ANNOUNCEMENT - CCI IIT Regional Funding Review Committee Recipients Fall 2018

19 March 2019

Dear Colleagues:

The CCI Clinical Trials Unit mission statement is "To initiate and conduct interventional clinical trials that improve the lives of current and future cancer patients"

Clinical trials advance the standard of care and provide access to better treatments for every patient that comes to the Cross Cancer Institute. Centres that conduct clinical trials "raise the bar" by adopting best processes and state-of-the-art multidisciplinary care. This competition provides an opportunity to support local, potentially practice-changing, investigator initiated trials (IITs).

I would like to thank each and every applicant for submitting their proposals and I am pleased to announce the three recipients of the Alberta Cancer Foundation, CCI Investigator Initiated Trials Fall 2018 competition. Please join us in congratulating the following recipients:

Dr. Kurian Joseph

Protocol: RT-Vertebroplasty - A Phase II Randomized Trial of Combined Radiotherapy and Vertebroplasty to Improve the Quality of Life of Patients with Painful Metastatic Localized Spinal Lesions.

The primary objective is to prospectively evaluate the efficacy of combing Vertebroplasty and External Beam Radiotherapy (EBRT) compared to EBRT alone in reducing pain and improve QOL in patients with localized spinal vertebral metastases.

Dr. Hatim Karachiwala

Protocol: Nivo Plus - A Study to Evaluate the Safety and Feasibility of the Combined Use of Nivolumab with Pemetrexed for the Treatment of Advanced Squamous Cell Carcinoma of the Head and Neck.

The primary objective of this clinical trial is to determine the feasibility of combination cytotoxic chemotherapy/anti-PD-1 immunotherapy for patients with SCCHN, who have either progressed on first-line platinum based chemotherapy or are ineligible/intolerant of platinum-based chemotherapy.

A co-primary objective of this clinical trial is to investigate and establish the safety of combining pemetrexed with nivolumab. It is anticipated that the results of this analysis may potentially be applicable to subsequent research studies in a variety of tumor types where single agent immunotherapy may be the standard of care.

Dr. John Walker

Protocol: IMPACT: Immune-Mediated Pathophysiology And Clinical Triage Program

Prophylactic Oral Mesalamine for the Prevention of Immune-related Colitis in Patients Treated with Ipilimumab/Nivolumab

The primary object is to determine the incidence of treatment-related diarrhea in patients receiving ipi/nivo concurrent with mesalamine in comparison with patients receiving ipi/nivo with placebo. The PI proposes to utilize mesalamine as a prophylactic therapy for patients eligible for standard of care ipilimumab nivolumab. The team further proposes novel correlative studies, including an investigation of immune therapy -driven alterations to gut permeability, as well as an exploration of the role of the gut microbiome in the development of immune-related toxicities, both gastrointestinal and non-gastrointestinal.


The next competition submission due date is April 1, 2019.

Thank you for making a difference.

Don Morrish

Chair, CCI IIT Regional Funding Review Committee