[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Providence Health & Services\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":174},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,39,70,89,111,133,153],{"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100640938","phase-1-can1012-in-pre-malignant-oral-dysplasia-100640938",false,"NCT07620496","CAN1012 in Pre-malignant Oral Dysplasia","A Phase I\u002FIb Study Evaluating Intralesional TLR7 Agonist, CAN1012, in Pre-malignant Oral Dysplasia","Inclusion Criteria:\n\n1. Clinically-identified oral epithelial dysplasia (OED)\n2. Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 deemed suitable by investigator or designee for requirements of study.\n4. Laboratory values within 72 hours of Day 0:\n\n   1. WBC ≥ 2.0 K\u002FµL, ANC ≥ 1.0 K\u002FµL\n   2. Hgb ≥ 10 g\u002FdL\n   3. Platelets ≥ 100,000 K\u002FµL\n   4. Creatinine Clearance (using Cockcroft-Gault)\n   5. AST\u002FALT ≤ 2.5 x ULN\n   6. Total bilirubin ≤ 3 x ULN, (except subjects with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg\u002FdL)\n   7. Negative pregnancy test (bHCG urine or serum, people of childbearing potential only)\n5. Patients and their partners who are capable of conceiving must agree to use effective methods of during the course of treatment and for 165 days after last dose of CAN1012.\n\nExclusion Criteria:\n\n1. Any serious underlying medical or psychiatric condition that, in the opinion of the investigator, would pose a risk to patient safety or interfere with the study procedures, completion, or evaluation.\n2. Need for corticosteroids ≥ 10mg prednisone daily equivalent; inhaled steroids are acceptable.\n3. Need for hormonal contraception including oral contraceptives, implant, injectable depots, vaginal rings, skin patches, and the progestin IUD; or any medication that is a sensitive substrate of the major CYPs.\n4. History of or current active autoimmune diseases which, in the judgment of the investigator, pose an active and significant risk. Vitiligo, lichen planus or lichenoid inflammation, and adequately controlled endocrine deficiencies such as hypothyroidism\u002F hyperthyroidism are not exclusionary.\n5. Previous history of bone marrow transplantation or oral Graft Versus Host Disease (GVHD).\n6. Has an active infection requiring systemic therapy. Investigator may allow if deemed not clinically significant.\n7. Has active or uncontrolled Hepatitis B, Hepatitis C, or HIV with AIDS (acquired immunodeficiency syndrome)- defined opportunistic infection.\n8. Has a baseline electrocardiogram (ECG) with a prolonged QTc interval \\> 480 msec. Medications which have a known and clinically significant risk of QT prolongation may be allowed per investigator discretion.\n9. Patients who have had a history of acute diverticulitis, intra-abdominal abscess, GI obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation, and in the judgment of the investigator still pose an active risk.","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The primary objective of this trial is to examine the safety of CAN1012 delivered by intralesional injection ahead of planned surgical resection.",[26],"Oral Epithelial Dysplasia (OED)","NOT_YET_RECRUITING","2026-05-27",{"date":30,"type":31},"2026-06-02","ACTUAL",{"date":33,"type":20},"2026-07-01",{"date":35,"type":20},"2033-07",{"name":37,"class":38},"Providence Health & Services","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100509435","phase-2-gb1211-and-pembrolizumab-versus-pembrolizumab-and-placebo-in-patients-with-metastatic-melanoma-and-head-and-neck-squamous-cell-carcinoma-100509435","NCT05913388","GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma","Randomized Double-Blind Placebo Controlled Phase II Study of a Galectin-3 Inhibitor (GB1211) and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Patients with unresectable or metastatic melanoma including unknown primary or mucosal melanomas. Histological confirmation of melanoma will be required by previous biopsy or cytology. Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression during or after platinum-containing chemotherapy are eligible. PD-L1 testing is not needed for OHN cancers.\n* Patients who have received anti-PD1 or anti-PD-L1 in the past are eligible if it has been at least 6 months since the last anti-PD-1 or PD-L1 dose, they meet all other eligibility criteria and progression of malignancy has been documented on imaging. Progression for this patient subset is defined as the appearance of one or more new metastatic sites, or a 5% or greater increase in the sum of diameter of target lesions or an unequivocal increase in non-target site. Treatment naïve melanoma patients are eligible.\n* Patients must be ≥ 18 years of age.\n* ECOG performance status of 0-2.\n* Women of childbearing potential must have a serum or urine pregnancy test performed within 72 hours prior to the start of protocol treatment. The results of this test must be negative in order for the patient to be eligible. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy.\n* No active bleeding.\n* Anticipated lifespan greater than 12 weeks.\n* Patients must sign a study-specific consent document.\n\nExclusion Criteria:\n\n* Patients who have previously received a galectin antagonist.