Clinical trial · Interventional
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)
NCT06377111CI-TRIAL-00113941active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| C-PAN | Dietary Supplement | — | UNRESOLVED |
| Ipilimumab | Biological | Ipilimumab | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- C-PAN in combination with ICI
- description
- C-PAN will be taken orally once daily in the morning prior to eating. The daily oral dose of C-PAN is 2000 mg (4 capsules of 500 mg each). Subjects will receive C-PAN exclusively for a run-in period of 3 to 7 days, and then a maintenance dose as long as the patient continues to receive SOC Nivolumab and Ipilimumab. Treatment will continue until unacceptable toxicity, progression of disease (PD), start of new anticancer therapy, or for a maximum of 1 year, whichever occurs earlier, and in the absence of criteria to discontinue C-PAN.
- interventionNames
- Dietary Supplement: C-PAN
- Biological: Nivolumab
- Biological: Ipilimumab
Primary outcomes (1)
- measure
- To determine if the dose of 2000 mg daily of pantothenic acid achieves an increase in plasmatic concentration of pantothenic acid by at least a 50% between baseline and week 9, in 9 or more of the patients treated with combined ICI.
- timeFrame
- 9 weeks
- description
- Blood samples will be collected at baseline, and at week 9 to evaluate level in plasmatic pantothenic acid level, measured in mcMol/L.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.