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

*FDA-approved anti–PD-1 therapy of the treating physician’s choosing.

INCLUSION CRITERIA
  • Advanced/metastatic (stage IIIB/C/D or IV per AJCC) unresectable melanoma 
  • Cutaneous melanoma—visceral metastases allowed (liver metastases excluded)
  • SITC-defined primary or secondary resistance to PD-1 checkpoint inhibitors
WEEK 26 RESPONSE ASSESSMENT
  • Primary: ORR, DOR, CD8+ TILs, PD-L1 expression
  • Secondary: OS, DCR, DRR
LERAPOLTUREV DOSE
  • 1.6x109 TCID50 (higher than initially used based on DSMC review) and a QW x7 weeks “induction schedule”

DCR, disease control rate; DOR, duration of response; DRR, durable radiographic response; DSMB, data safety monitoring committee; ORR, overall response rate; OS, overall survival; PD, progressive disease; SD, stable disease; TILs, tumor-infiltrating lymphocytes.  

LUMINOS-102 Study Design

Study design of LUMINOS-102
INCLUSION CRITERIA
  • Advanced/metastatic (stage IIIB/C/D or IVper AJCC) unresectable melanoma 
  • Cutaneousmelanoma—visceral metastases allowed (liver metastases excluded)
  • SITC-defined primary or secondary resistance to PD-1 checkpoint inhibitors
WEEK 26 RESPONSE ASSESSMENT
  • Primary: ORR,DOR, CD8+ TILs, PD-L1 expression
  • Secondary: OS,DCR, DRR
LERAPOLTUREV DOSE
  • 1.6x109 TCID50 (higher than initially used based on DSMC review) and a QW x7 weeks “induction schedule”
  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 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 >12 US sites.

A completed safety run-in and interim analysis cleared the way for an increased dose. The maximum lerapolturev dose was increased to 1.6 x 109 TCID50 across a maximum of 6 lesions. The schedule of administration is now weekly for 7 weeks (induction) followed by dosing every 3 or 4 weeks (maintenance).  This change demonstrated clinical benefit in 5 of 7 subjects treated with the new regimen as of October 1, 2022 and is summarized in a poster (below) presented at the Society for Melanoma Research (SMR) October 17-20, 2022.

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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