[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-nut-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-nut-carcinoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,68],{"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":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100467889","phase-1-testing-the-safety-and-efficacy-of-the-combination-of-two-anti-cancer-drugs-zen003694-and-abemaciclib-for-adult-and-pediatric-patients-12-17-years-with-metastatic-or-unresectable-nut-carcinoma-breast-cancer-and-other-solid-tumors-100467889",false,"NCT05372640","Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors","A Phase 1 Study of BET Bromodomain Inhibitor ZEN003694 in Combination With the CDK4\u002F6 Inhibitor Abemaciclib in Patients With NUT Carcinoma, Breast Cancer and Other Solid Tumors","Inclusion Criteria:\n\n* Participants must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective\n* Dose Escalation Cohort Only: Participants must have evaluable disease or measurable disease per RECIST 1.1 criteria\n* Dose Expansion Cohort Only:\n\n  * Participants must have a diagnosis of NUT carcinoma (NC) based on standard criteria for the disease, with diagnostic testing performed in a Clinical Laboratory Improvement Act (CLIA) certified laboratory:\n\n    * Ectopic expression of NUT protein per World Health Organization (WHO) criteria as determined by immunohistochemistry (IHC) testing, OR\n    * Detection of the NUT gene translocation as determined by fluorescence in situ hybridization (FISH) testing, OR\n    * Detection of the NUT gene translocation as determined by either deoxyribonucleic acid (DNA) next-generation sequencing (NGS) or ribonucleic acid (RNA) sequencing.\n  * Participants must have measurable disease per RECIST 1.1 criteria\n* Any number of prior lines of therapy in the metastatic setting are allowed, including prior BET inhibitor therapy and prior CDK4\u002F6 inhibitor therapy\n* Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] grade =\\\u003C 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy\n* Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy\n* Participants may have previously undergone surgical resection\n* Age \\>= 12 years. Patients 12-17 years of age must be \\> 40 kg at enrollment. Patients 12-17 years of age will not participate in the mandatory tumor biopsies. Since there is no data on patients less than 18 years of age, this population may require lower doses and additional safety precautions and should be closely monitored. Because no dosing or adverse event data are currently available on the use of ZEN003694 in combination with abemaciclib in patients \\\u003C 12 years of age, younger children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 for participants \\>= 16 years of age, Lansky \\>= 50% if \\\u003C 16 years of age\n* Hemoglobin \\>= 8 g\u002FdL; Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion\n* Absolute neutrophil count \\>= 1.5 x 10\\^9\u002FL\n* Platelets \\>= 1 x 10\\^11\u002FL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) for age. Patients with Gilbert's syndrome with a total bilirubin =\\\u003C 2.0 times ULN and direct bilirubin within normal limits are permitted\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN for age\n* Serum or plasma creatinine =\\\u003C 1.5 x institutional ULN OR calculated creatinine clearance \\>= 50 mL\u002Fmin (via the chronic kidney disease epidemiology \\[CKD-EPI\\] glomerular filtration rate estimation) for participants \\>= 18 years old, or 60 mL\u002Fmin\u002F1.73m\\^2 for patients 12-17 years as calculated based on bedside Schwartz formula\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Hepatitis C (HepC antibody) testing is required. Hepatitis C RNA is optional; however, a confirmatory negative Hepatitis C RNA test must be obtained to be able to enroll participants with positive Hepatitis C antibody due to prior resolved disease\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and has been clinically stable for at least 1 month. Patients must meet the following criteria:\n\n  * Disease outside the CNS is present\n  * Recovery from acute toxicity associated with the treatment to =\\\u003C CTCAE grade 1 or baseline (with the exception of alopecia), with no requirement for escalating doses of corticosteroids over the past 7 days\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients should be New York Heart Association Functional Classification of class 2B or better\n* Ability to swallow and retain oral medications\n* The effects of ZEN00364 and abemaciclib on the developing human fetus are unknown. For this reason and because BETi and CDKi-inhibiting agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Women of child-bearing potential must have a negative pregnancy test prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men and women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 weeks after completion of ZEN003694 and abemaciclib administration\n\n  * For female subjects of child-bearing potentially receiving ZEN003694, hormonal means of birth control alone, such as oral, injectable, dermal, subdermal or topical contraceptives are NOT acceptable forms of birth control given that their efficacy has not been evaluated when given in combination with the