\n* Patients with active autoimmune disease except for autoimmune thyroiditis or vitiligo.\n* Patients with history of autoimmune colitis.\n* Patients with untreated brain metastases. Patients with treated brain metastases who demonstrate control of brain metastases with follow-up imaging 4 or more weeks after initial therapy are eligible.\n* Patients requiring other systemic oncologic therapy, including experimental therapies.\n* Patients who have received anti-cancer treatment within 3 weeks or 5 half-lives before first study drug dose.\n* Patients with Child-Pugh C hepatic impairment.\n* Patients with active infection requiring antibiotics.\n* Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.\n* Need for steroids at greater than physiologic replacement doses. Inhaled corticosteroids are acceptable.\n* Laboratory exclusions (to be performed within 28 days of enrollment):\n\n  * WBC \\\u003C 3.0 x 109\u002FL\n  * Hgb \\\u003C 9.0 g\u002FdL\n  * AST or ALT \\> 1.5 times ULN\n  * Total bilirubin \\> 1.9 g\u002FdL, unless due to Gilbert's Syndrome. If Gilbert's Syndrome is present by clinical history, then direct bilirubin must by \\\u003C 3.0 g\u002Fdl.\n  * Active or known history of HIV\n  * Active or known history of Hepatitis B\n  * Active or known history of Hepatitis C\n  * Platelet counts \\\u003C 100 x 10E9 \u002F L (100,000\u002F μL) without transfusion\n  * INR \\> 1.5x ULN\n* Inability to give informed consent and comply with the protocol. Patients must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.\n* Any medical condition that in the opinion of the Principal Investigator would compromise the safety or conduct of the study procedures.\n* Unresolved immune-mediated pneumonitis, diarrhea, elevation of hepatocellular enzymes or other toxicities requiring greater than physiological replacement doses of steroids.",{"count":47,"type":20},92,[49],"PHASE2","The purpose of this study is to determine the objective response of GB1211 and pembrolizumab versus pembrolizumab and placebo in patients with advance metastatic melanoma or head and neck squamous cell carcinoma.",[52,53],"Metastatic Melanoma","Head and Neck Squamous Cell Carcinoma",[55,56,57,58,59],"metastatic melanoma","head and neck squamous cell carcinoma","pembrolizumab","galecto","GB1211","RECRUITING","2026-04-07",{"date":63,"type":31},"2026-04-13",{"date":65,"type":31},"2024-02-29",{"date":67,"type":20},"2030-02",{"name":37,"class":38},1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":69},"100398583","phase-1-phase-ib-trial-of-multivalent-autophagosome-vaccine-with-or-without-gitr-agonist-with-anti-pd-1-immunotherapy-in-hnscc-100398583","NCT04470024","Phase Ib Trial of Multivalent Autophagosome Vaccine With or Without GITR Agonist, With Anti-PD-1 Immunotherapy in HNSCC","A Phase Ib Study of Multivalent Autophagosome Vaccine, With or Without GITR Agonist, With Sequenced Checkpoint Inhibition (Anti-PD-1) - Immunotherapy Trio in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\n* Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Appendix C)\n* Age 18 years or above.\n* Laboratory values:\n* WBC ≥2000\u002FuL\n* Hgb \\>8.0 g\u002Fdl (patients may be transfused to reach this level)\n* Platelets \\>75,000 cells\u002Fmm3\n* Serum creatinine clearance ≥ 50 mL\u002Fmin measured or calculated by Cockcroft-Gault (C-G) equation\n* Negative bHCG (urine\u002Fserum) Women of childbearing potential only\n* AST (SGOT) and ALT (SGPT) ≤2.5 × upper limit of laboratory normal (ULN) OR ≤ 5 × ULN for participants with liver metastases\n* Alkaline phosphatase ≤2.5 × ULN OR ≤ 5 × ULN for participants with liver metastases\n* Total bilirubin ≤1.5 × ULN. If total bilirubin is \\>1.5, conjugated bilirubin must be ≤ ULN (conjugated bilirubin only needs to be tested if total bilirubin exceeds ULN). If there is no institutional ULN, then conjugated bilirubin must be \\\u003C 40% of total bilirubin.\n* Patients positive for hepatitis B core antibody (anti-HBc, total), are eligible only if HBV DNA is non-detectable by qPCR.\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if HCV RNA is non-detectable by qPCR.\n* Patients positive for HIV 1\u002F2 antibodies, are eligible if ARV treatment compliant with documented stable CD4 \\> 300 for at least 6 months and undetectable viral load\n* Ability to give informed consent and comply with the protocol.\n* Anticipated lifespan greater than 12 weeks.\n* Women of childbearing potential must have negative serum\u002Furine pregnancy test \\\u003C5 days prior to start of study.\n* Males and women of childbearing potential, must agree to take appropriate precautions to avoid pregnancy during treatment and through 180 days after last dose of study treatment (see Appendix A).\n\nExclusion Criteria:\n\n* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n* Receipt of any investigational anticancer therapy during the last 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment.\n* Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n* Local treatment of isolated lesions for palliative intent is acceptable (e.g., local surgery or radiotherapy), excluding target lesions, Palliative radiation therapy cannot be administered less than 1 week prior to the first dose of study treatment.