Masonic Cancer Center, University of Minnesota
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.
Inclusion Criteria: * Eligible for autologous stem cell transplant (ASCT) with BEAM conditioning regimen * KPS greater than 70 or ECOG ≤ 1 * Adequate organ function and blood counts within 14 days of study registration * Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization. * Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening. * HIV-infected participants must have well-controlled HIV on ART Exclusion Criteria: * Pati…
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.
On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
Patient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion.
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.
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.
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