[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"postneoadjuvant-therapy-stage-iva-gastroesophageal-junction-adenocarcinoma-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:postneoadjuvant-therapy-stage-iva-gastroesophageal-junction-adenocarcinoma-ajcc-v8":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,68,111,152],{"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":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100421724","phase-2-avapritinib-for-the-treatment-of-ckit-or-pdgfra-mutation-positive-locally-advanced-or-metastatic-malignant-solid-tumors-100421724",false,"NCT04771520","Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors","Phase 2 Study of Avapritinib in Patients With CKIT or PDGFRA Mutation-Positive Malignant Solid Tumors","Inclusion Criteria:\n\n1. The patient (or legally acceptable representative if applicable) provides written informed consent for the study.\n2. Male or female ≥18 years of age on the day of informed consent signing. Adolescent patients aged 12 years and older are allowed with signed assent and parental consent according to institutional guidelines and requirements.\n3. Cohorts 1 and 2: Patient has a locally advanced or metastatic solid tumor and has progressed on appropriate standard therapy, has not shown clinically meaningful benefit to appropriate standard therapy, has no available standard therapy, or has declined appropriate standard therapy.\n\n   • NOTE: Specific solid tumor types include but are not limited to melanoma, breast cancer, lung cancer, gastroesophageal cancer, colorectal cancer, sarcoma, solid tumors NOS, and primary CNS tumors. Patients with any other recurrent solid tumor type with the exception of gastrointestinal stromal tumor (GIST) will be eligible.\n4. Cohort 3: Patient has newly diagnosed IDH wild-type, MGMT-unmethylated glioblastoma. Patients must have received prior treatment with radiation and concurrent temozolomide per standard of care.27 Patients must have completed radiation and concurrent temozolomide 3-8 weeks prior to study treatment initiation.\n5. Measurable disease per the RECIST v1.1 or RANO criteria, as appropriate, for Cohorts 1 and 2. Patients in Cohort 3 can have measurable or non-measurable disease per the RANO criteria.\n\n6 Documented pathogenic CKIT activating mutation (Cohort 1) OR pathogenic PDGFRA activating mutation (Cohort 2) based on Clinical Laboratory Improvement Amendments-certified next-generation sequencing diagnostic test. Cohort 3 should have pathogenic CKIT or PDGFRA activating mutation\u002Famplification based on CLIA-certified NGS diagnostic test. CKIT and PDGFRA mutation pathogenicity will be verified by the MD Anderson Cancer Center's Precision Oncology Decision Support team. Acceptable CKIT\u002FPDGFRA mutations for study eligibility are listed in Appendix E.\n\n7\\. Has available archival tissue for CKIT\u002FPDGFRA mutation (amplification \\[Cohort 3 only\\]) retrospective testing.\n\n8\\. Adequate organ and marrow function as defined below within 7 days of study treatment initiation:\n\n* White blood cell count \\>2,500\u002FµL and \\\u003C15,000\u002FµL\n* Absolute neutrophil count ≥1.5 × 109\u002FL (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility)\n* Platelet count ≥75 × 109\u002FL (without transfusion within 2 weeks of laboratory test used to determine eligibility)\n* Hemoglobin ≥9.0 g\u002FdL (without blood transfusion within 7 days of laboratory test used to determine eligibility)\n* Total bilirubin ≤1.5 × upper limit of normal (ULN); if hepatic metastases are present, ≤3.0 × ULN\n* Aspartate transaminase and alanine transaminase ≤2.5 × ULN; if hepatic metastases are present, ≤5.0 × ULN\n* Serum creatinine ≤2.0 × ULN or creatinine clearance ≥45 mL\u002Fmin. 9. Cardiac ejection fraction \\>45% per screening echocardiogram or multigated acquisition scan.\n\n  10\\. Eastern Cooperative Oncology Group performance status of 0-2.\n\n  11\\. Life expectancy ≥3 months.\n\n  12\\. Willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations.\n\n  13\\. Willing to undergo biopsy as required by the study.\n\n  14\\. Females must be postmenopausal (defined as ≥45 years of age with at least 12 months of spontaneous amenorrhea) or premenopausal with documented surgical sterilization (tubal ligation, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), or evidence of non-childbearing status for women of childbearing potential (negative serum beta-human chorionic gonadotropin pregnancy test) within 3 days of study treatment initiation.\n\n  15\\. Females of childbearing potential must either abstain from heterosexual intercourse or use a highly effective method of contraception for the course of the study and for 6 weeks after the last dose of study treatment.\n\n  16\\. Males with female partners of reproductive potential must either abstain from sexual intercourse or they and their partners must use a highly effective method of contraception when engaging in sexual intercourse for the course of the study through 30 days after the last dose of study treatment.