[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Diwakar Davar\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":129},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,52,76,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100610118","phase-2-patient-preference-for-subcutaneous-vs-intravenous-immune-therapy-100610118",false,"NCT07223424","Patient Preference for Subcutaneous vs. Intravenous Immune Therapy","Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)","PSI-Immune","Inclusion Criteria:\n\n* Able to understand and willing to sign a written informed consent document.\n* Able to read and write in English.\n* Must be eligible to receive nivolumab (Cohorts A-1, B-1) or pembrolizumab (Cohorts A-2, B-2) singly or in combination with other FDA-approved agents (TKIs or chemotherapy) according to standard of care practices, as determined by the clinical judgment of the investigator.\n* Prior and concurrent therapy criteria\n\n  o Patients should either be ICI-naïve (Cohorts A-1, A-2) or be currently receiving adjuvant or front-line PD-(L)1 based therapy singly or in combination with FDA-approved agents (TKIs or chemotherapy) (Cohorts B-1, B-2).\n* Locally advanced or advanced\u002Fmetastatic solid tumor for which nivolumab OR pembrolizumab is on-label.\n\n  * NOTE: IV nivolumab is FDA-approved in the following indications: RCC, melanoma, NSCLC, SCCHN, UC, dMMR\u002FMSI-H CRC, HCC, esophageal cancer, and gastric, gastroesophageal and esophageal adenocarcinoma (gastric\u002FGEJ).\n  * NOTE: IV pembrolizumab is FDA-approved in the following indications: RCC, melanoma, NSCLC, SCCHN, UC, dMMR\u002FMSI-H CRC, HCC, esophageal cancer, gastric\u002FGEJ, cervical cancer, cutaneous squamous cell carcinoma (cSCC), Merkel cell carcinoma (MCC), endometrial carcinoma, tumor mutational burden-high (TMB-H) cancers, triple negative breast cancer (TNBC).\n* Cohort-specific criteria.\n\n  * Cohort A-1: Patients who are treatment-naive (i.e. for whom nivolumab is planned but has not yet been initiated) are eligible to enroll.\n  * Cohort B-1: Patients who are already receiving treatment with nivolumab (singly or in combination with TKI or chemotherapy) OR a different ICI-therapy but are willing to switch to nivolumab monotherapy or nivolumab based combinations may eligible to enroll if nivolumab is on-label for their cancer.\n  * Cohort A-2: Patients who are treatment-naive (i.e. for whom pembrolizumab is planned but has not yet been initiated) are eligible to enroll.\n  * Cohort B-2: Patients who are already receiving treatment with pembrolizumab (singly or in combination with TKI or chemotherapy) OR a different ICI-therapy but are willing to switch to pembrolizumab monotherapy or pembrolizumab based combinations may eligible to enroll if pembrolizumab is on-label for their cancer.\n  * NOTE: Patients who are currently receiving nivolumab + ipilimumab combination as induction may be eligible to enroll in Cohort B-1 following induction (i.e. during planned maintenance) in indications including but not limited to advanced\u002Fmetastatic melanoma, ccRCC, MSI-H\u002FdMMR mCRC.\n  * NOTE: Patients for whom nivolumab + ipilimumab combination is planned as maintenance are not eligible (i.e. NSCLC patients being treated per CheckMate-227 or CheckMate-9LA).\n  * NOTE: Patients for whom anti-PD-1 based immunotherapy is planned as neoadjuvant therapy are not appropriate. Such patients may be considered for enrollment at the time of commencing adjuvant therapy in cohorts A-2 or B-2 as appropriate.\n\nExclusion Criteria:\n\n* Participant unable to receive nivolumab (or pembrolizumab) due to prior allergic reactions to nivolumab (or pembrolizumab) or any of its ingredients.\n* Has severe hypersensitivity (≥Grade 3) to nivolumab (or pembrolizumab) and\u002For any of its excipients.