Clinical trials

The Imperial Clinical Trials Unit-Cancer (ICTU-Ca), led by  Professor Michael Seckl through its close association with the Imperial Clinical Trials Unit and Imperial Experimental Cancer Medicine Centre, provides a core accredited environment to develop and conduct world-class cancer clinical trials led by Imperial College. With a major focus on precision medicine and proof of concept clinical trials, the ICTU-Ca currently undertakes studies in the phase Ib to phase III space across multiple sites of disease, at both National and International levels.  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

ICTU-Ca 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, trial costings, application preparation then submission and subsequently successful trial set-up, co-ordination and close down of trials. 

ICTU-Ca forms part of the Imperial Clinical Trials Unit (ICTU). 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 ICTU-Ca Peer Oversight Committee, which consists of senior academics within the Division of Cancer (see below).

Active trials:

• Asp-PSC | Active | A phase III, double blinded trial using Aspirin and Placebo for PSC and IBD patients
• BEAT-Breast| Set up |A pilot nonrandomised single arm Phase 2 clinical trial in patients with primary breast cancer and brain metastases who are not suitable for stereotactic radiotherapy, embedded in a national needs analysis
• CUPem | Follow-up | 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)
• MAST | Active | Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant trial
• 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)
• RESOLVE | Active |  A feasibility window study of pembrolizumab prior to second evacuation for post-molar gestational trophoblastic neoplasia

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
• EBLIS |Closed| A study to identify biomarkers which offer a lead interval between predicted relapse and overt disease in post-operative, post-treatment breast cancer patients.
• 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.
• MICROBIOME | Closed | 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. 
• 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.