Background Currently, immunotherapy is a very active area of oncology research. It is a treatment that uses the body’s own natural defences to kill cancer cells. New immunotherapy drugs are showing significant and extended effectiveness, but they are complex and, to date, most are available only through clinical trials (CT).

Purpose To analyse the evolution of immuno-oncology clinical trials (IOCT) developed in the oncology unit over 5 years (2012–2016) and to evaluate the principal characteristics of currently ongoing IOCT.

Material and methods A retrospective analysis of IOCT over 5 years and a descriptive, transversal study about active IOCT were conducted. Variables collected were: study phase, experimental drug, type of experimental therapy (monotherapy, combination with chemotherapy or others), indication, cancer stage, treatment line (firstline, secondline, thirdline or maintenance) and number of patients included. Data were extracted from electronic clinical trials database (PK-ensayos).

Results IOCT have increased nearly 10 times in past 5 years, from 3.3% of the total active oncology CT in 2012 (1/30) to 31.6% in 2016 (12/38). Number of patients included has also increased, from 1 in 2012 to 45 patients currently. Ongoing IOCT (n=12) are for treatment of solid tumours: 75% lung cancer, 16.7% head and neck, and 8.3% colorectal cancer. Cancer stage: 75% stage IV, 25% stage I–III. 50% are evaluating anti-PDL1 (nivolumab, pembrolizumab), 41.6% anti-PD1 (atezolizumab, durvalumab) and 8.3% anti-CTLA4 antibodies (tremelimumab). 66% are using monotherapy, 25% combined with chemotherapy and 8.3% combining two immune checkpoint inhibitors. All studies are phase II and III (25% and 75%). In relation to treatment line: 50%, 16.6%, 16.6% and 25% are being checked for first, second, third and maintenance line, respectively.

Conclusion The rapid progress of cancer immunology has produced a high increase in IOCT. In our hospital, most of ongoing clinical trials are evaluating immune checkpoint inhibitors in monotherapy for advanced lung cancer. CT are critical in bringing new and potentially effective treatments to more patients, and may represent the greatest hope for patients currently facing the disease.

No conflict of interest