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Cancer-Killing virus plus immunotherapy shows promise in kidney cancer trial

NCT ID NCT03294083

Disease control Sponsor: SillaJen, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a combination of two experimental treatments for people with advanced kidney cancer that cannot be removed by surgery. The first is Pexa-Vec, a modified virus designed to infect and destroy cancer cells while also boosting the immune system. The second is cemiplimab, an immunotherapy drug that helps the immune system recognize and attack cancer. The trial involved 95 participants and aimed to find the safest dose and measure how well the combination shrinks tumors. Results will help determine if this approach is worth testing in larger studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pexa-Vec (a modified virus that infects and kills cancer cells) and cemiplimab (an immunotherapy drug that helps the immune system attack cancer)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced kidney cancer that hasn't responded to other therapies.
What could go wrong
This is an early-phase trial (phase 1b/2a) with only 95 participants, so results may not apply to everyone. The virus-based therapy can cause flu-like symptoms and other side effects, and the combination may not work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

95 people

The number who actually took part.

Started

Jun 2018

Finished

Feb 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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). 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 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 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

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Conditions

The condition(s) this trial relates to.

clear cell renal carcinoma neoplasm nonpapillary renal cell carcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Renal cell carcinoma

Contacts and locations

Locations

  • Site 2610 Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Site 2612 Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • Site 2613 Dong-A University Hospital

    Pusan, 49201, South Korea

  • Site 2614 Gyeongsang National University Hospital

    Jinju, 52727, South Korea

  • Site 2615 Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Site 2616 Chungnam National University Hospital

    Daejeon, 35015, South Korea

  • Site 2617 CHA University, CHA Bundang Medical Center

    Seongnam, 35015, South Korea

  • Site 2618 Chonnam National University Hwasun Hospital

    Gwangju, 58128, South Korea

  • Site 2619 Pusan National University Hospital

    Pusan, 49241, South Korea

  • Site 2620 Seoul National University Bundang Hospital

    Seongnam-si, 13620, South Korea

  • Site 2622 Gachon University Gil Medical Center

    Incheon, South Korea

  • Site 2623 Ajou University Hospital

    Suwon, 16499, South Korea

  • Site 2624 Pusan National University Yangsan Hospital

    Yangsan, 50612, South Korea

  • Site 2625 Wonju Severance Christian Hospital

    Wŏnju, 50612, South Korea

  • Site 2631

    Camperdown, Australia

  • Site 2632 Flinders Medical Centre

    Bedford Park, SA5042, Australia

  • Site 2641 University of Miami

    Miami, Florida, 33136, United States

  • Site 2642 Billings Clinic

    Billings, Montana, 59101, United States

  • Site 2643 Washington University

    St Louis, Missouri, 63141, United States

  • Site 2644 University of California, Irvine

    Irvine, California, 92868, United States

  • Site 2646 The Ohio State University

    Columbus, Ohio, 43201, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.