NCT04960618

Pembrolizumab in Combination With Gemcitabine in People With Advanced Mycosis Fungoides or Sézary Syndrome

Pembrolizumab in Combination With Gemcitabine for Previously Treated Mycosis Fungoides and Sézary Syndrome: Efficacy and Characterization of Immune Response

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether the combination of pembrolizumab and gemcitabine is an effective treatment for mycosis fungoides and Sézary syndrome.

Conditions

• Mycosis Fungoides
• Mycosis Fungoides/Sezary Syndrome
• Sezary Syndrome
• Sézary
• Advanced Mycosis Fungoides

Interventions

Type	Name	Description
DRUG	Gemcitabine	Participants will receive gemcitabine 1000 mg/m2 on days 1 and 8 on 21-days cycles for up to 6 cycles
DRUG	Pembrolizumab	Pembrolizumab 200 mg will be introduced with cycle 2 and will be given on day 1 of each 21-day cycle for up to 35 cycles

Timeline

• Start date: 2021-10-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2021-07-14
• Last updated: 2026-03-23

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study