ICONIC
Research type
Research Study
Full title
CCR 4557: Peri-operative Immuno-Chemotherapy in Operable oesophageal aNd gastrIc Cancer (ICONIC Trial)
IRAS ID
211599
Contact name
Marco Gerlinger
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2016-003306-13
Duration of Study in the UK
2 years, 9 months, 3 days
Research summary
Gastric and oesophageal cancers are a significant global health burden and overall the outcomes are poor. A survival benefit has been shown in large trials of peri-operative chemotherapy, that is down-staging chemotherapy given before surgery, followed by a surgery to remove the cancer and thereafter some more chemotherapy to reduce the risk of cancer returning. There remains an urgent need to further improve the poor survival rates, by developing innovative drug combinations to minimise the evolution of drug resistance.
ICONIC is a single centre phase II clinical trial of peri-operative chemo-immunotherapy (FOLFOX-Avelumab) in operable gastric, oesophageal or gastro-oesophageal adenocarcinoma (GOA). Avelumab is a new anti-PD-L1 antibody which inhibits PD-L1 interactions. These interactions are used by cancer cells to escape detection by the body’s own immune system. By inhibiting these interactions, Avelumab is thought to enable the activation of immune cells, called T cells, which can then work to attack or destroy the cancer cells. Laboratory experiments have shown that the combination of FOLFOX chemotherapy with Avelumab can increase the activation of the immune system at the site of the cancer. To our knowledge, this novel combination of FOLFOX-Avelumab has not been trialed in the peri-operative setting for localised GOAs.
This trial is designed to assess the safety and efficacy of this novel chemo-immunotherapy drug combination. It will be conducted in two stages:
- The first stage will be a safety run-in phase to evaluate the safe and tolerated maximum administered dose of Avelumab in combination with FOLFOX
- The second stage will assess the peri-operative safety and efficacy of this combination therapy in achieving a pathological complete response at the time of surgery and improving overall outcomes.
Enrolment into the main phase of the trial will continue until a total of 38 patients have been treated at the maximum administered dose and undergone surgical reaction.REC name
London - City & East Research Ethics Committee
REC reference
17/LO/0378
Date of REC Opinion
16 Mar 2017
REC opinion
Favourable Opinion