[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"phase-2\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:phase-2":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,67,91],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100638087","phase-2-blood-and-image-guided-optimization-of-neoadjuvant-therapy-in-people-with-early-stage-triple-negative-breast-cancer---the-better-trial-100638087",false,"NCT07610525","Blood and imagE-guided Optimization of Neoadjuvant Therapy in People With Early Stage Triple-negative Breast cancER - the BETTER Trial","Blood and imagE-guided Optimization of Neoadjuvant Therapy in People With Early Stage Triple-negative Breast cancER - the BETTER Tria","Inclusion Criteria\n\n* Participants must be 18 years of age or older, able to understand and give written informed consent.\n* Histologically proven TNBC, defined as ER ≤10%, PR ≤10%, and HER2 negative based on the 2023 ASCO\u002FCAP guidelines.\n* Clinical stage T1cN1-2 or T2-4N0-2 TNBC according to the primary tumor-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition.\n* Medically eligible to receive immunotherapy in combination with chemotherapy as part of standard of care\n* Willingness to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female Participants, between the onset of menses (as early as 8 years of age) and 55 years unless the Participant presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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.\n* 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.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* No active viral hepatitis (hepatitis B or C) at baseline\n\nExclusion Criteria\n\n* Stage IV (metastatic) breast cancer\n* History of any prior (ipsi- or contralateral) invasive breast cancer. Note: Prior DCIS is allowed.\n* History of other malignancies within the last 5 years except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, stage I uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above.\n* Prior excisional biopsy of the primary invasive breast cancer.\n* Participants with cognitive impairment\u002Fpsychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Participants not medically eligible for chemotherapy with taxanes, carboplatin, and\u002For anthracycline-based chemotherapy regimens\n* Participants not medically eligible for immunotherapy\n* Pregnant women are excluded from this study because of the potentially detrimental effect of magnetic resonance imaging on the fetus.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","To learn whether certain blood and imaging tests can show which people with early-stage TNBC may already have had a complete response to chemotherapy before they go to surgery.",[26,27,28,29],"Triple Negative Breast Cancer","Blood and Image Guided","Optimization of Neoadjuvant Therapy","Phase 2","NOT_YET_RECRUITING","2026-05-21",{"date":33,"type":34},"2026-05-28","ACTUAL",{"date":36,"type":20},"2026-11-05",{"date":38,"type":20},"2031-01-15",{"name":40,"class":41},"M.D. Anderson Cancer Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100614756","phase-2-phase-2-trial-of-zanzalintinib-and-pembrolizumab-in-select-subtypes-of-advancedmetastatic-soft-tissue-sarcoma-100614756","NCT07283731","Phase 2 Trial of Zanzalintinib and Pembrolizumab in Select Subtypes of Advanced\u002FMetastatic Soft-tissue Sarcoma","Eligibility Criteria\n\n* Participants must have histologically or cytologically confirmed undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma (MFS), high grade pleomorphic (HGPS) or undifferentiated sarcoma (HGUS).\n* Participant ≥ 18 years of age. Because no dosing or adverse event data are currently available on the use of zanzalintinib in combination with pembrolizumab in participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status ≤2 (Karnofsky ≥60%).\n* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.\n* At least 4 weeks since prior chemotherapy.\n* At least 2 weeks since radiation therapy for bone metastases, any other radiation therapy within 4 weeks before first dose of study treatment. At least 6 weeks since systemic treatment with radionuclides before first dose of study treatment.\n* Participants must have adequate organ and marrow function as defined below within 14 days before first dose of study treatment:\n\nabsolute neutrophil count ≥1,500\u002FmcL without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection.\n\nplatelets ≥100,000\u002FmcL without transfusion within 2 weeks of screening laboratory sample collection.\n\nhemoglobin ≥ 9 g\u002FdL (≥ 90 g\u002FL) without transfusion within 2 weeks prior to screening laboratory sample collection.\n\ninternational normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN ).\n\ntotal bilirubin ≤ 1.5 x institutional ULN AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN Alkaline phosphatase (ALP) ≤3 × institutional ULN, . For subjects with documented bone metastasis ALP ≤ 5 x ULN.\n\ncreatinine ≤ 1.5 x institutional ULN or calculated creatinine clearance ≥ 40 mL\u002Fmin (≥ 0.67 mL\u002Fsec) using the Cockcroft Gault equation.\n\nUrine protein-to-creatinine ratio (UPCR) ≤ 1 mg\u002Fmg (≤ 113.2 mg\u002Fmmol)\n\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 4 weeks. Note: Participants must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).\n* Participants 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 three cycles of therapy.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* The effects of zanzalintinib and pembrolizumab on the developing human fetus are unknown. For this reason, 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. