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PD-1 Inhibitor

Cemiplimab + ISA101b for Cervical Cancer

Phase 2

Waitlist Available

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Patient must be determined to be positive for HPV16 genotype, as determined by a specified central reference laboratory

ECOG performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

Study Summary

This trial is testing a new drug combo to see if it's more effective than chemotherapy for people with skin cancer that has progressed after first line treatment.

Who is the study for?

This trial is for adults over 18 with HPV16 positive recurrent or metastatic cervical cancer that worsened after platinum therapy. They must have a good performance status, adequate organ function, measurable disease by RECIST 1.1 criteria, and an expected lifespan of at least 20 weeks.Check my eligibility

What is being tested?

The study tests the combination of Cemiplimab and ISA101b vaccine in patients whose cervical cancer progressed post first-line chemo. It aims to measure how well this combo works (response rate) and its safety profile, along with how long it works (DOR), survival without progression (PFS), and overall survival (OS).See study design

What are the potential side effects?

While not explicitly listed here, side effects may include typical immune-related reactions such as inflammation in various organs due to Cemiplimab's action on the immune system, as well as potential injection site reactions from the ISA101b vaccine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tested positive for the HPV16 genotype.

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I am fully active or can carry out light work.

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My cervical cancer is HPV16 positive and has worsened after platinum-based treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR)

Secondary outcome measures

Duration of response (DOR)

Incidence and severity of adverse events of special interest (AESIs)

Incidence and severity of serious adverse events (SAEs)

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cemiplimab+ISA101bExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1340

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

615 Previous Clinical Trials

379,734 Total Patients Enrolled

ISA Pharmaceuticals B.V.Industry Sponsor

5 Previous Clinical Trials

119 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

259 Previous Clinical Trials

250,931 Total Patients Enrolled

Media Library

Cemiplimab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04646005 — Phase 2

Cervical Cancer Research Study Groups: Cemiplimab+ISA101b

Cervical Cancer Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT04646005 — Phase 2

Cemiplimab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04646005 — Phase 2

Frequently Asked Questions

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

Are new patients being accepted into this study?

"This is an ongoing trial, as evidenced by the most recent edit date on clinicaltrials.gov being 8/24/2022. It was first posted on 6/28/2021"

Answered by AI

What is the legal status of ISA101b in terms of federal approval?

"ISA101b's safety is only supported by Phase 2 trial data, meaning that while there have been some studies done on its safety, none have yet looked at whether or not the medication is effective."

Answered by AI

How many people are currently enrolled in this clinical trial?

"That is correct. The online clinicaltrial database has the most recent update from 8/24/2022, which states that this trial is still actively recruiting for 105 patients at 8 sites."

Answered by AI

What indications does ISA101b usually treat?

"ISA101b is an effective treatment for alk gene mutations, malignant neoplasms, and patients with advance directives."

Answered by AI

Are the findings from this study unique to ISA101b or have other drugs been studied in a similar fashion?

"ISA101b was first researched in 2010 by the team at City of Hope. So far, there have been 7 completed clinical trials related to this topic. Right now, 59 studies are actively recruiting participants; a number of these investigations are based in New Haven, Connecticut."

Answered by AI

In how many different medical clinics is this trial being performed today?

"At the moment, there are 8 clinical trial sites operational. They can be found in New Haven, Tucson and Houston as well other cities. If you enroll in this study, try to select a location near you to limit travel time and expenses."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy

2021. "Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04646005.

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