[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clinical-stage-ii-cutaneous-melanoma-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clinical-stage-ii-cutaneous-melanoma-ajcc-v8":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,78,193,235],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053929","phase-1-intralesional-influenza-vaccine-for-the-treatment-of-stage-i-iv-melanoma-100053929",false,"NCT04697576","Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma","Intralesional Influenza Vaccine for Patients With Melanoma","Inclusion Criteria:\n\n* Males or females\n* 18 to 99 years of age\n* Histologically confirmed cutaneous melanoma by historical pathology report review, clinical Stage I-III (Cohort #1), or Stage IV (Cohort #2) cutaneous melanoma\n* At least one, biopsy-proven, palpable melanoma tumor deposit suitable for intralesional injection measuring ≥ 1 cm by digital caliper (with digital photography documentation) or ultrasound (with ultrasound image documentation)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^3\u002Fmm\\^3 (drawn at or not more than 30 days prior to the screening visit)\n* Hemoglobin (Hgb) \\>= 8 g\u002FdL (drawn at or not more than 30 days prior to the screening visit)\n* Platelet count \\>= 100 x 10\\^3\u002Fmm\\^3 (drawn at or not more than 30 days prior to the screening visit)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 2.5 x upper limit of normal (ULN) or =\\\u003C 5 x ULN in patients with liver metastases (Cohort 2 only) (drawn at or not more than 30 days prior to the screening visit)\n* Prothrombin time =\\\u003C 1.5 x ULN (drawn at or not more than 30 days prior to the screening visit)\n* Total bilirubin =\\\u003C 1.5 x ULN (unconjugated bilirubin of \\\u003C 3 x ULN for patients with known Gilbert syndrome) (drawn at or not more than 30 days prior to the screening visit)\n* Creatinine clearance of \\>= 50 ml\u002Fmin by Cockcroft-Gault equation (drawn at or not more than 30 days prior to the screening visit)\n* Women of childbearing potential (WOCBP) must agree to use effective contraceptive methods from screening until at least:\n\n  * Cohort 1: 14 days after the surgical resection for subjects in Cohort 1\n  * Cohort 2:\n\n    * Nivolumab: 5 months after the last dose of either nivolumab or intralesional Flucelvax, whichever is later\n    * Pembrolizumab: 4 months after the last dose of either pembrolizumab or intralesional Flucelvax, whichever is later\n    * Ipilimumab: 3 months after the last dose of either ipilimumab or intralesional Flucelvax, whichever is later\n    * Relatlimab + nivolumab (marketed under the trade name Opdualag): 5 months after the last dose of either Opdualag or intralesional Flucelvax, whichever is later.\n    * Combination ipilimumab with other checkpoint inhibitor: Whichever is later:\n\n      * 3 months after the last dose of either ipilimumab or intralesional Flucelvax\n      * Above-bulleted recommendation for nivolumab or pembrolizumab\n* Non-childbearing potential is defined as a woman who meets either of the following criteria: a) postmenopausal state defined as no menses for 12 months without an alternative medical cause, or b) documented hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\n* Effective contraception methods are defined as one of the following:\n\n  * True abstinence, defined as refraining from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject\n  * Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception\n  * Condoms and spermicide\n  * Diaphragm and spermicide\n  * Oral or implanted hormonal contraceptive\n  * An intra-uterine device\n* WOCBP must have a negative pregnancy test (serum or urine)\n\nExclusion Criteria:\n\n* Known allergy or intolerance to influenza vaccination\n* Subjects with condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone\u002Fequivalent) or other immunosuppressive medications within 14 days of study drug administration\n* Active, known or suspected autoimmune disease\n* Active brain metastasis or leptomeningeal metastasis\n* Diagnostic biopsy of ocular or mucosal melanoma\n* Any melanoma therapy within 6 months of enrollment; though prior surgical resection is permitted\n* Incarcerated patients\n* Patients known to be HIV positive are eligible if they meet the following criteria within 30 days prior to randomization: stable and adequate CD4 counts (≥ 350 mm\\^3), and serum HIV