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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 1/Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

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

CONDITION

  • Cancer
  • Melanoma (Skin)
  • Melanoma
  • Uveal
  • Melanoma
  • Ocular
  • Bladder Cancer
  • Mismatch Repair Deficiency
  • Microsatellite Instability
  • Non-melanoma Skin Cancer

ELIGIBILITY


Inclusion Criteria:

- Must be willing and able to participate and comply with all trial requirements and
able to provide signed and dated informed consent prior to initiation of any trial
procedures

- Male or Female ≥ 18 years of age

- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

- At least one measurable and injectable lesion

- Have laboratory values (obtained ≤ 28 days prior to first infusion day) in accordance
with the study protocol

- Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test at
screening and a negative urine pregnancy test prior to administration of each dose of
RP1 or nivolumab

- WOCBP must agree to use adequate birth control throughout their participation and for
3 months after RP1 alone and 5 months after nivolumab last study treatment

- Males with partners of child-bearing potential must agree to use adequate birth
control throughout their participation and for 3 months for RP1 alone and 7 months
after nivolumab last study treatment

For Subjects in the Combination Treatment

- Baseline ECG that does not show abnormalities according to the protocol

- Baseline oxygen saturation levels that do not show abnormalities according to the
protocol

- Have provided a former tumor pathology specimen or be willing to supply a new tumor
sample from a biopsy

For Subjects in Phase 2 only

- Have a predicted life expectancy of ≥ 3 months

- Evaluable or measurable disease, according to Response Evaluation Criteria in Solid
Tumors (RECIST) v1.1 criteria,

- Subjects with melanoma: has Stage IIIb to IV (skin, eye or mucosal) for whom anti PD-1
therapy is indicated or who have previously received an anti-PD-1 therapy, or have
refused, become intolerant to or have no further therapy options available

- Subjects with MSI-H tumors: has diagnosis of MSI-H tumor (according to protocol
definition) for whom anti PD-1 therapy is indicated, or have refused, become
intolerant to or have no further therapy options available

- Subject with dMMR tumors: has diagnosis of dMMR tumor (according to protocol
definition) for whom anti PD-1 therapy is indicated, or have refused, become
intolerant to or have no further therapy options available

- Subject 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) for whom anti PD-1 therapy is indicated, or have refused,
become intolerant to or have no further therapy options available

- Subjects with bladder cancer: diagnosis of locally advanced or metastatic bladder
cancer for whom anti PD-1 therapy is indicated, or have refused, become intolerant to
or have no further therapy options available

- Subjects with cutaneous melanoma, that have confirmed progressive disease after at
least 12 weeks of anti-PD1 treatment

Exclusion Criteria:

- Prior treatment with an oncolytic therapy

- History of viral infections according to the protocol

- Systemic infection requiring IV antibiotics within 14 days prior to dosing

- Prior complications with herpes infections

- Chronic use of anti-virals

- Systemic therapies for cancer within 4 weeks of first dose (some others may be
accepted with shorter time periods)

- Conditions that require certain doses of steroids (some doses and types will be
permitted)

- Known active brain metastases - previously treated brain metastases may be permitted

- Prior certain other diagnosis of cancer

- Is participating in another clinical study or has participated in the past 4 weeks
prior to the first dose

Combination Phase Subjects

- Certain autoimmune diseases, some types will be permitted

- Allergy or sensitivity to study drug components

- History of interstitial lung disease

- History of non-infectious pnuemonitis

- Other serious or uncontrolled medical disorders

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Selda Samakoglu, MD

Role: Study Director

Affiliation: Replimune Inc.

