A Phase 2 interventional study of Pembrolizumab and Autologous stem cell transplant in Autologous Stem Cell Transplant and Classic Hodgkin Lymphoma, sponsored by Masonic Cancer Center, University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Masonic Cancer Center, University of Minnesota · Phase 2, Interventional, and Treatment
This is a Phase 2 single arm study to evaluate efficacy and safety of Pembrolizumab before with BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab Q3week starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.
Exclusion Criteria:
Patients will receive Pembrolizumab before BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.
Drug: Pembrolizumab · Procedure: Autologous stem cell transplant · Drug: Carmustine · Drug: Etoposide · Drug: Cytarabine · Drug: Melphalan
Patients will receive 200 mg Pembrolizumab on Day -28 and Day -6 by IV infusion. Pembrolizumab 200 mg IV will resume at day 30+ after ASCT every 3 weeks for 1 year.
Also known as: Keytruda; MK-3475
On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
Also known as: ASCT
Patient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion.
Also known as: BCNU, BICNU
Etoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2.
Cytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2.
Also known as: Ara-C
Melphalan will be given at dose of 140 mg/m2 intravenously on day -1 in a single 20 minute infusion; dose will be based on actual body weight but capped at 3.6 mg/kg as part of BEAM conditioning.
Progression free survival (PFS)
Number of participants with progression free survival at 1 year post transplant. Time from date of study enrollment to date of first documented progression, or death. Patients who do not progress or die at the time of analysis will be censored at their last known date alive.
Time frame: Baseline to 1 year post-ASCT
Overall survival (OS)
Time from date of study enrollment to date of death. Patients who do not die at the time of analysis will be censored at their last known date alive.
Time frame: Baseline to 2 years post-ASCT
Progression-free survival (PFS)
Number of participants with progression free survival at 1 year post transplant. Time from date of study enrollment to date of first documented progression, or death. Patients who do not progress or die at the time of analysis will be censored at their last known date alive.
Time frame: Baseline to 2 years post-ASCT
Non-relapse mortality (NRM)
Number of participants experiencing death without relapse.
Time frame: Day 100 post-ASCT
Overall Survival (OS)
Time from date of study enrollment to date of death. Patients who do not die at the time of analysis will be censored at their last known date alive.
Time frame: Baseline to 5 year post-ASCT
Complete Radiologic Response Rate
Participants experiencing complete radiologic response rate at day 28 post-ASCT.
Time frame: Day 28
Plan to share: No
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Masonic Cancer Center, University of Minnesota