Clinical Trials


Istari is advancing clinical research across multiple solid tumor types with lerapolturev (formerly PVSRIPO), the only investigational immunotherapy based on the Sabin oral poliovirus vaccine. Lerapolturev leverages multiple, unique mechanisms of action to activate a systemic antitumor response to fight cancer. Lerapolturev has been administered to more than 200 patients and is currently the subject of multiple ongoing phase 2 trials in 6 potential solid tumor indications.

Lerapolturev has been designated an Orphan Drug and granted Breakthrough Therapy Designation for recurrent glioblastoma (rGBM) by the FDA. Lerapolturev has also been designated an Orphan Drug in advanced melanoma (stage IIb-IV) and granted Fast Track status for patients with advanced melanoma who have disease progression after anti–PD-1/L1 therapy.

Ongoing lerapolturev clinical trials

Tumor Type
Phase 1
Phase 2
Phase 3
Lerapolturev Monotherapy
Lerapolturev + pembrolizumab
Lerapolturev + anti–PD-1/L1
Muscle-invasive bladder cancer (MIBC)
Head and neck squamous cell cancer (HNSCC)
Lerapolturev + anti–PD-1/L1*
Lerapolturev + anti–PD-1/L1*
Clinical trial pipeline

*Patients will be treated with lerapolturev monotherapy during phase 1 and lerapolturev in combination with anti–PD-1/L1 during phase 2.

LUMINOS-101 is recruiting adult patients with confirmed rGBM with enhancing lesions ≥1 cm to ≤5.5 cm in diameter.
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Lerapolturev and pembrolizumab in patients with recurrent glioblastoma
LUMINOS-102 is recruiting patients with advanced melanoma who have confirmed progression after PD-1 inhibitor therapy and who have failed or refused BRAF-targeted therapy if BRAF mutation positive. Stable CNS metastases are allowed.
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Lerapolturev with or without immune checkpoint blockade in patients with advanced anti–PD-1 refractory melanoma
LUMINOS-103 is a phase 1/2, single-arm trial evaluating the safety and efficacy of lerapolturev in several solid tumor types. Currently, cohorts are open in MIBC (subgroups include neoadjuvant and unresectable/metastatic settings) and in HNSCC (subgroups include neoadjuvant and unresectable/metastatic settings).
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A basket trial of lerapolturev and lerapolturev in combination with anti–PD-1/L1 checkpoint inhibitors in multiple solid tumor types