Abstract 4250
Background
The immune system plays a pivotal role in modulating response to monoclonal antibodies therapy in cancer. Novel immune-checkpoint inhibitors have demonstrated potent efficacy alone and in combinations with cytotoxic agents in several cancers. In this regard, avelumab in combination with cetuximab might be a relevant re-challenge strategy in RAS wild type (WT) metastatic colorectal cancer (mCRC) patients treated in first line with chemotherapy (CT) in combination with anti-epidermal growth factor receptor (EGFR) drugs and who achieved a complete or partial response.
Trial design
CAVE Colon is a single arm, multi-center phase II study designed to evaluate the efficacy of avelumab and cetuximab in pre-treated RAS WT mCRC patients. Eligible patients: pathologically confirmed KRAS (exon 2, 3 and 4) and NRAS (exon 2, 3 and 4) WT mCRC treated with a first line CT in combination with an anti-EGFR agent with a major response achieved (complete or partial), who have progressed to a second line therapy, and received no prior immunotherapy. Primary endpoint is overall survival; secondary endpoints are overall response rate according to RECIST 1.1, progression free survival and safety profile. This study seeks to demonstrate a median OS of 11 months by the experimental combination for comparison with historical median OS 8.0 with standard third line treatments, which correspond to an improvement of OS at 6 months from 40% to 57%. With 80% power and 1-sided 5% level test, it was estimated that it would be needed to enrol 66 patients. Considering a potential dropout of approximately 15% of patients, a total of 75 patients will be recruited. The accrual period, started in August 2018, will be 18 months and the total duration of the study will be 36 months. As per April 22nd 2019, thirty-five patients have been enrolled and started the treatment with avelumab 10 mg/kg q14 as a 1-hour i.v. infusion and cetuximab at 400 mg/m2 over 2-hour and subsequently 250 mg/m2 q7 as 1-hour i.v. infusion until disease progression or unacceptable toxicity.
Clinical trial identification
2017-004392-32.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
This study is partially supported by Merck KgA, Darmstadt, Germany.
Disclosure
E. Martinelli: Advisory / Consultancy: Amgen, Bayer, Merck, Roche, Sanofi, Servier. T. Troiani: Advisory / Consultancy: Amgen, Bayer, Merck, Novartis, Roche. F. Ciardiello: Advisory / Consultancy: Merck Kga, Bayer, Amgen, Rocher, Servier, Pfizer. All other authors have declared no conflicts of interest.
Resources from the same session
5612 - Evaluation of germ line mutational status among women with triple-negative breast cancer in Russia
Presenter: Elena Shagimardanova
Session: Poster Display session 2
Resources:
Abstract
4142 - Association of derived neutrophil-to-lymphocyte ratio (dNLR) with pathological complete response (pCR) after neoadjuvant chemotherapy (CT)
Presenter: Alberto Ocaña
Session: Poster Display session 2
Resources:
Abstract
1733 - Competing nomogram for late-period breast cancer-specific death in patients with early-stage hormone receptor-positive breast cancer
Presenter: Jianfei Fu
Session: Poster Display session 2
Resources:
Abstract
1978 - A Nomogram to Predict Pathologic Complete Response of Neoadjuvant Chemotherapy in Triple-Negative Breast Cancer Based on Simple Blood Indicators
Presenter: Fanrong Zhang
Session: Poster Display session 2
Resources:
Abstract
3062 - Identification of GSTP1 transferred by extracellular vesicles responsible for adriamycin-resistance in breast cancer cells
Presenter: Sujin Yang
Session: Poster Display session 2
Resources:
Abstract
5274 - Expression of X-linked Inhibitor of Apoptosis Protein (XIAP) and its Association with Clinicopathological Parameters in Invasive Breast Cancers
Presenter: Gayathri Devi
Session: Poster Display session 2
Resources:
Abstract
1324 - The prognostic significance of preoperative tumor marker (CEA, CA15-3) elevation in breast cancer patients
Presenter: Soo Youn Bae
Session: Poster Display session 2
Resources:
Abstract
4877 - Correlation of clinical and pathological features with the tumour microenvironment in DCIS. An institutional experience
Presenter: Ann Eapen
Session: Poster Display session 2
Resources:
Abstract
2471 - Correlation between radiologic complete response (rCR) in contrast-enhanced magnetic resonance imaging (CE-MRI) after neoadjuvant chemotherapy for early breast cancer and pathologic complete response and their impact in recurrence-free survival
Presenter: Ariadna Gasol Cudos
Session: Poster Display session 2
Resources:
Abstract
2632 - Ring-like uptake appearance on dedicated breast positron emission tomography before chemotherapy predicts outcome of neoadjuvant chemotherapy in breast cancer
Presenter: Norio Masumoto
Session: Poster Display session 2
Resources:
Abstract