\n* Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.\n* Radiation therapy in the thoracic region that is \\> 30 Gy within 6 months of the first dose of study treatment. Note: Participants must have recovered from all radiation-related toxicities, not require corticosteroids for this purpose, and not have had radiation pneumonitis.\n* Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment. Note: Local surgery of isolated lesions for palliative intent is acceptable.\n* History of organ transplant, including allogeneic stem cell transplantation.\n* Uncontrolled intercurrent illness as deemed by the investigator, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, unstable cardiac arrhythmia, interstitial lung disease or history of, serious chronic gastrointestinal conditions associated with diarrhea, active noninfectious pneumonitis, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n* History of another primary malignancy except for:\n\n  * Malignancy treated with curative intent and with no known active disease ≥1.5 years before the first dose of investigational product and of low potential risk for recurrence\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n  * Adequately treated carcinoma in situ without evidence of disease\n* History of leptomeningeal carcinomatosis\n* Has untreated central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients whose brain metastases have been treated may participate provided they show radiographic stability (imaging at least four weeks apart showing no evidence of intracranial progression). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or are stable on a steroid dose of ≤10mg\u002Fday of prednisone or its equivalent and anti-seizure medications for at least 14 days prior to the start of treatment. Patients on a stable dose of seizure medicines for epilepsy unrelated to cancer are eligible for the trial.\n* History of active primary immunodeficiency.\n* Active tuberculosis infection (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice).\n* Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\\> 10 mg\u002Fday of prednisone or equivalent).:\n\n  * Physiologic corticosteroid replacement therapy at doses \\> 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n  * Participants with asthma that requires intermittent use of bronchodilators, inhaled steroids, or local steroid injections may participate.\n  * Participants using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.\n  * Brief courses of corticosteroids for prophylaxis (eg, contrast dye allergy) or study treatment-related standard premedication are permitted.\n* Receipt of live attenuated vaccine within 28 days prior to the first dose of study treatment. Note: patients should not receive live vaccine during study treatment and up to 30 days after the last dose of study treatment.\n* Known allergy or hypersensitivity to study drug(s) or compounds of similar biologic composition to the study drug(s), or any of the study drug excipients.\n* Any unresolved NCI CTCAE Grade ≥2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia, and the laboratory values defined in the inclusion criteria.\n* Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Principal Investigator or one of the Co-Principal Investigators.\n* Patients with irreversible toxicity not reasonably expected to be exacerbated by study treatment may be included only after consultation with the Principal Investigator or one of the Co-Principal Investigators.\n* Immune-related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy is recommended (per product label or consensus guidelines) OR\n* any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well controlled on replacement hormones).\n* Receipt of systemic antibiotics ≤ 7 days prior to the first dose of study drug.",{"count":78,"type":20},56,[23],"This is a phase Ib study with a safety lead-in (n = 6 per arm) evaluating combinatorial DPV-001 + sequenced PD-1 blockade, with or without GITR agonist, in recurrent or metastatic HNSCC.",[82],"Cancer of the Head and Neck",{"date":63,"type":31},{"date":85,"type":31},"2021-08-05",{"date":87,"type":20},"2028-12-31",{"name":37,"class":38},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":69},"100624378","phase-1-can1012-in-pre-malignant-dcis-and-lcis-100624378","NCT07408856","CAN1012 in Pre-Malignant DCIS and LCIS","A Phase I\u002FIb Study Evaluating Intralesional TLR7 Agonist, CAN1012, in Pre-malignant Ductal Carcinoma in Situ and Lobular Carcinoma in Situ","Inclusion Criteria:\n\n1. Male or female patients with DCIS or LCIS found on core biopsy.\n2. Tumor types allowed:\n\n   Biopsy-identified DCIS or LCIS comprising a single lesion ≥ 1 cm and ≤ 5 cm in size by imaging (mammogram or MRI or ultrasound (US)) without evidence of invasive disease on the biopsy and US negative for suspicious ipsilateral lymph nodes.\n3. Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 deemed suitable by investigator or designee for requirements of study.\n5. Laboratory values within 72 hours of Day 0:\n\n   1. WBC ≥ 2.0 K\u002FµL, ANC ≥ 1.0 K\u002FµL\n   2. Hgb ≥ 10 g\u002FdL\n   3. Platelets ≥ 100,000 K\u002FµL\n   4. Creatinine Clearance (using Cockcroft-Gault) ≥ 60.