The Cancer Clinical Trials Section (CCTS), through its close association with the Imperial Clinical Trials Unit, Imperial Experimental Cancer Medicine Centre and Cancer Research UK Imperial Centre provides a core accredited environment to develop and conduct cancer clinical trials led from Imperial College. With a major focus on precision medicine and proof of concept clinical trials, the Cancer Clinical Trials currently undertakes studies in the phase Ib to phase III space across multiple sites of disease.  The cancer trial portfolio exploits the research expertise in our Department to enable trials that include new and exciting imaging modalities, translational research initiatives and innovative study designs as they evolve.

What we do

The CCTS provides a comprehensive service to support potential clinical principal investigators in the process of clinical trial development from concept to trial design, robust peer review, to synopsis and protocol, as well as statistical support, trials, costings, application preparation then submission and subsequently successful trial set-up. 

The CCTS has successfully developed and run multinational breast cancer trials through the International Collaborative Cancer Group (ICCG) for over 25 years under the leadership of Professor Charles Coombes. The CCTS, now led by Professor Michael Seckl, has more recently expanded to undertake clinical research in all phases of drug and device development. This includes ovary, cervical pre-cancer and cancer of unknown primary, as well as exciting new imaging and translational research initiatives.

The CCTS forms part of the Imperial Clinical Trials Unit (ICTU) – Section on Cancer (ICTU-Ca). Cancer is just one of several therapeutic areas including cardiovascular and metabolic disease, respiratory, HIV / infectious diseases, surgery and emergency and critical care. These disciplines all come together under the overarching, UKCRC registered ICTU.

Organisation of our team

Our team includes operations managers, statisticians, clinical trial coordinators, monitors, and administrators who advise upon, manage, co-ordinate and run clinical trials to the highest quality and scientific standards. They are supported by academics via the Oversight Committee, which consists of senior academics within the Division of Cancer (see below).

Active trials:

• CUPem | Recruiting | A Phase II; Two-Stage Trial of Pembrolizumab in Cancer of Unknown Primary 
• CURESPONSE | Recruiting | Prediction of Patient Drug Response Using an Ex Vivo Organ Culture (EVOC) on fresh tumour samples from Metastatic Patients
• DICE | Follow-up | An international multi-centre, randomised phase II study to assess the efficacy of TAK228 in combination with intravenous weekly paclitaxel compared with weekly paclitaxel alone in women with advanced/recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (of clear cell, endometrioid and high grade serous type, and carcinosarcoma)
• EBLIS | Follow-up | A study to identify biomarkers which offer a lead interval between predicted relapse and overt disease in post-operative, post-treatment breast cancer patients.
• MICROBIOME | Recruiting | A first in human, phase 1 safety study in two parts to determine the safety, tolerability and anti-cancer immuno-modulatory effects of MRx0518 in patients with solid tumours awaiting surgical removal of the tumour. 
• NOVEL | Follow-up | Nonavalent prophylactic HPV vaccine (GARDASIL9) after local conservative treatment for cervical intra-epithelial neoplasia: a randomised controlled trial.
• REFINE-Lung | Active | A phase III trial of reduced frequency pembrolizumab immunotherapy for first-line treatment of patients with advanced non-small cell lung cancer (NSCLC)

Closed trials:

• ALERT | Closed | A phase II study of alternating eribulin and hormonal therapy in pre-treated ER+ positive breast cancer.
• BSMS | Closed | A study to help improve how doctors look for and monitor breast cancer
• IRIS | Closed | A phase II study to assess the safety and efficacy of the steroid sulfatase inhibitor Irosustat, in combination with aromatase inhibition, in ER positive locally advanced or metastatic breast cancer patients.
• IPET | Closed | A phase II window study to access the efficacy of a novel steroid sulfatase inhibitor: Irosustat in postmenopausal women with ER+ve early untreated breast cancer.
• MALIBO | Closed | Development and application of MAchine Learning In whole Body MRI with diffusion weighted imaging in the staging Oncology patients.
• MROC | Closed | Multiparametric MRI and CT in staging and treatment planning for women with ovarian cancer.
• REACT | Closed | A phase III multicentre double blind trial of Celecoxib versus placebo, following chemotherapy in primary breast cancer patients.
• RADICAL  | Closed | A single arm phase IIa study (with combination safety run-in) to assess the safety and efficacy of AZD4547 in combination with either anastrozole or letrozole, in ER positive breast cancer patients, who have progressed on treatment with anastrozole or letrozole.
• SLNM | Closed | Near Infrared laparoscopy for intraoperative lymphatic mapping and sentinel node identification during standard surgical resection for early stage colonic neoplasia.