Clinical Trial

DPX-Survivac and Checkpoint Inhibitor in DLBCL

Study Description

DPX-Survivac and Checkpoint Inhibitor in DLBCL

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Biological - DPX-Survivac

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.

Biological - Pembrolizumab

Pembrolizumab 200mg administered intravenously every 3 weeks, commencing on study day 7 to a total of 18 infusions

Drug - Cyclophosphamide 50mg

Cyclophosphamide 50mg twice daily by mouth, administered 7 days on / 7 days off, stating at study day 0, until study day 384

Additional Information

Official Study 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)

Clinical Trial ID

NCT03349450

ParticipAid ID

0dNqKb