\n   5. AST\u002FALT ≤ 2.5 x ULN\n   6. Total bilirubin ≤ 3 x ULN, (except subjects with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg\u002FdL)\n   7. Negative pregnancy test for people of childbearing potential (bHCG urine or serum)\n6. Patients and their partners who are capable of conceiving must agree to use effective methods of contraception (non-hormonal only) during the course of treatment and for 165 days after last dose of CAN1012.\n\nExclusion Criteria:\n\n1. Any serious underlying medical or psychiatric condition that, in the opinion of the investigator, would pose a risk to patient safety or interfere with the study procedures, completion, or evaluation.\n2. Need for corticosteroids ≥ 10mg prednisone daily equivalent; inhaled steroids are acceptable.\n3. Need for hormonal contraception including oral contraceptives, implant, injectable depots, vaginal rings, skin patches, and the progestin IUD; or any medication that is a sensitive substrate of the major CYPs.\n4. History of or current active autoimmune diseases which, in the judgment of the investigator, pose an active and significant risk. Vitiligo, lichen planus or lichenoid inflammation, and adequately controlled endocrine deficiencies such as hypothyroidism\u002Fhyperthyroidism are not exclusionary.\n5. Previous history of bone marrow transplantation or oral Graft Versus Host Disease (GVHD).\n6. Has an active infection requiring systemic therapy. Investigator may allow if deemed not clinically significant.\n7. Has active or uncontrolled Hepatitis B, Hepatitis C, or HIV with AIDS (acquired immunodeficiency syndrome)- defined opportunistic infection.\n8. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known history of Hepatitis C virus (defined as HCV RNA) infection. Testing for Hepatitis B and Hepatitis C is not required unless mandated by local health authority.\n9. Has a baseline electrocardiogram (ECG) with a prolonged QTc interval \\> 480 msec. Medications which have a known and clinically significant risk of QT prolongation may be allowed per investigator discretion.\n10. Patients who have had a history of acute diverticulitis, intra-abdominal abscess, GI obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation, and in the judgment of the investigator still pose an active risk.",{"count":97,"type":20},24,[23],"This is a Phase I\u002FIb study evaluating CAN1012 in patients with ductal carcinoma in situ and lobular carcinoma in situ.",[101,102],"Ductal Carcinoma in Situ","Lobular Carcinoma in Situ","2026-04-02",{"date":105,"type":31},"2026-04-08",{"date":107,"type":20},"2026-05",{"date":109,"type":20},"2035-05",{"name":37,"class":38},{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},"100543294","phase-2-neoadjuvant-inbrx-106-in-combination-with-pembrolizumab-for-stage-iiiii-tnbc-patients-100543294","NCT06353997","Neoadjuvant INBRX-106 in Combination With Pembrolizumab for Stage II\u002FIII TNBC Patients","A Phase II, Single-arm, Multi-center, Open-label Study of Neoadjuvant INBRX-106 (Hexavalent OX40 Agonist) in Combination With Pembrolizumab as an Induction Immunotherapy for Stage II\u002FIII TNBC Patients","Inclusion Criteria:\n\n1. Age ≥ 18 years, inclusive of all genders.\n2. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 2.\n3. Patients must have histologically confirmed TNBC (ER\u002FPR ≤ 10% allowed, HER2- as defined by ASCO guidelines). HER2 negative permitted to enroll as IHC 0, 1, or 2+ with negative ISH.\n4. Primary breast tumor measurable by ultrasound and at least 1cm.\n5. Clinically appropriate to receive neoadjuvant pembrolizumab plus chemotherapy (e.g. Keynote-522) planned for curative intent per standard of care (as indicated following study therapy however not mandated on trial for Option 2).\n6. Multifocal\u002Fmulticentric disease is allowed. If clinically indicated per the standard of care, suspicious sites that do not appear to be part of the same disease process should be biopsied with reconfirmation of ER\u002FPR\u002FHER2 status. Up to 20 slides or 1 block may be submitted to conduct biomarkers studies on remaining tissue.\n7. No prior therapy of any kind for TNBC.\n8. Willingness to undergo serial ultrasounds, serial biopsies, and blood draws.\n9. Patients must have adequate organ function as defined below. Specimens must be collected within 28 days prior to the start of study treatment.\n\n   * Absolute neutrophil count (ANC) ≥1500\u002FµL\n   * Platelets ≥100 000\u002FµL\n   * Hemoglobin ≥8.0 g\u002FdL or ≥5.0 mmol\u002FL\n   * Creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n   * Total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN. Patients with elevated LFTs that are suggestive of Gilbert's disease (a benign process) are eligible.\n   * AST (SGOT) and ALT (SGPT) ≤2.5 × ULN\n   * International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n   * TSH and free T4 levels should be drawn within 14 days prior to start of treatment. Patients must have adequate thyroid function as demonstrated by free T4 values, regardless of TSH.\n10. Fertile male patients and female patients of childbearing potential must agree to avoid impregnating a partner or becoming pregnant, respectively. They must be willing to employ highly effective contraception methods (with a failure rate of less than 1% when used consistently and correctly) at least 28 days before the first dose of study treatment until 4 months after the last dose of study treatment.