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

NCT ID NCT04646005

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

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.

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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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