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

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 tumorsample 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-L1therapy.

• Subjects with NMSC: has diagnosis of locally advanced or metastatic NMSC that arenot considered treatable by surgery including basal cell carcinoma, cutaneoussquamous cell carcinoma, basosquamous carcinoma, Merkel cell carcinoma and othernon-melanoma skin cancers (per protocol). Patients must have received 8 weeks ofanti-PD1/PD-L1 as their last line of therapy and progressed while on treatment.

• Subjects with anti-PD1 failed cutaneous melanoma: has confirmed progressive diseasewhile 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, includingPD1/PD-L1 directed therapy administered either as monotherapy or in combination withplatinum-based chemotherapy or anti-CTLA-4. The most recent treatment given musthave included an anti-PD1/PD-L1 directed therapy with radiologic disease progressionon 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