[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-grade-ovarian-serous-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-grade-ovarian-serous-adenocarcinoma":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,50,80,129,170,193],{"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":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100550778","phase-1-this-is-a-phase-1-trial-of-zm008-an-anti-llt1-antibody-used-as-single-agent-followed-by-combination-treatment-with-toripalimab-in-patients-with-advanced-solid-tumors-100550778",false,"NCT06451497","This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors","Phase 1 Dose Escalation Trial of ZM008, an Anti-LLT1 Antibody, as Single Agent Followed by Combination With Toripalimab in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Adult patients aged 18 years and older, at the time of signing the informed consent form.\n2. Part 1: Patients with histologically confirmed diagnosis of advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors that have no standard therapeutic option with a proven clinical benefit or are intolerant to these therapies with the following selected tumor histologies: NSCLC, triple-negative breast cancer, head and neck squamous cell carcinoma, prostate cancer, colorectal cancer, pancreatic ductal adenocarcinoma, biliary tract cancer, high grade serous ovarian cancer, diffuse large B cell lymphoma, kidney cancer, or urothelial cancer. This selection corresponds to tumor histologies known to express higher LLT1 levels. Other tumor histologies can be enrolled only if approved by the sponsor after discussion with the investigator. Tumors should be progressing or deserving another anticancer treatment in the opinion of the investigator. Part 2: The same patient population as Part 1 although it will be enriched or modified based on the observed antitumor activity observed in Part 1. In case the patient population is modified to include patients with standard therapeutic alternatives, a substantial amendment will be issued.\n3. Patients with tumors with actionable mutations should have progressed to all approved targeted therapies or have them contraindicated.\n4. The patient has measurable disease with RECIST 1. 1 on computed tomography (CT), positron emission tomography (PET)\u002FCT, or magnetic resonance imaging (MRI) scan. Imaging tests outside the screening period are valid if performed not more than 3 weeks before consent signature and otherwise fulfill protocol criteria. Patients with non-measurable disease may be allowed in Part 1 only with the explicit approval of the trial Medical Monitor.\n5. The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. Patients with renal cell carcinoma (RCC) to be allocated to a backfill cohort in Part 1 can have PS ≤2.\n6. The patient has adequate hematologic function as defined by:\n\n   1. Hemoglobin ≥9 g\u002FdL (whole or partial blood transfusions not allowed in the two previous weeks).\n   2. Absolute neutrophil count (ANC) ≥1.0 × 109\u002FL (growth factors like granulocyte colony-stimulating factor are not allowed in the two previous weeks).\n   3. Platelet count ≥75 × 109\u002FL (platelet transfusions are not allowed in the two previous weeks).\n7. The patient has adequate hepatic function as defined by:\n\n   1. Total bilirubin ≤1.5 times upper limit of normal (ULN).\n   2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 times ULN, (if liver metastases are present, then ≤5.0 times ULN is allowed).\n   3. The patient has adequate renal function as defined by: estimated creatinine clearance (CrCL) using the Cockcroft- Gault formula ≥30 mL\u002Fminute.\n8. Women of childbearing potential (WOCBP) and men with sexual partners who are WOCBP must consent to adhere to contraceptive requirements as detailed in the protocol from the day of the signature of the informed consent to at least 4 months after the last dose of trial treatment.\n9. Suitable venous access for safe drug administration and the trial-required drug concentration and pharmacodynamic sampling.\n10. Permission to access archival biopsy located at the treating site or elsewhere. Note: Archival tissue does not need to be checked before Cycle 1 Day 1. The most modern archival biopsy is requested. If no archival tissue is available, the patient can still be enrolled in the escalation phase but not in Part 2.\n11. Pretreatment fresh biopsy is highly encouraged in Part 1 dose escalation once BED has been achieved. In Part 2, fresh pre-treatment and on-treatment biopsies should be obtained unless biopsy is associated with significant risk or declined by the patient and per discussion with the sponsor medical monitor (or designee).\n\nExclusion criteria:\n\n1. Patients should have recovered from toxicity related to previous anticancer treatments (including surgery and radiation) to Grade 0\u002F1 or baseline (except alopecia and peripheral neuropathy). Patients with endocrinopathies should have the replacement treatment in stable dosing.