Status:
ACTIVE_NOT_RECRUITING
A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma
Lead Sponsor:
SillaJen, Inc.
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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)...
Eligibility Criteria
Inclusion
- 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 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
- 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
Key Trial Info
Start Date :
June 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT03294083
Start Date
June 7 2018
End Date
November 1 2023
Last Update
October 27 2022
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Site 2644 University of California, Irvine
Irvine, California, United States, 92868
2
Site 2641 University of Miami
Miami, Florida, United States, 33136
3
Site 2643 Washington University
St Louis, Missouri, United States, 63141
4
Site 2646 The Ohio State University
Columbus, Ohio, United States, 43201