Early Phase Cancer Division The various aspects of the CTRU early phase section.

The early phase cancer division is the newest division within the CTRU, and has grown extensively over the past seven years. The portfolio of trials includes phase I and II trials, as well as feasibility studies, in myeloma, radiotherapy, and systemic therapies. The early phase division hosts the Myeloma UK clinical trials coordinating office and the Yorkshire Cancer Research centre for early phase clinical trials. The trials are developed in collaboration with local and national Chief Investigators, and are supported by a wide range of funders (e.g. Myeloma UK, Yorkshire Cancer Research, Cancer Research UK, NIHR, and industry partners).

The early phase cancer division’s research priorities are to:

  • Expedite research into new cancer treatments in the areas highlighted, working with key stakeholders across portfolios (investigators, funders, patients, industry, NICE)
  • Efficiently provide a pipeline of treatments to our late phase portfolio,
  • Continue to build relationships with industry partners, to provide real-world, supportive data and to provide patients with earlier access to novel therapies
  • Focus on phase I and IIa trials of: systemic therapies; radiotherapy-novel agent combinations; novel approaches to drug delivery; novel radiation techniques
  • Develop innovative approaches to conducting phase I radiotherapy-systemic therapy combination studies, working with key stakeholders to influence national guidance
  • Develop and apply innovative and novel methodologies to the design and analysis of early phase trials
  • Continue to develop and mentor early career researchers to become the next generation of clinical leaders

Research Lead
Dr Sarah Brown, Associate Professor of Early Phase Trials in Cancer, Division Director

Disease areas

Haematological Malignancies

Multiple myeloma

Trial acronym Title Modality Status
MUKNine OPTIMUM: A randomised phase II, pilot study, comparing two different approaches to the induction treatment of high risk (HR) myeloma Systemic therapy Set-up
MUKEleven VIRel: Viral immunotherapy in Relapsed/Refractory Multiple Myeloma (MM) - A Phase I Study to Assess the Safety and Tolerability of Reovirus in Combination with Lenalidomide and Pomalidomide Systemic therapy Set-up
MUKSeven Pomalidomide Specific Targeting in Relapsed and Refractory Myeloma Systemic therapy Recruiting
MUKEight A randomised phase II trial of Cyclophosphamide and Dexamethasone in combination with Ixazomib, in relapsed or refractory multiple myeloma (RRMM) patients who have relapsed after treatment with thalidomide, lenalidomide and bortezomib Systemic therapy Recruiting
MUKFive A phase II randomised, controlled, parallel group, multi-centre trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) vs. cyclophosphamide, bortezomib and dexamethasone (CVD) for multiple myeloma patients at first relapse or refractory to no more than 1 line of treatment Systemic therapy Follow-up
Myeloma X A phase III study to determine the role of a second autologous stem cell transplant as consolidation therapy in patients with relapsed multiple myeloma following prior high-dose chemotherapy and autologous stem cell rescue Systemic therapy Closed
MUKOne A study to find the best starting dose of bendamustine, when given in combination with thalidomide and dexamethasone, in relapsed /refractory myeloma Systemic therapy Closed
MUKThree A Phase I/IIa, Dose-Escalation, Study of CHR-3996 in Combination with Tosedostat in Participants with Relapsed, Refractory Multiple Myeloma Systemic therapy Closed
MUKFour An open label, multi-centre, single arm, phase II trial to assess the activity, safety and tolerability of combination therapy with vorinostat, bortezomib and dexamethasone (V2D) in patients with relapsed multiple myeloma Systemic therapy Closed
MUKSix A Phase I/IIa trial of VTD-panobinostat treatment and panobinostat maintenance in relapsed and relapsed/refractory multiple myeloma patients Systemic therapy Closed

Chronic lymphocytic leukaemia

Solid tumours

Gastro-intestinal cancers (including colorectal, gastro-oesophageal & anal cancers)

