On 16-22 June 2018, ECCO, AACR, EORTC and ESMO organised the 20th edition of the annual Workshop on Methods in Clinical Cancer Research in Zeist, the Netherlands. Hundreds of students over the years have successfully learned the essentials of clinical trial design thanks to this Workshop and this edition was no exception.
Under the guidance of the Workshop Directors – Stefan Sleijfer, Lee M. Ellis, Corneel Coens and Emiliano Calvo – along with other leading clinical experts in the field of oncology, the MCCR Workshop participants completed their trial protocols and are now expected to make every effort to implement them. Study concepts were rigorously vetted and scrutinised at all stages; starting from assessing the key clinical question and finishing with addressing post-protocol management issues. The Workshop is frequently described as an intensive experience by both faculty and fellows committed to advance cancer research and address daily practice challenges.
View the 20th Anniversary tribute video here.
View the photo gallery here.
The MCCR Workshop Innovative Protocol Awards were awarded to:
Dr Caterina Aversa
Royal Marsden Hospital and The Institute of Cancer Research, London UK
Summary of the trial design: This is a phase I trial study investigating the combination of Carboplatin AUC 5 with the extended infusion of the ATR inhibitor M6620 in advanced solid tumors.
The ATR axis promotes DNA damage repair in response to replication stress and DNA double strand breaks. M6620 synergizes with Carboplatin as shown in preclinical models and in early clinical trials. Based on the observation that ATR activation occurs as an early event in the DNA repair chain, the current trial aims at investigating the combination of Carboplatin with extended infusion of M6620 administered after Carboplatin and over 48 hours.
The trial will be divided in 3 parts:
- Part A: dose escalation part 3+3 design enrolling patients with all tumor types. Primary objectives of this part will be assessing safety and toxicity and establish a recommended phase II dose (RP2D). Secondary objectives will include the assessments of markers of replication stress in tumor biopsies and blood surrogates.
- Part B: biopsy cohort of patients affected by all tumor types treated at the RP2D. Patients in this part will have paired biopsies to assess how the treatment combination affects the immune system.
- Part C: biomarker expansion cohort of patients affected by ovarian cancer carrying DNA repair defects and resistant or refractory to platinum and patients of all tumor types carrying loss of ATM. Amongst secondary objectives of this part will be a preliminary assessment of antitumor activity.
Dr Capucine Baldini
Institut Gustave Roussy, Villejuif, France
Summary of the trial design: Prospective Registry study of incidence of toxicity ≥ grade 2 in OldEr patients ≥ 70 years old with solid tumors treated with anti PD-1/PD-L1 – PRObE study.
In the last years, immune checkpoint inhibitors have become the new therapeutic option in many solid tumors. However few prospective data are available in older patients ≥ 70 years old. The purpose of this prospective open-label registry study is to assess safety and efficacy of anti PD-1 and anti PD-L1 prescribed within an EMA approval or temporary utilization authorization (ATU) in patients over 70 years old with metastatic or locally advanced solid tumors.
The primary endpoint is the incidence of grade ≥ 2 immune related adverse-events during anti PD-1/PD-L1 therapy evaluated by CTCAE v5. The secondary endpoints are progression free survival (PFS), overall survival (OS), objective response rate (ORR), stable disease at 6 months, correlation between geriatric parameters (G8 screening tool and the Geriatric Core Dataset G-code) and changes in quality of life (QoL). Exploratory analysis will explore relationships between T cells immunophenotype in blood, microbiome and objective clinical response/toxicity.
The study will enroll 200 patients in 25 months.
Dr Michael Skwarski
CRUK/MRC Oxford Institute for Radiation Oncology, UK
Summary of the trial design: ARCADIAN is a two-centre phase I trial combining atovaquone with radical concurrent chemoradiotherapy in patients with locally advanced NSCLC. Atovaquone is a commonly prescribed anti-malarial drug recently shown to reduce tumour hypoxia resulting in tumour radiosensitisation. This study will utilise a time-to-event continuous reassessment model (TiTE-CRM) to determine the MTD and thus recommended phase II dose of atovaquone when combined with chemoradiation. In addition, this trial aims to further develop clinically deliverable hypoxia biomarkers to inform later phase study design, in particular with regards to enabling hypoxia-dependant patient selection.
The Outstanding Mentor Award was awarded to Dr Gabe Sonke from the Netherlands Cancer Institute, while the Outstanding Biostatistician Mentor Awards were awarded to Dr Yu Shyr from Vanderbilt University Medical Centre and Dr Sarah Brown from University of Leeds.
The 21st edition of the MCCR Workshop will take place on 15-21 June 2019 in Zeist, the Netherlands. To learn more about the MCCR Workshop click here.
MCCR Workshop Secretariat
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