Non-Small Cell Lung Cancer (NSCLC)Microsatellite Instability-High (MSI-H)Non-melanoma Skin Cancer (NMSC)Cutaneous Melanoma
Investigational drug(s) / intervention(s)
RP1nivolumab
RP1: Genetically modified herpes simplex type 1 virus
nivolumab: anti-PD-1 monoclonal antibody
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key 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.
Key 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
Primary outcome measure(s)
Percentage of adverse events (AEs) — 26 months Percentage of subjects with adverse events (AEs)
Percentage of serious adverse events (SAEs) — 26 months Percentage of subjects with serious adverse events (SAEs)
Percentage of dose limiting toxicities (DLTs) — 26 months Percentage of subjects with dose limiting toxicities (DLTs)
Percentage of overall response rate (ORR) — 26 months Percentage of overall response rate (ORR) for all participants
Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1 — 20 weeks Assess the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1 based on the safety and response data collected during Phase 1 Escalation
Trial sites (51)
Facility
City
Region
Status
University of Birmingham Alabama
Birmingham
Alabama
Banner MD Anderson Cancer Center
Gilbert
Arizona
Mayo Clinic
Phoenix
Arizona
Carti Cancer Center
Little Rock
Arkansas
UC San Diego
La Jolla
California
University of Southern California
Los Angeles
California
UCLA
Los Angeles
California
University of California, Irvine
Orange
California
University of California- San Francisco
San Francisco
California
Sylvester Comprehensive Cancer Center- University of Miami
Miami
Florida
University of Iowa-Cancer Center Research
Iowa City
Iowa
James Graham Brown Cancer Center- University of Louisville
Louisville
Kentucky
Mayo Clinic
Rochester
Minnesota
New York University Clinical Cancer Center
New York
New York
Weill Cornell Medical College
New York
New York
University of Rochester Medical Center
Rochester
New York
Duke Cancer Center
Durham
North Carolina
University of Cincinnati Medical Center
Cincinnati
Ohio
Providence Portland Medical Center
Portland
Oregon
MUSC Health
Charleston
South Carolina
West Cancer Center
Germantown
Tennessee
The University of Texas MD Anderson Cancer Center
Houston
Texas
Eccles Outpatient Care Center- Oncology Clinical Trials
Murray
Utah
Intermountain Cancer Center- Saint George Cancer Center
St. George
Utah
Seattle Cancer Care Alliance- University of Washington
Seattle
Washington
University of Wisconsin-Carbone Cancer Center
Madison
Wisconsin
CHU Besancon - Hopital Jean Minjoz
Besançon
France
Institut Bergonié
Bordeaux
France
CHU Dijon
Dijon
France
Centre Léon Bérard Lyon
Lyon
France
Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone
Marseille
France
CHU de Nice Hôpital l'Archet
Nice
France
Hôpital Saint Louis APHP
Paris
France
Institut Gustave Roussy
Villejuif
France
Charité (Campus Benjamin Franklin)
Berlin
Germany
University Hospital Essen, Klinik für Dermatologie
Essen
Germany
University of Kiel (UKSH), Dep. of Dermatology
Kiel
Germany
Uniklinik Marburg
Marburg
Germany
Hospital Universitari Vall d'Hebron
Barcelona
Spain
Hospital Clinic Barcelona
Barcelona
Spain
+ 11 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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