\n\n    A woman is considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. Postmenopausal state is defined as no menses for 12 months without an alternative medical cause.\n\n    Acceptable methods of contraception presented below are in compliance with the Clinical Trial Facilitation and Coordination Group (CTFG) recommendations related to contraception and pregnancy testing in clinical trials, Version 1.1 (September, 2020). However, if a contraception method listed below is restricted by local regulations\u002Fguidelines, then it does not qualify as an acceptable method of contraception in that country\u002Fregion. Local guidelines should be followed.\n    * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: Oral. Intravaginal. Transdermal.\n    * Progestogen-only hormonal contraception associated with inhibition of ovulation: Oral. Injectable. Implantable.\n    * Intrauterine device (IUD).\n    * Intrauterine hormone-releasing system (IUS).\n    * Bilateral tubal occlusion.\n    * Vasectomized partner. (Only considered to be highly effective contraception if he is the sole sexual partner of the female patient of childbearing potential and if the vasectomized partner has received medical assessment of the surgical success.)\n    * Sexual abstinence. (Only considered to be highly effective contraception if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient and if considered acceptable by local regulatory agencies and IRBs\u002FIECs.\n11. WOCBP must have a negative urinary or serum pregnancy test within 72 hours prior to start of treatment. If screening serum pregnancy test collected outside of 72 hours prior to start of treatment, this may be accepted for determination of eligibility but must be re-checked prior to treatment C1D1. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The following age-specific requirements apply:\n\n    Women \\\u003C 50 years of age are considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).\n\n    Women ≥ 50 years of age are considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).\n12. To be eligible by H\\&E, the tumor must have a stromal tumor infiltrating lymphocytes (sTILs) score of at least 1% on diagnostic biopsy as defined by the International TILs Working Group (https:\u002F\u002Fwww.tilsinbreastcancer.org\u002F), ascertained by local pathologist or study pathologist.\n\nExclusion Criteria:\n\n1. Bilateral breast cancer.\n2. Prior malignancies that require ongoing active therapy or are at clinically significant risk of systemic recurrence in the opinion of the investigator.\n3. Suspicion for, or histologically confirmed, metastatic disease.\n4. Primary tumor with potential for skin ulceration or invasion of the chest wall, or with pain that would suggest rapid progression or imminent muscle\u002Fskin involvement in the opinion of the enrolling investigator.\n5. Prior therapy with an anti-PD-1, anti-PD-L1, or antiPDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137). Patients who have received these agents more than 3 years prior for other malignancies may be considered if they are not still at clinically significant risk of systemic recurrence in the opinion of the investigator.\n6. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n7. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n8. Received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n\n   Additionally, COVID-19 vaccinations (including boosters) should not be scheduled within 72 hours (before or after) of dosing days for INBRX-106 and pembrolizumab.\n9. Participants with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n10. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n11. Pregnant or breastfeeding.\n12. History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n13. History of allogenic tissue\u002Fsolid organ transplantation.\n14. Has active autoimmune disease that has required systemic treatment in excess of prednisone 10mg daily or equivalent in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). 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. Has a known additional malignancy (other than their current breast cancer diagnosis) that is progressing or has required active systemic treatment within the past 3 years.\n\n    Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n15. History or current evidence of any condition, therapy, or clinically significant laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n16. Active infection requiring systemic therapy with the exception of UTI requiring oral antibiotic therapy and prophylactic anti-viral therapy (e.g. Acyclovir).\n17. Known history of Human Immunodeficiency Virus (HIV) infection.\n18. Known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Patients with naturally acquired immunity are allowed (i.e. HBsAg(-); HBcAb(+); HBsAb(+\u002F-).