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n  o Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n\n  o History of hysterectomy or bilateral salpingo-oophorectomy.\n\n  o Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n\n  o History of bilateral tubal ligation or another surgical sterilization procedure.\n\n  o Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n* Females must not be pregnant.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal ligation or hysterectomy, subject\u002Fpartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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.\n* Women of childbearing potential must comply for the duration of study participation and through 186 days after the last dose of zanzalintinib and 180 days after the last dose of pembrolizumab, whichever date is later. Men must comply for the duration of study participation and through 96 days after the last dose of zanzalintinib or 96 days of pembrolizumab, whichever date is later.\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.\n* Consent to MD Anderson companion laboratory protocol 2014-0938 for correlative analyses of biopsies obtained in this trial.\n\nExclusion Criteria\n\n* Prior treatment with immune checkpoint inhibitors (ICIs)\n* Prior treatment with zanzalintinib\n* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n* Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible. Additionally, if participants have received radiation therapy within 4 weeks or systemic therapy with radionucleotides within 6 weeks they are not eligible.\n* Participants who are receiving any other investigational agents, as well as cytotoxic or biological systemic anticancer therapy including investigational treatments within 4 weeks of initiating study treatment are excluded.\n* Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin inhibitors) and platelet inhibitors (eg, clopidogrel).\n\n  * Allowed anticoagulants are the following:\n\n    1. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n    2. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\nNote: Subjects must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer.\n\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\nUnstable of deteriorating cardiovascular disorders • Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (eg, ventricular flutter, ventricular fibrillation, Torsade's de pointes).\n\n* Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment.\n* Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction, or other clinically significant arterial thrombotic and\u002For ischemic event within 6 months before first dose of study treatment.\n* Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before first dose of study treatment.\n\nNote: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\nNote: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator.\n\no Prior history of myocarditis.\n\nGastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n\n* Tumors invading the GI-tract from external viscera.\n* Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis.\n* Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before first dose unless cause of obstruction is definitively managed and subject is asymptomatic.\n* Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n* Known gastric or esophageal varices.\n* Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks.\n\n  * Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose of study treatment.\n  * Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed).\n  * Tumors invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. Note: Subjects with intravascular tumor extension (eg, tumor thrombus in renal vein or inferior vena cava) may be eligible following Principal Investigator approval.\n  * Other clinically significant disorders that would preclude safe study participation.\n* Active infection requiring systemic treatment. Note: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are allowed.\n* Serious non-healing wound\u002Fulcer\u002Fbone fracture. Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.\n* Malabsorption syndrome.\n* Pharmacologically uncompensated, symptomatic hypothyroidism.\n* Moderate to severe hepatic impairment (Child-Pugh B or C).\n* Requirement for hemodialysis or peritoneal dialysis.\n* History of solid organ or allogeneic stem cell transplant.\n\n  * Participants with brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 3 months.\n  * History of allergic reactions attributed to compounds of similar chemical or biologic composition to zanzalintinib or pembrolizumab or other agents used in study.\n  * Moderate or strong CYP3A4 inhibitors (see section 5.4).\n  * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load and CD4+ T cell count ≥ 200\u002FµL within 6 months are eligible for this trial.\n* Note: To be eligible, participants taking CYP inhibitors (eg, zidovudine, ritonavir, cobicistat, didanosine) or CYP3 inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies (ART) must have been received for at least 4 weeks prior to the first dose. Note: CD4+ T cell counts, and viral load are monitored per standard of care by the local health care provider.\n\n  * Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n  * Pregnant women are excluded from this study because zanzalintinib has the potential for teratogenic or abortifacient effects based on its mechanism of action. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with zanzalintinib and pembrolizumab, breastfeeding should be discontinued if the mother is treated with either agent. These potential risks may also apply the other agents used in this study.