\n2. The patient has a history of uncontrolled brain metastasis. Patients with brain metastases are allowed if they are previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery and have new brain imaging confirming that brain metastasis are stable (without evidence of progression by imaging using the identical imaging modality for each assessment, either MRI or CT) and considered controlled with \\\u003C10 mg\u002Fday prednisone equivalent at the time of receiving the first dose of ZM008. For asymptomatic patients, screening brain imaging is not required.\n3. The patient has received extended field radiotherapy ≤4 weeks before the start of treatment (≤2 weeks for limited field radiation for palliation), and who has not recovered to Grade ≤1 or baseline from related side effects of such therapy (except for alopecia).\n4. The patient had an active infection requiring parenteral or oral antibiotics at the time of the first dose. Patients receiving oral antibiotics can be enrolled after discussion and approval of the trial Medical Monitor.\n5. The patient has evidence of serious uncontrolled medical disorder that, in the opinion of the investigator or Medical Monitor, makes it unwise for the patient to participate in the trial or that might jeopardize compliance with the protocol.\n6. The patient has a psychiatric illness\u002Fsocial circumstance that would limit compliance with trial requirements and substantially increase the risk of AEs or has compromised ability to provide written informed consent.\n7. The patient has clinical evidence of an active second invasive malignancy with the exception of stable prostate cancer on watchful waiting, in situ cervical cancer, in situ breast carcinoma or localized non-melanoma skin cancers.\n8. The patient has uncontrolled or significant cardiovascular disease defined as New York Heart Association classification III or IV.\n9. The patient has baseline QTc (using the Fridericia correction calculation) \\>470 msec in patients without pacemaker. Active autoimmune disease that is requiring systemic treatment (i.e., with use of disease modifying agents, corticosteroids at \\>10 mg\u002Fday of equivalent prednisone, or immunosuppressive drugs at any dose). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Participants with adrenal insufficiency on oral steroid replacement are allowed to participate in the study. Participants with controlled type I diabetes mellitus on stable insulin regimen are also eligible for the study. Participants with rheumatoid arthritis or psoriasis may be eligible if they have not experienced a flare in 2 years and do not require systemic therapy within the past year. Participants with vitiligo are also eligible.\n10. Use of therapeutic immunosuppressive medication (eg, prednisone dose of ≥ 10 mg\u002Fday or equivalent, tumor necrosis factor inhibitors at any dose) within 28 days prior to the first planned dose of study treatment. This does not include intranasal, intraocular, inhaled corticosteroids, topical and intra-articular joint injections, or physiologic replacement doses of systemic corticosteroids. Less than 10 mg prednisone per day or equivalent, short term, is allowed.\n11. For patients in the ZM008 monotherapy and combination arms: Patients who discontinued prior treatment with any immune checkpoint due to immune-related AEs, irrespective of grade, recovery, or need for continued steroid therapy. Also, patients without formal contraindication due to previous irAE are not eligible if the AE has not resolved to Grade 1 or better and\u002For still requires steroids (\\>10 mg of prednisone equivalent per day) for ongoing management.\n12. History of interstitial lung disease\u002Fnon-infectious pneumonitis, including immune-related pneumonitis of any Grade, radiation pneumonitis, active pulmonary tuberculosis, or evidence of active pneumonitis on screening chest CT scan. Participants with radiation therapy to the lung that is \\>30 Gy within 6 months of the first dose of treatment are excluded. Participants with active lung infections requiring treatment are also excluded.\n13. The patient has live vaccines reception within 30 days of enrollment.\n14. Known active hepatitis B or C.\n15. Patients positive for human immunodeficiency virus (HIV) can be enrolled only in Part 2 of the trial, but HIV-positive patients must meet the following criteria: a. have CD4+ T cell (CD4+) counts ≥350 cells\u002FμL. b. have not had an opportunistic infection within the past 12 months. Patients on prophylactic antimicrobials can be included in the trial. c. should be on established antiretroviral therapy for at least 4 weeks. d. have an HIV viral load of less than 400 copies\u002FmL prior to enrollment. e. known history of any other relevant congenital or acquired immunodeficiency other than HIV infection.\n16. Has known or suspected allergy to trial treatment, excipients, or related products.\n17. Prior allogeneic bone marrow transplantation or solid organ transplantation.