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

September 4, 2025 updated by: Regeneron Pharmaceuticals

A Phase 2 Study of Cemiplimab, an Anti-PD-1 Monoclonal Antibody, and ISA101b Vaccine in Patients With Recurrent/Metastatic HPV16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy

The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR).

The secondary objectives of the study are:

  • To characterize the safety profile of cemiplimab + ISA101b
  • To assess preliminary efficacy of cemiplimab + ISA101b as measured by duration of response (DOR), progression-free survival (PFS), and overall survival (OS)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
113

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1160
        • CHIREC Delta Hospital / Chirec Cancer Institute
    • East Flanders
      • Ghent, East Flanders, Belgium, 9000
        • Universitair Ziekenhuis Gent
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • UZ Leuven
  • Brazil
      • Rio de Janeiro, Brazil, 22793-080
        • Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA)
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
    • Rio de Janeiro
      • Santo Cristo, Rio de Janeiro, Brazil, 20220-410
        • Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA
    • Santa Catarina
      • Itajaí, Santa Catarina, Brazil, 88301-220
        • Centro de Novos Tratamentos Itajai
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Fundacao Pio XII - Hospital de Cancer de Barretos
  • Italy
      • Milan, Italy, 20141
        • IRCCS-Istituto Europeo di Oncologia
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen
      • Leiden, Netherlands, 2333 ZA
        • Leiden Universitair Medisch Centrum (LUMC)
      • Nijmegen, Netherlands, 6525 GA
        • Radboudumc
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Maastricht University Medical Center
  • Russia
    • Krasnodarskiy Kray
      • Krasnodar, Krasnodarskiy Kray, Russia, 350040
        • State Budgetary Healthcare Institution Clinical Oncology Dispensary 1 Of Healthcare Department Of Krasnodar Region
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 06273
        • Gangnam Severance Hospital
      • Seoul, South Korea, 08308
        • Korea University Guro Hospital
      • Seoul, South Korea, 05505
        • University of Ulsan College of Medicine - Asan Medical Center (AMC)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
    • Catalonia
      • Girona, Catalonia, Spain, 17007
        • Hospital Doctor Josep Trueta - Institut Catala d'Oncologia (ICO)
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Arizona Oncology Associates
      • Tucson, Arizona, United States, 85711
        • Arizona Oncology Associates
    • California
      • Orange, California, United States, 92868
        • Regeneron Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Adult patients ≥18 years of age (or the legal age of adults to consent to participate in a clinical study per country specific regulations).
  2. Has histologically confirmed recurrent or metastatic HPV16 positive cervical cancer as determined by an investigational HPV16 PCR assay, who have experienced disease progression after treatment with platinum containing therapy as defined in the protocol
  3. Patient must be determined to be positive for HPV16 genotype, as determined by a specified central reference laboratory.
  4. Patient must have measurable disease as defined by RECIST 1.1.
  5. Must have received prior bevacizumab and taxol unless meets pre-specified protocol criteria
  6. ECOG performance status of 0 or 1.
  7. Has adequate organ and bone marrow function as defined in the protocol.
  8. Anticipated life expectancy ≥20 weeks.

Key Exclusion Criteria:

  1. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
  2. Prior treatment with other systemic immune-modulating agents as defined in the protocol
  3. Major surgery or radiation therapy within 14 days of first administration of study drug
  4. Has received treatment with an approved systemic therapy within 4 weeks of first dose of study drug, or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities except for laboratory changes as described in the protocol
  5. Has another malignancy that is progressing or requires active treatment and/or history of malignancy other than cervical cancer within 3 years of date of first planned dose of study drug as defined in the protocol
  6. Has any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 4 weeks prior to the first dose of study drug. 7. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol

NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cemiplimab+ISA101b
Drug: Cemiplimab
Administered intravenously (IV) every three weeks (Q3W)
Other Names:
  • REGN2810
  • Libtayo
Biological: ISA101b
Administered by subcutaneous (SC) injection on day 1, day 29, and day 50

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From enrollment to last dose (~up to 23 months)
Objective response rate (ORR) is determined by the proportion of participants with best overall response of complete response (CR) or partial response (PR) in the Full analysis set (FAS).
From enrollment to last dose (~up to 23 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Treatment Emergent Adverse Events (TEAEs)
Time Frame: From enrollment to last dose (~up to 23 months)
Treatment-emergent AEs (TEAEs) are defined as AEs that developed or worsened during the on-treatment period and treatment-related AEs that occur during post-treatment period.
From enrollment to last dose (~up to 23 months)
Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)
Time Frame: From enrollment to last dose (~up to 23 months)
From enrollment to last dose (~up to 23 months)
Number of Participants With Any Treatment Emergent Adverse Events of Special Interest (TE AESIs)
Time Frame: From enrollment to last dose (~up to 23 months)
From enrollment to last dose (~up to 23 months)
Number of Participants With Any Serious TEAE
Time Frame: From enrollment to last dose (~up to 23 months)
From enrollment to last dose (~up to 23 months)
Number of Participants With at Least One Lab Abnormality
Time Frame: From enrollment to last dose (~up to 23 months)
From enrollment to last dose (~up to 23 months)
Number of Participants With at Least One Lab Abnormality With Severity of ≥ Grade 3
Time Frame: From enrollment to last dose (~up to 23 months)
Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
From enrollment to last dose (~up to 23 months)
Duration of Response (DOR)
Time Frame: From enrollment to last dose (~up to 23 months)
From enrollment to last dose (~up to 23 months)
Progression Free Survival (PFS)
Time Frame: From enrollment to last dose (~up to 23 months)
From enrollment to last dose (~up to 23 months)
Overall Survival (OS)
Time Frame: From enrollment to last dose (~up to 23 months)
From enrollment to last dose (~up to 23 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ISA Pharmaceuticals B.V.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R2810-ONC-ISA-1981
  • 2020-001239-29 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing Time Frame

When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.

IPD Sharing Access Criteria

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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