\n* Has had an allogenic tissue\u002Fsolid organ transplant.","ALL","18 Years",{"count":20,"type":21},880,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The study will evaluate patient and Health Care Professional- reported preference for Subcutaneous (SC) compared with IV nivolumab administration or similarly for SC compared with IV pembrolizumab.",[27,28,29,30,31,32,33,34,35,36,37,38],"Renal Cell Carcinoma","Non Small Cell Lung Cancer","Melanoma","Colo-rectal Cancer (dMMR\u002FMSI-H CRC)","Hepatocellular Carcinoma","Ulcerative Colitis","Esophageal Cancer","Squamous Cell Carcinoma","Gastric\u002FGEJ","Cervical Cancer","Gastro-Esophageal Adenocarcinoma","Esophageal Adenocarcinoma","RECRUITING","2026-04-13",{"date":42,"type":43},"2026-04-16","ACTUAL",{"date":45,"type":43},"2025-11-04",{"date":47,"type":21},"2030-11-30",{"name":49,"class":50},"Diwakar Davar","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":51},"100490724","phase-2-study-of-healthy-donor-fmt-hdfmt-and-pembrolizumab-in-relapsedrefractory-rr-pd-l1-positive-nsclc-100490724","NCT05669846","Study of Healthy Donor FMT (hdFMT) and Pembrolizumab in Relapsed\u002FRefractory (R\u002FR) PD-L1 Positive NSCLC","Phase II Feasibility Study of Healthy Donor FMT (hdFMT) and Pembrolizumab in Relapsed\u002FRefractory (R\u002FR) PD-L1 Positive NSCLC","Inclusion Criteria:\n\nMale participants:\n\n• A male participant must agree to use a contraception as detailed per protocol of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n\n* Female participants:\n\n  • A female participant is eligible to participate if she is not pregnant per protocol, not breastfeeding, and at least one of the following conditions applies:\n  * Not a woman of childbearing potential (WOCBP); OR\n  * A WOCBP who agrees to follow the contraceptive guidance per protocol during the treatment period and for at least 120 days after the last dose of study treatment.\n* Histologically or cytologically confirmed diagnosis of stage IV PD-L1+ NSCLC.\n\n  * NOTE: Patients with either squamous or non-squamous NSCLC may enroll.\n  * NOTE: Documented PD-L1 status (defined as 1% or greater) as determined by immunohistochemistry with anti-PD-L1 antibody (IHC 22C3 pharmDx or other FDA approved diagnostic method) from a core or excisional biopsy (fine needle aspirate is not sufficient).\n  * NOTE: Patients with small cell, large cell, neuroendocrine and\u002For sarcomatoid NSCLC are excluded.\n* Participants must have progressed on treatment with an anti-PD(L)1 ICI administered either as monotherapy or in combination with other checkpoint inhibitors or other standard\u002Finvestigational therapies. PD-1 treatment progression is defined by meeting all the following criteria:\n\n  * Has received at least 2 doses of an approved anti-PD(L)1 ICI administered as a single agent, in combination with chemotherapy, and\u002For in combination with other investigational therapy.\n  * Participants who progressed on\u002Fwithin 3 months of adjuvant therapy with anti-PD(L)1 ICI will eligible.\n  * Demonstrated disease progression after anti-PD-1\u002FL1 as defined by RECIST v1.1. The initial evidence of PD is to be confirmed by a second assessment no sooner than 4 weeks from the date of the first documented PD.\n  * Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1\u002Fanti-PD-L1 mAb.\n  * NOTE: Progressive disease must be determined as above.\n  * NOTE: This determination is made by the treating investigator. Once PD is confirmed, the initial date of PD documentation will be considered the date of PD.\n  * NOTE: Anti-PD(L)1 ICI need not be the most recent line of therapy administered.\n* Patients with CNS disease are eligible if CNS metastases are treated and deemed stable prior to date of enrollment.\n\n  * NOTE: All patients will undergo CNS imaging at the time of Screening. Patients with treated brain metastases will need repeat CNS imaging to document stability.\n  * NOTE: Stability is defined based on appearance of treated lesions on a contrast-enhanced CT or MRI brain study performed as part of screening by radiologist, radiation oncologist or neurosurgeon (whichever is most appropriate); absence of new or enlarging brain metastases; and no longer requiring systemic steroids (≤ 10 mg\u002Fday prednisone or equivalent) for at least one week prior to enrollment.