investigational drugs. \"Adequate contraception\" is defined as the following:\n\n    * Contraceptive methods with a failure rate of =\\\u003C 1% used in combination with the barrier method. The following contraceptive methods are acceptable to use in combination with the barrier method: intrauterine device (IUD), intrauterine system (IUS), or oral contraceptive pills (OCPs) that meet the \\\u003C 1% failure rate as stated in the product label. Note: Hormonal IUDs\u002FOCPs may only be used if the following criteria are met: male condoms are required AND subjects are informed of the potential for reduced systemic hormone levels from the IUD\u002FOCP when taking ZEN003694. Alternatively, male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, \"documented\" refers to the outcome of the investigator's\u002Fdesignee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records\n  * Male subjects with female partners of child-bearing potential must use one of the following contraceptive methods:\n\n    * Vasectomy with documentation of azoospermia OR\n    * Condom use PLUS partner use of a highly effective contraceptive (=\\\u003C 1% rate of failure per year) such as intrauterine device or system, or hormonal birth control such as contraceptive subdermal implant, combined estrogen and progestogen oral contraceptive, injectable progestogen, contraceptive vaginal ring, or percutaneous contraceptive patches\n  * Male subjects should not donate sperm while on study and for 12 weeks after the last dose of study medication. Male subjects whose partners are or become pregnant must continue to use condoms for 12 weeks after the last dose of study medication\n* Women of childbearing potential must have a negative pregnancy test within 7 days of starting treatment\n* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and\u002For family member available may be eligible after discussion with the Principal Investigator of this study. There will be a separate assent process for minors\n\nExclusion Criteria:\n\n* Participants who have had cytotoxic chemotherapy, immunotherapy, or other investigational therapy within 2 weeks prior to entering the study. There is a two-week required washout period for previous BET inhibitor therapy\n* Participants who have had radiotherapy within at least 2 weeks prior to entering the study. Stereotactic radiosurgery (SRS) within 1 week prior to entering the study will be allowed\n* Participants who have had major surgery within 3 weeks prior to entering the study\n* Participants who have received tyrosine kinase inhibitors (TKIs) or small molecules within 5 half-lives or 1 week (whichever is shorter) of study entry\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 or abemaciclib\n* Patients requiring medications or substances that are strong inhibitors or strong inducers of CYP3A4 or CYP3A enzymes are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694 and abemaciclib. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as http:\u002F\u002Fmedicine.iupui.edu\u002Fclinpharm\u002Fddis\u002Ftable.aspx; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Patients with uncontrolled intercurrent illness, including but not limited to: ongoing or active infection requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment (e.g. estimated creatinine clearance \\\u003C 30ml\u002Fmin), history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea that, in the judgment of the investigator, would preclude participation in this study\n* Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with narrow therapeutic windows are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694. As proton pump inhibitors (PPIs), H2 receptor antagonists, and antacids may alter the pharmacokinetics of ZEN003694 by reducing ZEN003694 exposure, patients receiving proton pump inhibitors are ineligible. If H2 blockers or other acid reducing agents are used concomitantly with ZEN003694, a staggered dosing schedule should be used. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Pregnant women are excluded from this study because ZEN003694 is a BETi agent with 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 with ZEN003694, breastfeeding should be discontinued if the mother is treated with ZEN003694. These potential risks may also apply to other agents used in this study\n* Fridericia's formula-corrected QT interval (QTcF) \\>= 450 msec on screening electrocardiogram (ECG) by Fredericia (machine or manual read allowed). Patients should avoid medications which prolong the QT\n* Patients receiving any medications or substances that are Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) or Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed\n* Patients with radiation to \\> 25% of the bone marrow\n* Patients who have had a bone-targeted radionuclide within 6 weeks of the first dose of ZEN003694\n* Myocardial infarction or unstable angina within 6 months prior to the first dose of ZEN003694\n* Impairment of gastrointestinal function that may significantly alter the absorption of ZEN003694 and\u002For abemaciclib\n* The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest","ALL","12 Years",{"count":19,"type":20},45,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial tests the safety, side effects, and best dose of ZEN003694 when given together with abemaciclib in treating patients with NUT carcinoma, breast cancer or other solid tumors that have spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that overproduce BET protein. