Cancer
Current Projects
BRAWM
Bendamustine, Rituximab and Acalabrutinib in Waldenstrom’s Macroglobulinemia (BRAWM) - A Multi-Center, Open-Label, Single-Arm Phase II Trial of Bendamustine, Rituximab and the Next Generation BTK Inhibitor Acalabrutinib in Previously Untreated Waldenstrom’s Macroglobulinemia
Principal investigator
Dr. Neil L. Berinstein, Sunnybrook Health Sciences Centre
Recruitment Status
Recruiting
Summary
BRAWM is a Canadian multi-centre, open label, phase II study looking at the addition of a BTK inhibitor, acalabrutinib, to standard of care bendamustine-rituximab (BR) first line treatment of Waldenstron’s Macroglobulinemia (WM). Enrollment is to include 59 participants from 9-10 sites with WM who are symptomatic, or have hematological or biochemical compromise related to WM. Primary outcome is looking at the combined complete response and very good partial response rates of BR with acalabrutinib in patients with WM in the first 18 months of treatment.
ClinicalTrials.gov (NCT#)
NCT04624906
Trial email
brawm@sunnybrook.ca
Trial Locations
Toronto, Ontario
Hamilton, Ontario
Ottawa, Ontario
Montreal, Quebec
Quebec, Quebec
Calgary, Alberta
Edmonton, Alberta
Halifax, Nova Scotia
Vancouver, British Columbia
CLIMB-LMD
CLIMB-LMD - Tucatinib, Trastuzumab and Capecitabine with brain and/or spinal radiotherapy (XRT) in patients with HER2+ metastatic breast cancer and leptomeningeal disease: A multi-centre phase II, single arm feasibility study.
Principal investigator
Dr. Katarzyna Jerzak, Sunnybrook Health Sciences Centre
Recruitment Status
Recruiting
Summary
The CLIMB-LMD trial is A multi-center phase II, single arm, open-label feasibility study with a safety run-in of 6 subjects. A total of 30 participants will be enrolled in the trial from approximately 10 centers across Canada. The primary outcome is to assess the overall survival (OS) from the start of XRT.
Trial email
CLIMB-LMD@sunnybrook.ca
PERIOP-06
PERIOP-06 - A Phase II Study of Perioperative QBECO Site Specific Immunomodulator (Qu Biologics®) in Patients with Metastatic Colorectal Adenocarcinoma within the Liver Undergoing Resection
Principal investigator
Dr. Paul Karanicolas: Sunnybrook Health Science Centre
Dr Rebecca Auer: The Ottawa Hospital Research Institute
Recruitment Status
Recruiting
Summary
PERIOP-06 is a multicenter, phase II, blinded, randomized, placebo-controlled trial in adult patients planned to undergo resection of colorectal liver metastases (CRLM) for complete clearance of all visible disease. The investigational product for the study is QBECO. QBECO is a site specific immunomodulator (SSI) designed to promote innate immune responses in the gastrointestinal tract and related organs, including the liver. This trial is motivated by the promising preclinical and clinical data supporting the safety and efficacy of QBECO in attenuating postoperative immunosuppression and the resulting proliferation of cancer.
The primary objective of this randomized controlled trial is to determine if QBECO administered perioperatively can improve 2-year Progression-Free Survival in adult patients undergoing resection of CRLMs for complete clearance of metastatic disease. The main secondary objectives will be to:
- Determine the effect of QBECO on the frequency and kinetics of clearance (and recurrence) of circulating tumor DNA (ctDNA) in the postoperative period and further evaluate the use ctDNA as part of ongoing surveillance.
- Determine the side-effect profile of perioperative QBECO
- Determine the effect of QBECO on 5-year overall survival
Approximately 115 participants will be randomized to receive a placebo or the investigational product, QBECO. QBECO or placebo will be administered according to the following regimen: 0.1mL subcutaneous injections every two days for 11-120 days preoperatively, and 41 days postoperatively. Participants will be followed for 5 years after surgery.
ClinicalTrials.gov (NCT#)
NCT05677113
Trial email
PERIOP-06@sunnybrook.ca
Trial Locations
Toronto; Ottawa; Kingston; Hamilton; London
SPiReL
SPiReL - Phase 2 Study of an Immune Therapy, DPX-Survivac (maveropepimut-S (MVP-S)) with Low Dose Cyclophosphamide administered with Pembrolizumab in Patients with persistent or recurrent/refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Principal investigators
Dr. Neil L. Berinstein, Sunnybrook Health Sciences Centre
Recruitment Status
Recruitment completed
Summary
SPiReL was a Phase 2, non-randomized, open-label, uncontrolled, efficacy and safety trial in patients with relapsed/refractory DLBLC. 25 participants were enrolled.
Participants received two 0.5 mL priming injections of DPX-Survivac (MVP-S) three weeks apart and up to six 0.1mL maintenance injections, subcutaneously over the course of the study. Participants received metronomic oral cyclophosphamide (50mg BID; 7 days on / 7 days off) for study period. Pembrolizumab 200mg was administered intravenously every three weeks.
Clinical efficacy was evaluated using the Modified Cheson Criteria and measurements of changes in tumour volume from baseline CT scans.
ClinicalTrials.gov (NCT#)
NCT03349450
Trial email
SPiReL@sunnybrook.ca
Trial Locations
Toronto, ON; London ON, Ottawa, ON; Calgary AB; Montreal, QC; Halifax, NS
Completed Projects
MOCHA
MOCHA - A Multi-Centre, Open-Label Phase 2 Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma
Principal investigator
Dr. Yoo-Joung Ko, Unity Health Toronto (SMH)
Summary
This is a multi-centre, open-label, single arm phase 2 study. The primary outcome is to assess the efficacy of Trifluridine/tipiracil (FTD/TPI), in patients with advanced cholangiocarcinoma as measured by median progression-free survival (PFS).
This study will enroll a total of 47 patients over a 12-month period, according to a two stage enrollment design. Nine patients will be enrolled during the first stage and the trial will be terminated if 4 or more out of the 9 have disease progression. If the trial goes on to the second stage, a total of 47 patients (38 in second stage) will be required.
FTD/TPI at 35 mg/m2 (based on BSA) will be administered in tablet form, orally, twice daily, within one hour of morning and evening meals, on days 1-5 and days 8-12 of a 28 day cycle.
Patients will be seen prior to enrolment (within 28 days of treatment), every 4 weeks while on treatment, at the end of treatment, and 30 days post-treatment. Patients will remain on long-term follow-up and will be seen every 12 weeks (+/- 14 days) until 1 year post-treatment when they will enter into the survival follow-up period and will be contacted every 12 weeks by phone until progression or toxicity.
ClinicalTrials.gov (NCT#)
NCT04076761
Trial email
MOCHA@sunnybrook.ca
Trial Locations
(Toronto, Ont, Canada)
