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Renal Cell CarcinomaPhase 1/2NCT03294083

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

A Phase 1/2 study testing Pexastimogene Devacirepvec (Pexa-Vec) and Cemiplimab in people with Renal Cell Carcinoma, run by SillaJen, Inc. at 21 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Pexastimogene Devacirepvec (Pexa-Vec) and Cemiplimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
21 sitesin 3 countries
Study dates
19 Jun 2018to 16 Feb 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.
  • Progressive disease after anti PD-1 or anti-PD-L1 will be defined according to RECIST v1.1. 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).
  • 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.
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  • Measurable disease based on RECIST v1.1 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

21 sites in 3 countries.

21 sites in 3 countries

South Korea14 sites

  • Site 2612 Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Site 2616 Chungnam National University Hospital

    Daejeon, 35015

  • Site 2618 Chonnam National University Hwasun Hospital

    Gwangju, 58128

  • Site 2622 Gachon University Gil Medical Center

    Incheon

  • Site 2614 Gyeongsang National University Hospital

    Jinju, 52727

  • Site 2613 Dong-A University Hospital

    Pusan, 49201

  • Site 2619 Pusan National University Hospital

    Pusan, 49241

  • Site 2617 CHA University, CHA Bundang Medical Center

    Seongnam, 35015

  • Site 2620 Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Site 2615 Korea University Anam Hospital

    Seoul, 02841

  • Site 2610 Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Site 2623 Ajou University Hospital

    Suwon, 16499

  • Site 2625 Wonju Severance Christian Hospital

    Wŏnju, 50612

  • Site 2624 Pusan National University Yangsan Hospital

    Yangsan, 50612

Other trials in South Korea

United States5 sites

  • Site 2642 Billings Clinic

    Billings, Montana, 59101

  • Site 2646 The Ohio State University

    Columbus, Ohio, 43201

  • Site 2644 University of California, Irvine

    Irvine, California, 92868

  • Site 2641 University of Miami

    Miami, Florida, 33136

  • Site 2643 Washington University

    St Louis, Missouri, 63141

Other trials in United States

Australia2 sites

  • Site 2632 Flinders Medical Centre

    Bedford Park, SA5042

  • Site 2631

    Camperdown

Other trials in Australia

About this study

Official title: 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.

Read the detailed description

For Pexa-Vec IV infusions (Part 1 / Part 2: Arm C and Arm D): Day -7, 1, 8, and 15), patients allocated to Part 1 or Part 2: Arm C or Arm D will receive an IV infusion of Pexa-Vec in approximately 250 mL buffered saline.

For Pexa-Vec IT Injections (Part 2 Arm A + Arm B), patients in Part 2, Arm A (and those in Arm B who progress on Cemiplimab monotherapy) will receive an IT injection of Pexa-Vec in a volume of buffered saline dependent on size of tumor(s).

For administration of Cemiplimab, Cemiplimab will be administered at a dose of 350 mg IV infusion over 30 minutes (±10 minutes) every 3 weeks per manufactures guidelines.

Being tested
Pexastimogene Devacirepvec (Pexa-Vec), Cemiplimab
Keywords
Cancer, Renal cell carcinoma, Clear cell renal cell carcinoma
Medical subject headings
Carcinoma, Renal Cell, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pexastimogene Devacirepvec (Pexa-Vec)Biological

    Also called JX-594

    Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells

  • CemiplimabBiological

    Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)

Study groups in NCT03294083
Study groupRoleWhat they receive
Part 1, Dose escalation 3 x 10^8 pfuExperimentalPexa-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 3 x 10^8 pfu. Cemiplimab will be administered via IV infusion every 3 weeks.
Receives: Biological: Pexastimogene Devacirepvec (Pexa-Vec); Biological: Cemiplimab
Part 1, Dose escalation 1 x 10^9 pfuExperimentalPexa-Vec will be administered via IV infusion at a dose of 1 x 10^9 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.
Receives: Biological: Pexastimogene Devacirepvec (Pexa-Vec); Biological: Cemiplimab
Part 2-Arm A, Pexa-Vec (IT) and CemiplimabExperimentalPexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. 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 Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)
Receives: Biological: Pexastimogene Devacirepvec (Pexa-Vec); Biological: Cemiplimab
Part 2-Arm B, CemiplimabExperimentalCemiplimab 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. 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 Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)
Receives: Biological: Pexastimogene Devacirepvec (Pexa-Vec); Biological: Cemiplimab
Part 2-Arm C, Pexa-Vec (IV) and CemiplimabExperimentalPexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. 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 Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)
Receives: Biological: Pexastimogene Devacirepvec (Pexa-Vec); Biological: Cemiplimab
Part 2-Arm D, Pexa-Vec (IV) and CemiplimabExperimentalPexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. 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 Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)
Receives: Biological: Pexastimogene Devacirepvec (Pexa-Vec); Biological: Cemiplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and Percentage of Participants With Adverse Events From Pexa-Vec Administered by IV Infusions or IT Injections in Combination With IV Cemiplimab

