Today’s Clinical Trials are Tomorrow’s Standards of Care
Clinical trials matter!
Today's cancer treatments were first developed from clinical trials. Participating in a clinical trial can bring you many benefits, like accessing new drugs and treatments still in the research stage. Participating in a clinical trial can also help advance science and the future of healthcare, helping others and improving cancer treatments.
Cambridge Memorial Hospital has supported our Oncology Department’s participation in clinical trials over the past 25 years. We are proud to have been a top enrolling Canadian site for the Novartis Bolero 1 Breast cancer study, second top enrolling Canadian site for the BNIT Prostvac Metastatic Prostate Cancer study and Provincial Applicant for the CLEE011A2207 Breast Cancer study.
“Our cancer clinical trials program makes cutting edge therapeutics and promising novel combinations available to patients closer to home,” says Dr. Anupam Batra, Medical Oncologist and Head of Clinical Trials at Cambridge Memorial Hospital. “We partner with the Canadian Cancer Trials Group (CCTG), Canadian Cancer Clinical Trials Network (3CTN), Juravinski Cancer Center (JCC) as a Network Associated Cancer Center (NACC) and numerous industry sponsors to improve delivery of care to cancer patients in our region.”
Enrolling in Clinical Trials
If you are interested in a clinical trial or if your team feels there is a trial that may be right for you, we will arrange an appointment with one of the researchers conducting the trial with your permission.
Sometimes your oncologist may also be the doctor in charge of the trial. You may also meet with a Clinical Trial Research Nurse (CTRN) or Clinical Research Associate (CRA) at one of your scheduled appointments.
Someone from the research team will review the clinical trial with you and answer any questions. They will also review the informed consent form with you. You do not have to agree to participate right away or at all. Please take as much time as you need to think about your decision and discuss your thoughts with others. Another appointment may be booked to talk about the trial further.
If you choose to participate, there are several steps to taking part in clinical trial which will be discussed with you. Our dedicated team will help you through these steps and will become your main contact throughout the trial. You do not have to stay in a trial if you do not wish to.
CMH Clinical Trials
|Clinical Trial Name||Clinical Trial Full Title||Principal Investigator||Project Site Status||Clinical trials gov number|
|(Novartis)CNIS793E12201||daNIS-3: An open-label, multi-center, phase II platform study evaluating the efficiancy and safety of NIS793 and other new investigational drug combinations with standard of care(SOC) anti-cancer therapy for the second line treatment of metastatic colorectal cancer(mCRC)||Dr. Anupam Batra||Site in Set up||NCT04952753||(Novartis)CNIS793B12301||daNIS-2: A randomized, double-blind, phase III study comparing NIS793 in combination with gemcitibine and nab-paclitaxel versus placebo combined with gemcitabine and nab-paclitaxel for first line treatment of metastatic pancreatic ductal adenocarcinoma(mPDAC)||Dr. Anupam Batra||Site in Set up||NCT04935359||(CCTG)CRC.9/NRG-GI005 Study||Phase II/III Study of Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Stage IIA Colon Cancer(COBRA)||Dr. Anupam Batra||Open to Recruitment||NCT04068103|
|(CCTG)GCC.1/SWOG S1823||A Prospective observational Cohort Study to Assess miRNA 371 for Outcome prediction in Patients with Newly Diagnosed Germ Cell Tumours||Dr. Anupam Batra||Open to recruitment||NCT04435756|
|(CCTG)CO.29/DYNAMIC III||Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomized Controlled Study(Dynamic-III)||Dr. Anupam Batra||Open to recruitment|
|(CCTG)BR.34||Randomized Trial of Durvalumab and Tremelimumab +- Platinum-Based Chemotherapy in Patients with Metastatic(Stage IV) Squamous or Non-Squamous Non-Small cell Lung Cancer (NCLSC)||Dr. Anupam Batra||Closed to Accrual||NCT03057106|
|(NCIC CTG) PR.17||Randomized Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET||Dr. Anupam Batra||Closed to Accrual||NCT02446405|
|(Novartis)CLEE011A2207||A phase II, multicenter, randomized, open-label study to evaluate the safety and efficacy of 400mg of ribociclib in combination with non-steroidal aromatase inhibitors for the treatment of pre and postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer who received no prior therapy for advanced disease||Dr. Anupam Batra||Closed to Accrual||NCT03822468|
|(Novartis) Non-Interventional Study: Treat ER+ Right||Treatment of Canadian Men and Pre/Post Menopausal Women with ER+ Advanced Breast Cancer in the Real-World Setting with Hormone Therapy +- Targeted Therapy||Dr. Helen Lin||Closed to Accrual||NCT02753686|
|(CCTG)MAC.20/Alliance A011401/BWEL Study||Randomized Phase III Trial Evalutating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women With Early Breast Cancer||Dr. Anupam Batra||Closed to Recruitment||NCT02750826|
|(CCTG)MAC.21/Alliance A011502 Study||Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial||Dr. Anupam Batra||Closed to Recruitment||NCT02927249|
|(SANOFI)ACT16105||An open-label randomized Phase 2 trial of SAR439859, versus endocrine monotherapy as per physician's choice in premenopausal and postmenopausal patients with estrogen receptor positive,, HER2-negative locally advanced or metastatic breast cancer with prior exposure to hormonal therapies||Dr. Helen Lin||Closed||NCT04059484|
Informed consent includes discussing, reading, and understanding the clinical trial. You must sign an informed consent form in order to participate in trial.
