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)

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Updated on 23 November 2020

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cancer

systemic therapy

measurable disease

carcinoma

karnofsky performance status

programmed cell death 1 ligand 1

renal function tests

metastatic renal cell carcinoma

clear cell renal cell carcinoma

renal cell cancer

unresectable renal cell carcinoma

Summary

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.

Description

Details

Condition	Renal Cell Carcinoma, Renal Cell Carcinoma, Renal Cell Cancer, Renal Cell Cancer, Renal Cancer, RCC
Clinical Study Identifier	TX257018
Last Modified on	23 November 2020

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Eligibility		Yes	No	Not Sure
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
	Received treatment of approved anti PD-1 or anti-PD-L1 (dosed per label of the country providing the clinical site) for at least 12 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

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Study Definition

Wikipedia

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)