\n19. Any known history of active TB (Bacillus Tuberculosis).",{"count":119,"type":20},12,[49],"This is a Phase II trial to assess efficacy and feasibility of pembrolizumab + INBRX-106 as an induction therapy preceding neoadjuvant therapy.",[123],"Triple Negative Breast Cancer","2026-01-13",{"date":126,"type":31},"2026-01-15",{"date":128,"type":31},"2024-09-05",{"date":130,"type":20},"2029-06",{"name":37,"class":38},4,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":152,"locationsCount":69},"100571369","phase-1-a-clinical-trial-to-evaluate-the-safety-tolerability-and-clinical-efficacy-of-m3t01-monotherapy-and-in-combination-with-pembrolizumab-and-other-systemic-therapies-100571369","NCT06719362","A Clinical Trial to Evaluate the Safety, Tolerability and Clinical Efficacy of M3T01 Monotherapy and in Combination With Pembrolizumab and Other Systemic Therapies","A First-in-human, Open-label, Dose Escalation, Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Clinical Efficacy of M3T01 Monotherapy and in Combination With Pembrolizumab and Other Systemic Therapies in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Life expectancy ≥ 12 weeks.\n3. Provision of written informed consent (see Section 16.1 and Appendix 18.5.5) for participation in the clinical trial.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1 for subjects with solid tumors other than glioblastoma.\n5. Karnofsky Performance Status of ≥ 70% for subjects with glioblastoma.\n6. Tumor tissue from a surgical or core needle biopsy must be provided to the sponsor (fine needle aspirate or cytology specimens are not acceptable). Archival formalin fixed paraffin embedded (FFPE) tissue is acceptable. If archival tumor tissue is not available, a fresh tumor biopsy must be performed.\n7. Subjects must have a tumor accessible for biopsy while on treatment. If the subject does not have a tumor that is safely accessible for biopsy, the subject may still participate in the clinical trial following authorization from the sponsor. NOTE: Subjects with glioblastoma are not required to have tumor accessible for biopsy and will not undergo a protocol specified biopsy on study.\n8. Eligible tumor types in Part 1 Dose Escalation will include subjects with histologically or cytologically confirmed metastatic or unresectable solid tumors who have developed disease progression following standard systemic therapy in the unresectable or metastatic setting. Subjects with cancers that harbor a molecularly defined oncogenic target for which an FDA approved therapy is available (including but not limited to EGFR, ROS1, ALK, BRAF, RET, NTRK, KRAS G12C, etc.) should have received this therapy.\n9. Measurable disease\n\n   * Subjects with solid tumors other than glioblastoma must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n   * Subjects with glioblastoma: Part 1: must have measurable disease per Response Assessment in Neuro-Oncology (RANO 2.0); Part 2: measurable disease at baseline is not required as these subjects will have undergone maximal safe resection prior to enrollment.\n10. Adequate organ function as defined by the following:\n\n    * Absolute neutrophil count (ANC) ≥ 1.2 x 109\u002FL.\n    * Hemoglobin ≥ 9.0 g\u002FdL (without a blood transfusion 2 weeks prior to the hemoglobin measurement).\n    * Platelet count ≥ 100 x 109\u002FL (without a platelet transfusion 2 weeks prior to the platelet measurement).\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN.\n    * Total bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN for subjects with Gilbert's syndrome).\n    * International normalized ratio (INR) ≤ 1.5 x ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (unless the subject is being treated with anticoagulant medication).\n    * Serum albumin ≥ 2.8 g\u002FdL.\n    * Creatinine clearance (measured or calculated) ≥ 30 mL\u002Fmin.\n11. Female subjects of reproductive potential who are sexually active with a male partner must:\n\n    * Have a negative serum beta-human chorionic gonadotropin (β-HCG) test within 3 days of cycle 1 day 1.\n    * Agree to use highly effective contraceptive measures (as defined in protocol) from the time of enrollment through 3 months after the last dose of study drug in the clinical trial.\n    * Female subjects are considered to be of non-reproductive potential if they: have been amenorrheic for greater than 1 year or have undergone surgical sterilization through tubal ligation, oophorectomy or hysterectomy.\n12. Male subjects with a female partner of reproductive potential must agree to use highly effective contraception (as defined in protocol) from the time of enrollment through 3 months after the last dose of study drug administration.\n13. Subjects must agree to not donate sperm or eggs (ova, oocytes) for the purpose of reproduction from the time of enrollment through 3 months after the last dose of study drug administration.\n14. Toxicities from prior anti-cancer therapy must have resolved to grade ≤ 1.\n\n    * Exceptions include vitiligo, endocrinopathies managed with hormone replacement therapy, alopecia, and grade 2 neuropathy or hearing loss.\n\nExclusion Criteria:\n\n1. Treatment with anticancer therapy within 14 days or 5 half-lives (whichever is shorter) of cycle 1 day 1. Palliative radiation therapy to a non-CNS metastasis is permitted if completed at least 14 days prior to cycle 1 day 1.\n2. History of other active malignancy that required treatment within 2 years of enrollment. Exceptions include the following:\n\n   * Early-stage\u002Flocalized tumors that have received definitive\u002Fcurative treatment and have low risk of recurrence (including but not limited to cutaneous squamous cell or basal cell carcinoma, in situ cervical or bladder cancer, and early-stage prostate cancer).