Clinical trial · Interventional
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]
NCT03767348CI-TRIAL-00103288IGNYTEactive not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Melanoma | Cutaneous Melanoma | ONTOLOGY_EXACT | 0.98 |
| Microsatellite Instability-High (MSI-H) | — | UNRESOLVED | — |
| Non-melanoma Skin Cancer (NMSC) | Skin Carcinoma | ALIAS | 0.85 |
| Non-Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nivolumab | Biological | Nivolumab | ALIAS |
| RP1 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (10)
- type
- EXPERIMENTAL
- label
- Dose escalation of RP1 by intratumoral (IT) injection in superficial tumors
- description
- anti-PD-1 monoclonal antibody
- interventionNames
- Biological: RP1
- type
- EXPERIMENTAL
- label
- Dose escalation of RP1 by intratumoral (IT) injection in deep/visceral tumors
- description
- Dose escalation of RP1 alone in 3 cohorts with IT injections in superficial tumors
- interventionNames
- Biological: RP1
- type
- EXPERIMENTAL
- label
- Dose expansion of RP1 and nivolumab (IV) in superficial tumors
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. * At least one measurable and injectable lesion * Have provided a former tumor pathology specimen or be willing to supply a new tumor sample from a biopsy * Have a predicted life expectancy of ≥ 3 months * Measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria * Subjects with MSI-H or dMMR tumors: has diagnosis of MSI-H or metatstatic dMMR tumor (according to protocol definition) who has progressed on prior anti-PD1/PD-L1 therapy. * Subjects with NMSC: has diagnosis of locally advanced or metastatic NMSC that are not considered treatable by surgery including basal cell carcinoma, cutaneous squamous cell carcinoma, basosquamous carcinoma, Merkel cell carcinoma and other non-melanoma skin cancers (per protocol). Patients must have received 8 weeks of anti-PD1/PD-L1 as their last line of therapy and progressed while on treatment. * Subjects with anti-PD1 failed cutaneous melanoma: has confirmed progressive disease while on anti-PD1 treatment for at least 8 weeks and documented BRAF mutation status * Subjects with anti-PD1 failed NSCLC: must have failed prior treatment, including PD1/PD-L1 directed therapy administered either as monotherapy or in combination with platinum-based chemotherapy or anti-CTLA-4. The most recent treatment given must have included an anti-PD1/PD-L1 directed therapy with radiologic disease progression on or after treatment. Key Exclusion Criteria: * Prior treatment with an oncolytic therapy * History of viral infections according to the protocol * Prior complications with herpes infections * Chronic use of anti-virals * Uncontrolled/untreated brain metastasis * History of interstitial lung disease * History of non-infectious pneumonitis * History of clinically significant cardiovascular disease
References
Publications (2)
- DERIVEDWong 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. PMID 40627813
- DERIVEDThomas 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. PMID 31399043