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Study of RP1 Monotherapy and RP1 in Combination With Nivolumab
Trial Status: active
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.
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT03767348.
