This study is in progress, not accepting new patients

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

a study on Lung Cancer Non-Small Cell Lung Cancer Microsatellite Instability Skin Cancer/Melanoma Solid Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
study ends around

Description

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 unresectable melanoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, non-melanoma skin cancer (NMSC), and non-small cell lung cancer (NSCLC).

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 [IGNYTE]

Keywords

Non-Small Cell Lung Cancer (NSCLC), Microsatellite Instability-High (MSI-H), Non-melanoma Skin Cancer (NMSC), Cutaneous Melanoma, RPL-001-16, Stage IIIb-IV Unresectable Melanoma, Non-melanoma Skin Cancer, Mismatch Repair Deficient (dMMR) Solid Tumors, Non-Small-Cell Lung Carcinoma, Melanoma, Turcot syndrome, 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

  • University of California, Irvine
    Orange California 92868 United States
  • UCLA
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
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