\n\nExclusion Criteria:\n\nPatients eligible for this study must not meet any of the following criteria:\n\n1. Patients who have GIST.\n2. Patients with tyrosine kinase inhibitor-resistant CKIT mutation V654A or T670I.\n3. Patients with meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases. Note: Patients with stable brain metastases (defined as asymptomatic or no requirement for high-dose or increasing dose of systemic corticosteroids) and without imminent need of radiation therapy) are eligible (including those with untreated brain metastases). If applicable, patients must have completed brain radiation therapy and recovered adequately from any associated toxicity and\u002For complications prior to eligibility assessment. For patients who have received prior radiation therapy, post-treatment magnetic resonance imaging scan should show no increase in brain lesion size\u002Fvolume.\n4. History of documented congestive heart failure (New York Heart Association functional classification III-IV) or serious cardiac arrhythmias requiring treatment.\n5. QT interval corrected using Fridericia's formula of \\>470 msec.\n6. Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 2 weeks prior to study treatment initiation.\n7. Prior anticancer chemotherapy, hormone therapy, immunotherapy, targeted therapy, radiation therapy, or surgery within 2 weeks prior to study treatment initiation.\n\n   * NOTE: Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline (except alopecia). Patients with ≤ Grade 2 neuropathy are eligible.\n   * NOTE: If patient received major surgery, she\u002Fhe must have recovered adequately from the toxicity and\u002For complications from the intervention prior to study treatment initiation.\n   * NOTE: Patients in Cohort 3 must have completed radiation and concurrent temozolomide 3-8 weeks prior to study treatment initiation.\n8. Symptomatic non-healing wound, ulcer, gastrointestinal perforation, or bone fracture.\n9. History of psychotic or depressive disorder. Patients whose disorder is well controlled on a stable antipsychotic or antidepressant medication for at least 12 months prior to study entry will be eligible.\n10. Concomitant use of a known strong cytochrome P450 (CYP)3A4 inhibitor or strong CYP3A4 inducer. The required washout period prior to study treatment initiation is 2 weeks or 5 half-lives, whichever is shortest.\n11. Females who are pregnant or breastfeeding.\n12. Unable to swallow and retain oral medications.\n13. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the study treatment (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n14. Known additional malignancy that is progressing or requires active treatment. NOTE: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in situ that have undergone potentially curative therapy are not excluded.\n15. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the investigator.\n16. Prior treatment with an intracerebral agent or bevacizumab (Cohort 3 only).\n17. Prior treatment including radiation, chemotherapy, or immunotherapy for low-grade glioma (Cohort 3 only).","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies the effect of avapritinib in treating malignant solid tumors that have a genetic change (mutation) in CKIT or PDGFRA and have spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Avapritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Avapritinib may help to control the growth of malignant solid tumors.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54],"Anatomic Stage IV Breast Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Locally Advanced Malignant Solid Neoplasm","Locally Advanced Melanoma","Locally Advanced Primary Malignant Central Nervous System Neoplasm","Locally Advanced Sarcoma","Metastatic Malignant Solid Neoplasm","Metastatic Melanoma","Metastatic Primary Malignant Central Nervous System Neoplasm","Metastatic Sarcoma","Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Prognostic Stage IIIC Breast Cancer AJCC v8","Prognostic Stage IV Breast Cancer AJCC v8","Stage IIIC Colorectal Cancer AJCC v8","Stage IIIC Lung Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","Stage IVA Colorectal Cancer AJCC v8","Stage IVA Lung Cancer AJCC v8","Stage IVB Colorectal Cancer AJCC v8","Stage IVB Lung Cancer AJCC v8","Stage IVC Colorectal Cancer AJCC v8","RECRUITING","2026-06-09",{"date":58,"type":59},"2026-06-11","ACTUAL",{"date":61,"type":59},"2021-01-20",{"date":63,"type":20},"2026-12-31",{"name":65,"class":66},"M.D. Anderson Cancer Center","OTHER",1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":67},"100401729","phase-1-trifluridinetipiracil-and-talazoparib-for-the-treatment-of-patients-with-locally-advanced-or-metastatic-colorectal-or-gastroesophageal-cancer-100401729","NCT04511039","Trifluridine\u002FTipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer","A Phase I Study of Trifluridine\u002F Tipiracil Plus the Poly (ADP) Ribose Polymerase Inhibitor Talazoparib in Advanced Cancers","Inclusion Criteria:\n\n* Histologically or cytologically confirmed CRC or EGC adenocarcinoma that is locally advanced or metastatic (Cohort A); histologically or cytologically confirmed p53mt\u002FRASonc (Cohort B1) or p53mt\u002FRASwt CRC (Cohort B2) that is locally advanced or metastatic. Patients with adenocarcinoma histology only are allowed to participate.