Overall Contact

Name: Selda Samakoglu, MD

Phone: 1-781-222-9570

Email: Clinicaltrials@replimune.com

LOCATION

Facility Status Contact
Facility: University of Alabama- The Kirklin Clinic
Birmingham, Alabama 35243
United States 		Status: Recruiting Contact: Lindsey Stephens, RN
205-978-4332
lmeggs@uabmc.edu
Facility: Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States 		Status: Recruiting Contact: Jenesse Moffett
480-256-5422
Jenesse.moffett@bannerhealth.com
Facility: University of California- San Francisco
San Francisco, California 94115
United States 		Status: Recruiting Contact: Melissa Chow
Melissa.chow@ucsf.edu
Facility: Yale School of Medicine- Smilow Cancer Center
New Haven, Connecticut 06519
United States 		Status: Recruiting Contact: Matthew Piscatelli
Matthew.piscatelli@yale.edu
Facility: Sylvester Comprehensive Cancer Center- University of Miami
Miami, Florida 33136
United States 		Status: Recruiting Contact: Reisy Guedes
305-243-8807
rxg957@med.miami.edu
Facility: University of Iowa-Cancer Center Research
Iowa City, Iowa 52242
United States 		Status: Recruiting Contact: Mariel McKay
mariel-mckay@uiowa.edu
Facility: James Graham Brown Cancer Center- University of Louisville
Louisville, Kentucky 40202
United States 		Status: Recruiting Contact: Stacy Baum
502-562-2280
mary.baum@louisville.edu
Facility: Summit Medical Group
Florham Park, New Jersey 07932
United States 		Status: Recruiting Contact: Michelle Mackenzie
mmackenzie@smgnj.com
Facility: New York University Clinical Cancer Center
New York, New York 10016
United States 		Status: Recruiting Contact: Mackenzie Tsang-Lee, RN
212-731-5431
mailto:Mackenzie.Tsang-lee@nyulangone.org
Facility: University of Rochester Medical Center
Rochester, New York 14642
United States 		Status: Recruiting Contact: Delaney Dretto
Delaney_Dretto@urmc.rochester.edu
Facility: Providence Portland Medical Center
Portland, Oregon 97213
United States 		Status: Recruiting Contact: Melissa Pomeroy
503-215-2714
Melissa.Pomeroy@providence.org
Facility: West Cancer Center
Germantown, Tennessee 38138
United States 		Status: Recruiting Contact: Alisa Harber
901-683-0055
aharber@westclinic.com
Facility: Houston Methodist Research Institute
Houston, Texas 77030
United States 		Status: Recruiting Contact: Raquel Bunge
rrbung2@houstonmethodist.org
Facility: Eccles Outpatient Care Center- Oncology Clinical Trials
Murray, Utah 84107
United States 		Status: Recruiting Contact: Tricia Fullmer
tricia.fullmer@imail.org
Facility: Intermountain Cancer Center- Saint George Cancer Center
Saint George, Utah 84790
United States 		Status: Recruiting Contact: Angi Cox
angi.cox@imail.org
Facility: Seattle Cancer Care Alliance- University of Washington
Seattle, Washington 98109
United States 		Status: Recruiting Contact: Hannah Lee
hpiek@seattlecca.org
Facility: University of Wisconsin-Carbone Cancer Center
Madison, Wisconsin 53792
United States 		Status: Recruiting Contact: Amy Forsyth
608-263-6222
ajforsyth@medicine.wisc.edu
Facility: Medical College of Wisconsin- Cancer Center
Milwaukee, Wisconsin 53226
United States 		Status: Recruiting Contact: Jennifer Fleischman, RN
414-805-3645
jfleischman@mcw.edu
Facility: University of Leeds- Teaching Hospital
Leeds, England LS97TF
United Kingdom 		Status: Recruiting Contact:
leedsth-tr.oncologytrials@nhs.net
Facility: Oxford University Hospitals NHS Trust
Oxford, Oxfordshire
United Kingdom 		Status: Recruiting Contact: N/A
Facility: Beatson West of Scotland Cancer Center
Glasgow, Scotland G12 0YN
United Kingdom 		Status: Recruiting Contact: N/A
Facility: The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, Wirral CH634JY
United Kingdom 		Status: Recruiting Contact:
+44 1515565212
joseph.sacco@nhs.net
Facility: Royal Marsden Hospital
London,
United Kingdom 		Status: Recruiting Contact:
+44 2073528171
H&NResearchnursefulham@rmh.nhs.uk

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