[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immune-related-dermatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immune-related-dermatitis":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,38],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":4},"100642623","phase-2-an-open-label-single-center-study-evaluating-the-safety-and-efficacy-of-roflumilast-foam-03-in-subjects-with-cutaneous-adverse-events-due-to-checkpoint-inhibitors-100642623",false,"NCT07639840","An Open-label, Single Center Study Evaluating the Safety and Efficacy of Roflumilast Foam 0.3% in Subjects With Cutaneous Adverse Events Due to Checkpoint Inhibitors","Inclusion Criteria:\n\n1. Male or female subjects aged 18 years or older.\n2. Life expectancy ≥ 36 weeks.\n3. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.\n4. Participants are legally competent to sign and give informed consent.\n5. Patients receiving current or recent (within 6-months) treatment with immune checkpoint inhibitor(s).\n6. Diagnosis of Immune Checkpoint Inhibitor-Related Toxicities Mild (G1 or \\\u003C10%), Moderate (G2 or 10-30% BSA), Severe (G3 or 30+ % BSA) using CTCAE v5.0 with the following: Maculopapular rash, pruritus, bullous dermatitis, eczematous rashes, lichenoid eruption, or Psoriasis\u002FPsoriasiform.\n7. Agreement to NOT use topical and systemic corticosteroids for treatment of ICI-related toxicity during the study for first 2 weeks.\n8. Agreement to not use systemic or biologic immunomodulating therapies during trial term unless cutaneous toxicity is not responding to Roflumilast therapy within the first 4 weeks and toxicity severity increases to high-grade (grade 3-4).\n9. Agreement not to change the dose, form or type of antihistamines if on a stable dose for at least 1 month prior to baseline and not to initiate use of any new antihistamines during participation in the study.\n10. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at Screening and Baseline\u002FDay 1. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial. The use of abstinence as a contraceptive measure is acceptable as long as this is a consistent part of a lifestyle choice and an acceptable backup method has been identified if the subject becomes sexually active.\n11. Females of non-childbearing potential should either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy).\n12. Subjects are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.\n\nExclusion Criteria:\n\n1. Subjects who have pre-existing non-cutaneous toxicities requiring systemic immunosuppression.\n2. Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments (Table Excluded Medications and Treatments to be added).\n3. Oral or colitis toxicities associated with immune checkpoint inhibitor therapy at time of study enrollment.\n4. Subjects with any condition in the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.\n5. Subjects with known genetic dermatological conditions that overlap with cutaneous adverse events related to checkpoint inhibitor per investigator.\n6. Subjects with moderate to severe liver impairment (Child-Pugh B or C).\n7. Subjects with known allergies to excipients in Roflumilast foam (petrolatum, isopropyl palmitate, methylparaben, propylparaben, diethylene glycol monoethyl ether, hexylene glycol, cetylstearyl alcohol, dicetyl phosphase and ceteth-10 phosphate).\n8. Subjects who cannot discontinue the use of systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously for 2 weeks prior to Baseline\u002FDay 1 and during the study period.\n9. Subjects who have received oral roflumilast (Daxas®, Daliresp®) within 4 weeks prior to Baseline\u002F Day 1.\n10. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.\n11. Previous treatment with Roflumilast cream or foam (any potency).\n12. Subjects with a history of a major surgery (excluding minor biopsies) within 4 weeks prior to Baseline\u002FDay 1 or subjects who have a major surgery planned during the study.\n13. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.\n14. Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.\n15. Subjects who are family members of the clinical study site, clinical study staff, or sponsor.","ALL","18 Years",{"count":18,"type":19},20,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","To assess the safety and efficacy of QD 0.3% topical roflumilast foam in patients with cutaneous adverse events due to checkpoint inhibitors over 16 weeks, with or without previous treatment.",[25],"Immune-related Dermatitis","NOT_YET_RECRUITING","2026-06-05",{"date":29,"type":30},"2026-06-10","ACTUAL",{"date":32,"type":19},"2026-08-01",{"date":34,"type":19},"2027-11-01",{"name":36,"class":37},"Massachusetts General Hospital","OTHER",{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":20,"phases":48,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"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":47,"type":19},30,[22],"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.",[51,25],"Immune-mediated Colitis (IMC)",[53,54],"gut microbiome","anti-PD-1 therapy","RECRUITING","2026-02-04",{"date":58,"type":30},"2026-02-09",{"date":60,"type":30},"2025-01-23",{"date":62,"type":19},"2031-09-30",{"name":64,"class":37},"Diwakar Davar",1]