When cancer is rare, aggressive, and difficult to treat, standard therapies can be limited. Patients and clinicians grappling with this reality are left asking: what else might help?
Two new clinical trials now open in Nova Scotia are trying to answer that question. One is testing whether today’s standard of care treatment of chemotherapy and immunotherapy for advanced biliary tract cancer can be improved upon. The other is investigating the safety and feasibility of a new way to deliver radiation for patients with solid tumours whose disease has progressed despite standard treatment.
The trials sit on opposite ends of the cancer research pipeline and are led by Dr. Ravi Ramjeesingh, oncologist and medical director of the Atlantic Clinical Cancer Research Unit (ACCRU).
Investigating a new immunotherapy approach in biliary tract cancer
The first study is the ARTEMIDE Biliary 02 Phase III international clinical trial sponsored by AstraZeneca. Nova Scotia Health’s solid tumour team at ACCRU was the first site in the world to launch the study and enroll its first patient.
Biliary tract cancer is a rare but highly aggressive disease that develops in the gallbladder or bile ducts. These structures are small and not routinely screened, which means the disease is often diagnosed late.
“These cancers can be just as aggressive as pancreatic cancer,” said Dr. Ramjeesingh. “Treatments for these patients are limited, and that’s why we need to keep studying new approaches.”
Until recently, chemotherapy was the standard treatment for metastatic biliary tract cancer but previous clinical trials showed that combining it with immunotherapy can improve outcomes, and that led to a new standard of care.
This trial compares two first-line immunotherapy treatment approaches: the current standard drug and a newer investigational drug called rilvegostomig. Rilvegostomig is designed to block two immune pathways instead of one, which may reduce the cancer’s ability to bypass immune-based treatment.
“The question we’re asking is whether we can do better than what’s already offered,” said Dr. Ramjeesingh. “You don’t know if a new approach will work until you do these studies, and when it works, it can really change the outcome for a patient.”
Phase III trials involve large numbers of participants and are used to determine whether a treatment should become a new standard of care. As more Nova Scotians with advanced biliary tract cancer enroll in the study, they’ll be among the first in the world to access this treatment option as part of their care.
ACCRU, the Nova Scotia Health research operations team, and the Research Ethics Board activated this clinical trial in just three months, the fastest of 172 sites spanning 19 countries.
Exploring a new way to deliver radiation to solid tumours
The second study led by Dr. Ramjeesingh through ACCRU and the nuclear medicine division is a Phase I trial, also sponsored by AstraZeneca. Phase I trials are the earliest stage of human testing and focus on establishing safety.
“This is the first time ACCRU has run a Phase I trial on adult solid tumours in Nova Scotia,” said Dr. Ramjeesingh, adding that studies like this generate the early evidence needed to move promising new treatments forward.
The AstraZeneca trial will test an experimental cancer treatment that uses a radioactive medicine designed to find cancer cells and deliver radiation directly to the tumour. By targeting tumours more precisely, the approach aims to reduce radiation exposure to healthy tissue.
The study will examine safe dosing, potential side effects, and how the treatment behaves in the body. It will enroll volunteer patients with advanced solid tumours who’ve exhausted all standard treatment options. Eligible participants may include patients with cancers of the lung, colorectum, pancreas, stomach, kidney, and head and neck.
Research is care
“The treatments we use today exist because patients took part in clinical trials years ago,” said Dr. Ramjeesingh.
Participation in a trial is completely optional, but it’s a path he says several of his patients choose to take when established treatments have been unsuccessful.
“Our job as oncologists is to give patients their options (which sometimes includes a clinical trial), explain the risks and benefits, and let them decide what they want to do,” said Dr. Ramjeesingh.
For those who do take part, a clinical trial can represent both a personal choice in their own care and a contribution to what future patients may one day be offered.
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Clinical studies help translate research into potentially life-changing therapies that can help you, your friends and your loved ones. Want to know more about how to get involved? Visit NovaStudies Connect today: novastudiesconnect.ca
