DPX-Survivac and Checkpoint Inhibitor in DLBCL (NCT03349450) | Clinical Trial Compass
CompletedPhase 2
DPX-Survivac and Checkpoint Inhibitor in DLBCL
Canada25 participantsStarted 2018-03-13
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Be willing and able to provide written informed consent/assent for the trial.
✓. Male or female 18+ years of age on day of signing informed consent and of any racial or ethnic group
✓. Has:
✓. Has had:
✓. Have at least one measurable site of disease based on Cheson Criteria using standard CT imaging.
✓. Be willing to provide tissue from a newly obtained (up to 3 months + 7 days prior to Study Day 0) biopsy of a tumour lesion. If this is not available, the patient must be willing to undergo a core biopsy prior to starting treatment. They must also be willing to provide an on-treatment biopsy.
✓. Have a performance status of 0-1 on the ECOG Performance Scale.
✓. Demonstrate adequate organ function as defined in Table 2, within 48 hours prior to receiving the first dose of study medication (SD0). Patients with abnormal liver enzymes of up to 5 times the upper limit of normal and/or reduced GFR of 50-100% normal range can be considered for enrolment if the alteration is due to lymphoma.
Exclusion criteria
✕. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 21 days of the first dose of treatment (SD0).
✕. Patients eligible for possible curative therapies such as ASCT.
What they're measuring
1
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
. LDH greater than 5 times the upper limit of normal.
✕. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 35 days prior to the first dose of trial treatment (SD0), except that used as pre-medication for chemotherapy or contrast-enhanced studies are eligible. Subjects may be on physiologic doses of replacement prednisone or equivalent doses of corticosteroid (\<10 mg daily).
✕. Has had previous allogeneic stem cell transplant
✕. Has known active TB (Bacillus Tuberculosis)
✕. Hypersensitivity to pembrolizumab or any of its excipients.
✕. Has had a prior anti-cancer monoclonal antibody (mAb) within 21 days prior to SD0 or who has not recovered (i.e., ≤ Grade 1) from adverse events due to agents administered more than 21 days earlier.