Official Title
Phase 2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide Administered With Pembrolizumab in Patients With Persistent or Recurrent/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
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 booster vaccinations 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.
Trial Description
Primary Outcome:
- To document the objective response rate using modified Cheson criteria to treatment with DPX-Survivac and low dose cyclophosphamide administered together with Pembrolizumab in patients with recurrent, survivin-expressing B cell lymphomas
Secondary Outcome:
- To document changes in tumour volume using waterfall analyses
- To document the toxicity profile
- To document duration of response using modified Cheson criteria.
- To document duration of response using immune related response criteria
This is a Phase 2, non-randomized, open-label, uncontrolled, efficacy and safety trial.
Participants will receive 2 priming injections (0.5ml) of the DPX-Survivac vaccine 3 weeks
apart on Study Days 7 and 28. In addition, up to 6 booster vaccinations (0.1ml) over the
course of the study occurring on Study Days 84, 140, 196, 252, 308, and 364. All injections
will be given under the skin of the upper thigh.
Participants will receive metronomic oral cyclophosphamide (50mg BID; 7 days on / 7 days off)
for study period.
Pembrolizumab 200mg will be administered intravenously every 3 weeks, commencing on study day
7, to a total of 18 infusions.
If a subject is removed from the trial prior to the completion of at least 4 doses of
Pembrolizumab and 3 vaccinations of DPX-Survivac, that subject may be replaced to determine
the efficacy of treatment in a minimum of 16 subjects.
DPX-Survivac injection sites will be evaluated throughout the study and if evidence of
significant reaction, an Injection site reaction biopsy will be sought.
During the course of the study, blood will be drawn to evaluate immune cells and the effect
that the vaccinations have on the participants immune system. During all treatment cycles a
physical exam and questions about the participants general health will be performed.
Participant will undergo "re-staging" to assess the status of their disease at approximately
study day 70 (if there is evidence of Grade 2 or greater injection site reaction or
ulceration evident on study day 49) or routinely at approximately study day 91 and repeated
at end of study or study withdrawal for all participants.
A follow-up tumour biopsy will be requested between study day 77-83 for subjects with any
grade 2 or greater Injection site reaction or ulceration on SD49 or between SD98 and SD104 if
no evidence of injection site reaction or ulceration.
Upon completion of study, participants will be monitored every 2 months for 1 year.
View this trial on ClinicalTrials.gov