\n   * Early-stage prostate cancer in which observation without treatment is recommended.\n3. Clinically significant cardiovascular conditions as defined by the following:\n\n   * New York Heart Association (NYHA) congestive heart failure class ≥ II.\n   * Left ventricular ejection fraction ≤ 50%.\n   * Clinically significant cardiac arrhythmia requiring treatment within 3 months of enrollment. Subjects with cardiac arrhythmias on stable management for over 3 months prior to enrollment are permitted.\n   * Prolonged QTcF interval \\> 480 ms.\n   * Myocardial infarction, stroke, or pulmonary embolism within 3 months of enrollment.\n4. CNS metastases or leptomeningeal carcinomatosis (applicable to subjects with solid tumors other than glioblastoma). Subjects with brain metastases are eligible for participation if one of the following criteria are met:\n\n   * CNS metastases have been treated with surgical resection or radiation therapy and have remained stable for at least 4 weeks (repeat imaging required at least 4 weeks following resection or last radiation therapy) prior to cycle 1 day 1.\n   * The subject is neurologically asymptomatic and there are ≤ 4 CNS metastases no larger than 1 cm.\n5. Treatment with immunosuppressive medications.\n\n   \\- Treatment with corticosteroids greater than the equivalent of prednisone 10 mg\u002Fday within 2 weeks of cycle 1 day 1 is exclusionary. Exceptions include: Premedication with corticosteroids for iodine contrasted CT scans; Chronic use of ≤ 10 mg\u002Fday of prednisone (or equivalent). Topical, inhaled, and intra-articular corticosteroid use is allowed; Subjects with glioblastoma are permitted to be on ≤ 3 mg\u002Fday dexamethasone (or equivalent).\n6. History of severe pulmonary disease defined as either of the following:\n\n   * History of interstitial lung disease, non-infectious pneumonitis (including immune checkpoint inhibitor induced pneumonitis), or pulmonary fibrosis.\n   * Currently dependent on supplemental oxygen.\n7. History of allogeneic stem cell or solid organ transplantation.\n8. History of autoimmune disease that required systemic immunosuppressive therapy within 2 years of enrollment. Subjects with autoimmune diseases managed with hormone replacement or topical therapies are eligible.\n9. History of an immune-mediated adverse event from treatment with an immune checkpoint inhibitor that resulted in treatment discontinuation.\n\n   \\- Subjects who discontinued treatment with ipilimumab due to toxicity and subsequently tolerated treatment with an anti-PD-(L)1 inhibitor without treatment-limiting toxicity are eligible.\n10. History of severe hypersensitivity reaction (≥ grade 3) to infusion of a therapeutic monoclonal antibody.\n11. Any major surgery within 4 weeks of receiving the first dose of the investigational treatment.\n12. Women who are pregnant or breast feeding.\n13. Subjects with active (acute or chronic) bacterial, viral, or fungal infection at the time of enrollment are ineligible with the following exceptions:\n\n    * Subjects with human immunodeficiency virus (HIV) are eligible for participation if the following criteria are met: CD4+ T cell count ≥350 cells\u002FµL, No history of AIDS-defining opportunistic infections within 12 months of enrollment, Subjects must be on antiretroviral therapy for at least 4 weeks and have an HIV viral load less than 400 copies\u002FmL prior to enrollment.\n    * Subjects with chronic hepatitis B (HBV) who are on suppressive antiviral therapy prior to enrollment are eligible. Subjects with chronic HBV who are not eligible for treatment with suppressive antiviral therapy are ineligible.\n    * Subjects with a history of hepatitis C (HCV) infection who have completed curative antiviral treatment and have an HCV viral load below the limit of quantification are eligible.\n14. Ongoing drug or alcohol abuse at the time of enrollment.\n15. Any medical or psychiatric illness or social circumstance that could jeopardize compliance with the protocol directed treatment and safety assessments.\n\nAdditional Exclusion Criteria Specific for the Part 2A - Newly Diagnosed MGMT Unmethylated Glioblastoma Cohort:\n\n1. Subjects with recurrent or secondary GBM.\n2. Subjects who underwent biopsy only without maximal safe resection.\n3. Subjects with a contraindication to MRI scans.\n4. Subjects with IDH-1 or IDH-2 mutations or H3 K27M diffuse midline glioma.\n5. Subjects with unresolved CNS hemorrhage, leptomeningeal or spinal metastases or ventricular invasion.\n6. Subjects treated with a carmustine wafer implant.\n7. Subjects treated with Tumor Treating Fields (TTF).",{"count":141,"type":20},110,[23],"Phase 1 first-in-human, open-label, dose-escalation (3 + 3), dose-expansion clinical trial to evaluate the safety, tolerability and preliminary clinical efficacy of M3T01 (fully human IgG4\u002Fkappa monoclonal antibody targeting FasL) in subjects with metastatic or unresectable solid tumors.",[145],"Advanced Solid Tumors","2025-07-07",{"date":148,"type":31},"2025-07-10",{"date":150,"type":31},"2025-06-17",{"date":67,"type":20},{"name":37,"class":38},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":5},"100529532","phase-2-maintenance-obinutuzumab-in-treating-patients-with-central-nervous-system-lymphoma-who-have-achieved-a-complete-or-partial-response-100529532","NCT06175000","Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response","Maintenance Obinutuzumab for Primary Central Nervous System Lymphoma Complete or Partial Responders","Inclusion Criteria:\n\n* CD20+ B-cell primary central nervous system lymphoma (PCNSL) confirmed at the time of diagnosis by histology, cytology, or immunocytochemistry from cerebrospinal fluid (CSF); diagnosis must be documented by pathology report.