RecruitingPhase 1NCT06377111

A Study to Test the Benefit of Vitamin B5 in Patients With Melanoma

Phase 1 Trial of PANtoTHEnic Acid in Patient With Metastatic or Unresectable Melanoma ON ImmunOtherapy (PANTHEON-IO)

Sponsor

University Health Network, Toronto

Enrollment

12 participants

Start Date

Jun 24, 2024

Study Type

INTERVENTIONAL

Conditions

Melanoma (Skin)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether taking vitamin B5 (pantothenic acid) improves outcomes — possibly by changing gut bacteria — in people with advanced melanoma (a serious form of skin cancer) who are about to start immunotherapy for the first time. **You may be eligible if...** - You are 18 or older - You have advanced melanoma (stage III that cannot be removed, or stage IV that has spread) confirmed by biopsy - You have not yet received any treatment for your advanced melanoma (no prior chemotherapy, immunotherapy, or targeted therapy) - You are willing to provide stool and blood samples at specified times - Your general health is reasonably good (ECOG score 0–2) **You may NOT be eligible if...** - You have already received systemic treatment for your advanced melanoma - You have difficulty swallowing pills - You are pregnant - You have other serious health conditions that would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTC-PAN

C-PAN is an essential nutrient as it is required for the synthesis of CoA, a key cofactor in the tricarboxylic acid cycle and fatty acid metabolism, as well as for the synthesis of acyl carrier protein. Pantothenate appears to be safe in humans with studies describing the administration of doses up to 10 grams per day over prolonged periods of time; hence, no upper limit for tolerability has been established. In this study, oral supplement consisting of 2000 mg daily of C-PAN will be administered to a single cohort of patients.

BIOLOGICALNivolumab

Nivolumab is an ICI, a type of immunotherapy. It is a monoclonal antibody that binds to the protein PD-1 on the surface of immune cells called T cells. Nivolumab 1 mg/kg every 3 weeks for up to 4 cycles (upon patient´s tolerability) followed by maintenance Nivolumab 3 mg/kg (or fixed dose 240 mg) every 2 weeks or Nivolumab 6 mg/kg (or fixed dose 480 mg) every 4 weeks.

BIOLOGICALIpilimumab

Ipilimumab is an ICI, a type of immunotherapy. It is a monoclonal antibody that binds to the protein CTLA-4 on immune cells called T cells. Ipilimumab 3 mg/kg every 3 weeks for up to 4 cycles.

Locations(1)

University Health Network- Princess Margaret Cancer Centre

Toronto, Ontario, Canada

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NCT06377111

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