viral load of \\\u003C 25,000 IU\u002Fml. Patients may be on or off anti-viral therapy so long as they meet the CD4 count criteria\n* Pregnant or lactating patients\n* Patients incapable of independently providing consent","ALL","18 Years","99 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This phase I trial investigates the effects of influenza vaccine in treating patients with stage I-IV melanoma. While intramuscular administration of influenza vaccine provides immunization against the influenza virus, giving influenza vaccine directly into the tumor (intralesional) may decrease the size of the injected melanoma tumor, or the extent of the melanoma within the body.",[27,28,29,30,31,32,33,34,35],"Clinical Stage I Cutaneous Melanoma AJCC v8","Clinical Stage IA Cutaneous Melanoma AJCC v8","Clinical Stage IB Cutaneous Melanoma AJCC v8","Clinical Stage II Cutaneous Melanoma AJCC v8","Clinical Stage IIA Cutaneous Melanoma AJCC v8","Clinical Stage IIB Cutaneous Melanoma AJCC v8","Clinical Stage IIC Cutaneous Melanoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Metastatic Melanoma","RECRUITING","2026-07-09",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2021-10-20",{"date":44,"type":21},"2027-12-31",{"name":46,"class":47},"Carlo Contreras","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100637599","a-study-on-how-to-safely-guide-surgery-for-melanoma-and-similar-skin-tumors-in-children-using-pathology-and-genetic-information-100637599","NCT07621614","A Study on How to Safely Guide Surgery for Melanoma and Similar Skin Tumors in Children Using Pathology and Genetic Information","A Multi-Institutional Central Pathology and Molecular Risk-Based Stratification Study of Surgical Management for Melanoma, Atypical Spitz\u002FSpitzoid Tumors, and Other Atypical Melanocytic Neoplasms in Pediatric Patients","Inclusion Criteria:\n\n* Patients ≤ 25 years old\n* Newly diagnosed localized cutaneous melanoma, atypical Spitz\u002FSpitzoid tumors, or other atypical melanocytic neoplasm by local institution pathology report\n* Patients must have disease that is localized to the skin on clinical assessment. Note that staging imaging is not required for the determination of eligibility, but if obtained prior to enrollment, all imaging must be consistent with localized cutaneous disease\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients ≤ 16 years of age\n* Patients must not have received any prior chemotherapy, immunotherapy, targeted therapy, radiation, or surgical therapy for melanoma other than the permitted biopsy\u002Fexcision of the lesion for which they are enrolling. Note that prior biopsies\u002Fsurgery for other benign melanocytic lesions is permitted\n\nExclusion Criteria:\n\n* Patients ≥ 18 years old with conventional adult-type melanoma are excluded. Note that patients 18-25 years old with atypical Spitz\u002FSpitzoid tumors, or other atypical melanocytic neoplasms are eligible\n* Patients with clinical evidence of metastatic disease such as palpable malignant adenopathy or symptomatic distant metastases are not eligible\n* Patients who have undergone re-excision to achieve a negative margin or sentinel lymph node biopsy for the melanocytic neoplasm under study are not eligible. Note that this does not exclude patients who have undergone the permitted diagnostic biopsy\u002Fexcision, including re-biopsy, of the lesion\n* Any of the following diagnoses\n\n  * Congenital nevi-associated proliferative nodules\n  * Agminated Spitz nevi\u002Ftumors\n  * Dysplastic nevus\n  * Combined nevus\n  * CRTC1::TRIM11 and\u002For MED15::ATF1 fused tumors (molecular testing is not required prior to enrollment)\n* Pre-existing conditions:\n\n  * Solid organ transplant recipients\n  * Known melanoma predisposition syndrome (i.e., patients with previously known pathogenic variants in moderate and high penetrance melanoma susceptibility genes \\[i.e., CDKN2A, CDK4, BAP1, POT1, TERT promoter, ACD, TERF2IP\\] or Xeroderma Pigmentosum). Note germline testing is not required prior to enrollment\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","25 Years",{"count":58,"type":21},51,[60],"NA","This clinical trial compares the effect of using risk-based stratification to guide surgical management to the usual approach in treating cutaneous melanoma, atypical Spitz\u002FSpitzoid tumors or other atypical melanocytic tumors that have not spread to other