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Cancer Vaccine
Cemiplimab 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
Study 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
Best radiographic response
Disease control rate
Overall survival
+1 moreTrial 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
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsIndustry Sponsor
628 Previous Clinical Trials
382,153 Total Patients Enrolled
SillaJen, Inc.Lead Sponsor
2 Previous Clinical Trials
579 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have not received any previous treatment for kidney cancer, or if you have, it did not work well or caused intolerable side effects.You are able to perform daily activities with minimal to no difficulty.You have a serious skin condition that is currently being treated by a doctor.You have had eczema in the past and needed medical treatment for it.Your tumor is invading important blood vessels or crucial body structures, like the carotid artery or airway in the lungs. Additionally, if you have a malignant tumor in your central nervous system, you will not be able to participate.You have a significant amount of fluid buildup in your abdomen, heart, or lungs that is causing health problems.You are currently taking interferon/pegylated interferon or ribavirin, and you cannot stop taking them for at least 14 days before receiving any Pexa-Vec treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1, Dose escalation
- Group 2: Part 2-Arm A, Pexa-Vec (IT) and Cemiplimab
- Group 3: Part 2-Arm B, Cemiplimab
- Group 4: Part 2-Arm C, Pexa-Vec (IV) and Cemiplimab
- Group 5: Part 2-Arm D, Pexa-Vec (IV) and Cemiplimab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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