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ZEN003694 and abemaciclib may help shrink or stabilize cancer in patients with NUT carcinoma, breast cancer or other solid tumors.",[26,27,28,29,30,31,32,33],"Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Breast Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic NUT Carcinoma","Unresectable Breast Carcinoma","Unresectable Malignant Solid Neoplasm","Unresectable NUT Carcinoma","RECRUITING","2026-06-16",{"date":37,"type":38},"2026-06-17","ACTUAL",{"date":40,"type":38},"2023-08-10",{"date":42,"type":20},"2027-06-07",{"name":44,"class":45},"National Cancer Institute (NCI)","NIH",7,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100440777","phase-1-testing-the-safety-and-efficacy-of-the-addition-of-a-new-anti-cancer-drug-zen003694-to-chemotherapy-treatment-cisplatin-and-etoposide-or-carboplatin-and-paclitaxel-for-adult-and-pediatric-patients-12-17-years-with-nut-carcinoma-100440777","NCT05019716","Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma","A Phase 1 Study of the Bromodomain Inhibitor ZEN003694 in Combination With Platinum-based Chemotherapy in Patients With NUT Carcinoma","Inclusion Criteria:\n\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants must have a diagnosis of NC based on standard criteria for the disease, with diagnostic testing performed in a Clinical Laboratory Improvement Act (CLIA) certified laboratory:\n\n  * Ectopic expression of NUT protein per World Health Organization (WHO) criteria (World Health Organization \\[WHO\\], 2021) as determined by immunohistochemistry (IHC) testing, OR\n  * Detection of the NUT gene translocation as determined by fluorescence in situ hybridization (FISH) testing, OR\n  * Detection of the NUT gene translocation as determined by sequencing, eg. DNA next generation sequencing (NGS) or RNA sequencing.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants must have disease that is metastatic, unresectable, or for which a surgical approach would not likely confer a survival benefit or would be otherwise contraindicated. Participants who have already undergone surgical resection are eligible to participate in Phase 1.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Age \\>= 12 years. Patients 12-17 years of age must be \\>= 40 kg at enrollment. Because no dosing or adverse event data are currently available on the use of ZEN003694 in combination with etoposide and cisplatin in patients \\\u003C 12 years of age, younger children are excluded from this study.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 2 (Karnofsky \\>= 60%) for patients \\>= 16 years of age, Lansky \\>= 50% if \\\u003C 16 years of age.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants must have measurable disease per RECIST version 1.1 criteria. Patients in the phase 1 portion do not need measurable disease if their disease is otherwise evaluable.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Ability to swallow and retain oral medications.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Absolute neutrophil count \\>= 1.5 x 10\\^9\u002FL.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Platelets \\>= 125 x 10\\^9\u002FL.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Hemoglobin \\>= 9.0 g\u002FdL.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Albumin \\>= 2.5 g\u002FdL.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) for age.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase(ALT)(serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN for age.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Calculated creatinine clearance \\>= 60 mL\u002Fmin (based on the calculated Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] glomerular filtration rate estimation for adults or 60 mL\u002Fmin\u002F1.73m\\^2 for patients 12-17 years as calculated based on bedside Schwartz formula).\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Prothrombin time (PT)\u002Finternational normalized ratio (INR) =\\\u003C 1.5 x ULN.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Partial thromboplastin time (PTT) =\\\u003C 1.5 x ULN.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: QT interval by Fridericia (QTcF) \\\u003C 450 ms (machine or manual read allowed). Patients should avoid medications which prolong the QT.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 3 months are eligible for this trial as long as their anti-retroviral therapy does not have the potential for drug-drug interactions as judged by the treating investigator.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Hepatitis C (HepC antibody) testing is required. Hepatitis C RNA is optional; however, a confirmatory negative hepatitis C RNA test must be obtained to be able to enroll participants with positive hepatitis C antibody due to prior resolved disease.