Phase 1 Trial of PANtoTHEnic Acid in Patient With Metastatic or Unresectable Melanoma ON ImmunOtherapy (PANTHEON-IO)
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.
• 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