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New combo therapy shows promise for Hard-to-Treat cervical cancer

NCT ID NCT04646005

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This phase 2 study tested a combination of the immunotherapy drug cemiplimab and an HPV16-targeting vaccine (ISA101b) in 113 adults with recurrent or metastatic HPV16-positive cervical cancer that had progressed after first-line chemotherapy. The goal was to see if the combination could shrink tumors and improve survival. The trial has been completed, and results will help determine if this approach is safe and effective enough for further study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cemiplimab (an immunotherapy drug) and ISA101b (a vaccine targeting HPV16)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced HPV16 cervical cancer whose disease has worsened after standard chemotherapy.
What could go wrong
This is a phase 2 trial with a moderate number of participants, so results may not be definitive. The combination may cause immune-related side effects, and not all patients may respond.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

113 people

The number who actually took part.

Started

Jun 2021

Finished

May 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

adenocarcinoma cervical cancer cervical carcinoma Neoplasm Metastasis Recurrence Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer

Contacts and locations

Locations

  • Arizona Oncology Associates

    Tucson, Arizona, 85704, United States

  • Arizona Oncology Associates

    Tucson, Arizona, 85711, United States

  • CHIREC Delta Hospital / Chirec Cancer Institute

    Brussels, 1160, Belgium

  • Centro De Novos Tratamentos Itajai

    Itajaí, Santa Catarina, 88301-220, Brazil

  • Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168, Italy

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • Gangnam Severance Hospital

    Seoul, 06273, South Korea

  • Hospital Doctor Josep Trueta - Institut Catala d'Oncologia (ICO)

    Girona, Catalonia, 17007, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • IRCCS-Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA)

    Rio de Janeiro, 22793-080, Brazil

  • Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA

    Santo Cristo, Rio de Janeiro, 20220-410, Brazil

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

    Meldola, Emilia-Romagna, 47014, Italy

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Leiden Universitair Medisch Centrum (LUMC)

    Leiden, 2333 ZA, Netherlands

  • Maastricht University Medical Center

    Maastricht, Limburg, 6229 HX, Netherlands

  • Radboudumc

    Nijmegen, 6525 GA, Netherlands

  • Regeneron Research Site

    Orange, California, 92868, United States

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • State Budgetary Healthcare Institution Clinical Oncology Dispensary 1 Of Healthcare Department Of Krasnodar Region

    Krasnodar, Krasnodarskiy Kray, 350040, Russia

  • UZ Leuven

    Leuven, Vlaams Brabant, 3000, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, East Flanders, 9000, Belgium

  • University Medical Center Groningen

    Groningen, 9713 GZ, Netherlands

  • University of Ulsan College of Medicine - Asan Medical Center (AMC)

    Seoul, 05505, South Korea

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