NCT03200847

Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma

Pembrolizumab and All-Trans Retinoic Acid in Combination Treatment of Advanced Melanoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I/Ib investigator-initiated open label of the combination of VESANOID and pembrolizumab treatment.

Detailed description

Primary Objective * To identify the MTD and RP2D of the combination of pembrolizumab and ATRA. Secondary Objective: * Describe the safety and toxicity of combined treatment with pembrolizumab and all-trans retinoic acid (ATRA) \[brand name VESANOID\] in melanoma patients. * To assess the anti-tumor activity in terms of a). The reduction in MDSC (immunosuppressive myeloid -derived suppressor cells) frequency and suppressive function (measured as a continuous variable)in peripheral blood of advanced melanoma patients undergoing pembrolizumab and VESANOID combination therapy. b). progression free survival. Exploratory Objective * To determine the clinical outcomes with tumor-specific T cell responses.

Conditions

• Stage IV Melanoma
• Stage III Melanoma
• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab with All-Trans Retinoic Acid	All the patients will receive 200mg Q3W pembrolizumab treatment plus the supplemental treatment of 150 mg/m2 All-Trans Retinoic Acid orally for 3 days surrounding each of the first four infusions of pembrolizumab

Timeline

• Start date: 2017-10-31
• Primary completion: 2022-07-20
• Completion: 2022-10-19
• First posted: 2017-06-27
• Last updated: 2024-10-01
• Results posted: 2023-03-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study