\n18. Toripalimab cohort only: Any contraindication present in the toripalimab prescribing information.","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a phase 1 dose escalation trial of ZM008, an anti-LLT1 antibody as a single agent followed by combination with Toripalimab in patients with advanced solid tumors who have exhausted all standard therapy available or are intolerant of the same.",[26,27,28,29,30,31,32,33,34,35,36],"Non Small Cell Lung Cancer","Head and Neck Squamous Cell Carcinoma","Pancreas Adenocarcinoma","Biliary Tract Cancer","Prostate Cancer","Urothelial Carcinoma","Colorectal Cancer","Triple Negative Breast Cancer","High Grade Ovarian Serous Adenocarcinoma","Diffuse Large B Cell Lymphoma","Renal Cell Cancer Metastatic","RECRUITING","2026-03-27",{"date":40,"type":41},"2026-04-02","ACTUAL",{"date":43,"type":41},"2024-05-22",{"date":45,"type":20},"2027-04",{"name":47,"class":48},"Zumutor Biologics Inc.","INDUSTRY",3,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100464579","phase-1-modi-1-moditope-in-breast-head-and-neck-ovarian-or-renal-cancer-100464579","NCT05329532","Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer","A Phase 1\u002F2, Multicentre, Open-Label Study of Modi-1 Moditope in Patients With Breast, Head and Neck, Ovarian, or Renal Cancer","ModiFY","INCLUSION CRITERIA\n\n1. Patient either has one of the following histologically or cytologically confirmed advanced cancers not amenable to curative intent surgical resection:\n\n   * TNBC\n   * SCCHN (oral cavity, oropharynx, hypopharynx, or larynx)\n   * HGSOC including fallopian tube and primary peritoneal cancers\n   * RCC Or the patient has histologically or cytologically confirmed SCCHN scheduled to have curative intent surgical resection.\n2. Patient must meet one of the following specific criteria for prior treatment of the relevant tumour type:\n\n   * TNBC:\n\n     * patient has received available standard therapy for advanced disease (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient stopped immunotherapy due to toxicity and with residual disease as measurable by RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient completing a systemic treatment regimen with immunotherapy, for whom a subsequent SOC therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient has refused SOC therapy (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n   * SCCHN:\n\n     * patient has received first-line platinum-containing chemotherapy (with or without radiotherapy) as treatment for advanced disease (Modi-1ev\u002FModi-1eKv monotherapy and Modi-1ev\u002FModi-1eKv + CPI cohorts).\n     * patient with locally advanced or metastatic disease measurable by RECIST 1.1 for whom all forms of platinum-based chemoradiotherapy treatment are contraindicated (Modi-1ev\u002FModi-1eKv monotherapy and Modi-1ev\u002FModi-1eKv + CPI cohorts).\n     * patient completing immunotherapy for whom a subsequent SOC therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient stopped immunotherapy due to toxicity or completion of immunotherapy but with measurable disease in accordance with RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient with untreated metastatic or unresectable recurrent SCCHN whose tumours express PD-L1 with a combined positive score (CPS) of one or more and are eligible for SOC immunotherapy (Modi-1ev\u002FModi-1eKv + CPI cohort only). Patients who received their first dose of CPI therapy within 28 days of the first dose of Modi-1ev\u002FModi-1eKv are eligible.\n     * patient has refused SOC therapy (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n   * SCCHN:\n\n     o neoadjuvant expansion cohort only; patients who are treatment-naïve and are scheduled to have tumour resection surgery, in whom minimum of 3 weeks of Modi-1ev\u002FModi-1eKv and a single 400 mg intravenous (i.v.) total dose of pembrolizumab immunotherapy can be administered. Patients will only be enrolled once the Modi-1 Moditope® expansion doses and a lack of increased anti-CCP antibodies (with, and without, concomitant pembrolizumab) have been established.\n   * HGSOC including fallopian tube and primary peritoneal cancers:\n\n     * patient must be considered unsuitable for platinum chemotherapy, defined as recurrence\u002Fprogression within 6 months of prior platinum-containing chemotherapy or patients in whom platinum therapy is no longer thought appropriate. Patient must have received no more than two non-platinum regimens, from the time the patient is considered unsuitable for platinum chemotherapy (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient completing a course of systemic therapy for whom a subsequent SOC therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient has refused SOC therapy (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n   * RCC:\n\n     * patient is untreated for advanced RCC (Modi-1ev\u002FModi-1eKv + CPI doublet cohort only).\n     * patient has received first-line treatment consisting of anti-angiogenic therapy (Modi-1ev\u002FModi-1eKv monotherapy cohort).\n     * patient has favourable or intermediate International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) risk score (Heng et al. 2013) (Modi-1ev\u002FModi-1eKv monotherapy cohort).\n     * patient has intermediate or poor International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) risk score (Heng et al. 2013) and is eligible for SOC nivolumab with ipilimumab immunotherapy (Modi-1ev\u002FModi-1eKv + CPI doublet cohort only).