|This Phase III study will test whether adding an anti-PD1 antibody, called PDR001, to the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib is better, worse or the same as just giving dabrafenib and trametinib.
This study will be open to participants who have advanced melanoma with an altered protein called BRAF V600. The melanoma is described as advanced when it cannot be removed by surgery or has spread other parts of the body. The participants won’t have received previous anti-cancer drug treatment for their advanced melanoma. The study will
consist of 3 parts:
Part 1: Safety run-in
6 to 18 participants: Part 1 will find the dose of PDR001 which can be given alongside dabrafenib and trametinib without causing unbearable side effects. This dose will be used for Parts 2 and 3 Part 2: Biomarker cohort 20 participants:
In part 2, all patients will be given PDR001+dabrafenib+trametinib. Biopsies (samples of the melanoma) and blood samples will be used to find out if dabrafenib and trametinib are helping immune cells to reach the cancer and increasing the ability of PDR001 to kill the melanoma.
Part 3: Randomised, double-blind, placebo-controlled part 500 participants: 250 participants will receive PDR001+dabrafenib+trametinib and another 250 will receive dabrafenib+trametinib.
This research is about measuring the impact of cancer and its treatment on patients and their informal caregivers (e.g. spouse, partner, family member, close friend). Having cancer can affect many aspects of life such as finances, work status and patients’ own caring roles with family or friends, which are important to understand but are not well captured by existing measures.
In studies 1-3 of PROACT we developed and evaluated two questionnaires measuring impact on caregiving and other responsibilities and lifestyle disruption for patients and caregivers. We developed the questionnaires through qualitative interview studies and through collaboration with advisors with lived experience of cancer or caring for someone with cancer. We then conducted some research to determine the reliability and validity of the new measures.
These comparisons are important to ensure that when health care professionals and researchers use our questionnaires, they can be confident that they are measuring wellbeing and impact with a reliable measure. Both
questionnaires performed well in this initial evaluation. In this fourth study we wish to repeat the evaluation with a new group of patients and caregivers. We will expand our inclusion criteria to include different types and stages of cancer. We will use the same methodology as study 3 and invite participants to complete the new PROACT measures three times over two months, along with other quality of life questionnaires at two of these time points. This enables us to see how our new measures perform over time; whether they are reliable if completed twice close together and whether they are able to detect change in wellbeing if completed two months apart in participants whose situations are changing. This next stage in validation is essential to ensure that the questionnaires are suitable for use in future research and practice across different types of cancer.