FOR PATIENTS
Clinical Trials

MELANOMA
(LUMINOS-102)

Lerapolturev (formerly PVSRIPO) with or without immune checkpoint blockade in patients with advanced PD-1–refractory melanoma

Lerapolturev (formerly PVSRIPO) with or without immune checkpoint blockade in patients with advanced PD-1–refractory melanoma

LUMINOS-102 Study Design

Study design of LUMINOS-102
  1. Blood and tissue from injected/noninjected lesions and draining lymph nodes will be collected throughout study for translational analyses..

  2. Lerapolturev administered at a dose up to 6x108 TCID50 into up to 6 lesions q3w or q4w.

  3. §IV pembrolizumab q3w or q6w or IV nivolumab q2w or q4w at discretion of the principal investigator.

LUMINOS-102 Study Design

Study design of LUMINOS-102
  1. Blood and tissue from injected/noninjected lesions and draining lymph nodes will be collected throughout study for translational analyses..

  2. Lerapolturev administered at a dose up to 6x108 TCID50 into up to 6 lesions q3w or q4w.

  3. §IV pembrolizumab q3w or q6w or IV nivolumab q2w or q4w at discretion of the principal investigator.

LUMINOS-102 (NCT04577807) is a multicenter, open-label, randomized phase 2 study investigating the efficacy and safety of lerapolturev with or without anti–PD-1 antibodies in patients with unresectable cutaneous or mucosal melanoma with injectable lesions who failed prior anti–PD-1 therapy.

The study enrolled its first patient in March 2021 and is currently ongoing at >20 US sites, with additional sites due to initiate soon.

A completed safety run-in characterized lerapolturev injections in up to 6 lesions/cycle or at a maximum dose of 6x108 TCID50. Randomization (1:1) of 50 patients to receive lerapolturev (Arm 1) or lerapolturev combined with anti–PD-1 (Arm 2) is now underway.  

LUMINOS-102 builds on the successful experience with lerapolturev in a previous phase 1 trial as published in the Journal for ImmunoTherapy of Cancer.

Get additional information

Please contact us or email LUMINOS-102@istarioncology.com.

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