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for treatment in the phase 1 portion, but not in the non-thoracic, non-BRD4 exploratory cohort. Participants enrolling to the non-thoracic, non-BRD4 exploratory cohort with a history of prior malignancy are eligible only if they fit one or more of the following criteria: participants with non-melanoma skin cancers that have been curatively treated; participants with adequately treated carcinomas in situ of any type; or participants who were diagnosed and curatively treated at least 3 years prior to the date of study entry and who are considered by the treating investigator to be at low risk for recurrence.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: The effects of ZEN003694 on the developing human fetus are unknown. For this reason and because the chemotherapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 4 months after completion of study therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study therapy. For female subjects of child-bearing potentially receiving ZEN003694, hormonal means of birth control alone, such as oral, injectable, dermal, subdermal or topical contraceptives are NOT acceptable forms of birth control given that their efficacy has not been evaluated when given in combination with the investigational drugs. \"Adequate contraception\" is defined as the following: Contraceptive methods with a failure rate of =\\\u003C 1% used in combination with the barrier method. The following contraceptive methods are acceptable to use in combination with the barrier method: intrauterine device (IUD), intrauterine system (IUS), or oral contraceptive pills (OCPs) that meet the \\\u003C 1% failure rate as stated in the product label. Note: Hormonal IUDs\u002FOCPs may only be used if the following criteria are met: male condoms are required AND subjects are informed of the potential for reduced systemic hormone levels from the IUD\u002FOCP when taking ZEN003694. Alternatively, male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, \"documented\" refers to the outcome of the investigator's\u002Fdesignee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records. Male subjects with female partners of child-bearing potential must use one of the following contraceptive methods:\n\n  * Vasectomy with documentation of azoospermia OR\n  * Condom use PLUS partner use of a highly effective contraceptive (=\\\u003C 1% rate of failure per year) such as intrauterine device or system, or hormonal birth control such as contraceptive subdermal implant, combined estrogen and progestogen oral contraceptive, injectable progestogen, contraceptive vaginal ring, or percutaneous contraceptive patches.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Male subjects should not donate sperm while on study and for 16 weeks after the last dose of study medication. Male subjects whose partners are or become pregnant must continue to use condoms for 16 weeks after the last dose of study medication.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Ability to understand and the willingness to sign a written informed consent document (or parent or legally authorized representative if minor). Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and\u002For family member available may be eligible after discussion with the Principal Investigator of this study.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Women of childbearing potential must have a negative pregnancy test within 7 days of starting treatment.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants who have not had cytotoxic chemotherapy, oral tyrosine kinase inhibitor (TKI) or small molecule therapy, or immunotherapy within 2 weeks prior to the first dose of study medication or 5 half-lives, whichever is shorter. For the phase 1 dose escalation, there is no required washout for previous EP therapy. For the carboplatin\u002Fpaclitaxel safety cohort, there is no required washout for prior carboplatin\u002Fpaclitaxel therapy\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants may have had a maximum of 1 prior cycle of EP (cisplatin + etoposide) or carboplatin\u002Fpaclitaxel. However, for consistency, cycle 1 day 1 will be the first day of EP or carboplatin\u002Fpaclitaxel on the Phase 1 portions of the study. There is no required washout for previous ZEN003694 therapy for patients enrolling to the phase 1 portion of the study\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants who have received prior radiation therapy can be enrolled at least 1 week after completing radiation.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants who have had major surgery can be enrolled at least 3 weeks after the surgery.\n* PHASE 1, CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT, \\& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Any therapy-related toxicities must have resolved to ≤ grade 1 or baseline (with the exception of alopecia, peripheral neuropathy, or rash that will be permitted at ≤ grade 2). Other grade 2 toxicities attributed to prior treatment may be permitted with agreement from the overall principal investigator if they are toxicities not commonly attributed to ZEN003694. Toxicities attributed to current EP or carboplatin\u002Fpaclitaxel therapy are excluded from this requirement for participants enrolling to the dose escalation or carboplatin\u002Fpaclitaxel safety cohort, as long as the participant meets all other eligibility criteria.