Status:
ACTIVE_NOT_RECRUITING
Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)
Lead Sponsor:
Replimune Inc.
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Non-Small Cell Lung Cancer (NSCLC)
Microsatellite Instability-High (MSI-H)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 u...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
September 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT03767348
Start Date
September 20 2017
End Date
December 1 2028
Last Update
December 17 2025
Active Locations (51)
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1
University of Birmingham Alabama
Birmingham, Alabama, United States, 35294
2
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
3
Mayo Clinic
Phoenix, Arizona, United States, 85054
4
Carti Cancer Center
Little Rock, Arkansas, United States, 72205