\n  * NOTE: The contrast-enhanced CT or MRI brain imaging study should be performed no sooner than 2 weeks after most recent surgical and\u002For radiological intervention.\n  * NOTE: If lesions were discovered during Screening, the patient may be eligible if the lesions are treated and stable based on the above criteria.\n  * NOTE: Patients with leptomeningeal involvement (leptomeningeal enhancement on MRI\u002FCT imaging and\u002For positive CSF cytology) are excluded regardless of stability.\n* Prior treatment(s)\n\n  * NOTE: Prior anti-CTLA-4 ICI is allowed but not required.\n  * NOTE: Patients with known oncogenic driver (including but not limited to EGFR, ALK, ROS, MET alterations) must have received and progressed past driver-specific therapy\n* Willingness to repeatedly receive FMT administered endoscopically (colonoscopy or sigmoidoscopy) and via pills following necessary bowel preparation pre-procedure.\n\n  * NOTE: Understands infectious risks associated with FMT administration. o Although FMT infusate has been screened for bacteria, viruses, fungi and parasites there is a risk of transmission of known and unknown infectious organisms contained in the donor stool. Post-FMT bacteremia (e.g. E. coli), sepsis and fatal events may rarely occur.\n  * NOTE: Understands non-infectious risks associated with FMT administration. o Possible allergy and\u002For anaphylaxis to antigens in donor stool.\n\n    o Theoretical risk of developing disease possibly related to donor gut microbiota including but not limited to: obesity, metabolic syndrome, cardiovascular disease, autoimmune conditions, allergic\u002Fatopic disorders, neurologic disorders, psychiatric conditions and malignancy.\n  * NOTE: Understand risks associated with endoscopy (colonoscopy or sigmoidoscopy) including risk of infection transmission, colonic perforation, aspiration pneumonia, and death.\n  * NOTE: Understand that data regarding the long-term safety risk of FMT are lacking.\n* Presence of measurable disease based on RECIST 1.1.\n\n  * Patients need to have at least one measurable lesion and a separate lesion for biopsy. Patients with only 1 lesion may be enrolled after discussion with Sponsor-Investigator.\n  * Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Able to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated to undergo tumor biopsy (core, punch, incisional or excisional).\n\n  • Biopsy must meet minimal sampling criteria as defined per protocol.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Have adequate organ function per protocol. Specimens must be collected within 28 days prior to the start of study intervention.\n* Criteria for patients with hepatitis B and C\n\n  * Screening for hepatitis B and C are required.\n  * For hepatitis B positive patients:\n\n    * Patients who are hepatitis B positive (i.e. HBsAg positive) or have a history of history of hepatitis B (i.e. HBcAb positive, or history of documented hepatitis B infection) are eligible if they have received hepatitis B directed antiviral therapy for at least 4 weeks and have undetectable HBV viral load (HBV DNA) prior to enrollment.\n    * Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.\n  * For hepatitis C positive patients:\n\n    * Patients who are hepatitis C positive (i.e. HCV antibody reactive) or have a history of history of hepatitis C (i.e. history of documented hepatitis C infection) are eligible if they have received and completed hepatitis C directed antiviral therapy at least 4 weeks and have undetectable HCV viral load (HCV RNA) prior to enrollment.\n\nExclusion Criteria:\n\n* Diagnosis of NSCLC histologies other than squamous and\u002For adenocarcinoma histologies including small cell, large cell, neuroendocrine and\u002For sarcomatoid histologies.\n* Prior therapies:\n\n  * Receipt of prior agent(s) targeting the intestinal microbiome including but not limited to: FMT, defined bacterial consortia, single bacterial species and\u002For microbiota derived peptides.\n  * Prior chemotherapy, targeted therapy, and\u002For small molecule therapy within 2 weeks (or 4 half lives) prior to study Day 1.