Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma

Sponsor
University Health Network, Toronto
Study ID
NCT04510636
Phase
PHASE2
Status
Unknown

Conditions

  • Classical Hodgkin Lymphoma
  • Refractory Cancer
  • Relapsed Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab is a intravenously administered humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
  • Bendamustine Hydrochloride — DRUG
    Bendamustine is a unique alkylating agent with substantial activity in hematologic malignancies.

Study Details

This is a phase 2 open-label study to test the safety and effectiveness of combining pembrolizumab and bendamustine in patients with relapsed (cancer that has come back or started getting worse) or refractory (cancer that is not responding or has stopped responding to treatment) Hodgkin lymphoma.

Key Dates

Start date
Dec 20, 2021
Status verified
Mar 2024
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab and Bendamustine
    The study drugs will be given in 3 week periods called cycles. Pembrolizumab is available in powder form or as a liquid for infusion. Pembrolizumab at a dose of 200 mg will be given over 30 minutes, once every cycle for up to 35 cycles (approximately 24 months). Bendamustine is available in powder form for injection. Bendamustine at a dose of 90 mg/m2 will be given over 60 minutes, on Days 1 and 2 of every cycle for up to 6 cycles.

Primary Outcome Measure

Overall response rate [ Time Frame: 5 years ]

Central Contacts

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