The biopharmaceutical company Bristol Myers-Squibb (BMS) is behind the trial. The purpose of the clinical trial is to test a combination of two different immunotherapies: Nivolumab, which is a PD-1 immune checkpoint inhibitor, and another antibody that is not yet on the market.
“The trial combines second and third generation immunotherapy for patients for whom the available treatments have not been effective. It’s too early to draw any conclusions about the effect, but we now have several patients who started treatment two years ago and who are still alive and whose cancer is kept under control. Many of them have been in full-time work throughout the trial, while others have experienced a number of side effects which we need to deal with,” says Marta Nyakas.
Nyakas is a senior consultant at the Norwegian Radium Hospital, an oncologist, and is responsible for the clinical trials on melanoma at the clinical trials unit.
Good collaboration with Oslo
The international trial, which started in 2013 and is set to run for several more years, has enrolled 1,500 patients, and 1,100 patients have already received treatment. This is according to Åsa Schääfof BMS, who is Senior Clinical Site Manager for the Nordic trial and based in Sweden.
“Enrolment in this trial has been very good in the Nordic countries, including Norway. We have collaborated with Marta Nyakas for many years and know that she is good at enrolling melanoma patients, and this trial was no exception. This is very much why Oslo is the preferred partner for us in Norway,” says Schääf.
To the question of how Nyakas and colleagues recruit their patients, the senior consultant answers:
“The recruitment comes because of our weekly multidisciplinary team meetings here at the hospital, where we go through all referred patients and check whether any of them are suitable candidates for our ongoing trials. I also distribute an email with information about ongoing trials to all the hospitals in the South-Eastern Norway health region. I attend many meetings with other professionals where colleagues from across the country ask me about trials, and I also receive calls from various local hospitals,” says Nyakas.
Originally, the trial was only intended to include about a dozen Norwegians, but since interest has been so great, Oslo has continued its recruitment and the trial remains open to new patients.
Filling a gap
Nyakas is very pleased with the good recruitment and that so many patients have been able to take part in the trial.
“As I see it, this trial is filling a gap in the treatment offered. Standard treatment has not been effective for the patients in the trial, and they have no other alternative,” says Nyakas.
She finds it exciting to see how research on melanoma in recent years has been driven by immunotherapy, and how these breakthroughs have spread to other forms of cancer, such as lung cancer and kidney cancer.
“Melanoma is a very difficult indication, and we want to find a treatment that can change it from a fatal to a chronic illness,” says Schääf.
Nyakas confirms that several of the patients have lived good lives for two years while on the treatment.
“It will be very exciting to follow these patients. They still have cancer, but it is stable, so they can be considered patients with a chronic illness,” says Nyakas.
The clinical trials unit was established in 1995 and is Norway’s leading centre for experimental cancer treatment.
The unit conducts phase I and II clinical trials in cooperation with cancer researchers from Oslo University Hospital and the pharmaceutical industry. We are one of very few centres in the Nordic countries that has expertise and experience in testing new cancer treatments, such as different forms of immunotherapy. The unit accepts patients from all over Norway and collaborates with leading cancer centres in the Nordic countries (Nordic NECT), Europe and the USA.