Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT03767348

Recruiting

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

Interventional

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.

Show Detailed Description

Treatment Category

Other Drugs, Checkpoint Inhibitors

Required Mutations

MSI

Trial Started

2017-09-20

Last Updated by Sponsor

2025-01-24

Estimated Completion

2025-12-01

Eligibility

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

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Design Details

AllocationNon-Randomized

Intervention ModelParallel Assignment

MaskingNone (Open Label)

Number to Enroll340

Arms & Interventions

Arms

Interventions

Type: Experimental

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

Interventions:

RP1
nivolumab

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

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Trial Sites

This study has 21 trial sites

Mayo Clinic
Rochester, Minnesota, US

Recruiting

Rochester, Minnesota, 55905 US

Mayo Clinic

Recruiting

Rochester, New York, 14642 US

University of Rochester Medical Center

Recruiting

Houston, Texas, 77030 US

The University of Texas MD Anderson Cancer Center

Recruiting

Los Angeles, California, 90033 US

University of Southern California

Recruiting

New York, New York, 10065 US

Weill Cornell Medical College

Recruiting

Los Angeles, California, 90095 US

UCLA

Recruiting

Morristown, New Jersey, 07960 US

Atlantic Health System

Recruiting

Gilbert, Arizona, 85234 US

Banner MD Anderson Cancer Center

Recruiting

Germantown, Tennessee, 38138 US

West Cancer Center

Recruiting

Orange, California, 92868 US

University of California, Irvine

Recruiting

Phoenix, Arizona, 85054 US

Mayo Clinic

Recruiting

Durham, North Carolina, 27710 US

Duke Cancer Center

Recruiting

Cincinnati, Ohio, 45267 US

University of Cincinnati Medical Center

Recruiting

Little Rock, Arkansas, 72205 US

Carti Cancer Center

Recruiting

San Francisco, California, 94115 US

University of California- San Francisco

Recruiting

Iowa City, Iowa, 52242 US

University of Iowa-Cancer Center Research

Recruiting

Louisville, Kentucky, 40202 US

James Graham Brown Cancer Center- University of Louisville

Recruiting

Murray, Utah, 84107 US

Eccles Outpatient Care Center- Oncology Clinical Trials

Recruiting

Seattle, Washington, 98109 US

Seattle Cancer Care Alliance- University of Washington

Recruiting

Charleston, South Carolina, 29425 US

MUSC Health

Recruiting

St. George, Utah, 84790 US

Intermountain Cancer Center- Saint George Cancer Center

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