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)

  • End date
    Nov 25, 2024
  • participants needed
  • sponsor
    Replimune Inc.
Updated on 25 October 2022
measurable disease
melanoma skin
squamous cell carcinoma
progressive disease
primary cancer
solid tumour
solid neoplasm
bladder cancer
bladder tumor
malignant melanoma of skin
merkel cell carcinoma


RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.


RP1 is a genetically modified herpes simplex type 1 virus that is designed to directly destroy tumors and to generate an anti-tumor immune response. This is a Phase 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, biodistribution, shedding, and preliminary efficacy of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent RP1, an expansion phase with a combination of RP1 and nivolumab and a Phase 2 portion in specified tumor types for the combination therapy.

Condition Cancer, Melanoma (Skin), Mismatch Repair Deficiency, Microsatellite Instability, Non-melanoma Skin Cancer, Cutaneous Melanoma, NSCLC
Treatment Nivolumab, RP1
Clinical Study IdentifierNCT03767348
SponsorReplimune Inc.
Last Modified on25 October 2022


Yes No Not Sure

Inclusion Criteria

Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Have a predicted life expectancy of ≥ 3 months
At least one measurable and injectable lesion
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) for whom anti PD-1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available
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) for whom anti-PD1/PD-L1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available
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: has confirmed progressive disease after no more than two prior systemic treatments including anti-PD1/PD-L1 treatment
Have provided a former tumor pathology specimen or be willing to supply a new tumor sample from a biopsy

Exclusion Criteria

Uncontrolled/untreated brain metastasis
History of non-infectious pneumonitis
History of clinically significant cardiovascular disease
Prior treatment with an oncolytic therapy
History of viral infections according to the protocol
Prior complications with herpes infections
Chronic use of anti-virals
History of interstitial lung disease
Clear my responses

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