Study of RP1 Monotherapy and RP1 in Combination With Nivolumab
a study on Cancer, General Skin Cancer/Melanoma Mismatch Repair Deficiency Microsatellite Instability Non-Small Cell Lung Cancer Solid Tumor
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at La Jolla, California and other locations
- Dates
- study startedcompletion around
Description
Summary
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.
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
Details
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.
Keywords
Cancer, Melanoma (Skin), Mismatch Repair Deficiency, Microsatellite Instability, Non-melanoma Skin Cancer, Cutaneous Melanoma, NSCLC, Oncolytic virus, Oncolytic Immuno-gene therapy, Anti-PD1 failed, Melanoma, Skin Neoplasms, Cutaneous Malignant Melanoma, Nivolumab, RP1 (IT) and nivolumab (IV) in melanoma, RP1 (IT) and nivolumab (IV) in MSI-H/dMMR solid tumors, RP1 (IT) and nivolumab (IV) in NMSC
Eligibility
You can join if…
Open to people ages 18 years and up
- 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.
You CAN'T join if...
- 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
Locations
- UC San Diego
in progress, not accepting new patients
La Jolla California 92093 United States - University of California, Irvine
accepting new patients
Orange California 92868 United States - UCLA
accepting new patients
Los Angeles California 90095 United States
Details
- Status
- accepting new patients at some sites,
but this study is not currently recruiting here - Start Date
- Completion Date
- (estimated)
- Sponsor
- Replimune Inc.
- ID
- NCT03767348
- Phase
- Phase 2 research study
- Study Type
- Interventional
- Participants
- Expecting 340 study participants
- Last Updated