Phase II Study of Second-line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma
Summary
The purpose of this study is to test any good and bad effects of the study drug, pembrolizumab, in combination with GVD in the treatment of Hodgkin lymphoma.
Arms & interventions
- Drugpembrolizumab
Age 10-17: 2mg/kg (cap at 200mg), Age ≥ 18: 200 mg (flat) ,Day 1 of each 3 week cycle IV infusion 2-4 cycles (pre-ASCT)
- Druggemcitabine
1000mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles
- Drugvinorelbine
20mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles
- Drugliposomal doxorubicin
15mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles
- ProcedureStem cell mobilization and collection
Stem cell mobilization and collection will be performed as per standard MSKCC guidelines after 2-4 cycles of pembrolizumab-GVD.
Outcome measures
Primary
Complete response rate (part 1)
Response to pembrolizumab-GVD will be assessed using the RECIL criteria.
Time frame: 2 years
Secondary
Evaluate the 2-year PFS rate (part 2)
Time frame: 2 years
Eligibility criteria
Study locations (10)
City of Hope Cancer Center (Data Collection Only)
Duarte, California, 91010
Stanford University Medical Center
Stanford, California, 94305-5408
University of Miami
Miami, Florida, 33136
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center @ Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
References
- Moskowitz AJ, Shah G, Schoder H, Ganesan N, Drill E, Hancock H, Davey T, Perez L, Ryu S, Sohail S, Santarosa A, Galasso N, Neuman R, Liotta B, Blouin W, Kumar A, Lahoud O, Batlevi CL, Hamlin P, Straus DJ, Rodriguez-Rivera I, Owens C, Caron P, Intlekofer AM, Hamilton A, Horwitz SM, Falchi L, Joffe E, Johnson W, Lee C, Palomba ML, Noy A, Matasar MJ, Pongas G, Salles G, Vardhana S, Sanin BW, von Keudell G, Yahalom J, Dogan A, Zelenetz AD, Moskowitz CH. Phase II Trial of Pembrolizumab Plus Gemcitabine, Vinorelbine, and Liposomal Doxorubicin as Second-Line Therapy for Relapsed or Refractory Classical Hodgkin Lymphoma. J Clin Oncol. 2021 Oct 1;39(28):3109-3117. doi: 10.1200/JCO.21.01056. Epub 2021 Jun 25.(PubMed)
- Ma S, Spinner MA. Optimizing the Role of Checkpoint Inhibitors in the Management of Hodgkin Lymphoma. J Natl Compr Canc Netw. 2026 Feb;24(2):e257125. doi: 10.6004/jnccn.2025.7125.(PubMed)