NCT03767348Phase 2Active not recruiting

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Open ClinicalTrials.gov record CSV export · Pro

Primary completion2028-06Estimated

Enrollment · participants340Estimated

Source updated2026-02-13Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

Pro unlocks the full available history and CSV export. View Pro features

Posted 2026-02-13 · 1 field changed

Primary completion date changed

− Before

~~Dec 2025~~

+ After

Jun 2028

Check registry source

Posted 2025-12-17 · 1 field changed

Recruitment status changed

− Before

~~Recruiting~~

+ After

Active not recruiting

Check registry source

Study details

Conditions studied

Non-Small Cell Lung Cancer (NSCLC); Microsatellite Instability-High (MSI-H); Non-melanoma Skin Cancer (NMSC); Cutaneous Melanoma

Treatments or interventions studied

RP1Biological
nivolumabBiologicalAlso known as Opdivo

Primary outcomes · main study measures

Read the study measures

measure: Percentage of adverse events (AEs); description: Percentage of subjects with adverse events (AEs); timeFrame: 26 months; measure: Percentage of serious adverse events (SAEs); description: Percentage of subjects with serious adverse events (SAEs); timeFrame: 26 months; measure: Percentage of dose limiting toxicities (DLTs); description: Percentage of subjects with dose limiting toxicities (DLTs); timeFrame: 26 months; measure: Percentage of overall response rate (ORR); description: Percentage of overall response rate (ORR) for all participants; timeFrame: 26 months; measure: Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1; description: Assess the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1 based on the safety and response data collected during Phase 1 Escalation; timeFrame: 20 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

How to read this history