\n* Must have undergone first-line treatment with a high-dose methotrexate-based chemotherapy regimen with or without brain radiotherapy; high-dose methotrexate is defined as \\>= 3 grams\u002Fm\\^2; methotrexate dose reduction for creatinine clearance \\\u003C 100 ml\u002Fmin is permitted\n* Must be within 75 days of completion of first-line treatment regimen at the time of randomization; must have achieved objective response (PR or CR\u002Funconfirmed complete response \\[CRu\\]) to first-line treatment\n* Brain magnetic resonance imaging (MRI) documenting objective response must be obtained within 30 days before randomization\n* If CSF was positive for lymphoma cells at diagnosis or during first-line treatment and\u002For a slit lamp examination was positive at diagnosis or during first-line treatment, then the CSF and vitreal studies must have been repeated and must have indicated CR; Note: CR requires complete disappearance of all enhancing abnormalities on gadolinium-enhanced MRI; if CSF was positive for lymphoma cells at diagnosis or during first-line treatment and\u002For slit lamp examination was positive at diagnosis or during first-line treatment, then the CSF and vitreal studies must have been repeated and must have indicated CR; for CRu, some patients will have a small but persistent enhancing abnormality on MRI related to biopsy or focal hemorrhage; it is often difficult to ascertain whether this represents a residual nidus of tumor or scar tissue; if the abnormality does not change or slowly involutes without therapy and corticosteroids, it is reasonable to categorize as a CRu; at the time CR\u002FCRu is determined, the patient should not have used corticosteroids for at least two weeks\n* Karnofsky performance status (KPS) \\>= 60; Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2\n* Signed informed consent form (ICF)\n* Ability and willingness to comply with the requirements of the study protocol\n* Total bilirubin \\\u003C 3 x the upper limit of normal (ULN), ≤ 7 days before date of randomization\n* Creatinine clearance \\> 30 mL\u002Fmin (calculated according to institutional standards or using Cockcroft-Gault formula), ≤ 7 days before date of randomization\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 5 x ULN, ≤7 days before date of randomization\n* Platelet ≤ 75,000 cells\u002Fmm\\^3, ≤ 7 days before date of randomization\n* Hemoglobin \\> 9 g\u002FdL, ≤ 7 days before date of randomization\n* Absolute neutrophil count \\> 1.5 x 10\\^3 cells\u002Fmm\\^3, ≤ 7 days before date of randomization\n* Surgically sterile or agree to use effective contraception using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly while receiving obinutuzumab and \\>= 18 months after the last dose of obinutuzumab for women, and 180 days after the last dose of obinutuzumab for men\n\nExclusion Criteria:\n\n* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy\n* Clinical evidence of extra-central nervous system (CNS) (systemic) non-Hodgkin lymphoma\n* Known hypersensitivity to any of the study drugs\n* History of other malignancy that could affect compliance with the protocol or interpretation of results\n* Patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible; patients with a malignancy that has been treated, but not with curative intent, will also be excluded, unless the malignancy has been in remission without treatment for \\>= 2 years prior to randomization\n* Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks prior to study randomization\n* Major surgery within 4 weeks prior to study randomization\n* Known infection with human immunodeficiency virus (HIV)\n* Positive hepatitis serologies:\n* Hepatitis B (HBV): patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management\n* Hepatitis C (HCV): patients with positive hepatitis C serology unless HCV ribonucleic acid (RNA) is confirmed negative and may be considered for inclusion in the study on a case-by-case basis\n* Women who are pregnant or lactating\n* Vaccination with a live vaccine a minimum of 4 weeks prior to study randomization",{"count":161,"type":20},28,[49],"This randomized phase II trial studies how well obinutuzumab works as maintenance treatment in patients with central nervous system lymphoma who have achieved the disappearance of all signs of cancer in response to treatment (complete response) or a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment (partial response). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.",[165],"Primary Central Nervous System Lymphoma","2025-06-04",{"date":168,"type":31},"2025-06-05",{"date":170,"type":31},"2024-03-13",{"date":172,"type":20},"2029-09-15",{"name":37,"class":38},""]