\n* Has received at least one prior line of therapy with progression or intolerance\n* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Life expectancy \\>= 3 months by investigator assessment\n* Hemoglobin \\>= 9 g\u002FdL\n* Absolute neutrophil count \\>= 1500\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3 without transfusion or growth factor support\n* Creatinine \\\u003C 1.5 upper limit of normal (ULN) or creatinine clearance \\> 60 mL\u002Fmin\n* Total bilirubin \\\u003C 1.5 x ULN\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 2.5 x ULN or \\\u003C x 5 ULN in the presence of liver metastasis\n* Albumin \\> 3 g\u002FdL\n* Ability to swallow oral medications\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Systemic antineoplastic therapy within 2 weeks prior to day -14 (Dose Escalation, Cohort A) or Cycle 1 day 1 (Dose Expansion, Cohorts B1 and B2) or within the past 6 weeks if this treatment is mitomycin C or nitrosourea\n* Radiotherapy within the past 2 weeks excluding palliative radiotherapy to painful bone lesions\n* Prior treatment with PARP inhibitor, FUDR or FTD\u002FTPI\n* Any condition that in the investigator's opinion can limit absorption of FTD\u002FTPI or talazoparib from the gastrointestinal (GI) tract\n* Gastrointestinal obstruction (without diversion) or perforation within 4 weeks from initiation of day -14 (Dose Escalation, Cohort A) or Cycle 1 Day 1 (Dose Expansion, Cohorts B1 and B2.\n* Refractory ascites (requiring weekly or more frequent paracentesis or permanent indwelling peritoneal catheter)\n* Untreated central nervous system (CNS) disease. Patients with leptomeningeal disease are ineligible but patients with treated, stable CNS metastasis for at least 4 weeks are allowed to participate\n* Significant cardiac disease defined as congestive heart failure stage III or IV (New York Heart Association \\[NYHA\\]), acute coronary event, cerebrovascular event, peripheral arterial embolic event, venous thromboembolic event (pulmonary embolism or lower extremity deep vein thrombosis), or ventricular arrhythmia within the past 3 months\n* Other malignancy requiring active therapy\n* Presence of toxicities from prior therapy of grade 2 or higher\n* Active infection requiring antibiotic therapy\n* Known human immunodeficiency virus (HIV) or hepatitis B infection or untreated hepatitis C infection. Patients with treated hepatitis C infection and undetectable viral load are allowed to participate\n* Any history of myelodysplastic syndrome, acute leukemia, or bone marrow transplant\n* Pregnant or nursing female participants\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug",{"count":76,"type":20},45,[78],"PHASE1","This phase I trial investigates the side effects and best dose of talazoparib when given together with trifluridine\u002Ftipiracil for the treatment of patients with colorectal or gastroesophageal cancer that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Drugs used in the chemotherapy, such as trifluridine\u002Ftipiracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving talazoparib with trifluridine\u002F tipiracil may inhibit certain enzymes in the cells that are responsible for tumor cell growth.",[81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,41,42,43,99,100,101,46,48,50,52,54],"Advanced Malignant Solid Neoplasm","Clinical Stage III Gastroesophageal Junction Adenocarcinoma","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma","Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma","Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma A","Locally Advanced Colorectal Carcinoma","Locally Advanced Gastroesophageal Junction Adenocarcinoma","Metastatic Colorectal Adenocarcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Pathologic Stage III Gastroesophageal Junction Adenocarcinoma","Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma","Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma","Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma","Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma","Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma","Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8","Stage III Colorectal Cancer AJCC v8","Stage IIIA Colorectal Cancer AJCC v8","Stage IIIB Colorectal Cancer AJCC v8","2026-04-30",{"date":104,"type":59},"2026-05-04",{"date":106,"type":59},"2021-06-08",{"date":108,"type":20},"2029-04-01",{"name":110,"class":66},"Roswell Park Cancer Institute",{"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":122,"conditions":123,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":67},"100442420","early-phase-1-pembrolizumab-and-lenvatinib-for-the-treatment-of-advanced-unresectable-or-metastatic-gastroesophageal-adenocarcinoma-100442420","NCT05041153","Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma","A