A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma

October 26, 2022 updated by: SillaJen, Inc.

A Phase 1b/2a Dose-escalation and Safety/Efficacy Evaluation Study of Pexa-Vec (Thymidine Kinase-Deactivated Vaccinia Virus Plus GM-CSF) in Combination With Cemiplimab (REGN2810; Anti-PD-1) in Patients With Metastatic or Unresectable Renal Cell Carcinoma (RCC)

This is a Phase 1b/2a, open-label, multi-center, dose-escalation and safety/efficacy evaluation trial of Pexa-Vec plus Cemiplimab in patients with metastatic or unresectable renal cell carcinoma (RCC). The trial consists of a dose-escalation stage, where the maximum feasible dose of Pexa-Vec in combination with Cemiplimab will be determined, followed by an expansion stage. During the expansion patients will receive Cemiplimab alone or in combination with Pexa-Vec, which will be administered either through intravenous (IV) or intratumoral (IT) injection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bedford Park, Australia, SA5042
        • Site 2632 Flinders Medical Centre
  • Korea, Republic of
      • Daegu, Korea, Republic of, 41404
        • Site 2612 Kyungpook National University Chilgok Hospital
      • Daejeon, Korea, Republic of, 35015
        • Site 2616 Chungnam National University Hospital
      • Gwangju, Korea, Republic of, 58128
        • Site 2618 Chonnam National University Hwasun Hospital
      • Incheon, Korea, Republic of
        • Site 2622 Gachon University Gil Medical Center
      • Pusan, Korea, Republic of, 49201
        • Site 2613 Dong-A University Hospital
      • Pusan, Korea, Republic of, 49241
        • Site 2619 Pusan National University Hospital
      • Seongnam, Korea, Republic of, 35015
        • Site 2617 CHA University, CHA Bundang Medical Center
      • Seongnam-si, Korea, Republic of, 13620
        • Site 2620 Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 02841
        • Site 2615 Korea University Anam Hospital
      • Seoul, Korea, Republic of, 03722
        • Site 2610 Severance Hospital, Yonsei University Health System
      • Suwon, Korea, Republic of, 16499
        • Site 2623 Ajou University Hospital
      • Wŏnju, Korea, Republic of, 50612
        • Site 2625 Wonju Severance Christian Hospital
      • Yangsan, Korea, Republic of, 50612
        • Site 2624 Pusan National University Yangsan Hospital
  • United States
    • California
      • Irvine, California, United States, 92868
        • Site 2644 University of California, Irvine
    • Florida
      • Miami, Florida, United States, 33136
        • Site 2641 University of Miami
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Site 2643 Washington University
    • Ohio
      • Columbus, Ohio, United States, 43201
        • Site 2646 The Ohio State University

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic or unresectable clear cell renal cell carcinoma (ccRCC)

  • Part 2 Arm D ONLY: Patients must be refractory to anti PD-1 or anti-PD-L1 (either as monotherapy or in-combination with other approved checkpoint inhibitors or targeted therapies according to their approved label) and patients must meet all of the following criteria:

    1. Received treatment of approved anti PD-1 or anti-PD-L1 (dosed per label of the country providing the clinical site) for at least 6 weeks. History of anti-PD-L1 only is not allowed.
    2. Progressive disease after anti PD-1 or anti-PD-L1 will be defined according to RECIST 1.1. The initial evidence of progressive disease is to be confirmed by a second assessment, no less than 4 weeks from the date of the first documented progressive disease, in the absence of rapid clinical progression. (This determination is made by the Investigator; the Sponsor will collect imaging scans for retrospective analysis. Once progressive disease is confirmed, the initial date of progressive disease documentation will be considered the date of disease progression).
    3. Documented disease progression within 12 weeks of the last dose of anti PD-1 or anti-PD-L1. Patients who were re-treated or on maintenance with anti-PD-1 or anti-PD-L1 will be allowed to enter the study as long as there is documented progressive disease within 12 weeks of the last treatment date.
  • Naive to systemic therapy for RCC or have progressed after, or were intolerant of, prior systemic therapy.
  • Measurable disease based on RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
  • Karnofsky performance status of 70-100
  • Age ≥20 years old (or appropriate age of consent for the region)
  • Adequate hematological, hepatic, and renal function

Exclusion Criteria:

