Trials / Active Not Recruiting
Active Not RecruitingNCT03767348
Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)
An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors [IGNYTE]
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- Sponsor
- Replimune, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The Phase 2 study is a multicenter, open-label study of RP1 to further investigate safety and to estimate the efficacy of RP1 at the RP2D in combination with nivolumab in patients with Stage IIIb-IV unresectable melanoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, non-melanoma skin cancer (NMSC), and non-small cell lung cancer (NSCLC).
Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Microsatellite Instability-High (MSI-H)
- Non-melanoma Skin Cancer (NMSC)
- Cutaneous Melanoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RP1 | Genetically modified herpes simplex type 1 virus |
| BIOLOGICAL | nivolumab | anti-PD-1 monoclonal antibody |
Timeline
- Start date
- 2017-09-20
- Primary completion
- 2028-06-01
- Completion
- 2028-12-01
- First posted
- 2018-12-06
- Last updated
- 2026-02-13
Locations
51 sites across 5 countries: United States, France, Germany, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03767348. Inclusion in this directory is not an endorsement.