Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

Description

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.

Conditions

Cancer, Melanoma (Skin), Mismatch Repair Deficiency, Microsatellite Instability, Non-melanoma Skin Cancer, Cutaneous Melanoma, NSCLC

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Study Overview

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Study Details

Study overview

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.

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

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

Condition
Cancer
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Birmingham Alabama, Birmingham, Alabama, United States, 35294

Gilbert

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

Phoenix

Mayo Clinic, Phoenix, Arizona, United States, 85054

Little Rock

Carti Cancer Center, Little Rock, Arkansas, United States, 72205

La Jolla

UC San Diego, La Jolla, California, United States, 92093

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Los Angeles

UCLA, Los Angeles, California, United States, 90095

Orange

University of California, Irvine, Orange, California, United States, 92868

San Francisco

University of California- San Francisco, San Francisco, California, United States, 94115

Miami

Sylvester Comprehensive Cancer Center- University of Miami, Miami, Florida, United States, 33136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Replimune Inc.,

Jeannie Hou, MD, STUDY_DIRECTOR, Replimune Inc.

Study Record Dates

2024-11