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Brief Title: Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

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

INTRODUCTION

  • Org Study ID: RPL-001-16
  • Secondary ID: N/A
  • NCT ID: NCT03767348
  • Sponsor: Replimune Inc.

BRIEF 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.

DETAILED DESCRIPTION

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.

  • Overall Status
    Recruiting
  • Start Date
    September 20, 2017
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Cancer
  • Melanoma (Skin)
  • Mismatch Repair Deficiency
  • Microsatellite Instability
  • Non-melanoma Skin Cancer
  • Cutaneous Melanoma
  • NSCLC

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Jeannie Hou, MD

Role: Study Director

Affiliation: Replimune Inc.

Overall Contact

Name: Clinical Trials at Replimune

Phone: 1-781-222-9570

Email: Clinicaltrials@replimune.com

LOCATION

Facility Status Contact

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