Urological

Trial acronym  Title  Modality Status
Prism A randomised phase II trial of nivolumab in combination with alternatively scheduled ipilimumab in first-line treatment of patients with advanced or metastatic renal cell carcinoma Systemic therapy Set-up
BRAVO BRAVO: High grade Bladder cancer: A randomised controlled trial of Radical Cystectomy against intra-vesical immunotherapy – A feasibility study Systemic therapy / surgery  Recruiting
FIESTA FGFR Inhibition for Epithelial Solid Tumours: a Phase Ib trial of AZD4547 in combination with gemcitabine and cisplatin Systemic therapy Closed

Lung

Trial acronym  Title  Modality  Status
ABLE An Open Label Multi-Centre Preoperative Window of Opportunity Study of Afatinib in Stage Ia to IIb Non-Small Cell Lung Cancer Systemic therapy Closed
SABRTOOTH A study to determine the feasibility and acceptability of conducting a Phase III randomised controlled trial comparing stereotactic Ablative Radiotherapy (SABR) with surgery in paTients with peripheral Stage I nOn-small cell lung cancer (NSCLC) cOnsidered To be at Higher risk of complications from surgical resection. Radiotherapy  / surgery Follow-up
Paris A Phase I Study of Pembrolizumab anti PD-1 monoclonal antibody in combination with Radiotherapy in locally advanced Non-Small Cell Lung Cancer (NSCLC) Radiotherapy / systemic therapy Set-up

Melanoma

Brain

Trial acronym  Title  Modality  Status
ReoGlio A multicentre, single arm, phase I trial of reovirus/GMCSF in combination with standard of care in adult patients with newly diagnosed glioblastoma Systemic therapy Set-up

Others (including neuroendocrine cancers, thyroid cancer)

Trial acronym  Title  Modality  Status
CATALYST A phase Ib study of Carfilzomib Thalidomide Dexamethasone in relapsed AL amyloidosis Systemic therapy Set-up
AlphaCAP A randomised phase IB/IIA study of capecitabine plus radium-223 (Xofigo™) in metastatic breast cancer patients with bone metastases Systemic therapy Set-up
Selimetry Investigating the potential clinical benefit of selumetinib in resensitising advanced iodine refractory differentiated thyroid cancer to radioiodine therapy Systemic therapy Recruiting
CARBON A randomised phase IB/IIA study of CApecitabine plus Radium-223 (Xofigo™) in breast cancer patients with BONe metastases Systemic therapy Recruiting
CMML201 A phase II study of 5-azacitidine in chronic myelomonocytic leukaemia Systemic therapy Closed
AML - Len5 A pilot safety / tolerability study of Lenalidomide administered as monotherapy and in combination with standard chemotherapy for Acute Myeloid Leukaemia / high-risk Myelodysplastic Syndrome with structural abnormalities of chromosome 5 Systemic therapy Closed
JX594 A clinical study to evaluate the biological effects of pre-operative intravenous administration of JX-594 (thymidine kinase-deactivated Vaccinia virus plus GM-CSF) prior to planned surgical resection of locally advanced/poor prognosis or metastatic cancers. Systemic therapy Open

Treatment modalities

Systemic therapies (including targeted agents and immunotherapies)

