Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT03767348

Rekrutierung

IGNYTE: Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

Interventionsstudie

Phase 2

Mayo Clinic

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.

Detaillierte Beschreibung anzeigen

Behandlungskategorie

Andere Medikamente, Checkpoint-Inhibitoren

Erforderliche Mutationen

MSI

Studie gestartet

2017-09-20

Zuletzt vom Sponsor aktualisiert

2025-01-24

Voraussichtlicher Abschluss

2025-12-01

Eignung

Einschlusskriterien

* 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.

Ausschlusskriterien

* 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

Glauben Sie, dass diese klinische Studie fälschlicherweise angezeigt wird?

Design-Details

ZuteilungNon-Randomized

InterventionsmodellParallel Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer340

Arme & Interventionen

Arme

Interventionen

Typ: Experimental

Beschreibung: Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with melanoma

Interventionen:

RP1
nivolumab

Ergebnismessungen

Primäre Ergebnismessungen

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 RP120 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

Sekundäre Ergebnismessungen

Percentage of biologic activity20 weeks

Percentage of subjects with biological activity determined by tumor biopsies and biomarker data

Percentage subjects with detectable RP120 weeks

Data gathered from blood, urine, swabs of injection site, dressings, and oral mucosa to determine the shedding and biodistribution of RP1

Percentage of complete response (CR)26 months

Percentage of subjects with a complete response (CR)

Median duration of response26 months

Median duration of response of subjects

Median progression-free survival26 months

Median duration of progression-free survival of subjects

Median overall survival26 months

Median overall survival rate of subjects

Studie vormerken

Studie teilen

Studie herunterladen

Interessiert an einer Teilnahme?

Erfahren Sie mehr über diese Studie und ob Sie für eine Teilnahme in Frage kommen.

Glauben Sie, dass diese klinische Studie fälschlicherweise angezeigt wird?

Studie melden

Studie herunterladen

Studienzentren

Diese Studie hat 21 Studienzentren

Mayo Clinic
Rochester, Minnesota, US

Rekrutierend

Rochester, Minnesota, 55905 US

Mayo Clinic

Rekrutierend

Rochester, New York, 14642 US

University of Rochester Medical Center

Rekrutierend

Houston, Texas, 77030 US

The University of Texas MD Anderson Cancer Center

Rekrutierend

Los Angeles, California, 90033 US

University of Southern California

Rekrutierend

New York, New York, 10065 US

Weill Cornell Medical College

Rekrutierend

Los Angeles, California, 90095 US

UCLA

Rekrutierend

Morristown, New Jersey, 07960 US

Atlantic Health System

Rekrutierend

Gilbert, Arizona, 85234 US

Banner MD Anderson Cancer Center

Rekrutierend

Germantown, Tennessee, 38138 US

West Cancer Center

Rekrutierend

Orange, California, 92868 US

University of California, Irvine

Rekrutierend

Phoenix, Arizona, 85054 US

Mayo Clinic

Rekrutierend

Durham, North Carolina, 27710 US

Duke Cancer Center

Rekrutierend

Cincinnati, Ohio, 45267 US

University of Cincinnati Medical Center

Rekrutierend

Little Rock, Arkansas, 72205 US

Carti Cancer Center

Rekrutierend

San Francisco, California, 94115 US

University of California- San Francisco

Rekrutierend

Iowa City, Iowa, 52242 US

University of Iowa-Cancer Center Research

Rekrutierend

Louisville, Kentucky, 40202 US

James Graham Brown Cancer Center- University of Louisville

Rekrutierend

Murray, Utah, 84107 US

Eccles Outpatient Care Center- Oncology Clinical Trials

Rekrutierend

Seattle, Washington, 98109 US

Seattle Cancer Care Alliance- University of Washington

Rekrutierend

Charleston, South Carolina, 29425 US

MUSC Health

Rekrutierend

St. George, Utah, 84790 US

Intermountain Cancer Center- Saint George Cancer Center

Loading Maps...