Study on RP1 Alone and Combined with Nivolumab for Advanced Solid Tumors

Sponsor: Replimune Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03767348

Provider View

This clinical trial is testing a new treatment using RP1, a modified virus, alone and with the drug nivolumab, to see if it can safely and effectively treat advanced solid tumors in adults.

Patient Parameters

Program Overview

This study is exploring a new treatment called RP1, which is a genetically modified virus designed to attack cancer cells and boost the immune system's response against tumors. The trial is in its early stages and aims to find the safest dose and see how well the treatment works when used alone or with another drug called nivolumab. It involves adults with advanced solid tumors that have not responded to other treatments.

Description

RP1 is a specially modified virus that targets and destroys cancer cells while also helping the immune system fight the cancer. This study is the first time RP1 is being tested in humans. It is divided into two main parts: Phase 1, where researchers will determine the safest dose of RP1, and Phase 2, where they will test RP1 in combination with nivolumab on specific types of tumors. The study will take place at multiple centers and will involve monitoring the safety, distribution, and effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be in good general health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have at least one tumor that can be measured and injected with the treatment.
  • Must provide a previous tumor sample or be willing to undergo a biopsy for a new sample.
  • Must have a life expectancy of at least 3 months.
  • Must have measurable disease according to specific medical criteria.
  • For patients with certain genetic tumor markers (MSI-H or dMMR), must have cancer that has progressed after previous treatment with anti-PD1/PD-L1 therapy.
  • For patients with certain skin cancers (NMSC), must have advanced cancer not treatable by surgery and have progressed after 8 weeks of anti-PD1/PD-L1 therapy.
  • For patients with melanoma, must have cancer that has progressed after at least 8 weeks of anti-PD1 treatment and have documented BRAF mutation status.
  • For patients with non-small cell lung cancer (NSCLC), must have failed previous treatments including anti-PD1/PD-L1 therapy and have shown disease progression.

Exclusion Criteria

  • Have received previous treatment with a similar oncolytic therapy.
  • Have a history of certain viral infections as specified in the study protocol.
  • Have had complications from herpes infections in the past.
  • Are using antiviral medications regularly.
  • Have untreated or uncontrolled cancer spread to the brain.
  • Have a history of lung diseases like interstitial lung disease or non-infectious pneumonitis.
  • Have significant heart disease.

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