Last updated on March 2017

LTX-315 in Patients With Transdermally Accessible Tumours as Monotherapy or Combination With Ipilimumab or Pembrolizumab


Brief description of study

The study will assess the safety, tolerability, PK and efficacy of different intra-tumoral dosing regimens of LTX-315; a lytic-peptide that induces long-term anti-cancer immune responses, as monotherapy or in combination with ipilimumab or pembrolizumab.

Detailed Study Description

In this phase I, open-label, multi-arm, multicentre, multi-dose dose escalation study in patients with transdermally accessible tumours; the safety, PK and efficacy of different dosing regimens of LTX-315 will be assessed. Patients will be allocated into 4 separate (parallel) arms depending on the tumour type and the number of lesions available. Arm A: Single lesion/sequential lesion treatment arm (LTX-315 monotherapy) (Completed) Arm B: Concurrent multiple lesion treatment arm with all tumour types (LTX-315 monotherapy) Arm C: LTX-315 combination with ipilimumab in patients with melanoma Arm D: LTX-315 combination with pembrolizumab in patients with TNBC All patients will have at least one lesion available for injection. Treatment schedule: Arm A: Injection of LTX-315 3 days week 1, 1 day in week 2, 3, 4, 5 and 6. Every 2 weeks starting with week 8. Arm B (all tumours): Injection of LTX-315 2 days week 3 weeks (Day 1, 2, 8, 9, 15 and 16). Arm C (melanoma): Injection of lTX-315 2 days week 3 weeks (Day 1, 2, 8, 9, 15 and 16) in combination with ipilimumab given in week 1 and every 3 weeks 4 cycles. Arm D (TNBC): Injection of LTX-315 2 days week 3 weeks (Day 1, 2, 8, 9, 15 and 16) in combination with pembrolizumab given in week 1 and every 3 weeks up to 2 years. Patients will be enrolled into a dose cohort in order of study entry. Staring with the lowest dose. A minimum of 3 patients will be enrolled into each cohort. Dose escalation determined by the Safety Review Committee and the Sponsor. The the optimal regimen will be based on the results of the Dose Escalation from the following information: 1. Safety parameters including blood samples and cardiovascular effects 2. Immunohistology and ultrasound confirmation of necrosis and tumour infiltrating lymphocytes 3. Systemic inflammatory response 4. Evidence of clinical responses Cohorts may be utilized to: 1. Evaluate different doses of LTX-315 2. Explore potential modifications to the dosing schedule 3. Evaluate the potential to include appropriate combination therapies with LTX-315 4. Gain further information on clinical efficacy

Clinical Study Identifier: NCT01986426

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Ahmed Awada, MD, PhD

Jules Bordet Institute
Bruxelles, Belgium
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Jean-Francois Baurain, MD PhD

Cliniques Universitaires St-Luc, Service d'oncologie m dicale
Bruxelles, Belgium
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Christophe Le Tourneau, MD PhD

Institut Curie
Paris, France
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Aurelien Marabelle, MD. Ph. D

Institute Gustave Roussy
Paris, France
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Andrew Saunders, MD

Intotuto Europeo di Oncologia (IEO)
Milano, Italy
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Andrew Saunders, MD

San Raffaele Hospital
Milano, Italy
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Paolo Ascierto, MD PhD

Intituto Nazionale dei Tumori
Napoli, Italy
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Vanna C Sileni, MD PhD

Instituto Oncologico Venneto (IOV)
Padova, Italy
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Dag E Joessang, MD

Haukeland University Hospital
Bergen, Norway
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Paal Fr Brunsvig, MD PhD

Oslo University Hospital Radiumhospitalet
Oslo, Norway
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James Spicer, MD, PhD

Guy's Hospital
London, United Kingdom
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Andrew Saunders, MD

Royal Marsden Hospital
London, United Kingdom
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Rebecca Kristeleit, MD Ph. D

University College of London Hospital
London, United Kingdom
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Anne Armstrong, MD PhD

Christie Hospital NHS Foundatin Trust
Manchester, United Kingdom
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