Trial record 1 of 1 for:
Ren-026
A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03294083 |
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Recruitment Status :
Active, not recruiting
First Posted : September 26, 2017
Last Update Posted : October 27, 2022
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Sponsor:
SillaJen, Inc.
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
SillaJen, Inc.
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Brief 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). 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Renal Cell Carcinoma | Biological: Pexastimogene Devacirepvec (Pexa-Vec) Biological: Cemiplimab | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 89 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | June 7, 2018 |
| Estimated Primary Completion Date : | August 2023 |
| Estimated Study Completion Date : | November 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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 Name: JX-594 Biological: Cemiplimab Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
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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 Name: JX-594 Biological: Cemiplimab Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
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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 Name: JX-594 Biological: Cemiplimab Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
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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 Name: JX-594 Biological: Cemiplimab Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
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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 Name: JX-594 Biological: Cemiplimab Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
Primary Outcome Measures :
- 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
- 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
- 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)
Secondary Outcome Measures :
- 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 ]
- 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 ]
- 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 ]
- 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 ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic or unresectable clear cell renal cell carcinoma (ccRCC)
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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 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).
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294083
Locations
Show 18 study locations
Sponsors and Collaborators
SillaJen, Inc.
Regeneron Pharmaceuticals
| Responsible Party: | SillaJen, Inc. |
| ClinicalTrials.gov Identifier: | NCT03294083 |
| Other Study ID Numbers: |
JX594-REN026 |
| First Posted: | September 26, 2017 Key Record Dates |
| Last Update Posted: | October 27, 2022 |
| Last Verified: | August 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by SillaJen, Inc.:
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Cancer Renal cell carcinoma Clear cell renal cell carcinoma |
Additional relevant MeSH terms:
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Vaccinia Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Female Urogenital Diseases |
Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Kidney Diseases Urologic Diseases Male Urogenital Diseases Poxviridae Infections DNA Virus Infections Virus Diseases Infections Cemiplimab Antineoplastic Agents, Immunological Antineoplastic Agents |