Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06377111

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

Led by University Health Network, Toronto · Updated on 2025-07-14

12

Participants Needed

1

Research Sites

109 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written and voluntary informed consent.
  • Age 18 years or older, male or female.
  • Histologically or cytologically confirmed unresectable stage III or stage IV metastatic melanoma (AJCC 8th edition).
  • No prior systemic treatment for advanced melanoma including chemotherapy, immunotherapy, or targeted therapy.
  • Willing and able to provide stool and blood samples at specified times.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Females of childbearing potential must have a negative pregnancy test within 72 hours before study start.
Not Eligible

You will not qualify if you...

  • Unable to swallow oral medications or have gastrointestinal disorders interfering with absorption (e.g., bowel obstruction, short gut syndrome, blind loop syndrome, ileostomy), though colostomy patients may enroll.
  • Diagnosis of inflammatory bowel disease.
  • Any condition that could affect safety or study results at the investigator's discretion.
  • Pregnant or planning pregnancy within 6 months.
  • Breastfeeding female patients.
  • Allergy to calcium pantothenate, Nivolumab, Ipilimumab, or their non-medicinal ingredients.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Health Network- Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

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Research Team

M

Minge Xu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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