\n     * patient has stopped immunotherapy due to toxicity and with residual disease as measurable by RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient completing immunotherapy, for whom a subsequent SOC therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient on active surveillance (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient is eligible for SOC nivolumab with ipilimumab immunotherapy (Modi-1ev\u002FModi-1eKv + CPI doublet cohort only).\n     * patient has refused SOC therapy (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n3. Where applicable, patient has completed last dose of prior cancer therapy at least 4 weeks before the first dose of study treatment.\n4. Patient has been fully vaccinated against COVID-19, the last vaccination being at least 14 days prior to the patient's first dose of IMP, except for those who have declined or are not eligible for COVID-19 vaccination.\n5. Patient has recovered to Grade ≤1 (CTCAE v5.0) from the effects (excluding alopecia) of any prior therapy for their malignancies.\n6. Patient has at least one measurable lesion per RECIST 1.1 criteria by computed tomography (CT) scan or magnetic resonance imaging (MRI) (non-neoadjuvant cohorts).\n7. Wherever possible, patients not scheduled for curative intent resection surgery should have a fresh tumour biopsy (or have an archival biopsy \\[obtained within the past 5 years\\] if obtaining a fresh biopsy is not feasible) at baseline for molecular studies, and agree to a post-treatment biopsy (at Week 25 or one of the EOT visits), if feasible. Patients in the SCCHN neoadjuvant cohort must have both a fresh pre-treatment biopsy and agree to have their resected tumour analysed.\n8. Patient is male or female and at least 18 years of age.\n9. Patient has a life expectancy of more than 6 months.\n10. Patient has an ECOG performance status of 0 or 1.\n11. Patient has adequate organ function as determined by the following laboratory values: absolute neutrophil count ≥1.5 x 109\u002FL, platelets ≥100 x 109\u002FL, haemoglobin \\>90 g\u002FL (\\>5.6 mmol\u002FL), lymphocytes ≥ 1 x 109\u002FL, serum creatinine ≤1.5 x upper limit of the normal range (ULN), serum total bilirubin ≤1.5 x ULN, serum transaminases (aspartate aminotransferase \\[AST\\]\u002Falanine aminotransferase \\[ALT\\]) ≤2.5 x ULN or ≤5.0 x ULN if liver metastases present.\n12. Patient must be able and willing to provide written informed consent prior to any study related procedure. (In the event that the patient is re-screened for study participation or if a protocol amendment alters the care of an ongoing patient, a new informed consent form must be signed).\n13. Women of child-bearing potential must have a negative serum pregnancy test during Screening (and a urine test within the 7 days prior to Day 1) and be neither breastfeeding nor intending to become pregnant during study participation. Women of child-bearing potential must agree to use highly effective contraceptive methods prior to study entry, for the duration of study participation, and for 120 days after discontinuation of vaccine monotherapy or 5 months after use with a CPI (or longer if the Summary of Product Characteristics \\[SmPC\\] of the CPI requires it).\n14. Men who are potentially fertile with partners of child-bearing potential must agree to use highly effective contraceptive methods for the duration of study participation, and for 120 days after discontinuation of vaccine monotherapy or 5 months after use with a CPI (or longer if the SmPC of the CPI requires it).\n15. Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n16. Patient scheduled to receive a CPI (e.g., pembrolizumab alone or nivolumab alone or where applicable with ipilimumab) together with Modi-1ev\u002FModi-1eKv must have been clinically evaluated, have not received prior CPI therapy, and the CPI must be deemed an appropriate treatment for their disease according to the CPI's SmPC (this does not apply to the neoadjuvant SCCHN cohort).\n\nEXCLUSION CRITERIA\n\n1. Patient has symptomatic central nervous system metastases or carcinomatous meningitis.\n2. Patient is taking any systemic steroid therapy (exceeding 10 mg\u002Fday of prednisolone or equivalent) or is on any other form of immune suppressant medication within 2 weeks prior to the first dose of IMP. Physiological doses of systemic steroids such as those for the management of adrenal insufficiency, topical and inhaled steroids, such as those for the management of asthma, and patients with hypothyroidism stable on hormone replacement, are permitted.\n3. Patient has a history of malignancy other than the disease under study within 2 years prior to Screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 2-year overall survival rate \\>90%), such as adequately treated carcinoma-in-situ of the breast or the cervix, melanoma-in-situ, non-melanoma skin carcinoma, superficial bladder cancer, prostate cancer with Gleason grade ≤6 and prostate specific antigen within normal range or stage I endometrial cancer.