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Specialty: Oral and Gastrointestinal (Colorectal) 

CPMS No: 42483

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Description: Bowel cancer is the second commonest cause of cancer death in the UK with 16000 people dying per year. Although the NHS Bowel Cancer Screening Programme (BCSP) detects cancers at an earlier stage only 10% of all cancers are detected through screening.

Currently, the only criteria for screening is age and no account is taken of other known risk factors such as smoking, alcohol, family history or obesity. Stool FIT (a new stool test which detects blood that can’t be seen with the naked eye) will be introduced into the English BCSP, but there is poor evidence for its use in patients presenting with symptoms. There are emerging data that there may be differences in the gut bacteria of people with and without cancer or pre cancerous bowel polyps (adenomas).

This will be a national multi-centre study over 5-years. 10000 Patients undergoing colonoscopy as part of BCSP or due to symptoms will be recruited. They will be asked to fill in a health questionnaire, have their height, weight, waist circumference measured. They will also receive blood tests, stool tests or saliva tests depending on the indication for their colonoscopy. The results of the colonoscopy and any samples taken will be collated. Patients will receive a patient experience questionnaire or food frequency questionnaire. 10000 patients from the North of England will also be consented to be contacted for future studies with some of the information above collected.

Our aim is to develop a risk model to help determine which patients are at highest risk of having adenomas or bowel cancer. We will also explore the significance of the gut bacteria composition in patients with adenomas or cancer to help inform this risk model. Additionally we will develop a large platform of patients who consent to be contacted for future research. 

CPMS No: 60707

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DOMENICA (GINECO-EN105b/ENGOT-en13 study) Randomized phase III trial in MMR deficient endometrial cancer patients comparing chemotherapy alone versus Dostarlimab in first line advanced/metastatic setting.

Summary:

The DOMENICA study aims to evaluate the effectiveness of dostarlimab, as a new treatment for advanced/metastatic endometrial cancer by significantly reducing the chance of relapse. Dostarlimab is a type of immunotherapy (doesn’t target the tumour directly, but has an impact on the immune system to be able to attack and destroy the cancer cells). When the immune system detects a foreign body (virus, bacteria, etc), it produces antibodies which are proteins that combat infections. They can attach to other molecules or cells of your body, and work by helping your immune system to fight the cancer. The current standard treatment for this cancer is chemotherapy alone (Paclitaxel and Carboplatin). Despite chemotherapy, the cancer can progress in some patients. The study will be carried out among 142 patients with advanced or metastatic endometrial cancer, in more than 60 healthcare facilities in 7 countries (France, Belgium, Spain, Italy, Germany, Canada and United Kingdom) over an 8 year period. In order to evaluate the efficacy of dostarlimab, it is necessary to compare this treatment to the standard treatment. In order to be able to make comparisons, it is necessary that the distribution between the 2 groups is randomly selected by a computer (this is called randomization). There will be the same number of patients in each treatment group therefore patients have 1 possibility out of 2 to receive dostarlimab. The duration of participation in this research study for each patient is around 5 years. Participation will be divided into 5 periods: • Collection of a tumour sample (standard of care, not an extra procedure), • Ensuring the criteria for inclusion is met, • Allocation of treatment, • Treatment period, • Follow up period. Participants will have the right to withdraw at any point and treatment will not be compromised. If successful this study could help patients get quicker access to the therapeutic innovation, especially immunotherapy.

SIV: End of April

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CPMS No: 40167 

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Description: A Phase 1b/2 Study of BXCL701, a Small Molecule Inhibitor of Dipeptidyl Peptidases (DPP), Administered in Combination with the Anti-Programmed Cell Death 1 (PD 1) Monoclonal Antibody Pembrolizumab (PEMBRO; Keytruda®) in Patients with Small Cell Neuroendocrine Prostate Cancer (SCNC; NEPC)