MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma

June 27, 2025 updated by: Masonic Cancer Center, University of Minnesota

MT2022-60: A Phase II Study of Pembrolizumab+ BEAM Conditioning Regimen Before Autologous Stem Cell Transplant (ASCT) Followed by Pembrolizumab Maintenance in Patients of Relapsed or Refractory Classic Hodgkin Lymphoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • Masonic Cancer Center
        • Contact:
          • Sanjal Desai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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
  • Has known active CNS disease.
  • History of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents. Exceptions: Participants with vitiligo, resolved childhood asthma or atopy, hypothyroidism, or Sjogren's syndrome, as well as participants requiring only intranasal steroids, intermittent use of bronchodilators, local steroid injections, or physiologic replacement doses of prednisone (≤ 10 mg/d) may enroll.
  • Has had an allogenic tissue/solid organ transplant.
  • Pregnant or breastfeeding as agents used in this study are Pregnancy Category D (positive evidence of risk). Females of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days of study registration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year.
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

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.

Other Names:
  • Keytruda; MK-3475
Procedure: Autologous stem cell transplant
On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
Other Names:
  • ASCT
Drug: Carmustine
Patient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion.
Other Names:
  • BCNU
  • BICNU
Drug: Etoposide
Etoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2.
Drug: Cytarabine
Cytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2.
Other Names:
  • Ara-C
Drug: Melphalan
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: Baseline to 1 year post-ASCT

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.
Baseline to 1 year post-ASCT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Baseline to 2 years post-ASCT
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.
Baseline to 2 years post-ASCT
Progression-free survival (PFS)
Time Frame: Baseline to 2 years post-ASCT

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.
Baseline to 2 years post-ASCT
Non-relapse mortality (NRM)
Time Frame: Day 100 post-ASCT
Number of participants experiencing death without relapse.
Day 100 post-ASCT
Overall Survival (OS)
Time Frame: Baseline to 5 year post-ASCT
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.
Baseline to 5 year post-ASCT
Complete Radiologic Response Rate
Time Frame: Day 28
Participants experiencing complete radiologic response rate at day 28 post-ASCT.
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masonic Cancer Center, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 27, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022LS174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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