Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

INTRODUCTION

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

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.

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 Outcome 1 - Measure: Percentage of adverse events (AEs)

Primary Outcome 1 - Timeframe: 26 months

Primary Outcome 2 - Measure: Percentage of serious adverse events (SAEs)

Primary Outcome 2 - Timeframe: 26 months

Primary Outcome 3 - Measure: Percentage of dose limiting toxicities (DLTs)

Primary Outcome 3 - Timeframe: 26 months

Primary Outcome 4 - Measure: Percentage of overall response rate (ORR)

Primary Outcome 4 - Timeframe: 26 months

Primary Outcome 5 - Measure: Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1

Primary Outcome 5 - Timeframe: 20 weeks

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

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

Name: Jeannie Hou, MD

Role: Study Director

Affiliation: Replimune Inc.

Name: Clinical Trials at Replimune

Phone: 1-781-222-9570

Email: [email protected]

Facility	Status	Contact
Facility: Banner MD Anderson Cancer Center Gilbert, Arizona 85234 United States	Status: Recruiting	Contact: Contact Jenesse Moffett Principal Investigator Jiaxin Niu, MD
Facility: Mayo Clinic Phoenix, Arizona 85054 United States	Status: Recruiting	Contact: Principal Investigator Mahesh Seetharam, MD
Facility: Carti Cancer Center Little Rock, Arkansas 72205 United States	Status: Recruiting	Contact: Principal Investigator Issam Makhoul, MD
Facility: University of Southern California Los Angeles, California 90033 United States	Status: Recruiting	Contact: Contact Gino In, MD
Facility: UCLA Los Angeles, California 90095 United States	Status: Recruiting	Contact: Contact Danell Johnson Principal Investigator Bartosz Chmielowski, MD
Facility: University of California, Irvine Orange, California 92868 United States	Status: Recruiting	Contact: Principal Investigator John Fruehauf, MD
Facility: University of California- San Francisco San Francisco, California 94115 United States	Status: Recruiting	Contact: Contact Melissa Chow Principal Investigator Katy Tsai, MD
Facility: University of Iowa-Cancer Center Research Iowa City, Iowa 52242 United States	Status: Recruiting	Contact: Contact Mariel McKay Principal Investigator Mohammed Milhem, MBBS
Facility: James Graham Brown Cancer Center- University of Louisville Louisville, Kentucky 40202 United States	Status: Recruiting	Contact: Contact Stacy Baum Principal Investigator Jason Chesney, MD
Facility: Mayo Clinic Rochester, Minnesota 55905 United States	Status: Recruiting	Contact: Principal Investigator Robert McWilliams, MD
Facility: Atlantic Health System Morristown, New Jersey 07960 United States	Status: Recruiting	Contact: Contact Eric Whitman, MD
Facility: Weill Cornell Medical College New York, New York 10065 United States	Status: Recruiting	Contact: Principal Investigator Anna Pavlick, DO
Facility: University of Rochester Medical Center Rochester, New York 14642 United States	Status: Recruiting	Contact: Contact Delaney Dretto Contact Janice Cifelli Principal Investigator Rachael Turner, MD
Facility: Duke Cancer Center Durham, North Carolina 27710 United States	Status: Recruiting	Contact: Contact Georgia Beasley, MD
Facility: University of Cincinnati Medical Center Cincinnati, Ohio 45267 United States	Status: Recruiting	Contact: Principal Investigator Trisha Wise-Draper, MD
Facility: MUSC Health Charleston, South Carolina 29425 United States	Status: Recruiting	Contact: Contact John Kaczmar, MD
Facility: West Cancer Center Germantown, Tennessee 38138 United States	Status: Recruiting	Contact: Contact Alisa Harber Principal Investigator Ari Vanderwalde, MD
Facility: The University of Texas MD Anderson Cancer Center Houston, Texas 77030 United States	Status: Recruiting	Contact: Principal Investigator ADi Diab, MD
Facility: Eccles Outpatient Care Center- Oncology Clinical Trials Murray, Utah 84107 United States	Status: Recruiting	Contact: Contact Tawnya Bowles Principal Investigator Tawnya Bowles, MD
Facility: Intermountain Cancer Center- Saint George Cancer Center Saint George, Utah 84790 United States	Status: Recruiting	Contact: Contact Angi Cox Principal Investigator Terence Rhodes, MD
Facility: Seattle Cancer Care Alliance- University of Washington Seattle, Washington 98109 United States	Status: Recruiting	Contact: Contact Katie Kim Principal Investigator Evan Hall, MD

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

BRIEF SUMMARY

DETAILED DESCRIPTION

PRIMARY OUTCOMES

CONDITION

ELIGIBILITY

OFFICIAL INFORMATION

Overall Contact

LOCATION

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