\n4. Patient is pregnant, lactating, or is expecting to conceive\u002Ffather children within the duration of the study.\n5. Patient has a concurrent illness which would preclude study conduct and assessment, including, but not limited to, uncontrolled medical conditions, uncontrolled and active infection (considered opportunistic, life threatening, or clinically significant), uncontrolled risk of bleeding, uncontrolled diabetes mellitus, pulmonary disease (including obstructive pulmonary disease and pulmonary fibrosis), alcoholic liver disease, or primary biliary cirrhosis.\n6. Patient has New York Heart Association (NYHA) class III or IV heart disease, myocardial infarction or stroke within previous 6 months, a history of significant cardiac abnormality and\u002For significant abnormal baseline ECG readout, active ischaemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy, uncontrolled hypertension, significant cerebrovascular disease, or congestive heart failure.\n7. Patient has anti-CCP antibody levels classified as equivocal or positive according to NHS guidelines, i.e., ≥ the ULN, or has an active autoimmune disease that may impact on the study treatment in the opinion of the Investigator.\n8. Patient has received a live vaccine within 28 days, or an influenza vaccine within 14 days prior to the first dose of IMP. The timing of any other vaccines should be assessed on a case-by-case basis by the Investigator prior to study enrolment.\n9. Patient has a known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV; surface antigen reactive) or hepatitis C (HCV; RNA detected).\n10. COVID-19 vaccination within 14 days prior to the first dose of IMP.\n11. Patient has a known current or recent history (within the last year) of substance abuse including illicit drugs or alcohol.\n12. History of any of the following: drug-induced severe cutaneous adverse reaction (SCAR; including, but not limited to Stevens-Johnson syndrome\u002Ftoxic epidermal necrolysis \\[SJS\u002FTEN\\], or drug reaction with eosinophilia and systemic symptoms \\[DRESS\\]), or dose-limiting immune-mediated reactions (Modi-1ev\u002FModi-1eKv + CPI RCC cohort only).\n13. Patient has a known hypersensitivity to the IMP under study or their excipients. Where SOC CPIs are planned to be given with the IMP, the patient must not have a known hypersensitivity to the CPIs or their excipients.",{"count":59,"type":20},168,[23,61],"PHASE2","The main objectives of this study are to assess the safety, tolerability, immunological activity, and preliminary efficacy of the Modi-1 Moditope vaccine, both as monotherapy and in combination with a checkpoint inhibitor (CPI) such as pembrolizumab or nivolumab with or without Ipilimumab (where these are standard of care in a non-neoadjuvant setting), in patients with advanced triple negative breast cancer (TNBC), advanced\u002Funresectable human papillomavirus-negative squamous cell carcinoma of the head and neck (SCCHN), high grade serous ovarian carcinoma (HGSOC), or renal cell carcinoma (RCC).\n\nModi-1 Moditope will also be investigated in the neoadjuvant setting for patients with SCCHN undergoing curative intent surgical resection in combination with pembrolizumab versus the Modi-1 alone.",[33,64,34,65],"Renal Cell Cancer","Squamous Cell Carcinoma of the Head and Neck",[67,68,69],"vaccine","peptide","Phase II","2025-09-11",{"date":72,"type":41},"2025-09-17",{"date":74,"type":41},"2022-04-07",{"date":76,"type":20},"2027-07-01",{"name":78,"class":48},"Scancell Ltd",16,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":87,"minAge":88,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":108,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":5},"100423474","developing-a-test-of-uterine-lavage-for-the-detection-of-ovarian-cancer-100423474","NCT04794322","Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer","Ovarian Cancer Detection by Uterine Lavage DNA and Serum Proteins: a Phase 2 Biomarker Study","Inclusion Criteria:\n\n* Has intact uterus (no history of uterine ablation, tubal ligation or bilateral salpingectomy)\n* Cohort 1 (n=200 participants): Women scheduled for surgery or diagnostic laparoscopy for suspected but undiagnosed ovarian\u002Ffallopian tube cancer\n* Cohort 2 (n=50 participants): Known BRCA1 or BRCA2 mutation carrier scheduled for risk-reducing salpingo-oophorectomy\n\nExclusion Criteria:\n\n* Current tissue or cytology diagnostic procedure positive for ovary cancer or any cancer\n* Inability to provide informed consent\n* Age less than 30 years\n* Inability to obtain the minimum amount of blood\n* Inability to obtain the minimum amount of uterine lavage sample\n* At risk if blood were drawn (e.g. hemophilia, serious anemia- Hb less than 8.0 gm\u002FdL)\n* Prior history of known ovarian or endometrial cancer\n* Treatment less than 1 year (excluding hormonal therapy) for cancer that spread beyond its origin\n* History of untreated high-grade cervical dysplasia (CIN3)\n* History of treated high grade cervical dysplasia (CIN3) with a cytologically abnormal pap smear within the past year. If there is no post treatment Pap smear in the medical record, perform a Pap smear prior to the day of surgery. If this Pap smear is abnormal, the participant is ineligible.