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RECRUITING
NCT06377111
PHASE1

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

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2024-06-24

Completion Date

2026-08

Last Updated

2025-07-14

Healthy Volunteers

No

Conditions

Interventions

DIETARY_SUPPLEMENT

C-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.

BIOLOGICAL

Nivolumab

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.

BIOLOGICAL

Ipilimumab

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