Recruiting
Phase 2

Pembro & BEAM

Sponsor:

Masonic Cancer Center, University of Minnesota

Code:

NCT06377540

Conditions

Autologous Stem Cell Transplant

Classic Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab

Autologous stem cell transplant

Carmustine

Etoposide

Cytarabine

Study Details

Brief summary:

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.

Conditions

Autologous Stem Cell Transplant

Classic Hodgkin Lymphoma

Study ID

NCT06377540

Start date

Dec 4, 2024

Status verified date

Jul, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

28 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Autologous stem cell transplant

On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.

Carmustine

Patient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion.

Etoposide

Etoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2.

Cytarabine

Cytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2.

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.

Primary outcome measure

  • Progression free survival (PFS) [ Time Frame: Baseline to 1 year post-ASCT ]

Central Contacts and Locations

Central contacts

Sanjal Desai

612-625-5469desai171@umn.edu

Roberta Nicklow

nickl004@umn.edu

Locations

Masonic Cancer Center

Recruiting

Minneapolis, Minnesota, United States, 55455

More Information

Sponsor

Masonic Cancer Center, University of Minnesota

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • BEAM
  • cHL
  • ASCT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Masonic Cancer Center, University of Minnesota on 2026-07-06.