    Safety will be determined by assessing the incidence, severity, and frequency of all treatment-emergent adverse events (TEAEs), Grade 3 or greater AEs, serious adverse events (SAEs), laboratory toxicity, AEs requiring discontinuation of study agent(s), and deaths. The severity of all adverse events and laboratory abnormalities is assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Safety is monitored from the first dose throughout the treatment period (up to a maximum of 1 year) and up to 28 days after the last dose of study treatment.

    Measured: Through study completion without survival follow-up period, an average of 1 year

  2. Overall Response Rate

    Overall response rate (ORR) is defined as the proportion of patients whose best overall responses either complete response (CR) or partial response (PR). The best overall response is the best response recorded from the randomization until disease progression.

    Proportions of patients with a best overall response of CR, disappearance of all target tumors; or PR, at least 30% decrease in the sum of longest diameter of target tumors will be presented by treatment arm along with exact 95% CIs. Analyses will be performed based on central assessments using RECIST v1.1.

    Measured: Every 9 weeks until documented progression or discontinuation beyond documented progression. After 1 year, every 12 weeks from EOT visit, up to 36 months.

  3. Number of Participants With Dose Limiting Toxicities of Pexa-Vec Administered by IV Infusions in Combination With Cemiplimab (Part 1 Only)

    Dose-limiting toxicity (DLT) was assessed to determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of Pexa-Vec. Patients were observed for DLTs during the IV treatment phase through Day 29. DLTs are evaluated based on the severity and frequency of adverse events and laboratory abnormalities using NCI CTCAE Version 5.0.

    Measured: The 29-day cycle of therapy

Secondary outcomes (3)

  1. Progression Free Survival

    Defined as the date of the first study treatment to the date of first documented radiographic tumor progression or death due to any cause, whichever occurs first (RECIST v1.1). Progression free survival will be presented descriptively using Kaplan-Meier curves. Summary statistics from the Kaplan-Meier distributions will be determined, including median PFS and 25% and 75% quartiles with corresponding 95% CIs. The proportions of patients.

    Measured: Every 9 weeks until documented progression or discontinuation beyond documented progression. After 1 year, every 12 weeks from EOT visit, up to 36 months

  2. Disease Control Rate

    Defined as the proportion of patients whose best overall response is either complete response (CR), partial response (PR), or stable disease (SD). (RECIST v1.1)

    Measured: Every 9 weeks until documented progression or discontinuation beyond documented progression. After 1 year, every 12 weeks from EOT visit, up to 36 months

  3. Overall Survival

    Overall survival is defined as the time from first study treatment until death from any cause. For patients not known to have died at the time of the analysis, overall survival will be censored on the date they were last known to be alive. If a patient withdraws early, overall survival will not be censored at the date of withdrawal unless this is the date they were last known to be alive. Date of death will be obtained from the death certificate (preferable) or from a written statement from the primary care or attending physician, or from death registry data. Additionally, for censored date, the latest date of (in the following order): End of Treatment visit(EOT) / Last Radiologic Timepoint(LastRTP) / End of Study(EOS) / Last Drug Date(D.LastDrug) / before cutoff date(2023-02-16) is the censored date.

    Measured: Every 9 weeks until documented progression or discontinuation beyond documented progression. After 1 year, every 12 weeks from EOT visit, up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2017
  2. Study start19 Jun 2018
  3. Primary completion16 Feb 2023
  4. Study completion16 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03294083
Sponsor's protocol ID
JX594-REN026
Status last verified
May 2026
First submitted
19 Sep 2017
Last updated
18 Jun 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pexastimogene Devacirepvec (Pexa-Vec) and Cemiplimab in people with Renal Cell Carcinoma, run by SillaJen, Inc. at 21 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in South Korea, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Percentage of Participants With Adverse Events From Pexa-Vec Administered by IV Infusions or IT Injections in Combination With IV Cemiplimab (time frame: Through study completion without survival follow-up period, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03294083.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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