PRIME-ROSE clinical trials target refractory cancer patients who have an advanced malignancy and are progressing on standard treatment, but with sufficient quality of health to anticipate benefit from another line of treatment. The DRUP-like clinical trial protocols contain few inclusion and exclusion criteria to ensure high patient participation and generation of data that reflects a real-world setting. Furthermore, primary and most secondary endpoints are aligned between the different national DLCTs.
Analysis of the cancer types represented in PCM trials show that although the large tumour groups are the most common, a significant number of rare cancers as well as cancers of unknown origin (CUP, cancer of unknown primary) are also included in these trials. This demonstrates that these trials provide treatment options for patients with high unmet needs, irrespective of the frequency of their cancer type and that the pan-cancer design of the DLCTs is an ideal approach to combine access to new therapies while systematically generating evidence to refine decision-making at all levels. European collaboration will scale up access to the trials, speed up development as well as increase the body of evidence and economic validity.
Overview of current ongoing national DRUP-like clinical trials in PRIME-ROSE:
DRUP, The Netherlands
FOCUSE (former MEGALiT), Sweden
megaMOST, MOSTplus, France
Planned national DRUP-like clinical trials in PRIME-ROSE