ACTIVE_NOT_RECRUITING

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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 [IGNYTE]

Quick Facts

Study Start:2017-09-20
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03767348

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
  2. * At least one measurable and injectable lesion
  3. * Have provided a former tumor pathology specimen or be willing to supply a new tumor sample from a biopsy
  4. * Have a predicted life expectancy of ≥ 3 months
  5. * Measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
  6. * 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.
  7. * 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.
  8. * 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
  9. * 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.
  1. * Prior treatment with an oncolytic therapy
  2. * History of viral infections according to the protocol
  3. * Prior complications with herpes infections
  4. * Chronic use of anti-virals
  5. * Uncontrolled/untreated brain metastasis
  6. * History of interstitial lung disease
  7. * History of non-infectious pneumonitis
  8. * History of clinically significant cardiovascular disease

Contacts and Locations

Principal Investigator

Jeannie Hou, MD
STUDY_DIRECTOR
Replimune Inc.

Study Locations (Sites)

University of Birmingham Alabama
Birmingham, Alabama, 35294
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
Mayo Clinic
Phoenix, Arizona, 85054
United States
Carti Cancer Center
Little Rock, Arkansas, 72205
United States
UC San Diego
La Jolla, California, 92093
United States
University of Southern California
Los Angeles, California, 90033
United States
UCLA
Los Angeles, California, 90095
United States
University of California, Irvine
Orange, California, 92868
United States
University of California- San Francisco
San Francisco, California, 94115
United States
Sylvester Comprehensive Cancer Center- University of Miami
Miami, Florida, 33136
United States
University of Iowa-Cancer Center Research
Iowa City, Iowa, 52242
United States
James Graham Brown Cancer Center- University of Louisville
Louisville, Kentucky, 40202
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
New York University Clinical Cancer Center
New York, New York, 10016
United States
Weill Cornell Medical College
New York, New York, 10065
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Duke Cancer Center
Durham, North Carolina, 27710
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
MUSC Health
Charleston, South Carolina, 29425
United States
West Cancer Center
Germantown, Tennessee, 38138
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Eccles Outpatient Care Center- Oncology Clinical Trials
Murray, Utah, 84107
United States
Intermountain Cancer Center- Saint George Cancer Center
St. George, Utah, 84790
United States
Seattle Cancer Care Alliance- University of Washington
Seattle, Washington, 98109
United States
University of Wisconsin-Carbone Cancer Center
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Replimune Inc.

  • Jeannie Hou, MD, STUDY_DIRECTOR, Replimune Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-09-20
Study Completion Date2028-12

Study Record Updates

Study Start Date2017-09-20
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • RPL-001-16
  • Stage IIIb-IV Unresectable Melanoma
  • Non-melanoma Skin Cancer
  • Mismatch Repair Deficient (dMMR) Solid Tumors

Additional Relevant MeSH Terms

  • Non-Small Cell Lung Cancer (NSCLC)
  • Microsatellite Instability-High (MSI-H)
  • Non-melanoma Skin Cancer (NMSC)
  • Cutaneous Melanoma