NCT06377111Active, not recruitingPhase 1
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)
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 5 Apr 2024
- Start date
- Jun 2024
- Primary completion date
- Aug 2027
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Melanoma
- NCT number
- NCT06377111
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From Jun 2024 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- 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
Other
- 4\. Pregnant or planning to get pregnant in the next 6 months.
- 5\. Female patient breastfeeding.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network - Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.