Pilot Study of Pembrolizumab and Lenvatinib Combination Therapy in Patients With Previously Treated Advanced Gastroesophageal Adenocarcinoma","Inclusion Criteria:\n\n* The subject (or legally acceptable representative if applicable) provides written informed consent for the trial\n* Male and female subjects who are at least 18 years of age on day of signing informed consent with histologically and cytologically documented diagnosis as gastric or gastroesophageal adenocarcinoma\n* Has a documented, previously treated, advanced (unresectable and\u002For metastatic) gastroesophageal adenocarcinoma that is incurable and for which prior first-line or later-line standard of care (SOC) treatments have failed. Prior neoadjuvant or adjuvant therapy included in initial treatment may not be considered first- or later-line SOC treatment unless such treatments were completed less than 12 months prior to the current tumor recurrence\n* Has submitted an evaluable tissue sample for biomarker analysis from a newly obtained irradiated. The tumor tissue submitted for analysis must be from a single tumor tissue specimen and of sufficient quantity and quality to allow biomarker study (see laboratory manual). A \"newly obtained\" tumor specimen, defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1, for biomarker characterization will be required for enrollment of all subjects. Tissue from tumor progressing at a site of prior radiation (at least 6 weeks interval after last radiation) may be allowed for biomarker characterization upon agreement from Merck. Subjects for whom newly-obtained samples cannot be provided (e.g., inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Merck\n* Has measurable disease based on RECIST 1.1 as assessed by the Investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions\n* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale within 5 days of starting study treatment\n* Has a life expectancy of greater than 3 months per the judgment of the investigators\n* Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP =\\\u003C 150\u002F90 mm Hg at screening and no change in antihypertensive medications within 1 week of cycle 1 day 1\n* Absolute neutrophil count (ANC) \\>= 1,500\u002FuL (specimens must be collected within 5 days prior to the start of study treatment)\n* Platelets \\>= 100,000\u002FuL (specimens must be collected within 5 days prior to the start of study treatment)\n* Hemoglobin \\>= 9 g\u002FdL or \\>= 5.6 mmol\u002FL without transfusion or EPO dependency (within 7 days of assessment) (specimens must be collected within 5 days prior to the start of study treatment)\n* Serum creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) \\>= 60 mL\u002Fmin for subject with creatinine levels \\> 1.5 x institutional ULN (specimens must be collected within 5 days prior to the start of study treatment)\n\n  * Creatinine clearance should be calculated per institutional standard\n* Total bilirubin \\\u003C 1.5 x ULN OR direct bilirubin =\\\u003C ULN for subjects with total bilirubin levels \\> 1.5 x ULN (specimens must be collected within 5 days prior to the start of study treatment)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 2.5 x ULN OR =\\\u003C 5 x ULN for subjects with liver metastases (specimens must be collected within 5 days prior to the start of study treatment)\n* Albumin \\>= 2.5 mg\u002FdL (specimens must be collected within 5 days prior to the start of study treatment)\n* International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (specimens must be collected within 5 days prior to the start of study treatment)\n* Male subjects are eligible to participate if they agree to the following during the intervention period and for at least 30 days after the last dose of lenvatinib\n\n  * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR\n  * Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:\n\n    * Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a women of child birth potential (WOCBP) who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n  * Please note that 30 days after lenvatinib is stopped, if the subject is on pembrolizumab only, no male contraception measures are needed\n* A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n  * Is not a WOCBP OR\n  * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year) and has a low user dependency, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), as described in Appendix 12.8 during the intervention period and for at least 120 days post pembrolizumab or 30 days post lenvatinib, whichever occurs last. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention\n  * A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention\n  * If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the subject must be excluded from participation if the serum pregnancy result is positive\n  * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy\n\nExclusion Criteria:\n\n* Is currently participating in or has participated in a study of an investigational agent or used an investigational device within 4 weeks prior to the first dose of study treatment.