Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma
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|ClinicalTrials.gov Identifier: NCT03200847|
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : July 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stage IV Melanoma Stage III Melanoma Advanced Melanoma||Drug: Pembrolizumab with All-Trans Retinoic Acid||Phase 1 Phase 2|
- To identify the MTD and RP2D of the combination of pembrolizumab and ATRA.
- 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.
- To determine the clinical outcomes with tumor-specific T cell responses.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pembrolizumab and All-Trans Retinoic Acid in Combination Treatment of Advanced Melanoma|
|Actual Study Start Date :||October 31, 2017|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Pembrolizumab with All-Trans Retinoic Acid
Patients will receive pembrolizumab infusions every three weeks. Patients will also receive 3 days of all-trans retinoic acid treatment surrounding each of the first 4 infusions of pembrolizumab, beginning one day prior to the infusion (a total of 12 days of all-trans retinoic acid).
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
- Maximally Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of the combination of pembrolizumab and All-Trans Retinoic Acid [ Time Frame: 5 years ]MTD is defined as the highest dose level with no more than 3 DLT reported in 6 DLT-evaluable subjects. A target toxicity rate of approximately 33% of all 24 patients will be used to establish the RP2D.
- Dose-Limiting Toxicity (DLT) for the combined treatment of pembrolizumab and All-Trans Retinoic Acid for each patient [ Time Frame: 5 years ]Toxicity will be evaluated according to NCI CTCAE Version 4.0. A dose limiting toxicity (DLT) will be defined as any grade 3 or higher related to VESNOID and/or Pembrolizumab.
- The anti-tumor activity for each patient [ Time Frame: 5 years ]Anti-tumor activity will be determined by the reduction in MD (immunosuppressive myeloid-derived suppressor cells) frequency and suppressive function (measured as a continuous variable) in peripheral blood of advanced melanoma patients undergoing the combined treatment of pembrolizumab and All-Trans Retinoic Acid
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200847
|Contact: Christine Christensenfirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Denver||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Christine Christensen 720-848-0592 email@example.com|
|Principal Investigator: Martin McCarter, MD|
|Poudre Valley Hospital||Not yet recruiting|
|Fort Collins, Colorado, United States, 80528|
|Contact: Valerie Cummins 970-297-6159 firstname.lastname@example.org|
|Principal Investigator: Steven Schuster, MD|
|Principal Investigator:||Martin McCarter, MD||University of Colorado, Denver|