\n* NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants must have a diagnosis of NC but lack BRD4-NUT rearrangement. If the fusion status is unknown after NC diagnosis, the BRD4-NUT fusion status will be determined by centralized FISH testing at the BWH Center for Advanced Molecular Diagnostics (CAMD).\n\nExclusion Criteria:\n\n* PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \\& CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT: Participants with known untreated central nervous system (CNS) metastases. Patients with a history of treated CNS metastases are eligible, provided they meet the following criteria:\n\n  * Radiologically stable for 4 weeks.\n  * Disease outside the CNS is present.\n  * Recovery from acute toxicity associated with the treatment to =\\\u003C Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or baseline (with the exception of alopecia), with no requirement for escalating doses of corticosteroids over the past 7 days.\n  * Subjects currently taking enzyme-inducing anticonvulsants (EIAC) must be transitioned to non-enzyme inducing anticonvulsants at least 14 days or 5 half-lives prior to the first dose of study medication\n  * No presence of symptomatic or untreated leptomeningeal metastases or spinal cord compression.\n* PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \\& CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT: History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 or other agents used in study.\n* PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \\& CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT: Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring systemic treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. Patients with myocardial infarction or unstable angina within 6 months prior to the first dose of ZEN003694 will be excluded.\n* PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \\& CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT: Any gastrointestinal (GI) disorder that may affect absorption of ZEN003694 and other oral medications in the opinion of the treating investigator, such as malabsorption syndrome or major bowel or stomach resection.\n* PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \\& CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT: Patients who are receiving any other investigational agents.\n* PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \\& CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT: Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with narrow therapeutic windows are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694. As proton pump inhibitors (PPIs), H2 receptor antagonists, and antacids may alter the pharmacokinetics of ZEN003694 by reducing ZEN003694 exposure, patients receiving proton pump inhibitors are ineligible. If H2 blockers or other acid reducing agents are used concomitantly with ZEN003694, a staggered dosing schedule should be used, either dose ZEN-3694 2 hours before the H2 blocker or 10-12 hours after an H2 blocker. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.\n* PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \\& CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT: Pregnant women are excluded from this study because ZEN003694 is a bromodomain and extraterminal domain (BET) inhibitor with 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 with ZEN003694, breastfeeding should be discontinued if the mother is treated with ZEN003694. These potential risks may also apply to other agents used in this study.\n* PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \\& CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT: Patients receiving therapeutic-dose anticoagulation (e.g., warfarin, low-molecular weight heparin \\[LMWH\\], or novel oral anticoagulants) are not eligible. Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran) is not permitted. Prophylactic anticoagulation, with low doses (per standard practice) of agents such as low molecular weight heparin (LMWH) is permitted.\n* PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \\& CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT: Patients with radiation to \\> 25% of the bone marrow.\n* PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \\& CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT: Cardiac abnormalities as evidenced by any of the following:\n\n  * Clinically significant conduction abnormalities or arrhythmias.\n  * History or evidence of current \\>= class II congestive heart failure as defined by New York Heart Association (NYHA).\n  * History of acute coronary syndromes (including unstable angina and myocardial infarction), coronary angioplasty, or stenting within the past 3 months. Subjects with a history of stent placement requiring ongoing antithrombotic therapy (e.g., clopidogrel, prasugrel) will not be permitted to enroll.\n  * Clinically significant cardiomegaly, ventricular hypertrophy, or cardiomyopathy.\n* PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \\& CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT: Patients with uncontrolled intercurrent illness.