\n  * Prior radiotherapy within 2 weeks of start of study intervention.\n\n    * Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.\n    * A 2-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to disease including CNS disease.\n* Presence of an absolute contraindication(s) to FMT administration\n\n  • Toxic megacoon\n  * Severe dietary allergies (e.g. shellfish, nuts, seafood)\n  * Inflammatory bowel disease\n* Patients who have not adequately recovered (i.e., ≤Grade 1 or at baseline or ≤Grade 2 endocrinopathy) from adverse events (AEs) due to a previously administered agent.\n* A WOCBP who has a positive urine pregnancy test at Screening (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Has received a live vaccine within 30 days prior to the first dose of study drug.\n\n  * Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), SARS-CoV-2 and typhoid vaccine.\n  * Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of study drug.\n* Has 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).\n\n  • NOTE: Replacement therapy (eg., 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* Concurrent non-hematologic malignancy within 3 years of data of first planned dose of therapy except for tumors with a negligible risk of metastasis and\u002For death as defined below:\n\n  * Adequately treated non-invasive malignancies including but not limited to melanoma in situ (MIS), cutaneous squamous cell carcinoma (cSCC), in situ cSCC, basal cell carcinoma (BCC), CIS of cervix, or DCIS\u002FLCIS of breast.\n  * Low-risk early-stage prostate adenocarcinoma (T1-T2a N0 M0 and Gleason score ≤6 and PSA ≤10 ng\u002FmL) for which the management plan is active surveillance, or prostate adenocarcinoma with biochemical-only recurrence with documented PSA doubling time of \\> 12 months for which the management plan is active surveillance.\n  * Indolent hematologic malignancies for which the management plan is active surveillance including but not limited to CLL\u002Findolent lymphoma.\n\n    * Patients with high-risk hematologic malignancies (CML, ALL, AML, Hodgkin's or non-Hodgkin's lymphoma) are excluded even if the management plan is active surveillance.\n* Active (i.e., symptomatic or growing) central nervous system (CNS) metastases.\n\n  * NOTE: Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 2 weeks by repeat imaging (note that the repeat imaging should be performed during Screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention as delineated in Section 4.1.7.\n  * NOTE: Patients with leptomeningeal disease are excluded.\n* Has severe hypersensitivity (≥Grade 3) to anti-PD(L)1 inhibitor.\n* Has a systemic disease that requires systemic pharmacologic doses of corticosteroids greater than 10 mg daily prednisone (or equivalent).\n\n  * NOTE: Participants who are currently receiving steroids at a dose of ≤10 mg daily do not need to discontinue steroids prior to enrollment.\n  * NOTE: Participants that require topical, ophthalmologic, injected and\u002For inhalational steroids are not excluded from the study.\n  * NOTE: Participants with hypothyroidism stable on hormone replacement or Sjogren's syndrome are not excluded from the study.\n  * NOTE: Participants who require active immunosuppression (greater than steroid dose discussed above) for any reason are excluded from the study.\n* Has a history of interstitial lung disease or active, non-infectious pneumonitis that required steroids or has current pneumonitis.\n* Has a history of non-infectious myocarditis or symptomatic cardiac co-morbidities requiring active management.\n\n  * NOTE: Patients with a history of symptomatic congestive heart failure (New York Heart Association Functional Classification III or IV) are excluded.\n  * NOTE: Patients with a history of unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction 6 months prior to study entry are excluded.\n* Active infections\n\n  * Any active infection requiring systemic therapy.\n  * Active TB (Bacillus Tuberculosis).