\n\n  * Note: Subjects who have entered the follow-up phase of an investigational trial may participate as long as it has been 4 weeks after the last dose of the previous investigational agent\n* Has a diagnosis of immunodeficiency or is receiving 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 trial treatment\n* Has had major surgery within 3 weeks prior to first dose of study interventions.\n\n  * Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility\n* Has preexisting \\>= grade 3 gastrointestinal or non-gastrointestinal fistula\n* Has urine protein \\>= 1 g\u002F24 hours.\n\n  * Note: subjects with proteinuria \\>= 2+ (\\>= 100 mg\u002FdL) on urine dipstick testing\u002Furinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria\n* Has significant gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib\n* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n\n  * Note: The degree of proximity to major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage\u002Fnecrosis following lenvatinib therapy\n* Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug\n* Significant cardiovascular impairment within 12 months of the first dose of study drug: such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA) stroke, or cardiac arrhythmia associated with hemodynamic instability\n* Prolongation of corrected QT (QTc) interval to \\> 480 ms\n* Has left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range as determined by multi-gated acquisition scan (MUGA) or echocardiogram (ECHO)\n* Has known intolerance or severe hypersensitivity (grade \\>= 3) to pembrolizumab, lenvatinib, or any of their excipients\n* Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent, a VEGFR2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137)\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 times the half-life time, whichever is shorter prior to allocation.\n\n  * Note: Subjects must have recovered from all adverse events (AEs) due to previously therapies to =\\\u003C grade 1 or baseline. Subjects with =\\\u003C grade 2 neuropathy may be eligible\n* Has received prior radiotherapy within 2 weeks prior to study day 1.\n\n  * Note: Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=\\\u003C 2 weeks of radiotherapy) to non-central nervous system (CNS) disease\n* Has a known additional malignancy that is progressing or requires active treatment.\n\n  * Note: Subjects 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\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiological stable (i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to the first dose of trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability\n* Has an active autoimmune disease that has required systemic treatment 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 and is allowed\n* Has symptomatic ascites or pleural effusion. A subject who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible\n* Has a history of (non-infectious) pneumonitis that required treatment with steroids or has current pneumonitis\n* Has an active infection requiring systemic therapy\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* Has known psychiatric or substance-abuse disorders that would interfere with cooperation with the requirements of the trial\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment\n* Has a known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies).\n* Had an allogenic tissue\u002Fsolid organ or hematologic transplant\n* Has a known history of hepatitis B virus (HBV; hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (HCV ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected) infection.\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed",{"count":119,"type":20},15,[121],"EARLY_PHASE1","This early phase I trial studies the effect of pembrolizumab and lenvatinib in treating patients with gastroesophageal adenocarcinoma that has spread to other places in the body (advanced\u002Fmetastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and lenvatinib may kill more tumor cells.",[124,125,126,127,128,27,129,28,130,29,131,89,132,133,134,135,136,137,138,139,38,39,40,140,96,97,98,141,41,42,43,142,143],"Advanced Gastric Adenocarcinoma","Advanced Gastroesophageal Junction Adenocarcinoma","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IVA Gastric Cancer AJCC v8","Clinical Stage IVB Gastric Cancer AJCC v8","Metastatic Gastric Adenocarcinoma","Pathologic Stage III Gastric Cancer AJCC v8","Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IIIA Gastric Cancer AJCC v8","Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IIIB Gastric Cancer AJCC v8","Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IIIC Gastric Cancer AJCC v8","Pathologic Stage IV Gastric Cancer AJCC v8","Postneoadjuvant Therapy Stage III Gastric Cancer AJCC v8","Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8","Unresectable Gastric Adenocarcinoma","Unresectable Gastroesophageal Junction