\n* PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \\& CARBOPLATIN\u002FPACLITAXEL SAFETY COHORT: Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* PHASE 1: Patients who are currently receiving EP or ZEN003694, or received EP or ZEN003694 in the past, must be candidates to receive the study agents at the protocol-defined dose level and schedule as judged by the treating investigator. Patients who previously required dose reductions of their EP or ZEN003694 due to unacceptable toxicities attributed to the agent(s) are not eligible.\n* ZEN003694\u002FCARBOPLATIN\u002FPACLITAXEL SAFETY COHORT: Patients who are currently receiving carboplatin\u002Fpaclitaxel or ZEN003694, or received carboplatin\u002Fpaclitaxel or ZEN003694 in the past, must be candidates to receive the study agents at the protocol-defined dose level and schedule as judged by the treating investigator. Patients who previously required dose reductions of their carboplatin\u002Fpaclitaxel or ZEN003694 due to unacceptable toxicities attributed to the agent(s) are not eligible.\n* PHASE 1 OR ZEN003694\u002FCARBOPLATIN\u002FPACLITAXEL SAFETY COHORT: Patients ineligible for receiving EP or carboplatin\u002Fpaclitaxel for either the phase 1 dose escalation or the carboplatin\u002Fpaclitaxel safety cohort, respectively.\n* NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Patients with disease that definitively originated in the thoracic cavity. In the case of patients with metastatic disease at diagnosis where disease origin is uncertain, the patient may be allowed to enroll.\n* NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Patients who previously received treatment with a BET inhibitor (BETi), including but not limited to previous ZEN003694 therapy.",{"count":55,"type":20},36,[23,57],"PHASE2","This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with cisplatin and etoposide or carboplatin and paclitaxel in treating patients with NUT carcinoma. Another purpose of this study is to see whether there are any changes in patient's tumor or blood characteristics (e.g. genes, molecules, etc.) due to combination therapy. ZEN003694 inhibits the production of certain growth-promoting proteins and may prevent proliferation of tumor cells that use those proteins for their growth. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Combination therapy with ZEN003694 and etoposide and cisplatin or carboplatin and paclitaxel may be safe and effective in treating patients with NUT carcinoma.",[60,30,33],"Advanced NUT Carcinoma",{"date":37,"type":38},{"date":63,"type":38},"2022-07-13",{"date":65,"type":20},"2026-06-30",{"name":44,"class":45},5,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":75,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100596800","phase-2-cemiplimab-for-the-treatment-of-incurable-metastatic-or-unresectable-nut-carcinoma-100596800","NCT07050186","Cemiplimab for the Treatment of Incurable Metastatic or Unresectable NUT Carcinoma","A Single Arm Open-Label Pilot Study to Investigate the Safety and Clinical Activity of Cemiplimab, A Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Incurable NUT Carcinoma (NC)","Inclusion Criteria:\n\n* Patients must have a histologically confirmed NUT carcinoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.\n* Patient may be treatment naïve or have had prior surgery, radiation, or any systemic therapy (with the exceptions noted in the Exclusion Criteria).\n* Patients must have histologically or cytologically confirmed NUT carcinoma based on the ectopic expression of NUT protein per World Health Organization (WHO) criteria as determined by immunohistochemistry (IHC) and\u002For detection of NUT gene translocation as determined by fluorescence in situ hybridization (FISH) at a Clinical Laboratory Improvement Act (CLIA) certified laboratory and\u002For by detection of the NUT gene translocation as determined by sequencing (e.g., deoxyribonucleic acid \\[DNA\\] next generation sequencing \\[NGS\\] or ribonucleic acid \\[RNA\\] sequencing) at a CLIA certified laboratory.\n* Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.\n* Patients must be age ≥ 18 years.\n* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Leukocytes (WBC) ≥ 3,000\u002FmcL.\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL.\n* Hemoglobin (Hgb) ≥ 9 g\u002FdL.\n* Platelets (PLT) ≥ 100,000\u002FmcL.\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) ≤ 3 x institutional ULN.\n* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 x institutional ULN.\n* Creatinine ≤ 1.5 x institutional ULN.\n* Glomerular filtration rate (GFR) ≥ 40 mL\u002Fmin\u002F1.73 m\\^2.\n\n  * Estimated (e)GFR is estimated GFR calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) equation.\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.\n* The effects of cemiplimab on the developing human fetus are unknown. For this reason and because immune checkpoint inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception from time of informed consent, for the duration of study participation, and for 6 months following completion of cemiplimab therapy. Should a POCBP become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately.\n\n  * NOTE: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:\n\n    * Has not undergone a hysterectomy or bilateral oophorectomy\n    * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n* POCBP must have a negative pregnancy test prior to registration on study.