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

University of Minnesota (UMN)

Status and phase: Enrolling; Phase 2

Conditions: Autologous Stem Cell Transplant; Classic Hodgkin Lymphoma

Treatments: Procedure: Autologous stem cell transplant; Drug: Melphalan; Drug: Etoposide; Drug: Cytarabine; Drug: Carmustine; Drug: Pembrolizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06377540

2022LS174

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year.

Experimental group

Description:

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.

Treatment:

Drug: Pembrolizumab

Drug: Cytarabine

Drug: Carmustine

Drug: Melphalan

Drug: Etoposide

Procedure: Autologous stem cell transplant