parts of the body (localized). Melanoma is a cancer that in children is sometimes difficult to tell apart from benign (not harmful) or atypical (uncertain if harmful) skin lesions. Failure to diagnose melanoma can result in inadequate surgical removal and increase the risk of recurrence and metastatic disease (spread from where it first started to other places in the body). In addition, diagnosing a tumor a benign (not cancer) tumor as cancer may lead to unnecessary surgery and treatment. This trial reviews tumor pathology and genetic markers and classifies the tumor as not atypical, atypical but low risk for spread and\u002For recurrence (coming back after a period of improvement), and atypical and high risk for spread and\u002For recurrence. The classifications are then used to provide surgical recommendations. Tumors that are not atypical do not receive any surgical treatment. Low-risk recommendations include removing a small layer of normal skin around the tumor. High-risk recommendations include the usual adult melanoma approach of removing a larger layer of normal skin around the tumor with or without a biopsy of the sentinel lymph node (the first lymph node to which tumor cells are likely to spread from a primary tumor). Risk-based guided surgical management may help avoid unnecessary surgery while improving outcomes in younger patients with localized cutaneous melanoma, atypical Spitz\u002FSpitzoid tumors or other atypical melanocytic tumors.",[63,27,30,64,65,66],"Clinical Stage 0 Cutaneous Melanoma AJCC v8","Cutaneous Melanocytic Neoplasm","Cutaneous Melanoma","Cutaneous Spitz Melanocytoma","NOT_YET_RECRUITING","2026-06-03",{"date":70,"type":40},"2026-06-05",{"date":72,"type":21},"2026-08-18",{"date":74,"type":21},"2028-07-31",{"name":76,"class":77},"Children's Oncology Group","NETWORK",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":190,"locationsCount":192},"100612878","social-health-activity-behaviors-and-quality-of-life-among-young-adult-cancer-survivors-100612878","NCT07259304","Social Health, Activity Behaviors, and Quality of Life Among Young Adult Cancer Survivors","Social Health, Activity Behaviors, and Quality of Life Among Young Adult Cancer Survivors: A Longitudinal Study","Inclusion Criteria:\n\n* Diagnosed and\u002For treated with cancer between ages 18-39 at USC hospitals.\n* Cancer types prototypical for adolescents and young adults (AYAs) and cancer stages I-III; select patients with stage IV disease may be eligible, with approval by the principal investigator (PI) and in consultation with the treating clinician.\n* Must be within three months of a de novo cancer diagnosis at recruitment and on\u002Findicated for curative therapy (any modality). Patients may continue on adjuvant therapy throughout duration of the study.\n* Patients must have anticipated survival of \\>1-year at time of diagnosis.\n\nExclusion Criteria:\n\n* Diagnosis of blood malignancies such as leukemias (these cancers have divergent treatment patterns of longer duration than other cancers and are more commonly pediatric cancers). Some early stage lymphomas with favorable prognoses may be eligible, with approval by the PI and in consultation with the treating clinician.\n* Primary language other than English or Spanish.\n* Inability to complete a survey and\u002For wear an accelerometer either per the patient or in consultation with the clinician's judgment.","39 Years",{"count":87,"type":21},250,"OBSERVATIONAL","This study assesses how personal relationships (such as friendships, family relationships, or romantic partners) influence the physical activity (exercise) and well-being of young adult cancer survivors. Researchers also hope to learn how social relationships change after a cancer diagnosis, and how these changes might impact important health behaviors. The information provided may help researchers learn more about better ways to support young cancer patients in the future through interventions that help maintain good social relationships and health levels of physical activity.",[91,92,93,94,95,96,97,98,99,100,101,27,28,29,30,31,32,33,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage IA Breast Cancer AJCC v8","Anatomic Stage IB Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage IIA Breast Cancer AJCC v8","Anatomic Stage IIB Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Central Nervous System Neoplasm","Clinical Stage