Trial Acronym Title
Disease Area Status
MUKNine OPTIMUM: A randomised phase II, pilot study, comparing two different approaches to the induction treatment of high risk (HR) myeloma Multiple Myeloma Set-up
MUKEleven VIRel: Viral immunotherapy in Relapsed/Refractory Multiple Myeloma (MM) - A Phase I Study to Assess the Safety and Tolerability of Reovirus in Combination with Lenalidomide and Pomalidomide Multiple Myeloma Set-up
MUKSeven Pomalidomide Specific Targeting in Relapsed and Refractory Myeloma Multiple Myeloma Recruiting
MUKEight A randomised phase II trial of Cyclophosphamide and Dexamethasone in combination with Ixazomib, in relapsed or refractory multiple myeloma (RRMM) patients who have relapsed after treatment with thalidomide, lenalidomide and bortezomib Multiple Myeloma Recruiting
MUKFive A phase II randomised, controlled, parallel group, multi-centre trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) vs. cyclophosphamide, bortezomib and dexamethasone (CVD) for multiple myeloma patients at first relapse or refractory to no more than 1 line of treatment Multiple Myeloma Follow-up
MUKOne A study to find the best starting dose of bendamustine, when given in combination with thalidomide and dexamethasone, in relapsed /refractory myeloma Multiple Myeloma Closed
MUKThree A Phase I/IIa, Dose-Escalation, Study of CHR-3996 in Combination with Tosedostat in Participants with Relapsed, Refractory Multiple Myeloma Multiple Myeloma Closed
MUKFour An open label, multi-centre, single arm, phase II trial to assess the activity, safety and tolerability of combination therapy with vorinostat, bortezomib and dexamethasone (V2D) in patients with relapsed multiple myeloma Multiple Myeloma Closed
MUKSix A Phase I/IIa trial of VTD-panobinostat treatment and panobinostat maintenance in relapsed and relapsed/refractory multiple myeloma patients Multiple Myeloma Closed
Prism A randomised phase II trial of nivolumab in combination with alternatively scheduled ipilimumab in first-line treatment of patients with advanced or metastatic renal cell carcinoma Urological Cancer Set-up
BRAVO BRAVO: High grade Bladder cancer: A randomised controlled trial of Radical Cystectomy against intra-vesical immunotherapy – A feasibility study Urological Cancer Recruiting
FIESTA FGFR Inhibition for Epithelial Solid Tumours: a Phase Ib trial of AZD4547 in combination with gemcitabine and cisplatin Urological Cancer closed
Paris A Phase I Study of Pembrolizumab anti PD-1 monoclonal antibody in combination with Radiotherapy in locally advanced Non-Small Cell Lung Cancer (NSCLC) lung Set-up
ABLE An Open Label Multi-Centre Preoperative Window of Opportunity Study of Afatinib in Stage Ia to IIb Non-Small Cell Lung Cancer Lung Closed
ReoGlio A multicentre, single arm, phase I trial of reovirus/GMCSF in combination with standard of care in adult patients with newly diagnosed glioblastoma Brain Set-up
CATALYST A phase Ib study of Carfilzomib Thalidomide Dexamethasone in relapsed AL amyloidosis Others Set-up
AlphaCAP A randomised phase IB/IIA study of capecitabine plus radium-223 (Xofigo™) in metastatic breast cancer patients with bone metastases Others Set-up
Selimetry Investigating the potential clinical benefit of selumetinib in resensitising advanced iodine refractory differentiated thyroid cancer to radioiodine therapy Others Recruiting
CARBON A randomised phase IB/IIA study of CApecitabine plus Radium-223 (Xofigo™) in breast cancer patients with BONe metastases Others Recruiting
JX594 A clinical study to evaluate the biological effects of pre-operative intravenous administration of JX-594 (thymidine kinase-deactivated Vaccinia virus plus GM-CSF) prior to planned surgical resection of locally advanced/poor prognosis or metastatic cancers. Others Open
CMML201 A phase II study of 5-azacitidine in chronic myelomonocytic leukaemia Others Closed
AML - Len5 A pilot safety / tolerability study of Lenalidomide administered as monotherapy and in combination with standard chemotherapy for Acute Myeloid Leukaemia / high-risk Myelodysplastic Syndrome with structural abnormalities of chromosome 5 Others Closed

Radiotherapy

Trial Acronym Title Disease Area Status
Paris A Phase I Study of Pembrolizumab anti PD-1 monoclonal antibody in combination with Radiotherapy in locally advanced Non-Small Cell Lung Cancer (NSCLC) Lung Set-up
SABRTOOTH A study to determine the feasibility and acceptability of conducting a Phase III randomised controlled trial comparing stereotactic Ablative Radiotherapy (SABR) with surgery in paTients with peripheral Stage I nOn-small cell lung cancer (NSCLC) cOnsidered To be at Higher risk of complications from surgical resection. Lung Follow-up

Surgery (including devices)

Trial Acronym Title Disease Area Status
BRAVO BRAVO: High grade Bladder cancer: A randomised controlled trial of Radical Cystectomy against intra-vesical immunotherapy – A feasibility study Urological Cancer Recruiting