Adenocarcinoma","2026-01-09",{"date":146,"type":59},"2026-01-12",{"date":148,"type":59},"2022-02-14",{"date":150,"type":20},"2026-12-30",{"name":65,"class":66},{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100379539","radiation-therapy-for-the-treatment-of-metastatic-gastrointestinal-cancers-100379539","NCT04221893","Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers","Phase II Study of Hypofractionated Radiation Therapy to Augment Immune Response in Patients With Metastatic GastroIntestinal Malignancies Progressing on Immune Therapy (ARM-GI)","Inclusion Criteria:\n\n1. Patients must have a histologically, cytologically, or radiographically confirmed metastatic gastrointestinal (GI) malignancy (esophageal, gastroesophageal, gastric, small intestine, hepatocellular, pancreaticobiliary, colorectal, or anal cancer).\n2. Patients must be receiving immunotherapy (checkpoint inhibitor or CTLA4 inhibitor) with overall response of progressive disease by RECIST criteria.\n3. Patients must have at least two metastases which are individually progressing as per RECIST criteria, one of which can be safely unirradiated as adjudicated by the treating radiation oncologist (e.g. lesions for which small increases in dimensions are unlikely to precipitate significant symptoms).\n4. Patients must have 1-5 sites of disease meeting standard-of-care indications for palliative radiation therapy as adjudicated by the treating radiation oncologist. For example:\n\n   * Symptomatic disease causing pain, bleeding, dyspnea, dysphagia, or nausea\n   * At-risk for neurologic, respiratory, cardiovascular, gastrointestinal, musculoskeletal, or hepatobiliary compromise\n5. Evaluation by a radiation oncologist within 28 days of study registration.\n6. Must have adequate organ function to administer radiation therapy and immunotherapy as per standard of care.\n7. Age \\>= 18 years.\n8. Life expectancy exceeding 6 months.\n9. Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky performance status \\>= 50.\n10. Radiation therapy is known to be teratogenic and therefore women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of radiation therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after completion of radiation therapy. Contraception requirements during the follow-up period of 6 months will be according to standard of care for immunotherapy administration.\n\n    a. If a woman is of child-bearing potential, a negative pregnancy test within 28 days prior to study enrollment is required.\n11. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Enrollment on immunotherapy clinical trial for which radiation therapy is not permitted.\n2. Administration of radiation therapy within 4 weeks prior to study enrollment.\n3. Treatment with systemic corticosteroids or other immunosuppressive medications which would significantly diminish the effect of immunotherapy as judged by the treating physician.\n4. Radiation therapy is contraindicated as adjudicated by the radiation oncologist.",{"count":160,"type":20},28,[162],"NA","This phase II trial studies how well radiation therapy works for the treatment of gastrointestinal cancer that are spreading to other places in the body (metastatic). Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. This trial is being done to determine if giving radiation therapy to patients who are being treated with immunotherapy and whose cancers are progressing (getting worse) can slow or stop the growth of their cancers. It may also help researchers determine if giving radiation therapy to one tumor can stimulate the immune system to attack other tumors in the body that are not targeted by the radiation therapy.",[165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,89,181,182,183,184,139,185,186,187,188,40,189,141,41,190,191,42,192,193,43,194,48,195,50,196,52,197,54],"Stage IV Esophageal Adenocarcinoma","Stage IV Esophageal Squamous Cell Carcinoma","Stage IV Gastric Cancer","Stage IV Adenocarcinoma of the Gastroesophageal Junction","Stage IVA Esophageal Adenocarcinoma","Stage IVA Esophageal Squamous Cell Carcinoma","Stage IVA Gastric Cancer","Stage IVA Adenocarcinoma of the Gastroesophageal Junction","Stage IVB Esophageal Adenocarcinoma","Stage IVB Esophageal Squamous Cell Carcinoma","Stage IVB Gastric Cancer","Stage IVB Gastroesophageal Junction Adenocarcinoma","Metastatic Anal Canal Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Esophageal Carcinoma","Metastatic Gastric Carcinoma","Metastatic Hepatocellular Carcinoma","Metastatic Malignant Digestive System Neoplasm","Metastatic Small Intestinal Carcinoma","Pancreatobiliary Carcinoma","Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8","Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8","Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8","Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC V8","Stage IV Anal Cancer AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","2025-09-30",{"date":200,"type":59},"2025-10-06",{"date":202,"type":59},"2020-08-07",{"date":204,"type":20},"2028-04-30",{"name":206,"class":66},"University of California, San Francisco",2]