Testing Vitamin B5 for Patients with Melanoma
Phase 1 Trial of PANtoTHEnic Acid in Patient With Metastatic or Unresectable Melanoma ON ImmunOtherapy (PANTHEON-IO)
This study is testing if taking Vitamin B5 can help boost the immune response in patients with advanced melanoma who are already receiving immunotherapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | Nivolumab, Ipilimumab, chemotherapy, immunotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06377111 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of oral calcium pantothenate (Vitamin B5) on patients with unresectable or metastatic melanoma who are receiving immunotherapy. Conducted at the Princess Margaret Cancer Centre, the study will enroll 12 participants and aims to assess whether Vitamin B5 can enhance immune response when combined with immune checkpoint inhibitors Nivolumab and Ipilimumab. Patients will take a daily dose of 2000 mg of calcium pantothenate for a maximum of one year, while their immune cell activity and gut microbiome will be monitored to evaluate treatment efficacy and safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with unresectable stage III or IV metastatic melanoma who have not received prior systemic treatments.
Not a fit: Patients with gastrointestinal disorders that may interfere with the absorption of oral medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for melanoma patients by enhancing the effectiveness of immunotherapy.
How similar studies have performed: While the combination of Vitamin B5 with immunotherapy is a novel approach, similar studies exploring dietary supplements in cancer treatment have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto, Ontario
- University Health Network- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Samuel Saibil — The Princess Margaret Cancer Foundation
- Study coordinator: Minge Xu
- Email: minge.xu@uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.