\n* Currently pregnant\n* Known Lynch syndrome","FEMALE","30 Years",{"count":90,"type":20},250,"OBSERVATIONAL","The study aims to develop a test for early detection of ovarian cancer using DNA from a growth involving the ovary found in a washing of the uterus (womb), and proteins found in the blood. The samples of the wash and the blood will be taken before surgery. After surgery, doctors will determine whether the participant had ovarian cancer or a benign disease of the ovaries. The tests of the washings and the blood will be examined to see how much the participants with ovarian cancer can be separated from the participants with a benign ovarian disease by the tests. Small amounts from the washing and the blood samples will be sent to four sites for analysis.\n\nStatistical analyses of these data will compare tumor DNA found in the washing of the uterus with proteins in the blood to detect cases of ovarian cancer. The primary goal is to find tests that are mostly positive for cases of ovarian cancer and mostly negative for patients with benign disease. It is hoped that if the tests work for participants with symptoms of the disease that these tests will also work when testing women who have no symptoms. A new study would be needed to see if the tests worked in this situation. If the tests work, this could lead to increasing the number of cases detected in early stage disease and decreasing the number of cases detected in late stage disease. If this change in late stage is large, it will likely reduce deaths due to ovarian cancer.",[94,95,96,34,97,98,99,100,101,102,103,104,105,106,107],"Ovarian Neoplasms","Ovarian Epithelial Carcinoma","Fallopian Tube Neoplasms","Stage I Ovarian Cancer","Stage II Ovarian Cancer","Stage III Ovarian Cancer AJCC v8","Stage IIIA Ovarian Cancer AJCC v8","Stage IIIA1 Ovarian Cancer AJCC v8","Stage IIIA2 Ovarian Cancer AJCC v8","Stage IIIB Ovarian Cancer AJCC v8","Stage IIIC Ovarian Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IVA Ovarian Cancer AJCC v8","Stage IVB Ovarian Cancer AJCC v8",[109,110,111,112,113,114,115,116,117,118],"Uterine Lavage","Tumor DNA","Serum proteins","Ovarian neoplasms","Ovarian epithelial carcinoma","Ovarian cancer","Ovarian epithelial cancer","Neoplasms","Ovarian diseases","Early detection","2025-09-10",{"date":121,"type":41},"2025-09-16",{"date":123,"type":41},"2020-04-13",{"date":125,"type":20},"2028-08-31",{"name":127,"class":128},"Massachusetts General Hospital","OTHER",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":87,"minAge":17,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":169},"100427509","multi-layer-data-to-improve-diagnosis-predict-therapy-resistance-and-suggest-targeted-therapies-in-hgsoc-100427509","NCT04846933","Multi-layer Data to Improve Diagnosis, Predict Therapy Resistance and Suggest Targeted Therapies in HGSOC","Integration of Multiple Data Levels to Improve Diagnosis, Predict Treatment Response and Suggest Targets to Overcome Therapy Resistance in High-grade Serous Ovarian Cancer","DECIDER","Inclusion Criteria:\n\n* Patients with a suspected ovarian cancer diagnosis treated at the Turku University Hospital\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Age \\\u003C18 years, too poor condition for active treatment (surgery, chemotherapy)\n* FDG PET\u002FCT scan is not performed for patients with diabetes mellitus and poor glucose balance.",{"count":138,"type":20},200,[140],"NA","Chemotherapy resistance is the greatest contributor to mortality in advanced cancers and severe challenges remain in finding effective treatment modalities to cancer patients with metastasized and relapsed disease. High-grade serous ovarian cancer (HGSOC) is typically diagnosed at a stage where the disease is already widely spread to the abdomen and current standard of practice treatment consists of surgery followed by platinum-taxane based chemotherapy and maintenance therapy. While 90% of HGSOC patients show no clinically detectable signs of cancer after surgery and chemotherapy, only 43% of the patients are alive five years after diagnosis because of chemoresistant cancer.\n\nThis prospective, observational trial focuses on revealing major mechanisms causing chemoresistance in HGSOG patients and derive personalized treatment regimens for chemotherapy resistant HGSOC patients. The investigators recruit newly diagnosed advanced stage HGSOC patients who are then thoroughly followed during their cancer treatment. Longitudinal sampling includes digitalized H\\&E stained histology slides mainly collected during routine diagnostics, fresh tumor \\& ascites samples for next-generation sequencing\u002Fproteomics (WGS, RNA-seq, DNA-methylation, ATAC-seq, ChIP-seq, mass cytometry, etc.) and ex vivo experiments, plasma samples for circulating tumor DNA (ctDNA) analyses. Broad range of clinical parameters such as laboratory and radiologic parameters (e.g., FDG PET\u002FCT), given cancer treatments and their outcomes are collected. Radiomic analyses are performed to PET\u002FCT and CT scans. Long-term patient derived organoid lines are established from fresh tumor tissues. Actionable genomic alterations are searched.