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Cancer Vaccine

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

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

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

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 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor

617 Previous Clinical Trials

380,116 Total Patients Enrolled

SillaJen, Inc.Lead Sponsor

2 Previous Clinical Trials

579 Total Patients Enrolled

Media Library

Cemiplimab (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03294083 — Phase 1 & 2

Kidney Cancer Research Study Groups: Part 1, Dose escalation, Part 2-Arm A, Pexa-Vec (IT) and Cemiplimab, Part 2-Arm B, Cemiplimab, Part 2-Arm C, Pexa-Vec (IV) and Cemiplimab, Part 2-Arm D, Pexa-Vec (IV) and Cemiplimab

Kidney Cancer Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT03294083 — Phase 1 & 2

Cemiplimab (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03294083 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many distinct venues are providing access to this research initiative?

"Patients have the opportunity to participate in this trial at Site 2641 University of Miami, Site 2646 The Ohio State University, and Site 2643 Washington University - as well as four additional medical centres."

Answered by AI

What is the uppermost participant limit for this investigation?

"Currently, no patients are being admitted to this particular trial. The study was initially made public on June 7th 2018 and last updated on October 26th 2022. If you search for alternatives, there are 2590 research studies looking for people with carcinoma or renal cell and 58 trials actively searching participants that may benefit from Cemiplimab treatment."

Answered by AI

What medical conditions can Cemiplimab be utilized to assist with?

"Cemiplimab has been approved to treat alk gene mutation, but it is also efficacious in treating other advanced medical issues such as metastatic cutaneous squamous cell carcinoma, advance directives and various malignant neoplasms."

Answered by AI

Are there still opportunities for enrolment in this experiment?

"This clinical trial is no longer searching for participants, as the posting was made in June 2018 and updated last October. For those looking to take part in medical research, there are 2590 studies actively recruiting patients with carcinoma, renal cell and 58 trials seeking volunteers for Cemiplimab treatments."

Answered by AI

Are there any prior studies involving Cemiplimab that could be taken into consideration?

"The initial study of cemiplimab was conducted by City of Hope in 2010. Since then, 17 clinical trials have been concluded while 58 are still ongoing with a considerable number taking place at Miami, Florida."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03294083.

All > Renal Cell Carcinoma