protocolSection identificationModule nctId: NCT06377111, orgStudyIdInfo id: PANTHEON-IO, briefTitle: A Study to Test the Benefit of Vitamin B5 in Patients With Melanoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: This study is open to patients with a type of cancer called melanoma. Patients can join the study if their tumor cannot be removed by surgery or has spread to other organs, and are planned to receive immunotherapy as treatment for their cancer. This study is looking at whether taking calcium pantothenate supplement (a type of Vitamin B5) can increase its levels in the blood and have an effect in the immune system, when its used in combination with the immunotherapy., conditionsModule conditions: Melanoma (Skin), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: C-PAN, interventions name: Nivolumab, interventions name: Ipilimumab, outcomesModule primaryOutcomes measure: To determine if the dose of 2000 mg daily of pantothenic acid achieves an increase in plasmatic concentration of pantothenic acid by at least a 50% between baseline and week 9, in 9 or more of the patients treated with combined ICI., secondaryOutcomes measure: Evaluate the overall response rate (ORR) of the enrolled cohort., secondaryOutcomes measure: Evaluate the progression free survival (PFS) of the enrolled cohort., secondaryOutcomes measure: Incidence of immune-related colitis., secondaryOutcomes measure: Correlation between baseline intestinal microbiome composition to the development of immune-related colitis., secondaryOutcomes measure: Correlation between the early changes in composition of intestinal microbiome and the development of immune-related colitis., secondaryOutcomes measure: The incidence of treatment-related adverse events., secondaryOutcomes measure: The incidence of treatment-related adverse events, secondaryOutcomes measure: Correlation between change in plasmatic pantothenic acid level between baseline and at first day of ICI, and ORR., otherOutcomes measure: Correlation between change in pantothenic acid plasmatic level in mcMol/L between baseline and first day of ICI, and ORR by RECIST and iRECIST., otherOutcomes measure: Correlation between change in plasmatic pantothenic acid level between baseline and week 9 assessment, and immune profiling., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Health Network- Princess Margaret Cancer Centre, city: Toronto, state: Ontario, zip: M5G 2M9, country: Canada, contacts name: Minge Xu, role: CONTACT, phone: 416-946-4501, phoneExt: 7754, email: minge.xu@uhn.ca, contacts name: Samuel Saibil, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False