MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMasonic Cancer Center, University of Minnesota
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with prior history of any grade 2 or higher autoimmune reaction to PD-1 inhibitors, necessitating permanent discontinuation of the PD-1 inhibitor or necessitating systemic immunosuppressants.
Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Has received any chemotherapy within 3 weeks prior to the first dose of study intervention
Trial design
Design model
Single group
Treatments tested in this trial
Pembrolizumab
DrugPatients 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.
Autologous stem cell transplant
Procedure/SurgeryOn day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
Carmustine
DrugPatient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion.
Etoposide
DrugEtoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2.
Cytarabine
DrugCytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2.
Melphalan
DrugMelphalan 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.
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year.Experimental treatment 6 interventions
Trial outcomes
Primary outcomes
1
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-ASCTSecondary outcomes
1
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-ASCT2
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-ASCT3
Non-relapse mortality (NRM)
Number of participants experiencing death without relapse.
Time frame
Day 100 post-ASCT4
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-ASCTSponsors and contacts
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Source ClinicalTrials.gov