Pexastimogene Devacirepvec (Pexa-Vec) for Kidney Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by SillaJen, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of first treatment until 28 days after last treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination treatment for renal cell carcinoma that has spread or cannot be removed by surgery. The trial will find the highest dose of the new treatment that is safe, and then test how well it works.

Eligible Conditions

Kidney Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first treatment until 28 days after last treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first treatment until 28 days after last treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first treatment until 28 days after last treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose(MTD) / Maximum feasible dose (MFD)

Overall response rate

Severity and frequency of adverse events to determine safety of Pexa-Vec administered by IV infusions or IT injections in combination with IV Cemiplimab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Part 2-Arm D, Pexa-Vec (IV) and CemiplimabExperimental Treatment2 Interventions

Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks.

Group II: Part 2-Arm C, Pexa-Vec (IV) and CemiplimabExperimental Treatment2 Interventions

Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks.

Group III: Part 2-Arm B, CemiplimabExperimental Treatment2 Interventions

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.

Group IV: Part 2-Arm A, Pexa-Vec (IT) and CemiplimabExperimental Treatment2 Interventions

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.

Group V: Part 1, Dose escalationExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

FDA approved

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