\n\nThe general objective is to establish a clinically useful precision oncology approach based on multi-level data collected in longitudinal setting, and translate the most potent and validated discoveries into clinical use. DECIDER project will produce AI-powered diagnostic tools, cutting-edge software platforms for clinical decision-making, novel data analysis \\& integration methods, and high-throughput ex vivo drug screening approaches.",[34,143],"High Grade Serous Carcinoma",[145,146,147,148,149,150,151,152,153,154,155,156,157,158],"chemoresistance","personalized medicine","WGS","ctDNA","digital pathology","FDG PET\u002FCT","bioinformatics","AI","ovarian cancer","tumor evolution","artificial intelligence","organoid","DNA methylation","radiomics","2025-01-14",{"date":161,"type":41},"2025-01-16",{"date":163,"type":41},"2012-02-01",{"date":165,"type":20},"2029-12",{"name":167,"class":168},"Turku University Hospital","OTHER_GOV",1,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":87,"minAge":17,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":183,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":169},"100558639","high-definition-profiling-of-ovarian-cancer-ascites-100558639","NCT06553742","High Definition Profiling of Ovarian Cancer Ascites","High Definition Profiling of Ovarian Cancer Ascites for the Identification of Prognostic Biomarkers and Immunotherapeutic Targets: an Integrative Cell of Origin-guided Approach","Inclusion Criteria:\n\n* Patients with suspicious or confirmed ovarian cancer pathology undergoing debulking surgery\n* Diagnosis of high grade serous ovarian cancer confirmed by histopathology assessment\n* Patients who provided written informed consent\n\nExclusion Criteria:\n\n* HIV-positive patients\n* HBV-positive patients\n* HCV-positive patients",{"count":178,"type":20},50,"This project entails the collection of a prospective cohort of ascites (AS) samples from High Grade Serous Ovarian Cancer (HGSOC) patients.\n\nHigh Grade Serous Ovarian Cancer (HGSOC) is a major cause of cancer-related mortality, due to the late-stage diagnosis and failure of surgery and chemotherapy (CHT) to eradicate the disease with no significant improvement in overall survival.\n\nThe primary objective of the project is to generate a comprehensive map of ascites cell components, detailing both their intrinsic features and the landscape of cellular interactions mediated by soluble factors in ascitic fluid.",[181,34,182],"Ovarian Cancer","Ascites","NOT_YET_RECRUITING","2024-11-18",{"date":186,"type":41},"2024-11-20",{"date":188,"type":20},"2024-11",{"date":190,"type":20},"2033-12",{"name":192,"class":128},"European Institute of Oncology",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":87,"minAge":17,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":21,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":169},"100513104","phase-2-alternative-dosing-of-niraparib-to-decrease-dose-interruption-in-first-line-maintenance-treatment-for-ovarian-cancer-100513104","NCT05961124","Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer","A Phase II, Single-Arm Trial Assessing Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer: Dose Escalation","Inclusion Criteria\n\n1. Patients must be able to understand the study, agree to participate and provide written, informed consent\n2. Patients must be female and age \\>\u002F= 18 years of age\n3. Newly diagnosed, histologically confirmed, high-grade serous and grade 3 endometrioid ovarian, primary peritoneal, or fallopian tube cancer undergoing frontline treatment\n4. Stage III and IV cancer according to International Federation of Gynecology and Obstetrics (FIGO) 2018 criteria and all patients undergoing neoadjuvant chemotherapy (NACT)\n5. Patients must meet the following front-line treatment requirements:\n\n   i. Patients must have completed a minimum of 4 cycles of platinum-based chemotherapy (carboplatin, cisplatin, oxaliplatin). Primary or interval debulking therapy and intraperitoneal chemotherapy are allowed.\n\n   ii. Patients must have a complete response or partial tumor response (no lesion \\>1cm) to platinum-based regimen\n\n   iii. CA-125 must be either:\n   1. CA-125 in normal range or\n   2. CA-125 decreased by 90% during front-line treatment and stable for a minimum of 7 days (does not increase by more than 15%) iv. Study drug can start within 12 weeks of completing chemotherapy\n6. Patients must be post-menopausal with no menses for \\>1 year, or surgically sterilized, or willing to use adequate contraception to prevent pregnancy or abstain from intercourse and agrees not to donate eggs for the purpose of reproduction from study enrollment until 6 months following the last dose of treatment.\n\n   i. Patients of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin \\[hcg\\]) within 3 days prior to receiving the first dose of study treatment.\n7. Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n8. Patients must have adequate organ function at enrollment, as follows:\n\n   i. Absolute neutrophil count \\>\u002F= 1.5 x109\u002FL ii. Platelets \\>\u002F= 100 x109\u002FL iii. Hemoglobin \\>\u002F= 100 g\u002FL without transfusion iv. Creatinine clearance \\>\u002F= 60 mL\u002Fmin using the Cockcroft-Gault equation v. Total bilirubin \\\u003C\u002F= 1.5 times the upper limit of normal (ULN) or direct bilirubin \\\u003C 1 times the upper limit of normal vi. Aspartate aminotransferase and Alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN\n9. Patients with hypertension should have their blood pressure adequately treated and controlled prior to starting study treatment\n10. Patients must be able to take oral medications\n11. Patients must agree to complete blood samples prior to cycle 1, then weekly for the first month and as outlined in the protocol\n\nExclusion Criteria:\n\n1. Patient's age is \\\u003C18 years.\n2. Patient who are pregnant, breastfeeding, or expecting to conceive children during the study treatment of for 6 months after completion of the study treatment.\n3. Patients with a known hypersensitivity to niraparib or any of its components\n4. Patients who have received a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor as part of their previous treatment or participated in a trial where PARP inhibitors were administered in one arm of the trial.\n5. Patients enrolled in another investigational trial\n6. Patients who received another investigational therapy within 4 weeks or 5 halflives of the investigational agent, whichever is longer\n7. Patients with previous persistent (\\>4 weeks) or \\>\u002F= grade 3 hematologic toxicity or fatigue from prior cancer therapy.\n8. Patients with known history of myelodysplastic syndrome or pre-treatment cytogenetic testing at risk for myelodysplastic syndrome or acute myeloid leukemia\n9. Patients receiving concurrent, prohibited medications\n10. Patients with previous major surgery within 3 weeks of starting study treatment and must have recovered from any effects of previous surgery.\n11. Patients with ascites drained within 4 weeks of starting study treatment\n12. Patients receiving palliative radiotherapy to \\>20% of bone marrow within 2 weeks or any other radiotherapy within 1 week of study treatment\n13. Patients receiving a transfusion (platelets or red blood cells) within 4 weeks of treatment\n14. Patients planning to donate blood during the study or 90 days after treatment.\n15. Patients with a diagnosis of another invasive cancer (other than ovarian cancer), within 2 years prior to randomization (except basal or squamous cell carcinoma of the skin that has been definitively treated i. Patients with uncontrolled brain or leptomeningeal metastases. Controlled brain or leptomeningeal metastasis is defined as: ii. Central nervous system disease that has undergone treatment with radiation or chemotherapy \\> 1 month before study entry\n16. No new or progressive signs or symptoms, stable steroid dose x 4 weeks or not taking steroids\n17. Patients considered poor medical risk due to serious, uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection i. Patients with known HIV considered high risk for serious and fatal outcome\n18. Patients with evidence of any condition, therapy, or laboratory abnormality that might confound study results or patient participation for full duration of study (Ex. Myelodysplastic syndrome, anemia, leukopenia, neutropenia, thrombocytopenia, etc)\n19. Patients who are immunocompromised (Patients with splenectomy are allowed)\n20. Patients with known, active hepatic disease (Ex. Hepatitis B or C), active biliary disease (exceptions for Gilbert's syndrome, asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease as per investigator assessment)\n21. Patients with QT prolongation \\>470 milliseconds at screening\n22. Patients with a known breast cancer susceptibility gene (BRCA1 and 2) mutation (as they routinely receive olaparib at our institution) If BRCA unknown they are not excluded.\n23. Patients with a history of posterior reversible encephalopathy syndrome (PRES)\n24. Patients who have had a live vaccine within 30 days of planned start date of study treatment\n25. Patients with gastrointestinal abnormalities that may limit absorption\n26. Patients with significant cardiovascular disease\n27. Patients undergoing serial blood counts to achieve a value to meet eligibility\n28. Patients receiving blood product transfusions in order to meet eligibility criteria",{"count":201,"type":20},40,[61],"The goal of this clinical trial is to test alternative dosing of niraparib in patients with newly diagnosed high-grade, advanced stage ovarian cancer. The main questions it aims to answer are:\n\nWhat is the incidence of hematologic and other adverse events? What is the incidence of dose interruption, dose reduction and discontinuation? What is the length of time of progression-free survival at 24 months?",[181,205,206,34],"Stage III Ovarian Cancer","Stage IV Ovarian Cancer","2023-11-21",{"date":209,"type":41},"2023-11-22",{"date":211,"type":41},"2023-08-21",{"date":213,"type":20},"2027-09",{"name":215,"class":128},"Sunnybrook Health Sciences Centre"]