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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

3241 - Preoperative Nivolumab in patients(pts) with locally advanced colon cancer (T3 or T4): a window-of-opportunity study (NICOLE)

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Immunotherapy

Tumour Site

Colon and Rectal Cancer

Presenters

Antonio Avallone

Citation

Annals of Oncology (2018) 29 (suppl_8): viii150-viii204. 10.1093/annonc/mdy281

Authors

A. Avallone1, P. Delrio1, G. Nasti2, A. Cassata1, L. Silvestro1, A. De Stefano1, S. Lastoria3, R. Casaretti1, C. Romano1, A. Ottaiano4, E. Di gennaro5, A. Nappi1, P. Maiolino6, E. Cavalcanti7, A. Petrillo3, F. Tatangelo7, D. Giannarelli8, J. Galon9, P.A. Ascierto10, A. Budillon5

Author affiliations

  • 1 Abdominal Oncology, Istituto Nazionale Tumori, IRCCS, Fondazione "G. Pascale", 80131 - Naples/IT
  • 2 Ssd Innovative Therapies For Abdominal Metastases - Abdominal Oncology, Istituto Nazionale Tumori, IRCCS, Fondazione "G. Pascale", 80131 - Napoli/IT
  • 3 Radiology, Istituto Nazionale Tumori, IRCCS, Fondazione "G. Pascale", 80131 - Naples/IT
  • 4 Ssd Innovative Therapies For Abdominal Metastases - Abdominal Oncology, Istituto Nazionale Tumori – I.R.C.C.S - Fondazione Pascale, 80131 - Napoli/IT
  • 5 Clinical Pharmacology Experimental, Istituto Nazionale Tumori, IRCCS, Fondazione "G. Pascale", 80131 - Naples/IT
  • 6 Pharmacology, Istituto Nazionale Tumori, IRCCS, Fondazione "G. Pascale", 80131 - Naples/IT
  • 7 Pathology, Istituto Nazionale Tumori, IRCCS, Fondazione "G. Pascale", 80131 - Naples/IT
  • 8 Statistica, IFO Regina Elena Roma, Roma/IT
  • 9 Pathology, National Institute of Health and Medical Research, Paris/FR
  • 10 Melanoma, Cancer Immunotherapy And Innovative Therapy Unit, Istituto Nazionale Tumori – I.R.C.C.S - Fondazione Pascale, 80131 - Napoli/IT
More

Resources

Abstract 3241

Background

Colorectal cancer (CRC) is one of the most common malignancies, and a leading cause of cancer death worldwide. Surgery is the only curative therapy available for locally advanced colon cancer (LACC), however, the disease is associated with a significant recurrence rate and even with adjuvant therapy its prognosis is far from satisfactory. Preoperative treatment strategy is an attractive concept in LACC because it has the theoretical advantages to eradicate micrometastases, to reduce tumor cell shedding during surgery, to allow the assessment of initial tumor response and could be better tolerated than adjuvant treatment. The results of the recently reported FOxTROT trial has shown that preoperative chemotherapy in LACC is feasible with no increase in surgical morbidity or mortality. The immune contexture of solid tumors has become an emerging hallmark of cancers. Recent evidences indicate that immune infiltrate (immunoscore) is an informative prognostic indicator in LACC. Moreover, it was demonstrated that immunoscore is also a stronger predictor of patient survival than microsatellite instability. Based on these considerations, we designed a window of opportunity study to determine the feasibility of nivolumab in the preoperative setting in pts with LACC.

Trial design

Pts will receive nivolumab at a flat dosage of 240 mgs every two weeks on Day -28 and Day-14 (+/- one day) prior to planned surgery on Day 0 or up to + 7 days. An initial 6-pts safety run-in cohort will be followed by an expansion cohort, with a planned accrual of 16 pts. Postoperatively, standard adjuvant chemotherapy will be administered as recommended by guidelines. Primary objective is to determine the safety and feasibility of Nivolumab in the preoperative setting. The exploratory primary objective is the rate of pathological complete tumor regression, as well as correlative studies to determine molecular and immunophenotypic changes in tumor and peripheral blood samples as potential biomarkers of toxicity/efficacy. Secondary objective are tumor response rate defined by RECIST, postoperative complications, relapse-free survival, overall survival and metabolic response changes evaluated by FDG-PET-CT scan prior to surgery.

Clinical trial identification

EudraCT: 2017-003739-12.

Legal entity responsible for the study

Società Campana di Immunoterapia Oncologica (SCITO).

Funding

Società Campana di Immunoterapia Oncologica (SCITO) with funding from BMS.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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