n13. Patient is willing and able to comply with all protocol-required assessments, visits, and procedures.\n14. Provide written informed consent prior to performing any trial-related procedure.\n\nExclusion Criteria:\n\n1. Any active second malignancy within the 2 years prior to the screening visit, unless the patient has undergone curative surgery for the tumors such as in situ cervical cancer or squamous cell cancer of the skin.\n2. Has had cytotoxic chemotherapy or radiation therapy within 3 weeks; and less than 5 half-lives or 6 weeks, whichever is shorter, from prior biologic therapies, prior to the first dose of SVV-001.\n3. Has undergone a major surgical procedure (as defined by the Investigator) or significant traumatic injury within 28 days prior to the first dose of SVV-001.\n4. Has any physical abnormality of the tissue\u002Forgan to be biopsied that would put the patient at increased risk of bleeding secondary to the injection and\u002For biopsy.\n5. Has received a live-virus immunization within 30 days prior to the screening visit or anticipates receiving a live virus immunization during the trial or within 30 days of the last treatment with IMP.\n6. Presence of an active autoimmune or inflammatory disease requiring systemic treatment within the past 2 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or other immunosuppressive medications. Local steroid injections, intermittent use of topical, inhaled, ophthalmologic, intra-articular, or intranasal corticosteroids, or systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or equivalent would not result in exclusion from the trial.\n7. Presence of primary immunodeficiency or receiving systemic steroids of \\>10 mg\u002Fday prednisone or equivalent or other immunosuppressive agents within 14 days prior to the first dose of SVV-001.\n8. Any active infection, including known infection with human immunodeficiency virus (HIV), active hepatitis, or seropositive for hepatis B immunoglobulin (Ig) M core antibody or hepatitis C ribonucleic acid (RNA) at the screening visit.\n9. Patients with a history of solid-organ or bone marrow transplant.\n10. Known hypersensitivity to ipilimumab or nivolumab or their excipients\n11. Has known untreated central nervous system metastases. Patients with treated brain metastases are eligible as long as they are stable and there is no evidence of progression for at least 4 weeks after central nervous system-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging (MRI) or computed tomography (CT)) during the screening period.\n12. Any clinically significant (i.e., active) cardiovascular disease, including cerebral vascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.\n13. Patients with an ejection fraction (EF) \\\u003C 50 on a 2D echocardiogram (ECHO).\n14. Patients whose baseline pulse oximetry (saturation of peripheral oxygen (SpO2)) is \\\u003C 92% on Room air.\n15. Any chronic illness, psychiatric condition, or social situation that is life threatening or, in the opinion of the Investigator, renders the patient unsuitable for participation in a clinical trial due to possible noncompliance or would place the patient at an unacceptable risk and\u002For have the potential to affect interpretation of the results of the trial.\n16. Female participants who are breastfeeding and\u002For who have a positive pregnancy test result prior to receiving any treatment with IMP.\n17. Patients with impaired decision-making capacity.",{"count":49,"type":20},36,[51],"PHASE1","The purpose of this study is to determine:\n\n1. The highest dose of the trial intervention that targets neuroendocrine tumors and is tolerated by patients.\n2. The highest frequency of dosing of the trial intervention that targets neuroendocrine tumors and is tolerated by patients.\n3. The highest dose and frequency of dosing of the trial intervention that targets neuroendocrine tumors with at least the same degree of effectiveness and tolerability as currently available (standard of care) treatments for patients with neuroendocrine tumors.",[54,55],"Neuroendocrine Carcinoma","Neuroendocrine Tumors","RECRUITING",{"date":58,"type":32},"2026-04-28",{"date":60,"type":32},"2025-05-19",{"date":62,"type":20},"2030-06-01",{"name":38,"class":39},""]