III Cutaneous Melanoma AJCC v8","Hodgkin Lymphoma","Malignant Bone Neoplasm","Malignant Brain Neoplasm","Malignant Solid Neoplasm","Malignant Testicular Neoplasm","Non-Hodgkin Lymphoma","Pathologic Stage I Cutaneous Melanoma AJCC v8","Pathologic Stage IA Cutaneous Melanoma AJCC v8","Pathologic Stage IB Cutaneous Melanoma AJCC v8","Pathologic Stage II Cutaneous Melanoma AJCC v8","Pathologic Stage IIA Cutaneous Melanoma AJCC v8","Pathologic Stage IIB Cutaneous Melanoma AJCC v8","Pathologic Stage IIC Cutaneous Melanoma AJCC v8","Pathologic Stage III Cutaneous Melanoma AJCC v8","Pathologic Stage IIIA Cutaneous Melanoma AJCC v8","Pathologic Stage IIIB Cutaneous Melanoma AJCC v8","Pathologic Stage IIIC Cutaneous Melanoma AJCC v8","Pathologic Stage IIID Cutaneous Melanoma AJCC v8","Prognostic Stage I Breast Cancer AJCC v8","Prognostic Stage IA Breast Cancer AJCC v8","Prognostic Stage IB Breast Cancer AJCC v8","Prognostic Stage II Breast Cancer AJCC v8","Prognostic Stage IIA Breast Cancer AJCC v8","Prognostic Stage IIB Breast Cancer AJCC v8","Prognostic Stage III Breast Cancer AJCC v8","Prognostic Stage IIIA Breast Cancer AJCC v8","Prognostic Stage IIIB Breast Cancer AJCC v8","Prognostic Stage IIIC Breast Cancer AJCC v8","Stage I Cervical Cancer AJCC v8","Stage I Colorectal Cancer AJCC v8","Stage I Differentiated Thyroid Gland Carcinoma AJCC v8","Stage I Ovarian Cancer AJCC v8","Stage I Thyroid Gland Medullary Carcinoma AJCC v8","Stage I Uterine Corpus Cancer AJCC v8","Stage IA Cervical Cancer AJCC v8","Stage IA Ovarian Cancer AJCC v8","Stage IA Uterine Corpus Cancer AJCC v8","Stage IA1 Cervical Cancer AJCC v8","Stage IA2 Cervical Cancer AJCC v8","Stage IB Cervical Cancer AJCC v8","Stage IB Ovarian Cancer AJCC v8","Stage IB Uterine Corpus Cancer AJCC v8","Stage IB1 Cervical Cancer AJCC v8","Stage IB2 Cervical Cancer AJCC v8","Stage IC Ovarian Cancer AJCC v8","Stage II Cervical Cancer AJCC v8","Stage II Colorectal Cancer AJCC v8","Stage II Differentiated Thyroid Gland Carcinoma AJCC v8","Stage II Ovarian Cancer AJCC v8","Stage II Thyroid Gland Medullary Carcinoma AJCC v8","Stage II Uterine Corpus Cancer AJCC v8","Stage IIA Cervical Cancer AJCC v8","Stage IIA Colorectal Cancer AJCC v8","Stage IIA Ovarian Cancer AJCC v8","Stage IIA1 Cervical Cancer AJCC v8","Stage IIA2 Cervical Cancer AJCC v8","Stage IIB Cervical Cancer AJCC v8","Stage IIB Colorectal Cancer AJCC v8","Stage IIB Ovarian Cancer AJCC v8","Stage IIC Colorectal Cancer AJCC v8","Stage III Cervical Cancer AJCC v8","Stage III Colorectal Cancer AJCC v8","Stage III Differentiated Thyroid Gland Carcinoma AJCC v8","Stage III Ovarian Cancer AJCC v8","Stage III Thyroid Gland Medullary Carcinoma AJCC v8","Stage III Uterine Corpus Cancer AJCC v8","Stage IIIA Cervical Cancer AJCC v8","Stage IIIA Colorectal Cancer AJCC v8","Stage IIIA Ovarian Cancer AJCC v8","Stage IIIA Uterine Corpus Cancer AJCC v8","Stage IIIA1 Ovarian Cancer AJCC v8","Stage IIIA2 Ovarian Cancer AJCC v8","Stage IIIB Cervical Cancer AJCC v8","Stage IIIB Colorectal Cancer AJCC v8","Stage IIIB Ovarian Cancer AJCC v8","Stage IIIB Uterine Corpus Cancer AJCC v8","Stage IIIC Colorectal Cancer AJCC v8","Stage IIIC Ovarian Cancer AJCC v8","Stage IIIC Uterine Corpus Cancer AJCC v8","Stage IIIC1 Uterine Corpus Cancer AJCC v8","Stage IIIC2 Uterine Corpus Cancer AJCC v8","2026-05-26",{"date":186,"type":40},"2026-05-28",{"date":188,"type":40},"2021-11-24",{"date":44,"type":21},{"name":191,"class":47},"University of Southern California",2,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":48},"100348630","phase-1-role-of-gut-microbiome-and-fecal-transplant-on-medication-induced-gi-complications-in-patients-with-cancer-100348630","NCT03819296","Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer","Role of Microbiome in the Realm of Immune-Checkpoint Inhibitor Induced GI Complications In Cancer Population","Inclusion Criteria:\n\n1. Diagnosis of any stage melanoma, Non-Small Cell Lung Cancer or genitourinary (GU) malignancies (Project 1).