\n  * Active COVID-19 infection and\u002For exposure to SARS-CoV-2 as defined below:\n\n    * Positive SARS-CoV-2 result on nasopharyngeal (by RT-PCR test)\n    * Active COVID-19 infection (per CDC guidelines)\n    * Exposure to active COVID-19 infected patient (as confirmed using SARS-CoV-2 RT-PCR test or other approved test) as defined per CDC guidelines.\n  * Active human immunodeficiency virus (HIV) infection.\n\n    o Patients will be evaluated for HIV during screening.\n  * Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant 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 study, starting with the Screening visit through 120 days after the last dose of trial treatment.\n* Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":60,"type":21},26,[24],"This study is to determine if Healthy Donor FMT (hdFMT) improves the body's ability to fight cancer in patients with relapsed\u002Frefractory PD-L1 Positive NSCLC.",[28],[65,66,67],"Relapsed","Refractory","Healthy Donor FMT (hdFMT)","2026-03-19",{"date":70,"type":43},"2026-03-23",{"date":72,"type":43},"2025-01-08",{"date":74,"type":21},"2036-12-31",{"name":49,"class":50},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100521470","phase-2-tebentafusp-in-hla-a0201-positive-previously-untreated-metastatic-uveal-melanoma-100521470","NCT06070012","Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma","Phase II Open-label, Multi-center Study of Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma (mUM) With Integrated Circulating Tumor DNA (ctDNA) Biomarker (TARGET-tebe)","Inclusion Criteria:\n\nHistologically or cytologically confirmed untreated metastatic uveal melanoma (mUM).\n\nHLA-A\\*0201 genotype positive as assessed using a CLIA-certified blood typing method and confirmed by central review.\n\n* If HLA-A status is not known, blood for HLA-A testing must be submitted during Screening, and HLA-A\\*0201 positive status confirmed prior to enrollment using a CLIA- certified blood typing method.\n* If the patient is known to be HLA-A\\*0201 positive, this information must be provided in the Screening packet and centrally reviewed by treating PI and Sponsor-Investigator prior to enrollment.\n* The following HLA testing methodologies are suitable to determine HLA-A\\*0201 positivity:\n\n  * Multiplex real-time PCR based testing performed by entities including but not limited to Labcorp, and American Red Cross.\n  * HLA testing as part of peripheral blood molecular profiling technology including but not limited to Caris Life Sciences Molecular Profiling Technology.\n* Patients be willing to undergo ctDNA assessment using Signatera assay.\n* Have provided newly obtained core biopsy of a tumor lesion not previously irradiated.\n* Adequate organ function on screening labs obtained within 4 weeks of Week 1 day 1\n* Must meet the following criteria related to prior treatment:\n\n  * No prior systemic therapy in the metastatic or advanced setting including chemotherapy, or targeted therapy.\n\n    * NOTE: Patients must be tebentafusp naïve.\n    * NOTE: Patients must not have received prior PD-1, CTLA-4, LAG-3 directed Immune Checkpoint Inhibitor therapy delivered in the adjuvant, and\u002For neoadjuvant settings unless such therapy was received \\>6 months prior initial diagnosis of mUM.\n  * No prior regional, liver-directed therapy including chemotherapy, radiotherapy, or embolization.\n  * Prior surgical resection of oligometastatic disease is allowed.\n  * Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in patients with localized disease.\n* Life expectancy of \\>6 months as estimated by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at Screening.\n* Patients have measurable disease according to RECIST v.1.1.\n* All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to first administration of study drug.\n\nExclusion Criteria:\n\n* History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies.\n* Clinically significant cardiac disease or impaired cardiac function, including any of the following:\n\n  * Clinically significant and\u002For uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment.\n  * QTcF \\> 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome.\n\n    * NOTE: If the initial automated QTcF interval is \\> 470 msec at screening, for the purpose of determining eligibility, the mean QTcF, based on at least 3 ECGs obtained over a brief time interval (ie, within 30 minutes), should be manually determined by a medically qualified person.\n    * NOTE: Acute myocardial infarction or unstable angina pectoris \\\u003C 6 months prior to Screening.\n* Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require doses of corticosteroids within the prior 3 weeks to study Day 1.\n* Presence of active brain metastases.\n\n  * NOTE: Patients with brain metastases are eligible if all lesions have been treated surgically and\u002For radiosurgically and there is no evidence of progression for at least 2 weeks by MRI prior to the first dose of study drug.\n  * NOTE: Patients with any evidence of leptomeningeal disease are excluded.\n* Active infection requiring systemic antibiotic therapy.\n\n  • NOTE: Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug.\n* Known history of uncontrolled active human immunodeficiency virus (HIV), hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV) infection.\n\n  * NOTE: Testing for HIV, HBV and\u002For HCV is not necessary unless clinically indicated or the patient has a history of HBV\u002FHCV and\u002For HIV infection.\n  * NOTE: Patients with curatively treated HBV and\u002For HCV infection may be enrolled. In these instances, HBV (quantitative HBV DNA) and\u002For HCV (quantitative HCV RNA) resolution must be documented using a quantitative viral load assay.\n  * NOTE: Patients with HIV who are stably controlled on highly active antiretroviral therapy (HAART) therapy with a low HIV viral load may be enrolled. In these instances, stable control is defined as HAART compliant with a CD4 count of ≥200 cells\u002FμL, and low viral load is defined as \\\u003C200 copies\u002FmL on tests done during Screening.\n* Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following:\n\n  * Completely resected carcinoma in situ of any type, resected basal cell and squamous cell carcinomas.\n  * Malignancies that were treated curatively and have not recurred within 2 years prior to study treatment;\n  * Any malignancy considered to be indolent that has never required therapy Sponsor-Investigator evaluation.\n* Any medical condition that would, in the judgment of the Sponsor-Investigator, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.\n* Patients receiving systemic steroid therapy or any other immunosuppressive medication at any dose level, as these may interfere with the mechanism of action of study treatment.\n\nNOTE: Local steroid therapies (eg, otic, ophthalmic, intra-articular or inhaled medications) are acceptable.\n\n* History of symptomatic autoimmune disease including:\n\n  * Interstitial lung disease.\n  * Pneumonitis requiring corticosteroid treatment or current pneumonitis.\n  * Colitis or inflammatory bowel disease. NOTE: However, patients with a history of autoimmune disease who are currently on physiologic hormone repletion (prednisone or equivalent of 10mg or less) and are otherwise asymptomatic may be enrolled.\n* Major surgery within 2 weeks of the first dose of study drug (minimally invasive procedures such as bronchoscopy, tumor biopsy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery and are not exclusionary).\n* Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass.\n* Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GM-CSF, M-CSF) ≤ 2 weeks prior to start of study drug. An erythroid-stimulating agent is allowed as long as it was initiated at least 2 weeks prior to the first dose of study treatment and the patient is not red blood cell transfusion dependent.\n* Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation).\n* Women of childbearing potential who are sexually active with a non-sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during study treatment and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician.