A Study of Recombinant Vaccinia Virus in Combination With REGN2810 for Renal Cell Carcinoma



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/8/2019
Start Date:June 7, 2018
End Date:September 2020
Contact:Angelica Craighead
Email:patient_inquiry@sillajen.com
Phone:(415) 814-9865

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A Phase 1b, Dose-escalation Study of Pexa-Vec (Thymidine Kinase-Deactivated Vaccinia Virus Plus GM-CSF) in Combination With REGN2810 (Anti-PD-1) in Patients With Metastatic or Unresectable Renal Cell Carcinoma (RCC)

This is a Phase 1b, open-label, multi-center, dose-escalation trial of Pexa-Vec plus REGN2810
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
REGN2810 will be determined, followed by an expansion stage. During the expansion patients
will receive REGN2810 alone or in combination with Pexa-Vec, which will be administered
either through intravenous (IV) or intratumoral (IT) injection.


Inclusion Criteria:

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

- 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: 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
We found this trial at
3
sites
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Jaime Merchan, MD
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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Bedford Park,
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801 North 29th Street
Billings, Montana 59107
406-238-2500
Principal Investigator: Jesus Fabregas, MD
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Billings, MT
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