\n* Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must also agree to use adequate contraception with partners of childbearing potential from time of informed consent, for the duration of study participation, and for 6 months after completion of administration.\n\nExclusion Criteria:\n\n* Patients must have the ability to understand and the willingness to sign a written informed consent document prior to the start of any study activities (e.g. before screening\u002Fbaseline activities and before registration on the study) and comply with the study requirements.\n* Prior treatment with PD-1 or PD-L1 inhibitors.\n* Received systemic therapy, radiation, or had surgery ≤ 14 days prior to planned treatment start date.\n\n  * NOTE: Prior therapy must meet requirements of criteria listed in Exclusion Criteria\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy, (i.e., have residual toxicities \\> grade 1 per National Cancer Institute \\[NCI\\] Common Terminology Criteria for Adverse Events \\[CTCAE\\] v5) with the exception of alopecia, neuropathy, and other non-significant adverse events.\n* Patients who are receiving any investigational agents or devices ≤ 14 days from planned start of treatment date.\n* History of allergic reactions or acute hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to immune checkpoint inhibitors and\u002For to antibody treatments.\n* Patients with a known history of Human immunodeficiency virus (HIV).\n\n  * NOTE: Infected patients on effective anti-retroviral therapy with an undetectable viral load for 6 months prior to start of study participation are eligible to participate.\n  * NOTE: CD4+ T cell counts and viral load are monitored per standard of care.\n* Patients with a known history of chronic hepatitis B virus (HBV) infection.\n\n  * NOTE: Patients with HBV and an undetectable viral load on suppressive therapy are eligible to participate.\n  * NOTE: CD4+ T cell counts, and viral load are monitored per standard of care.\n* Patients with a known history of hepatitis C virus (HCV) infection.\n\n  * NOTE: For patients with a known HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load OR\n  * NOTE: Patients with an HCV infection must have been treated and cured in order to participate.\n  * NOTE: CD4+ T cell counts, and viral load are monitored per standard of care.\n* Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following:\n\n  * Hypertension that is not controlled on medication\n  * Ongoing or active infection requiring systemic treatment\n\n    * NOTE: Prophylactic antibiotic treatment is allowed (e.g. for uncomplicated infections such as urinary tract infections \\[UTIs\\] or sinus infections being treated with oral antibiotics)\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * History of pneumonitis within the last 5 years\n  * Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints.\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients have received a prior allogeneic stem cell transplant or received an organ transplant.\n* Patients have ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune mediated adverse events (imAEs).\n\n  * NOTE the following are not exclusionary:\n\n    * Vitiligo,\n    * Childhood asthma that has resolved,\n    * Type 1 diabetes,\n    * Residual hypothyroidism that required only hormone replacement,\n    * Psoriasis that does not require systemic treatment.\n    * And the following medications:\n\n      * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection);\n      * Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent;\n      * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n* Patients that received prior treatment with other immune modulating agents that was:\n\n  * Less than 4 weeks (28 days) prior to the first dose of cemiplimab, or\n  * Associated with imAEs that were grade ≥ 1 within 90 days prior to the first dose of cemiplimab, or\n  * Associated with toxicity that resulted in discontinuation of the immune-modulating agent.\n* Patients of child-bearing potential (POCBP) who are pregnant or nursing.\n\n  * NOTE: POCBP that are pregnant or are nursing are excluded from this study; cemiplimab is an immune checkpoint inhibitor agent with potential for teratogenic or abortifacient effect. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cemiplimab; breastfeeding should be discontinued if the patient is a nursing parent treated with cemiplimab.\n* Patient with a current or prior malignancy within the previous 2 years and in the opinion of the treating investigator would interfere with monitoring of radiological assessments of response to cemiplimab. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. Incidentally diagnosed prostate cancer is also allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.","18 Years",{"count":77,"type":20},15,[57],"This phase II trial studies how well cemiplimab works in treating patients with nuclear protein of testis (NUT) carcinoma for which no treatment is currently available (incurable) and that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.",[30,33],"2025-09-23",{"date":83,"type":38},"2025-09-29",{"date":85,"type":38},"2025-08-15",{"date":87,"type":20},"2035-11-20",{"name":89,"class":90},"Northwestern University","OTHER",1]