Clinical trial · no report yet · Phase 2
IGNYTE
Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)
- NCT03767348 ↗
- Active not recruiting
- Replimune, Inc.
- 18 commentary sources found
- Standard
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.
| Channel | Found | |
|---|---|---|
| X threads | 10 | |
| YouTube | 6 | |
| Podcasts | 2 |
The trial
ClinicalTrials.gov- Official title
- 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]
- Phase
- Phase 2
- Status
- Active not recruiting
- Conditions
- Non-Small Cell Lung Cancer (NSCLC); Microsatellite Instability-High (MSI-H); Non-melanoma Skin Cancer (NMSC); Cutaneous Melanoma
- Interventions
- RP1; nivolumab
- Arms
- Dose escalation of RP1 by intratumoral (IT) injection in superficial tumors · Experimental
- Dose escalation of RP1 by intratumoral (IT) injection in deep/visceral tumors · Experimental
- Dose expansion of RP1 and nivolumab (IV) in superficial tumors · Experimental
- Dose expansion of RP1 and nivolumab (IV) in deep/visceral tumors · Experimental
- RP1 (IT) and nivolumab (IV) in melanoma · Experimental
- RP1 (IT) and nivolumab (IV) in MSI-H/dMMR solid tumors · Experimental
- RP1 (IT) and nivolumab (IV) in NMSC · Experimental
- RP1(IT) and nivolumab (IV) in anti-PD1 Failed Cutaneous Melanoma · Experimental
- RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NMSC · Experimental
- RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NSCLC · Experimental
- Enrollment
- 340 (estimated)
- Primary outcomes
- Percentage of adverse events (AEs)
- Percentage of serious adverse events (SAEs)
- Percentage of dose limiting toxicities (DLTs)
- Percentage of overall response rate (ORR)
- Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1
- Sponsor
- Replimune, Inc. with Bristol-Myers Squibb
- Start
- Sep 20, 2017
- Primary completion
- Jun 2028 (estimated)
- Results posted
- No
- Registry record
- NCT03767348 · updated Feb 13, 2026
Publications
linked from the registry- Wong MK, Milhem MM, Sacco JJ, Michels J, In GK, Munoz Couselo E, Schadendorf D, Beasley GM, Niu J, Chmielowski B, Wise-Draper TM, Bowles TL, Tsai KK, Lebbe C, Gaudy-Marqueste C, Middleton MR, Skolariki A, Samson A, Chesney JA, VanderWalde AM, Zakharia Y, Harrington KJ, Appleton E, Bommareddy PK, Zhu J, Viana M, Hou JW, Coffin RS, Robert C. RP1 Combined With Nivolumab in Advanced Anti-PD-1-Failed Melanoma (IGNYTE). J Clin Oncol. 2025 Nov 20;43(33):3589-3599. doi: 10.1200/JCO-25-01346. Epub 2025 Jul 8. PubMed 40627813
- Thomas S, Kuncheria L, Roulstone V, Kyula JN, Mansfield D, Bommareddy PK, Smith H, Kaufman HL, Harrington KJ, Coffin RS. Development of a new fusion-enhanced oncolytic immunotherapy platform based on herpes simplex virus type 1. J Immunother Cancer. 2019 Aug 10;7(1):214. doi: 10.1186/s40425-019-0682-1. PubMed 31399043