  • Known significant immunodeficiency due to underlying illness (e.g., human immunodeficiency virus [HIV] / acquired immune deficiency syndrome [AIDS]) and/or immune-suppressive medication including high-dose corticosteroids
  • Part 2 only: Arm A,B,C: Prior treatment with any anti-cancer immunotherapy, including therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent (prior IL-2 or interferon allowed) . For Part 1: patients are excluded if they were intolerant to anti-PD-1 or anti-PD-L1 targeted therapies
  • Major surgery within 4 weeks of study treatment (minor surgical procedures are allowed)
  • Ongoing severe inflammatory skin condition requiring prior medical treatment
  • History of eczema requiring prior medical treatment
  • Tumor(s) invading a major vascular structure (e.g., carotid artery) or other key anatomical structure (e.g., pulmonary airway) OR viable central nervous system malignancy
  • Clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural effusions.
  • Symptomatic cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months.
  • Asymptomatic cardiovascular disease (current or past history) unless cardiology consultation and clearance has been obtained for study participation.
  • Inability to suspend treatment with anti-hypertensive medication for 48 hours prior to and 48 hours after all Pexa-Vec treatments
  • Use of interferon/pegylated interferon (PEG-IFN) or ribavirin that cannot be discontinued within 14 days prior to any Pexa-Vec dose
  • Known active Hepatitis B or Hepatitis C

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Part 1, Dose escalation

Pexa-Vec will be administered via IV infusion at a dose of 3 x 10^8 pfu once per week for 4 treatments. Based on the occurrence of dose-limiting toxicities, patients may subsequently be enrolled to receive Pexa-Vec on the same schedule at a dose of 1 x 10^9 pfu.

Cemiplimab will be administered via IV infusion every 3 weeks.
Biological: Pexastimogene Devacirepvec (Pexa-Vec)
Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells
Other Names:
  • JX-594
Biological: Cemiplimab
Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)
EXPERIMENTAL: Part 2-Arm A, Pexa-Vec (IT) and Cemiplimab

Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments.

Cemiplimab will be administered via IV infusion every 3 weeks.
Biological: Pexastimogene Devacirepvec (Pexa-Vec)
Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells
Other Names:
  • JX-594
Biological: Cemiplimab
Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)
EXPERIMENTAL: Part 2-Arm B, Cemiplimab

Cemiplimab will be administered via IV infusion every 3 weeks.

At disease progression, Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will continue every 3 weeks.
Biological: Pexastimogene Devacirepvec (Pexa-Vec)
Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells
Other Names:
  • JX-594
Biological: Cemiplimab
Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)
EXPERIMENTAL: Part 2-Arm C, Pexa-Vec (IV) and Cemiplimab

Pexa-Vec will be administered via IV infusion once per week for 4 treatments.

Cemiplimab will be administered via IV infusion every 3 weeks.
Biological: Pexastimogene Devacirepvec (Pexa-Vec)
Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells
Other Names:
  • JX-594
Biological: Cemiplimab
Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)
EXPERIMENTAL: Part 2-Arm D, Pexa-Vec (IV) and Cemiplimab

Pexa-Vec will be administered via IV infusion once per week for 4 treatments.

Cemiplimab will be administered via IV infusion every 3 weeks.
Biological: Pexastimogene Devacirepvec (Pexa-Vec)
Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells
Other Names:
  • JX-594
Biological: Cemiplimab
Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose(MTD) / Maximum feasible dose (MFD)
Time Frame: 36 days after first treatment
MTD/MFD of Pexa-Vec administered by IV infusion in combination with Cemiplimab
36 days after first treatment
Severity and frequency of adverse events to determine safety of Pexa-Vec administered by IV infusions or IT injections in combination with IV Cemiplimab
Time Frame: From date of first treatment until 28 days after last treatment
Safety will be determined by assessing the severity and frequency of adverse events and laboratory toxicity using CTCAE v4.03
From date of first treatment until 28 days after last treatment
Overall response rate
Time Frame: Every 9 weeks, then every 12 weeks after 1 year until date of first documented progression, up to 72 months
Evaluate anti-tumor activity and efficacy of IV or IT Pexa-Vec combined with IV Cemiplimab with respect to overall response rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Every 9 weeks, then every 12 weeks after 1 year until date of first documented progression, up to 72 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Progression free survival
Time Frame: Every 9 weeks, then every 12 weeks after 1 year until date of first documented progression, up to 72 months
Every 9 weeks, then every 12 weeks after 1 year until date of first documented progression, up to 72 months
Disease control rate
Time Frame: Every 9 weeks, then every 12 weeks after 1 year until date of first documented progression, up to 72 months
Every 9 weeks, then every 12 weeks after 1 year until date of first documented progression, up to 72 months
Best radiographic response
Time Frame: Every 9 weeks, then every 12 weeks after 1 year until date of first documented progression, up to 72 months
Every 9 weeks, then every 12 weeks after 1 year until date of first documented progression, up to 72 months
Overall survival
Time Frame: Every 9 weeks, then every 12 weeks after 1 year until date of death from any cause, up to 72 months
Every 9 weeks, then every 12 weeks after 1 year until date of death from any cause, up to 72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SillaJen, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Regeneron Pharmaceuticals

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 Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JX594-REN026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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