\n  * Major surgery (as defined in Appendix 2) within 8 weeks prior to first dose of study treatment. Prior laparoscopic surgeries (ie nephrectomy) within 4 weeks prior to first dose of study treatment. Minor surgery (eg, simple excision, tooth extraction) within 5 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment.\n\nNote: Fresh tumor biopsies should be performed at least 5 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.\n\n• Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment.\n\nNote: Triplicate ECG evaluations one minute apart will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility.\n\n* Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube.\n* Another malignancy that requires active therapy and in the opinion of the Investigator would interfere with monitoring of radiologic assessments of response to Investigational Product, within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n* Suspected autoimmune disease, or active or prior documented autoimmune disease within the last 2 years.\n\nNote: Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n\n* Known positive test for tuberculosis infection if supported by clinical or radiographic evidence of disease.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computerized tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Free thyroxine (FT4) outside the laboratory normal reference range. Asymptomatic subjects with FT4 abnormalities can be eligible after Principal Investigator approval.\n* Diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\> 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment. Inhaled, intranasal, intraarticular, and topical corticosteroids and mineralocorticoids are allowed. Note: Adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. Transient short-term use of higher doses of systemic corticosteroids for allergic conditions (eg, contrast allergy) is also allowed.\n* Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.\n* Other conditions, which in the opinion of the Investigator, would compromise the safety of the participant or the participant's ability to complete the study.",{"count":50,"type":20},20,[23],"To learn if zanzalintinib and pembrolizumab can help to control select subtypes of advanced\u002Fmetastatic soft-tissue sarcoma (UPS, MFS, HGPS, and HGUS",[29,54,55,56,57],"Zanzalintinib","Pembrolizumab","Advanced\u002FMetastatic","Soft-Tissue Sarcoma","RECRUITING","2026-04-14",{"date":61,"type":34},"2026-04-17",{"date":63,"type":20},"2026-06-02",{"date":65,"type":20},"2030-11-01",{"name":40,"class":41},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":42},"100622370","phase-2-a-phase-2-study-of-radiotherapy-induced-immune-priming-to-enhance-elranatamab-elra-in-relapsed-refractory-multiple-myeloma-rrmm-with-extramedullary-disease-emd-and-paramedullary-disease-pmd-prime-emd-pmd-100622370","NCT07382739","A Phase 2 Study of Radiotherapy-induced Immune Priming to Enhance Elranatamab (Elra) in Relapsed Refractory Multiple Myeloma (RRMM) With Extramedullary Disease (EMD) and Paramedullary Disease (PMD) \"PRIME-EMD-PMD\"","Inclusion Criteria\n\n* RRMM exposed to IMID, PI, anti-CD38 mAb, relapsed or refractory to at least one prior line of therapy (LOT), progressed on or after the last regimen:\n\n  1. Relapsed disease: progressive disease (PD) \\>60 days after cessation of prior therapy\n  2. Refractory disease: PD \\\u003C=60 days after cessation of prior therapy, \\\u003C25% reduction in paraprotein (monoclonal protein \\[M-protein\\] or serum free light chains \\[sFLC\\]) or measurements of EMD\u002FPMD\n* Diagnosis of relapsed or refractory multiple myeloma as indicated by progression by IMWG criteria\n* At least one locus of EMD or PMD present on imaging (either PET\u002FCT or magnetic resonance imaging \\[MRI\\]):\n* EMD: extramedullary plasmacytoma, not a contiguous extension from a bone lesion.\n* PMD: paraskeletal plasmacytoma, contiguous extension from a bone lesion At least one locus of EMD\u002FPMD that was not previously radiated and can be treated with radiation\n* Hematology (supportive care is allowed, including transfusions and granulocyte colony stimulating factor (G-CSF), if cytopenia is deemed secondary to myeloma disease burden):\n* Hemoglobin (Hgb) \\>=7g\u002FdL\n* Platelet\\>=50K\u002FuL\n* Absolute neutrophil count (ANC) \\>=0.75K\u002FuL\n* Chemistry:\n* Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) \\\u003C=2.5 x upper\n* limit of normal (ULN)\n* Total bilirubin (TBili) \\\u003C=1.5ULN (except for a known history of Gilbert syndrome)\n* Creatinine clearance (CrCL) \\>=30mL\u002Fmin\u002F1.73m2\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) \\\u003C=2, unless ECOG PS due to pain\u002Fmorbidity secondary to underlying myeloma disease, with the potential of improved ECOG PS to \\\u003C=2.\n* All participants must be either\n* Not of childbearing potential, or\n* Practicing at least 1 highly effective method of contraception until 6 months after the last dose of study treatment.\n* Childbearing age female participantsmust have a negative serum pregnancy test at screening and must agree to further pregnancy tests during the study.\n\nExclusion Criteria\n\n1. Prior or concurrent exposure to any of the following in the specified time frame prior to the first dose of Elra treatment:\n\n   * Within 14 days or at least 5 half-lives, whichever is less, of any investigational treatment\n   * Within 7 days of IMIDs, PI, anti-CD38 mAb, or cytotoxic systemic myeloma therapies\n   * Within 12 weeks of autologous stem-cell therapy (ASCT) or 6 months of AlloSCT and has to be off immunosuppressive agents \\>=42 days without signs of graft versus host disease (GVHD)\n   * Within 2 weeks of major surgery\n   * Within 6 months of cerebrovascular accident (CVA) events\n2. Waldenstrom, POEMS, Amyloidosis, ongoing plasma cell leukemia (PCL)\n3. History of Human Immunodeficiency Virus (HIV)\n4. Active, uncontrolled HBV infection despite antiviral therapy.