\n* Male patients must be surgically sterile or use double barrier contraception methods from enrollment through treatment and for 6 months following administration of the last dose of study drug.\n* Receipt of live or attenuated vaccinations 2 weeks prior to starting study therapy. Patients may receive vaccinations on treatment.",{"count":84,"type":21},44,[24],"This is a phase II open-label, single-arm, multi-center study of tebentafusp in HLA- A\\*0201 positive previously untreated (1L) untreated metastatic uveal melanoma (mUM) with an integrated circulating tumor DNA (ctDNA) biomarker.",[88],"Uveal Melanoma",[90,91,92,93],"CD8+ TILs","tumor-associated macrophages (TAMs)","PD-L1 (B7- H1)","PD-L2 (B7-DC)","2026-02-25",{"date":96,"type":43},"2026-02-27",{"date":98,"type":43},"2025-08-18",{"date":100,"type":21},"2030-09-30",{"name":49,"class":50},3,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":51},"100554500","phase-2-healthy-donor-microbiome-mtp-101-c-in-steroid-relapserefractory-immune-related-cutaneous-adverse-events-ircaes-and-immune-mediated-colitis-imc-100554500","NCT06499896","Healthy-donor Microbiome MTP-101-C in Steroid Relapse\u002FRefractory Immune-related Cutaneous Adverse Events (irCAEs) and Immune-mediated Colitis (IMC)","Phase II Trial of Healthy-donor Derived Full-spectrum Microbiome Therapeutic MTP-101-C in Steroid Relapse\u002FRefractory Immune-related Cutaneous Adverse Events (irCAEs) and Immune-mediated Colitis (IMC) (FMT-ELIMINATE)","FMT-ELIMINATE","Inclusion Criteria:\n\n* Able to swallow oral medication.\n* The participant provides written informed consent for the trial.\n* Willingness to use contraception for duration of trial participation. Male participants: A male participant must agree to use a contraception per protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n\nFemale participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\nNot a woman of childbearing potential (WOCBP) per protocol; OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.\n\n-Clinically confirmed inflammatory irCAE or endoscopically confirmed IMC. Cohort 1 (irCAE): Patients with maculopapular rash, psoriasiform, lichenoid eruptions or bullous pemphigoid of at least grade 3 severity per CTCAE grading system (i.e. \\>30% BSA with moderate or severe symptoms) during Screening.\n\nCohort 2 (IMC): Endoscopically confirmed inflammatory colitis as determined by colonoscopy or flexible sigmoidoscopy during Screening with minimum severity per Mayo endoscopic subscore 1-¬3 \\[MES1-3\\].\n\n-Prior receipt of anti-PD(L)1 and\u002For anti-CTLA-4 singly or in combination with other approved or investigational agents including chemotherapy or targeted therapy.\n\nNOTE: Patient may have received or are receiving ICI therapy as standard-of-care or part of a clinical trial.\n\nPatient must have received treatment with an anti-PD-(L)1 ICI, anti-CTLA-4 ICI singly and\u002For in combination with other approved and\u002For investigational anti-cancer agent(s), as their most recent therapy prior to development of colitis.\n\nCohort 1 (steroid relapsed\u002Frefractory Grade ≥3 irCAE) only\n\n* Receipt of high-dose systemic corticosteroids defined as 1-2mg\u002Fkg prednisone equivalent daily (either oral or intravenous) with a taper over 4-6 weeks as defined by society consensus guidelines102-105; AND\n* No receipt of biologic such as but not limited to (dupilumab, rituximab) prior to enrollment.\n* NOTE: Patients must have received steroids to be eligible.\n* NOTE: Steroid \"resistant\" disease: patients whose symptoms responded (reduction in a CTCAE grade) initially but who developed recurrence upon steroid taper or discontinuation.\n* NOTE: Steroid \"refractory\" disease: patients whose symptoms have not clinically improved by a CTCAE grade in ≥48 hours or maximum of 14 days.\n\nCohort 2 (steroid-relapsed\u002Frefractory Grade ≥3 IMC) only\n\n* Receipt of high-dose systemic corticosteroids defined as 1-2mg\u002Fkg prednisone equivalent daily (either oral or intravenous) with a taper over 4-6 weeks as defined by society consensus guidelines102-105; AND\n* No receipt of biologic such as but not limited to (TNFα inhibitor infliximab OR α₄β₇ integrin inhibitor vedolizumab) prior to enrollment.