Could a common vitamin boost immunotherapy for melanoma?
NCT ID NCT06377111
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase trial is testing whether taking high-dose vitamin B5 (pantothenic acid) can help standard immunotherapy work better for people with advanced melanoma that cannot be surgically removed. The study includes 12 participants who have not had prior treatment for their advanced cancer. Researchers will measure vitamin B5 levels in the blood and look for signs of immune system changes and tumor response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vitamin B5 (pantothenic acid, calcium pantothenate)
- What this could lead to
- If it works, this could point toward a simple vitamin supplement that helps immunotherapy work better for advanced melanoma.
- What could go wrong
- This is a very small, early phase 1 trial with only 12 people. It mainly checks if vitamin B5 levels rise in the blood, not whether it actually improves cancer outcomes. Success is uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Signed written and voluntary informed consent. * 2\. Age ≥18 years, male or female. * 3\. Have histologically or cytological documented unresectable stage III or stage IV metastatic melanoma (AJCC 8th edition). * 4\. Have not received any previous systemic treatment for advanced melanoma, including chemotherapy, immunotherapy or targeted therapy. * 5\. Be willing and able to provide stool and blood specimen for analyses at protocol specified time points. * 6\. Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale. * 7\. Not pregnant for females of child bearing potential as indicated by negative serum or urine pregnancy test within 72 hours of study start Exclusion Criteria: * 1\. Subjects unable to swallow orally administered medications or any subjects with gastrointestinal disorders likely to interfere with absorption (e.g. bowel obstruction, short gut syndrome, blind loop syndrome, ileostomy, etc.). Subjects with colostomies may be enrolled. * 2\. Subjects with inflammatory bowel disease. * 3\. Any condition that, in the opinion of the Investigator, would interfere with subject safety, or evaluation of the collected specimen and interpretation of study result. * 4\. Pregnant or planning to get pregnant in the next 6 months. * 5\. Female patient breastfeeding. * 6\. Allergy to the investigational product (or its non-medicinal ingredients)- Calcium Pantothenate (stearic acid, Hydroxypropyl methylcellulose) or Immune checkpoint inhibitors (or its non-medicinal ingredients)- Nivolumab (Hydrochloric acid, mannitol (E421), pentetic acid, polysorbate 80, sodium chloride, sodium citrate, sodium hydroxide) and Ipilimumab (diethylene triamine pentaacetic acid (DTPA), mannitol, polysorbate 80, sodium chloride, Tris-hydrochloride, sodium hydroxide, hydrochloric acid
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University Health Network- Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Real-World melanoma care under the microscope
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a DNA vaccine teach the immune system to hunt melanoma?
- Can an immune booster make chemo hit melanoma harder?
- A simple dye might replace radioactive tracers in cancer staging
- A quest to find biomarkers that match melanoma patients with the right immunotherapy