Cervical CancerPhase 2NCT04646005
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
A Phase 2 study testing Cemiplimab and ISA101b in people with Cervical Cancer, run by Regeneron Pharmaceuticals at 26 sites in 8 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Cemiplimab and ISA101b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 26 sitesin 8 countries
- Study dates
- 28 Jun 2021to 29 May 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ≥18 years of age (or the legal age of adults to consent to participate in a clinical study per country specific regulations).
- 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
- Patient must be determined to be positive for HPV16 genotype, as determined by a specified central reference laboratory.
- Patient must have measurable disease as defined by RECIST 1.1.
- Must have received prior bevacizumab and taxol unless meets pre-specified protocol criteria
- ECOG performance status of 0 or 1.
- Has adequate organ and bone marrow function as defined in the protocol.
- Anticipated life expectancy ≥20 weeks.
Who cannot join
- Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
- Prior treatment with other systemic immune-modulating agents as defined in the protocol
- Major surgery or radiation therapy within 14 days of first administration of study drug
- 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
- 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
- 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
Trial locations and contacts
26 sites in 8 countries.
26 sites in 8 countries
Brazil5 sites
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
Centro De Novos Tratamentos Itajai
Itajaí, Santa Catarina, 88301-220
Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA)
Rio de Janeiro, 22793-080
Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA
Santo Cristo, Rio de Janeiro, 20220-410
Netherlands4 sites
University Medical Center Groningen
Groningen, 9713 GZ
Leiden Universitair Medisch Centrum (LUMC)
Leiden, 2333 ZA
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
Radboudumc
Nijmegen, 6525 GA
South Korea4 sites
Seoul National University Hospital
Seoul, 03080
University of Ulsan College of Medicine - Asan Medical Center (AMC)
Seoul, 05505
Gangnam Severance Hospital
Seoul, 06273
Korea University Guro Hospital
Seoul, 08308
United States3 sites
Regeneron Research Site
Orange, California, 92868
Arizona Oncology Associates
Tucson, Arizona, 85704
Arizona Oncology Associates
Tucson, Arizona, 85711
Belgium3 sites
CHIREC Delta Hospital / Chirec Cancer Institute
Brussels, 1160
Universitair Ziekenhuis Gent
Ghent, East Flanders, 9000
UZ Leuven
Leuven, Vlaams Brabant, 3000
Italy3 sites
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
Meldola, Emilia-Romagna, 47014
IRCCS-Istituto Europeo di Oncologia
Milan, 20141
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00168
Spain3 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Doctor Josep Trueta - Institut Catala d'Oncologia (ICO)
Girona, Catalonia, 17007
Hospital Universitario La Paz
Madrid, 28046
Russia1 site
State Budgetary Healthcare Institution Clinical Oncology Dispensary 1 Of Healthcare Department Of Krasnodar Region
Krasnodar, Krasnodarskiy Kray, 350040
About this study
Official title: 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)
- Conditions
- Cervical Cancer
- Being tested
- Cemiplimab, ISA101b
- Keywords
- HPV16 positive, Squamous histology, Recurrent, Metastatic, Adenocarcinoma/adenosquamous histology
- Medical subject headings
- Uterine Cervical Neoplasms, Recurrence, Neoplasm Metastasis, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Also called REGN2810, Libtayo
Administered intravenously (IV) every three weeks (Q3W)
ISA101bBiological
Administered by subcutaneous (SC) injection on day 1, day 29, and day 50
| Study group | Role | What they receive |
|---|---|---|
| Cemiplimab+ISA101b | Experimental | Not described Receives: Drug: Cemiplimab; Biological: ISA101b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
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).
Measured: From enrollment to last dose (~up to 23 months)
Secondary outcomes (9)
Number of Treatment Emergent Adverse Events (TEAEs)
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.
Measured: From enrollment to last dose (~up to 23 months)
Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)
Measured: From enrollment to last dose (~up to 23 months)
Number of Participants With Any Treatment Emergent Adverse Events of Special Interest (TE AESIs)
Measured: From enrollment to last dose (~up to 23 months)
Number of Participants With Any Serious TEAE
Measured: From enrollment to last dose (~up to 23 months)
Number of Participants With at Least One Lab Abnormality
Measured: From enrollment to last dose (~up to 23 months)
Number of Participants With at Least One Lab Abnormality With Severity of ≥ Grade 3
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.
Measured: From enrollment to last dose (~up to 23 months)
Duration of Response (DOR)
Measured: From enrollment to last dose (~up to 23 months)
Progression Free Survival (PFS)
Measured: From enrollment to last dose (~up to 23 months)
Overall Survival (OS)
Measured: From enrollment to last dose (~up to 23 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start28 Jun 2021
- Primary completion22 May 2023
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ISA Pharmaceuticals B.V.
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646005
- Sponsor's protocol ID
- R2810-ONC-ISA-1981
- Other IDs
- 2020-001239-29
- Status last verified
- Sep 2025
- First submitted
- 20 Nov 2020
- Last updated
- 8 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04646005
- Acronym / sponsor ID
- R2810-ONC-ISA-1981
- Conditions
- Cervical Cancer
- Keywords
- HPV16 positive, Squamous histology, Recurrent, Metastatic, Adenocarcinoma/adenosquamous histology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- ISA Pharmaceuticals B.V.
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cemiplimab+ISA101b | Experimental | Drug: Cemiplimab, Biological: ISA101b |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients ≥18 years of age (or the legal age of adults to consent to participate in a clinical study per country specific regulations).
- 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
- Patient must be determined to be positive for HPV16 genotype, as determined by a specified central reference laboratory.
- Patient must have measurable disease as defined by RECIST 1.1.
- Must have received prior bevacizumab and taxol unless meets pre-specified protocol criteria
Key exclusion criteria (7 listed)
- Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
- Prior treatment with other systemic immune-modulating agents as defined in the protocol
- Major surgery or radiation therapy within 14 days of first administration of study drug
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CemiplimabAlso: REGN2810, LibtayoAdministered intravenously (IV) every three weeks (Q3W) | Drug | Cemiplimab+ISA101b |
| ISA101bAdministered by subcutaneous (SC) injection on day 1, day 29, and day 50 | Biological | Cemiplimab+ISA101b |
Primary outcome
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).
9 secondary outcomes
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: 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)
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)
Number of Participants With Any Serious TEAE
Time frame: 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)
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)
Duration of Response (DOR)
Time frame: From enrollment to last dose (~up to 23 months)
Progression Free Survival (PFS)
Time frame: From enrollment to last dose (~up to 23 months)
Overall Survival (OS)
Time frame: From enrollment to last dose (~up to 23 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Summary is available on TrialSummaries.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
26 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cemiplimab and ISA101b in people with Cervical Cancer, run by Regeneron Pharmaceuticals at 26 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Brazil, Netherlands, South Korea, United States, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From enrollment to last dose (~up to 23 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.