DPX-Survivac and Checkpoint Inhibitor in DLBCL

Sponsor
Sunnybrook Health Sciences Centre
Study ID
NCT03349450
Phase
PHASE2
Status
Completed

Conditions

  • Adult Diffuse Large Cell Lymphoma
  • Adult Refractory Diffuse Large B-Cell Lymphoma
  • Recurrent

Eligibility Criteria

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

Interventions

  • DPX-Survivac — BIOLOGICAL
    DPX-Survivac Priming dose of 0.5ml on Study days 7 and 28. DPX-Survivac Booster dose of 0.1ml on Study days 84, 140, 196, 252, 308, and 364.
  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab 200mg administered intravenously every 3 weeks, commencing on study day 7 to a total of 18 infusions
  • Cyclophosphamide 50mg — DRUG
    Cyclophosphamide 50mg twice daily by mouth, administered 7 days on / 7 days off, stating at study day 0, until study day 384

Study Details

This is a Phase 2 non-randomized, open label, uncontrolled, efficacy and safety study. Study participants will receive two priming doses of 0.5mL of DPX-Survivac 21 days apart and up to six 0.1ml maintenance injections every two months with low dose metronomic oral cyclophosphamide (50 mg BID) for one year or until disease progression, whichever occurs first. Pembrolizumab 200 mg will be administered every 3 weeks for up to one year or until disease progression, whichever occurs first.

Key Dates

Start date
Mar 13, 2018
Status verified
Jan 2026
Primary completion
Oct 31, 2021
Completion
Jul 18, 2023

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm-Investigational
    DPX-Survivac Priming dose of 0.5ml. DPX-Survivac Booster dose of 0.1ml. Pembrolizumab 200mg Intravenously. Cyclophosphamide 50mg Twice daily orally.

Primary Outcome Measure

Objective Response Rate Using Modified Cheson Criteria to Treatment With DPX-Survivac and Low Dose Cyclophosphamide Administered Together With Pembrolizumab in Participants With Recurrent, Survivin-expressing B Cell Lymphomas [ Time Frame: 1 Year ]

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