\n5. Uncontrolled cardiac, pulmonary, gastrointestinal (GI), hepatic, renal, central nervous system(CNS) diseases not due to myeloma, at the discretion of investigator, that are not a candidate for T cell engager (TCE) therapy\n6. Uncontrolled or recurrent infections\n7. Autoimmune disease requiring systemic treatment (except for low dose steroids, equivalent to 10mg\u002Fday or less of prednisone)\n8. Disabling psychiatric conditions, substance abuse (alcohol, or drug), dementia, altered mental status\n9. Any other active malignancies within 5 years of completing treatment (with the exception of hormonal therapies for breast or prostate cancer) and \\>minimal risk of recurrence\n10. Myelodysplastic syndromes (MDS)\n11. Any issues that may impair the ability of the participant to receive or tolerate the planned treatment, to understand the informed consent, or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that would prevent, limit, or confound the protocol specified assessments.\n12. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Elra or other agents used in study.\n13. History or possible non-compliance with recommended treatments",{"count":74,"type":20},34,[23],"To learn if low doses of radiation therapy can help the drug elranatamab enhance the killing effect of the cancer cells.",[29,78,79,80,81,82,83],"Radiotherapy-Induced Immune Priming","Elranatamab","Relapsed Refractory Multiple Myeloma (RRMM)","Extramedullary Disease in Multiple Myeloma","Paramedullary Disease","PMD","2026-04-09",{"date":59,"type":34},{"date":87,"type":34},"2026-03-31",{"date":89,"type":20},"2030-12-31",{"name":40,"class":41},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":42},"100632233","phase-2-phase-2-trial-of-sacituzumab-tirumotecan-for-treatment-of-refractory-metastatic-or-unresectable-squamous-cell-carcinoma-of-the-anusrectum-100632233","NCT07511023","Phase 2 Trial Of Sacituzumab Tirumotecan For Treatment Of Refractory Metastatic Or Unresectable Squamous Cell Carcinoma Of The Anus\u002FRectum","Eligibility Criteria\n\n1. Participants must have histologically or cytologically confirmed squamous cell carcinoma of the anus or rectum that is metastatic or unresectable at the discretion of the treating investigator.\n2. Participants must have measurable disease according to the standard RECIST version 1.1 as assessed by the local site investigator\u002Fradiology. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n3. Participants must have been treated with at least one, but no more than three, prior line(s) of systemic treatment, including prior cytotoxic chemotherapy and immunotherapy, for incurable advanced or metastatic SCC of the anal canal. Prior cytotoxic chemotherapy for metastatic disease is not required for participants who develop new metastatic lesions during or within 6 months of completion of chemoradiation for limited-stage disease.\n4. Participants must be ≥18 years old.\n5. ECOG performance status 0 or 1.\n6. Ability to understand and the willingness to sign a written informed consent document. 7. For male participants, if capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate the study intervention after the last dose of study intervention. The length of time required to continue contraception for Sacituzumab tirumotecan is 120 days. o Refrains from donating sperm o Uses a penile\u002Fexternal condom when having penile-vaginal intercourse with a nonparticipant of childbearing potential who is not currently pregnant PLUS partner use of an additional contraceptive method (refer to Section 14.3.3), as a condom may break or leak.\n\n8\\. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.\n\n9\\. Note: If the participant is azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview), no contraception is required.\n\n10\\. For female participants, a participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n* Is not a POCBP, OR OR o Is a POCBP and:\n\n  * Uses a contraceptive method that is highly effective (with a failure rate of 1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 4 during the intervention period and for at least the time needed to eliminate the study intervention after the last dose of study intervention. The participant agrees not to donate eggs (ova, oocytes) to others or freeze\u002Fstore eggs during this period for the purpose of reproduction. The length of time required to continue contraception for sacituzumab tirumotecan is 210 days.\n  * The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.\n  * Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after study intervention are in Section 6.3.1.\n  * Abstains from breastfeeding during the study intervention period and for at least 10 days after study intervention.\n  * Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.\n\n    11\\. Has provided an archival tumor tissue sample or most recently obtained core, incisional, or excisional biopsy of a tumor lesion from any site not previously irradiated. Tumors that have grown following previous radiotherapy are permitted. Sites should follow local guidelines regarding fresh tissue collection. Tissue is required for determination of TROP2 status by the supporting company's (Merck) central laboratory.\n\n    12\\. Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except for alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible.