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Poster Display session

425 - A phase I dose escalation trial evaluating the impact of an in situ immunization strategy with intra-tumoral injections of Pexa-Vec in combination with ipilimumab in advanced solid tumors with injectable lesions


14 Dec 2018


Poster Display session


Aurelien Marabelle


Annals of Oncology (2018) 29 (suppl_10): x24-x38. 10.1093/annonc/mdy487


A. Marabelle1, L. Eberst2, C. Terret3, F. Pilleul4, C. Mastier4, A. Bouhamama4, L. Gilles-Afchain3, S. Laurent3, I. Delzano3, C. Reynaud3, C. Caux5, C. Caux5, G. Garin6, A. Bidaux6, D. Perol6, N. Stojkowitz7, M. Homerin7, H. Leenders7, P. Cassier3

Author affiliations

  • 1 Drug Development Department, Gustave Roussy, 94805 - Villejuif/FR
  • 2 Medical Oncology, Centre Léon Bérard, 69373 - Lyon/FR
  • 3 Medical Oncology, Centre Léon Bérard, 69008 - Lyon/FR
  • 4 Radiology Department, Centre Léon Bérard, 69008 - Lyon/FR
  • 5 Cancer Research Center Of Lyon, INSERM, Cancer Research Center of Lyon, Centre Léon Bérard, 69008 - Lyon/FR
  • 6 Clinical Research, Centre Léon Bérard, 69008 - Lyon/FR
  • 7 Oncology, TRANSGENE, Paris/FR


Abstract 425


In situ immunization is a strategy where immunomodulatory products are injected into one tumor site in order to use the tumor as its own vaccine and to trigger a systemic anti-tumor immune response. The Pexa-Vec (JX-594, Transgene) is an oncolytic virus genetically modified to secrete GM-CSF. We formulate the hypothesis that IT treatment with this oncolytic virus could synergize with anti-CTLA4 therapy via oncolytic virus-induced tumor cell death & tumor-antigen release, GM-CSF-induced recruitment/maturation/activation of antigen presenting cells, and anti-CTLA4-induced Treg blockade/depletion and reversion of T effectors inhibition.

Trial design

ISI-JX is a multicentric, Phase I dose escalation trial followed by an extension part aiming to evaluate the safety, feasibility, and anti-tumor effects of an in situ immunization strategy with IT injections of ipilimumab with Pexa-Vec in adults patients (pts) with solid tumors. The trial is conducted in pts with at least one injectable lesion (≥2 and ≤8 cm) and one distant non-injected measurable target site. Pts are treated with an IT injection of Pexa-Vec alone (1 x 109pfu) at Week 1 (W1) Day 1 (D1) followed by 3 IT injections of Pexa-Vec (1 x 109pfu) + ipilimumab (4 dose levels: 2.5, 5, 7.5, 10 mg/injection) at W3 D1, W5 D1 and W9 D1. Primary endpoint for escalation part is the occurrence of Dose Limiting Toxicities (DLT) defined as the toxicities occurring during the DLT assessment window (the first 5 weeks) related to Pexa-Vec, Ipilimumab or both; and the objective response rate as per immune related Response Criteria after 3 months of treatment for extension part. Secondary endpoints include the disease control rate, duration of response, progression free survival and overall survival. The dose escalation part follows a classical 3 + 3 design with 3 to 6 pts at each DL depending of the number of DTL observed (maximum of 24 pts). In the extension part, according to on the first stage of a Gehan design, 12 patients per cohort (3) will be enrolled (maximum of 36 pts). Up to date, the dose escalation part is ongoing: 8 pts were enrolled (DL1 n = 3; DL2 n = 3; DL3 n = 2).

Editorial acknowledgement

Bidaux As & Garin G; Centre Léon Bérard; DRCI Promotion Phase Précoce.

Clinical trial identification

EudraCT: 2014-001692-32; NCT02977156.

Legal entity responsible for the study

Centre Léon Bérard DRCI Promotion/Essais Précoces.


Centre Léon Bérard & Transgene S.A.


All authors have declared no conflicts of interest.

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