\n2. Diagnosis of any cancer type (Projects 2 and 3)\n3. Treatment with any ICPI agent\n4. Ability to understand and willingness to sign an informed consent form and rate surveys\n5. Life expectancy \\> 4 months (Project 3)\n6. ICPI-related diarrhea and\u002For colitis of any grade with or without concurrent non- GI toxicity as the toxicity group (project 1)\n7. Patients with no organ toxicity as the control group (project 1)\n8. ICPI-related colitis and\u002For diarrhea of grade ≥ 2 as GI toxicity (initial episode or recurrence) receiving standard treatment of immunosuppressive agents (steroid, infliximab, vedolizumab, or ustekinumab) any time during the colitis disease course until sustained resolution of GI toxicity, or one- year time point after enrollment (Project 2)\n9. ICPI-related colitis and\u002For diarrhea of grade ≥ 2 as GI toxicity without involvement of non- GI toxicity within 45 days prior to FMT (Project 3)\n10. ICPI-related colitis and\u002For diarrhea of grade ≥ 2 within 45 days prior to FMT with ANY of the following characteristics (project 3):\n\n    (i) refractory to treatment of steroid and two doses of non-steroidal immunosuppressants e.g. infliximab, vedolizumab or ustekinumab,\n\n    (ii) contraindication for immunosuppressive treatment,\n\n    (iii) recurrence after successful initial treatment,\n\n    (iv) recurrent symptoms once steroid is tapered down\u002Foff or diarrhea\u002Fcolitis symptoms are steroid dependent, or\n\n    (v) patients with a history of refractory ICPI-related colitis and\u002For diarrhea to medical treatment, even if they have improved symptoms from supportive care within 45 days prior to FMT\n11. No concern for active concomitant GI infection for the ICPI diarrhea\u002Fcolitis work up at the time of protocol therapy initiation as confirmed by stool tests or as per the treating physician based on clinical presentation (project 3)\n12. Patient who has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of diarrhea\u002Fcolitis treatment (project 3)\n\nExclusion Criteria:\n\n1. Age younger than 18 years\n2. History of inflammatory bowel disease, and\u002For radiation enteritis or colitis with active disease status at the time of study treatment initiation\n3. Pregnant and breastfeeding women\n4. Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was \\> 1 year prior to consent and\u002F or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment\n5. Patients who develop concurrent non- GI toxicity at the time of FMT treatment (project 3)\n6. Patients with active bacterial or fungal infection (Project 3)\n7. Donors at risk for monkeypox infection and\u002F or exposure as determined by a questionnaire (Project 3)\n\nWithdrawal Criteria\n\n1. Patients may withdraw from the trial at any time\n2. Patients who develop GI perforation or toxic colitis that require surgery from ICPI colitis\n3. In project 3, if the first 30% of cases fail the fecal transplant treatment, then project 3 will be terminated",{"count":201,"type":21},800,[24],"This trial studies the role of the gut microbiome and effectiveness of a fecal transplant on medication-induced gastrointestinal (GI) complications in patients with melanoma or genitourinary cancer. The gut microbiome (the bacteria and microorganisms that live in the digestive system) may affect whether or not someone develops colitis (inflammation of the intestines) during cancer treatment with immune-checkpoint inhibitor drugs. Studying samples of stool, blood, and tissue from patients with melanoma or genitourinary cancer may help doctors learn more about the effects of treatment on cells, and help doctors understand how well patients respond to treatment. Treatment with fecal transplantation may help to improve diarrhea and colitis symptoms.",[63,27,28,29,30,31,32,33,102,34,205,206,207,106,208,109,110,111,112,113,114,115,116,117,118,119,120,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225],"Colitis","Lung Non-Small Cell Carcinoma","Malignant Genitourinary System Neoplasm","Pathologic Stage 0 Cutaneous Melanoma AJCC v8","Pathologic Stage IV Cutaneous Melanoma AJCC v8","Stage 0 Lung Cancer AJCC v8","Stage I Lung Cancer AJCC v8","Stage IA1 Lung Cancer AJCC v8","Stage IA2 Lung Cancer AJCC v8","Stage IA3 Lung Cancer AJCC v8","Stage IB Lung Cancer AJCC v8","Stage II Lung Cancer AJCC v8","Stage IIA Lung Cancer AJCC v8","Stage IIB Lung Cancer AJCC v8","Stage III Lung Cancer AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIB Lung Cancer AJCC v8","Stage IIIC Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","Stage IVA Lung Cancer AJCC v8","Stage IVB Lung Cancer AJCC v8","2026-03-10",{"date":228,"type":40},"2026-03-11",{"date":230,"type":40},"2021-02-21",{"date":232,"type":21},"2026-10-31",{"name":234,"class":47},"M.D. Anderson Cancer