Trial · NCT03767348
Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)
NCT03767348, Phase 2, Active not recruiting, Replimune, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE). Trials, record NCT03767348. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03767348
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)
- NCT number
- NCT03767348
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 340 participants, estimated
- Lead sponsor
- Replimune, Inc.
- Conditions
- Non-Small Cell Lung Cancer (NSCLC), Microsatellite Instability-High (MSI-H), Non-melanoma Skin Cancer (NMSC), Cutaneous Melanoma
- Interventions
- RP1, nivolumab
- First posted
- 2018-12-06
- Last updated
- 2026-02-13
- Other registries' IDs
- eudract:2016-004548-12
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of adverse events (AEs) | 26 months | Percentage of subjects with adverse events (AEs) |
| Primary | Percentage of serious adverse events (SAEs) | 26 months | Percentage of subjects with serious adverse events (SAEs) |
| Primary | Percentage of dose limiting toxicities (DLTs) | 26 months | Percentage of subjects with dose limiting toxicities (DLTs) |
| Primary | Percentage of overall response rate (ORR) | 26 months | Percentage of overall response rate (ORR) for all participants |
| Primary | Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1 | 20 weeks | 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 |
| Secondary | Percentage of biologic activity | 20 weeks | Percentage of subjects with biological activity determined by tumor biopsies and biomarker data |
| Secondary | Percentage subjects with detectable RP1 | 20 weeks | Data gathered from blood, urine, swabs of injection site, dressings, and oral mucosa to determine the shedding and biodistribution of RP1 |
| Secondary | Percentage of complete response (CR) | 26 months | Percentage of subjects with a complete response (CR) |
| Secondary | Median duration of response | 26 months | Median duration of response of subjects |
| Secondary | Median progression-free survival | 26 months | Median duration of progression-free survival of subjects |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03767348
GET https://conductscience.org/api/trials/v1/NCT03767348/registered