Informed consent includes talking about why the trial is being done, who is involved, how long the trial will be, how many patients will be involved, risks and benefits, your legal rights, what you can expect from the trial (screening, tests, your appointments, possible side effects, follow-ups, costs), how the information is collected, how we will protect your privacy, and how you will receive updates about the trial.
By signing the informed consent form, you indicate that you understand all of the information you have been given. You can change your mind at any time for any reason. A copy of the signed consent form is given to you to keep. Once you sign the informed consent form, you will be screened to see if you are eligible for the trial.
Informed consent is a constant process. You are encouraged to ask questions and whenever new information about the clinical trial is known we will share it with you.
It is common that the consent form updates occur throughout a study. If there is a consent update while you are participating in a clinical trial, you will be presented with this updated information to review
Many clinical trials include the collection of blood and tissue samples for medical research. These are called biospecimens. Medical researchers use your samples along with samples from thousands of other patients to look for ways to prevent, find, or treat health problems like cancer, diabetes, heart disease. Many people find comfort knowing that by donating samples, they will help researchers make discoveries that can advance medicine and improve the treatment of others in their community. These samples are usually stored within Canada or the USA. To protect your privacy, your samples will be coded with a random number instead of your name and any identifiers will be removed before the sample is sent to the biobank research facility. Federal law requires the protection of your private medical information.
Every trial has eligibility criteria which determines who can and cannot participate in a trial. This is to protect your safety. You may be asked to undergo certain tests, procedures, or blood work to determine if this trial is right for you.
Treatment and Interventions
Your research team will follow strict rules outlined in the clinical trial protocol when giving the trial treatments or interventions. There are many types of clinical trials.
In clinical trials that use an intervention, such as testing different cancer scanning techniques, the goal is usually to prevent cancer, detect cancer earlier, or improve symptoms. Other clinical trials may test different treatments. The goal of treatment is to get rid of, stop, slow, or reduce the growth of your cancer.
In treatment trials, your research team will watch you and your cancer closely to see if the treatment is working and to manage any side effects. In some trials, there is a prescribed number or amount of treatment given; in others, you may stay on the treatment as long as it is benefitting you. If the treatment does not seem to be working for you, meaning your cancer is growing, the trial treatment will be stopped and other treatment options will be discussed with you.
Treatment can be stopped for various reasons, such as if your cancer does not respond to treatment, or you are having side effects that cannot be easily managed, or if it is no longer in your best interest to be on that particular treatment (such as if there’s a better treatment available for you). You can choose to stop participating in a trial at any time as well.
When the trial treatment or intervention is completed or stopped, you enter the follow-up stage of the clinical trial. You may be asked to complete tests, procedures, bloodwork, or assessments in order to measure the trial.
After you are finished in the trial, you may be asked for further tests or assessments. Follow-up may be done by appointment, over the phone, or even by looking at your medical records (which may not require any action on your part).
Once all patients have had their follow-up completed, the study results are analyzed.
Final Study Results
Most trials will look at their data during the study itself, called an “interim analysis”. This helps determine if the trial is working, and if so the trial will continue.
At the end of the trial, the final results are reviewed, analyzed, presented, and published. As a participant, you may also be given the results of the study. If the new treatment is proven safe and effective, further testing may occur or Health Canada may review and approve the treatment for wider use.
Clinical trials are constantly changing the standard of care to bring new and better treatments to the forefront.
All clinical trials need ethics approval. This is to protect the health, safety, and privacy of everyone who participates in the trial. Trials at Cambridge Memorial Hospital are approved by either our local regional Tri-Hospital Research Ethics Boards (THREB) or by the Ontario Clinical Trial Research Ethics Boards (OCREB).
We have been involved in Clinical Trials for over 25 years. Our top accomplishments include:
- Top enrolling Canadian Site for the Novartis AMALEE Breast Cancer Study
- Top enrolling Canadian site for the Novartis Bolero 1 Breast Cancer study
- Second top enrolling Canadian site for the BNIT Prostvac Metastatic Prostate Cancer study
Our Research Team
- Medical Head of Clinical Trials – Dr. Anupam Batra, Medical Oncologist
- Clinical Trial Research Nurses – Amanda Taylor, RN, Teresa Krajewski, RN
- Program Study Coordinator – Stephanie Evans
- Research Pharmacists
- Laboratory Technicians