\n* Patients must have received steroids to be eligible.\n* Steroid \"resistant\" disease: patients whose symptoms responded (reduction in a CTCAE grade) initially but who developed recurrence upon steroid taper or discontinuation.\n* Steroid \"refractory\" disease: patients whose symptoms have not clinically improved by a CTCAE grade in ≥48 hours or maximum of 14 days.\n\n  * Patient may have received any number of lines of prior systemic therapy.\n  * Patient with any solid tumor or hematologic malignancy are eligible.\n  * Patient must not be receiving concurrent radiation therapy.\n  * Willingness to undergo cohort-specific evaluation.\n* Cohort 1: Dermatologic evaluation, and skin biopsy evaluation prior to and after MTP-101-C administration.\n* Cohort 2: GI evaluation, and endoscopic evaluation including colonoscopies prior to and after MTP-101-C administration.\n\n  * Willingness to undergo correlative blood and stool sampling.\n  * Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.\n* Patients with ECOG PS 2 wherein the decline in PS from baseline is deemed secondary to IMC may be enrolled at the discretion of Sponsor-Investigator.\n* Patients with ECOG PS 2 wherein PS is at baseline and deemed secondary to disease are excluded.\n\n  * Have adequate organ function per specimens must be collected within 7 days prior to the start of study treatment.\n\nExclusion Criteria:\n\n* Multiple irAEs besides irCAE or IMC.\n\n  * Patients with concurrent ≥Grade 3 irAEs besides irCAE or IMC that necessitate systemic immune suppression are not candidates for this trial.\n  * Patients with irCAE and\u002For IMC that are not otherwise clarified in Section 5.1.5 (irCAE including alopecia etc.) are not candidates for this trial.\n  * Patients with concomitant irAEs that are well controlled (≤Grade 1 or Grade 2 on repletion medication) may be enrolled at the discretion of Sponsor-Investigator.\n* Diagnosis of immunodeficiency, immunosuppression or any other form of immunosuppressive therapy besides steroids\u002Fbiologics within 7 days prior to the first dose of MTP-101-C treatment.\n* Patients at high risk of MDRO colonization including: nursing home residence, age \\>85, underlying diseases (dementia, poorly controlled diabetes, chronic wounds), in-dwelling medical devices (urinary catheters, feeding tubes, PEG tubes) and a prior history of MDRO colonization.\n* Contraindication to endoscopy (cohort 2 only).\n* Contraindication to MTP-101-C administration.\n* Any prior head\u002Fneck and\u002For abdominal surgery resulting in potentially altered absorption of orally administered FMT pills.\n* Active bacterial infection requiring systemic antibiotic therapy.\n* Received live vaccines within 30 days prior to the first dose of study treatment and while participating in the study",{"count":112,"type":21},30,[24],"Multiple retrospective studies suggest that the administration of corticosteroids to treat irAEs is safe, and does not compromise efficacy of ICI therapy in cancer patients. While \\~67% of patients respond to corticosteroids, 33% of patients require biologic therapy such as TNFα inhibitors (e.g. infliximab), integrin α4β7 inhibitors (e.g. vedolizumab), or JAK\u002FSTAT inhibitors (e.g. tofactinib). This study aims to determine that distinct pathobionts govern the development of irCAE and IMC; and that the administration of hdFMT may reverse steroid-refractory irCAEs or IMC. The use of hdFMT has been shown to be effective in steroid and biologic (TNFα and\u002For integrin α₄β₇ inhibitor) refractory colitis in PD-1 and\u002For CTLA-4 ICI treated cancer patients in single-institution case series.",[116,117],"Immune-mediated Colitis (IMC)","Immune-related Dermatitis",[119,120],"gut microbiome","anti-PD-1 therapy","2026-02-04",{"date":123,"type":43},"2026-02-09",{"date":125,"type":43},"2025-01-23",{"date":127,"type":21},"2031-09-30",{"name":49,"class":50},""]