Solid Tumours - Clinical Trial Programme

In collaboration with the Cancer Research UK Clinical Trials Unit (CRCTU) and the NIHR/Wellcome Trust Clinical Research Facility, we run an active clinical trial programme in solid tumours, featuring numerous NIHR Cancer Research Network-linked trials involving Birmingham-based Chief Investigators.

This involves close interaction with the CRCTU Early phase Drug Development team, and also with key members of the Wellcome Trust Clinical Research Facility facilities, which are based both at University Hospital Birmingham and Birmingham Children’s Hospital. This has enabled us to develop several National Cancer Research Institute-badged national trialsĀ  in Birmingham, in addition to a range of industry-led immunotherapy trials.

Details on some of the current clinical trials in which CIIC members are involved are outlined in the table below.

TRIAL/STUDY
THERAPEUTIC CONCEPT
FUNDER
INVESTIGATOR
LUNG CANCER
The National Lung Matrix TrialThe National Lung Matrix Trial: multi-drug, genetic-marker directed, non-comparative, multi-centre, multi-arm phase II trial in non-small cell lung cancer CRUKProfessor Gary Middleton
RUXSACA double-blind randomised placebo-controlled phase II study of pemetrexed and cisplatin with and without ruxolitinib in pleural mesotheliomaNIHR/EMEProfessor Gary Middleton
TORCMEKA phase I trial of AZD2014 and Selumetinib in non-small cell lung cancerAstraZeneca/CRUKProfessor Gary Middleton/Peter Scmidt Co-CI's
TIMEA phase III trial of the MUC1 vaccine TG4010 together with chemotherapy in non-small cell lung cancerTRANSGENEProf Elisabeth Quoix (Intnl lead); Local PI Professor Gary Middleton
PePS2A phase II trial of MK-3475 in patients with non-small cell lung cancer with a performance status of 2Merck Sharp and DohmeUK CI Professor Gary Middleton
STOMPA randomised phase II trial of maintenance olaparib in small cell lung cancerCRUKProf Penella Woll (Natnl lead); Local PI Professor Gary Middleton
COLORECTAL CANCER
FOCUS4AA placebo-controlled randomised trial of dabrafenib/trametenib and panitumumab in patients with BRAF mutant colorectal cancer (BRAF arm of FOCUS-4: Molecular selection of therapy in colorectal cancer)NIHR/EME/CRUKProfessor Gary Middleton (Prof Tim Maugham overall CI for FOCUS4)
MEK116833An open label, phase I/II study consisting of three parts to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of the MEK inhibitor trametinib, BRAF inhibitor dabrafenib and the anti-EGFR antibody Panitumumab in combination with patients with BRAF-mutation V600E or positive colorectal cancer (precedes FOCUS4A)GSKUK CI Professor Gary Middleton
FOxTROTFOxTROT - Fluoropyrimidine, Oxaliplatin & Targeted Receptor pre-Operative Therapy for colon cancer. A randomised trial assessing whether preoperative chemotherapy and/or an anti-EGFR monoclonal antibody improves outcome in high-risk operable colon cancer.CRUKProfessor Dion Morton
HEAD AND NECK CANCER
De-ESCALaTE-HPVDe-ESCALaTE HPV - De-ESCALaTE HPV: Determination of Epidermal growth factor receptor-inhibitor (cetuximab) versus Standard Chemotherapy (cisplatin) early And Late Toxicity Events in Human Papillomavirus-positive oropharyngeal squamous cell carcinomaCRUKProfessor Hisham Mehanna
COMPARECompare - Comparing Alternative Regimens for Escalating treatment of higher-risk oropharyngeal cancerCRUKProfessor Hisham Mehanna
RAPPERRapper - Radiogenomics: assessment of polymorphisms for predicting the effects of radiotherapyCRUKDr Catherine West; Local PI Professor Hisham Mehanna
MOREXMorEx - Exploratory study of MTL-005 Radiosensitizaion in patients with advanced H&N cancer to evaluate safety in a dose excalation design in patients indicated for palliative radiotherapyMOREX DEVELOPMENT PARTNERS LLPDr Stefano Schipani ; Local PI Professor Hisham Mehanna
Head and Neck 5000Head & Neck 5000 - Evaluation of centralisation in head and neck cancerNIHR RfPBProf Andy Ness; Local PI Professor Hisham Mehanna
PACiFiCPacific - a trial of Atu027 in combination with Cisplatin, 5-FU and cetuximab in patients with H&N cancerSilence TherapeuticsProfessor Hisham Mehanna
ImmunGenImmuGen - Immunology and genomics of oropharyngeal cancerUoB UKProfessor Hisham Mehanna
MVAEBNA1/LMP2A Phase Ib trial of MVAEBNA1/LMP2 vaccine in nasopharyngeal carcinoma - A Cancer Research UK Phase Ib trial to determine the safety, immunogenicity and tolerability of extended schedule vaccination with MVAEBNA1/LMP2 in patients with Epstein Barr Virus (EBV) positive nasopharyngeal carcinoma.CRUKDr Neil Steven
SKIN CANCER
IMCgp100A Phase 1, Open label, Dose Finding Study to Assess the Safety and Tolerability of IMCgp100, a Monoclonal T Cell Receptor anti-CD3 scFv Fusion Protein in Patients with Advanced Malignant MelanomaImmunocore Dr Neil Steven
UKMCC01A Phase II Study of Pazopanib in Metastatic Merkel Cell Carcinoma. CRUK/GSKNational lead Dr Paul Nathan, Translational lead and lcoal PI, Dr Neil Steven
SPOTSquamous cell carcinoma Prevention in Organ Transplant recipients using topical treatments: a feasibility studyNIHRLead Prof Catherine Harwood (Queen Mary University of London; trial manager Dr Sarah Bowden (CRCTU)
SCARTPhase I/II study of oral MEK inhibitor Selumetinib (AZD6244 Hyd-Sulphate) in Combination with Highly Active Anti-Retroviral Therapy (HAART) in AIDS-associated Kaposi's sarcoma (KS). AstraZeneca/CRUKChief Investigator Professor Penella Woll. Local PI Prof Lucinda Billingham
LIVER CANCER
IMMUNOTACEIMMUNOTACE - A randomised phase II clinical trial of conditioning cyclophosphamide and chemoembolisation with or without vaccination with dendritic Cells pulsed with HepG2 lysate in vivo in patients with Hepatocellular CarcinomaCRUKProfessor David Adams