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.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | September 20, 2017 | Phase 1/Phase 2 | Interventional |
Primary Outcome 1 - Measure: Percentage of adverse events (AEs)
Primary Outcome 1 - Time Frame: 26 months
Primary Outcome 2 - Measure: Percentage of serious adverse events (SAEs)
Primary Outcome 2 - Time Frame: 26 months
Primary Outcome 3 - Measure: Percentage of dose limiting toxicities (DLTs)
Primary Outcome 3 - Time Frame: 26 months
Primary Outcome 4 - Measure: Percentage of overall response rate (ORR)
Primary Outcome 4 - Time Frame: 26 months
Primary Outcome 5 - Measure: Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1
Primary Outcome 5 - Time Frame: 20 weeks
Criteria:
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
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Selda Samakoglu, MD
Role: Study Director
Affiliation: Replimune Inc.
Name: Clinical Trials at Replimune
Phone: 1-781-222-9570
Email: Clinicaltrials@replimune.com
Facility | Status | Contact |
---|---|---|
University of Alabama- The Kirklin Clinic Birmingham, Alabama 35243 United States |
Recruiting |
Lindsey Stephens, RN 205-978-4332 lmeggs@uabmc.edu |
Banner MD Anderson Cancer Center Gilbert, Arizona 85234 United States |
Recruiting |
Jenesse Moffett 480-256-5422 Jenesse.moffett@bannerhealth.com |
University of California- San Francisco San Francisco, California 94115 United States |
Recruiting |
Melissa Chow Melissa.chow@ucsf.edu |
Yale School of Medicine- Smilow Cancer Center New Haven, Connecticut 06519 United States |
Recruiting |
Matthew Piscatelli Matthew.piscatelli@yale.edu |
Sylvester Comprehensive Cancer Center- University of Miami Miami, Florida 33136 United States |
Recruiting |
Reisy Guedes 305-243-8807 rxg957@med.miami.edu |
University of Iowa-Cancer Center Research Iowa City, Iowa 52242 United States |
Recruiting |
Mariel McKay mariel-mckay@uiowa.edu |
James Graham Brown Cancer Center- University of Louisville Louisville, Kentucky 40202 United States |
Recruiting |
Stacy Baum 502-562-2280 mary.baum@louisville.edu |
Summit Medical Group Florham Park, New Jersey 07932 United States |
Recruiting |
Michelle Mackenzie mmackenzie@smgnj.com |
New York University Clinical Cancer Center New York, New York 10016 United States |
Recruiting |
Mackenzie Tsang-Lee, RN 212-731-5431 mailto:Mackenzie.Tsang-lee@nyulangone.org |
University of Rochester Medical Center Rochester, New York 14642 United States |
Recruiting |
Delaney Dretto Delaney_Dretto@urmc.rochester.edu |
Providence Portland Medical Center Portland, Oregon 97213 United States |
Recruiting |
Melissa Pomeroy 503-215-2714 Melissa.Pomeroy@providence.org |
West Cancer Center Germantown, Tennessee 38138 United States |
Recruiting |
Alisa Harber 901-683-0055 aharber@westclinic.com |
Houston Methodist Research Institute Houston, Texas 77030 United States |
Recruiting |
Raquel Bunge rrbung2@houstonmethodist.org |
Eccles Outpatient Care Center- Oncology Clinical Trials Murray, Utah 84107 United States |
Recruiting |
Tricia Fullmer tricia.fullmer@imail.org |
Intermountain Cancer Center- Saint George Cancer Center Saint George, Utah 84790 United States |
Recruiting |
Angi Cox angi.cox@imail.org |
Seattle Cancer Care Alliance- University of Washington Seattle, Washington 98109 United States |
Recruiting |
Hannah Lee hpiek@seattlecca.org |
University of Wisconsin-Carbone Cancer Center Madison, Wisconsin 53792 United States |
Recruiting |
Amy Forsyth 608-263-6222 ajforsyth@medicine.wisc.edu |
Medical College of Wisconsin- Cancer Center Milwaukee, Wisconsin 53226 United States |
Recruiting |
Jennifer Fleischman, RN 414-805-3645 jfleischman@mcw.edu |
University of Leeds- Teaching Hospital Leeds, England LS97TF United Kingdom |
Recruiting |
leedsth-tr.oncologytrials@nhs.net |
Oxford University Hospitals NHS Trust Oxford, Oxfordshire United Kingdom |
Recruiting | |
Beatson West of Scotland Cancer Center Glasgow, Scotland G12 0YN United Kingdom |
Recruiting | |
The Clatterbridge Cancer Centre NHS Foundation Trust Bebington, Wirral CH634JY United Kingdom |
Recruiting |
+44 1515565212 joseph.sacco@nhs.net |
Royal Marsden Hospital London, United Kingdom |
Recruiting |
+44 2073528171 H&NResearchnursefulham@rmh.nhs.uk |