Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377111
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-04-05
Brief Title:
A Study to Test the Benefit of Vitamin B5 in Patients With Melanoma
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Phase 1 Trial of PANtoTHEnic Acid in Patient With Metastatic or Unresectable Melanoma ON ImmunOtherapy PANTHEON-IO
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
This single-center single-cohort study aims to investigate the effectiveness of oral calcium pantothenate C-PAN in raising plasma pantothenic acid levels in melanoma patients Conducted at Princess Margaret Cancer Centre the study will enroll 12 eligible subjects with locally unresectable or metastatic melanoma undergoing first-line standard of care SOC with combined immune checkpoint inhibitor ICI therapy Nivolumab and Ipilimumab Additionally the study will explore changes in immune cell subsets metabolomics and gut microbiome to understand the impact of pantothenateCoA pathway manipulation on ICI efficacy and immune-mediated colitis prevention
Patients will initially receive a run-in period of C-PAN at a dose of 2000 mg daily for 3 to 7 days alongside approved SOC drugs Subsequently patients will continue with the maintenance dose of 2000 mg daily starting on the same day as the first cycle of combined ICI This maintenance dose will be continued until the occurrence of unacceptable toxicity disease progression by iRECIST criteria or for a maximum duration of 1 year whichever comes first unless there are specific criteria indicating the discontinuation of C-PAN
For all subjects radiologic imaging to assess response to treatment will be performed as per standard practice ideally every 8 to 12 weeks with first assessment at week 9 Fecal samples will be collected from all subjects at baseline 1st sample at week 9 following the start of ICI and at study completion or discontinuation An additional fecal sample will be collected in case of development of immune-related colitis or immune-related diarrhea
Standard laboratory investigations for immunotherapy will be collected as per institutional practice Blood samples for biomarkers will be collected at various time points
Patients will initially receive a run-in period of C-PAN at a dose of 2000 mg daily for 3 to 7 days alongside approved SOC drugs Subsequently patients will continue with the maintenance dose of 2000 mg daily starting on the same day as the first cycle of combined ICI This maintenance dose will be continued until the occurrence of unacceptable toxicity disease progression by iRECIST criteria or for a maximum duration of 1 year whichever comes first unless there are specific criteria indicating the discontinuation of C-PAN
For all subjects radiologic imaging to assess response to treatment will be performed as per standard practice ideally every 8 to 12 weeks with first assessment at week 9 Fecal samples will be collected from all subjects at baseline 1st sample at week 9 following the start of ICI and at study completion or discontinuation An additional fecal sample will be collected in case of development of immune-related colitis or immune-related diarrhea
Standard laboratory investigations for immunotherapy will be collected as per institutional practice Blood samples for biomarkers will be collected at various time points
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None