\n\n    13\\. Adequate laboratory evaluation (within 10 days before the start of study intervention), defined as:\n* ANC ≥1,500\u002FmcL\n* Hemoglobin ≥ 9.0 gm\u002FdL\n* Platelet count ≥100,000\u002FmcL\n* Total bilirubin ≤ 1.5x \\~ institutional upper limit of normal (ULN) OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n* AST(SGOT)\u002FALT(SGPT) ≤ 2.5x\\~ ULN (≤5 × ULN for participants with liver metastases)\n* Creatinine clearance (CrCl) ≥ 30 mL\u002Fmin\n* INR or PT and aPTT ≤ 1.5x\\~ ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n\n  * Criteria must be met without colony-stimulating factors, erythropoietin dependency, and without pRBC transfusion within the preceding 2 weeks.\n  * Criteria must be met without albumin supplementation within the last 72 hours.\n  * CrCl is calculated by the Cockcroft-Gault CrCl formula = \\[\\[140 - age (years)\\] × weight (kg)\\] \u002F \\[72 × serum Cr (mg\u002FdL) × 0.85 for female participants\\]. As an alternative, CrCl can be determined from a 24-hour urine collection.\n\n    14\\. Be willing and able to comply with study procedures, laboratory tests, and other requirements of the study.\n\n    15\\. HIV-infected participants must have well-controlled HIV on ART, defined as:\n* Having a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n* Having achieved and maintained virologic suppression, defined as confirmed HIV RNA level below 50 or the LLOQ using the locally available assay, at the time of screening and for at least 12 weeks before screening\n* Absence of any AIDS-defining opportunistic infections within the past 12 months\n* Being on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before start of treatment and agreeing to continue ART throughout the study. The ART regimen must not contain any antiretroviral medications that are strong CYP3A4 inducers\u002Finhibitors\u002Fsubstrates. Refer to https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactionslabeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally approved label for all concomitant therapy to ensure it is not a strong inducer\u002Finhibitor\u002Fsubstrate of CYP3A4. HIV testing at screening is not required unless:\n\n  * There is a known history of HIV infection\n  * Mandated by local guidelines 16. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load before start of treatment. Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention. Hepatitis B testing at screening is not required unless: o There is a known history of HBV infection o Mandated by local guidelines 17. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative antiviral therapy at least 4 weeks before start of treatment. Hepatitis C testing at screening is not required unless: o There is a known history of HCV infection o Mandated by local guideline\n\nExclusion Criteria\n\n1. Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n2. Has active inflammatory bowel disease requiring immunosuppressive medication or previous history or inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).\n3. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>480 ms, and\u002For other serious cardiovascular and cerebrovascular disease within 6 months before the first dose of study intervention.\n4. Exposure to prior systemic anticancer therapy or radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and\u002For has had radiation pneumonitis.\n5. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n6. Receipt of any other investigational agent(s) or investigational device within 4 weeks before the first dose of study intervention.\n7. Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited.\n8. Prior treatment with a topoisomerase 1 inhibitor-containing ADC.\n9. Prior treatment with irinotecan or topotecan.\n10. Prior treatment with a TROP2-targeted ADC.\n11. Receipt of a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n12. Treatment with strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to the first dose and during the study treatment.\n13. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n14. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) who have undergone potentially curative resection are not excluded.\n15. Note: Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n16. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable, and have not required steroid treatment for at least 14 days before the first dose of study intervention.\n17. Has an active infection requiring systemic therapy other than those permitted in Section 4.1.\n18. Severe hypersensitivity (Grades ≥3) to study intervention, any of their excipients, and\u002For to another biologic therapy.\n19. Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention. Anticipation of the need for major surgery during the course of treatment with study intervention is also exclusionary.\n20. Note: Participants who underwent major surgery must have adequately recovered from toxicity and\u002For complications from the surgery before starting study intervention.\n21. Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n22. History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study, such that it is not in the best interest of the participant to particip",{"count":50,"type":20},[23],"To look at the effectiveness of sacituzumab tirumotecan (MK-2870) in treating participants with treatment-refractory unresectable and\u002For metastatic anal\u002Frectal cancer.",[29,101,102,103,104],"Sacituzumab Tirumotecan","Refractory Metastatic","Unresectable Squamous","Cell Carcinoma of the Anus\u002F Rectum",{"date":106,"type":34},"2026-04-06",{"date":108,"type":20},"2026-09-25",{"date":110,"type":20},"2033-03-01",{"name":40,"class":41}]