Center",{"id":236,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":25,"conditions":240,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":244,"leadSponsor":245,"locationsCount":48},"100416047","Inclusion Criteria:\n\n* Males or females\n* 18 to 99 years of age\n* Histologically confirmed cutaneous melanoma by historical pathology report review, clinical Stage I-III (Cohort #1), or Stage IV (Cohort #2) cutaneous melanoma\n* At least one, biopsy-proven, palpable melanoma tumor deposit suitable for intralesional injection measuring ≥ 1 cm by digital caliper (with digital photography documentation) or ultrasound (with ultrasound image documentation)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^3\u002Fmm\\^3 (drawn at or not more than 30 days prior to the screening visit)\n* Hemoglobin (Hgb) \\>= 9 g\u002FdL (drawn at or not more than 30 days prior to the screening visit)\n* Platelet count \\>= 100 x 10\\^3\u002Fmm\\^3 (drawn at or not more than 30 days prior to the screening visit)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 2.5 x upper limit of normal (ULN) or =\\\u003C 5 x ULN in patients with liver metastases (Cohort 2 only) (drawn at or not more than 30 days prior to the screening visit)\n* Prothrombin time =\\\u003C 1.5 x ULN (drawn at or not more than 30 days prior to the screening visit)\n* Total bilirubin =\\\u003C 1.5 x ULN (unconjugated bilirubin of \\\u003C 3 x ULN for patients with known Gilbert syndrome) (drawn at or not more than 30 days prior to the screening visit)\n* Creatinine clearance of \\>= 50 ml\u002Fmin by Cockcroft-Gault equation (drawn at or not more than 30 days prior to the screening visit)\n* Women of childbearing potential (WOCBP) must agree to use effective contraceptive methods from screening until at least:\n\n  * Cohort 1: 14 days after the surgical resection for subjects in Cohort 1\n  * Cohort 2:\n\n    * Nivolumab: 5 months after the last dose of either nivolumab or intralesional Flucelvax, whichever is later\n    * Pembrolizumab: 4 months after the last dose of either pembrolizumab or intralesional Flucelvax, whichever is later\n    * Ipilimumab: 3 months after the last dose of either ipilimumab or intralesional Flucelvax, whichever is later\n    * Relatlimab + nivolumab (marketed under the trade name Opdualag): 5 months after the last dose of either Opdualag or intralesional Flucelvax, whichever is later.\n    * Combination ipilimumab with other checkpoint inhibitor: Whichever is later:\n\n      * 3 months after the last dose of either ipilimumab or intralesional Flucelvax\n      * Above-bulleted recommendation for nivolumab or pembrolizumab\n* Non-childbearing potential is defined as a woman who meets either of the following criteria: a) postmenopausal state defined as no menses for 12 months without an alternative medical cause, or b) documented hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\n* Effective contraception methods are defined as one of the following:\n\n  * True abstinence, defined as refraining from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject\n  * Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception\n  * Condoms and spermicide\n  * Diaphragm and spermicide\n  * Oral or implanted hormonal contraceptive\n  * An intra-uterine device\n* WOCBP must have a negative pregnancy test (serum or urine)\n\nExclusion Criteria:\n\n* Known allergy or intolerance to influenza vaccination\n* Subjects with condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone\u002Fequivalent) or other immunosuppressive medications within 14 days of study drug administration\n* Active, known or suspected autoimmune disease\n* Active brain metastasis or leptomeningeal metastasis\n* Diagnostic biopsy of ocular or mucosal melanoma\n* Any melanoma therapy within 6 months of enrollment; though prior surgical resection is permitted\n* Incarcerated patients\n* Patients known to be HIV positive are eligible if they meet the following criteria within 30 days prior to randomization: stable and adequate CD4 counts (≥ 350 mm\\^3), and serum HIV viral load of \\\u003C 25,000 IU\u002Fml. Patients may be on or off anti-viral therapy so long as they meet the CD4 count criteria\n* Pregnant or lactating patients\n* Patients incapable of independently providing consent",{"count":20,"type":21},[24],[27,28,29,30,31,32,33,34,35],"2026-03-07",{"date":226,"type":40},{"date":42,"type":40},{"date":44,"type":21},{"name":46,"class":47}]