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

NCT06377111 | Recruiting Phase 1 DMC

• 1 other identifier: PANTHEON-IO
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Melanoma (Skin)

Keywords

Vitamin B5; Unresectable melanoma; Metastatic melanoma; Pantothenic acid; Combined immune checkpoint inhibitors; ICI; Nivolumab; Ipilimumab; Anti-PD-1 antibody; Anti-CLTA-4 antibody; Skin cancer; Melanoma; Calcium pantothenate

Outcome Measures

Primary Outcomes (1)

• 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.

  Blood samples will be collected at baseline, and at week 9 to evaluate level in plasmatic pantothenic acid level, measured in mcMol/L.

  9 weeks

Secondary Outcomes (8)

• Evaluate the overall response rate (ORR) of the enrolled cohort.

  1 year

• Evaluate the progression free survival (PFS) of the enrolled cohort.

  1 year

• Incidence of immune-related colitis.

  1 year

• Correlation between baseline intestinal microbiome composition to the development of immune-related colitis.

  1 year

• Correlation between the early changes in composition of intestinal microbiome and the development of immune-related colitis.

  1 year

Other Outcomes (2)

• Correlation between change in pantothenic acid plasmatic level in mcMol/L between baseline and first day of ICI, and ORR by RECIST and iRECIST.

  2 weeks

• Correlation between change in plasmatic pantothenic acid level between baseline and week 9 assessment, and immune profiling.

  9 weeks

Study Arms (1)

C-PAN in combination with ICI

EXPERIMENTAL

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.

Dietary Supplement: C-PAN; Biological: Nivolumab; Biological: Ipilimumab

Interventions

C-PAN DIETARY_SUPPLEMENT

C-PAN is an essential nutrient as it is required for the synthesis of CoA, a key cofactor in the tricarboxylic acid cycle and fatty acid metabolism, as well as for the synthesis of acyl carrier protein. Pantothenate appears to be safe in humans with studies describing the administration of doses up to 10 grams per day over prolonged periods of time; hence, no upper limit for tolerability has been established. In this study, oral supplement consisting of 2000 mg daily of C-PAN will be administered to a single cohort of patients.

Also known as: Calcium Pantothenate, Vitamin B5

C-PAN in combination with ICI

Nivolumab BIOLOGICAL

Nivolumab is an ICI, a type of immunotherapy. It is a monoclonal antibody that binds to the protein PD-1 on the surface of immune cells called T cells. Nivolumab 1 mg/kg every 3 weeks for up to 4 cycles (upon patient´s tolerability) followed by maintenance Nivolumab 3 mg/kg (or fixed dose 240 mg) every 2 weeks or Nivolumab 6 mg/kg (or fixed dose 480 mg) every 4 weeks.

Also known as: anti-PD-1 antibody

C-PAN in combination with ICI

Ipilimumab BIOLOGICAL

Ipilimumab is an ICI, a type of immunotherapy. It is a monoclonal antibody that binds to the protein CTLA-4 on immune cells called T cells. Ipilimumab 3 mg/kg every 3 weeks for up to 4 cycles.

Also known as: anti-CLTA-4 antibody

C-PAN in combination with ICI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Signed written and voluntary informed consent.
• \. Age ≥18 years, male or female.
• \. Have histologically or cytological documented unresectable stage III or stage IV metastatic melanoma (AJCC 8th edition).
• \. Have not received any previous systemic treatment for advanced melanoma, including chemotherapy, immunotherapy or targeted therapy.
• \. Be willing and able to provide stool and blood specimen for analyses at protocol specified time points.
• \. Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
• \. Not pregnant for females of child bearing potential as indicated by negative serum or urine pregnancy test within 72 hours of study start

You may not qualify if:

• \. 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.
• \. Subjects with inflammatory bowel disease.
• \. 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.
• \. Pregnant or planning to get pregnant in the next 6 months.
• \. Female patient breastfeeding.
• \. 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network- Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Interventions

Pantothenic Acid; Nivolumab; spartalizumab; Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Imides; Organic Chemicals; beta-Alanine; Alanine; Amino Acids; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Samuel Saibil

  The Princess Margaret Cancer Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minge Xu

CONTACT

416-946-4501; minge.xu@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 22, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

CA (1)