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Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer (PROTECx)

24 de junio de 2026 actualizado por: University Medical Center Groningen
This is a nationwide, multicenter, registry-based prospective cohort study to assess real-world effectiveness of treatment with a pembrolizumab containing regimen in persistent, recurrent, or metastatic cervical cancer. Patients in the observation cohort continue treatment according to standard of care. In the discontinuation cohort, patients discontinue their maintenance treatment with pembrolizumab (with or without discontinuation of bevacizumab). Patients may choose to discontinue pembrolizumab prematurely (with or without discontinuation of bevacizumab) if they achieve a confirmed CR or a confirmed PR to treatment, or on patient's request or due to toxicity. If an eligible patient chooses not to discontinue treatment early they will remain in the observation cohort. The duration of the trial for the individual patient will be until two years from the start of treatment. Survival follow-up will continue for a maximum of 10 years

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

261

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: M. Jalving, MD, PhD
  • Número de teléfono: +31 50 361 2821
  • Correo electrónico: m.jalving@umcg.nl

Copia de seguridad de contactos de estudio

  • Nombre: G. M.M. Lenis, MD
  • Número de teléfono: +31 50 361 6161
  • Correo electrónico: g.m.m.lenis@umcg.nl

Ubicaciones de estudio

  • Países Bajos
      • Amsterdam, Países Bajos
        • Aún no reclutando
        • Amsterdam UMC
        • Contacto:
        • Investigador principal:
          • J. Tromp
      • Amsterdam, Países Bajos
        • Aún no reclutando
        • Antoni Van Leeuwenhoek Ziekenhuis
        • Contacto:
        • Investigador principal:
          • M. A. Rijlaarsdam
      • Eindhoven, Países Bajos
      • Enschede, Países Bajos
        • Aún no reclutando
        • Medisch Spectrum Twente
        • Contacto:
        • Investigador principal:
          • A. N.M. Wymenga
      • Groningen, Países Bajos, 9713 GZ
        • Reclutamiento
        • University Mecdical Center Groningen
        • Contacto:
          • M. Jalving, MD, PhD
          • Número de teléfono: +31 50 3612821
          • Correo electrónico: m.jalving@umcg.nl
        • Contacto:
          • A. K.L. Reyners, MD, PhD
          • Número de teléfono: +31 50 3612821
          • Correo electrónico: a.k.l.reyners@umcg.nl
        • Investigador principal:
          • M. Jalving, MD, PhD
      • Leiden, Países Bajos
        • Reclutamiento
        • LUMC
        • Contacto:
        • Investigador principal:
          • J. R. Kroep
      • Maastricht, Países Bajos
        • Aún no reclutando
        • Maastricht UMC
        • Contacto:
        • Investigador principal:
          • A. J.M. Beijers
      • Nijmegen, Países Bajos
        • Aún no reclutando
        • Radboud UMC
        • Contacto:
        • Investigador principal:
          • V. Soomers
      • Rotterdam, Países Bajos
        • Aún no reclutando
        • Erasmus MC
        • Contacto:
        • Investigador principal:
          • I. A. Boere
      • Utrecht, Países Bajos
        • Aún no reclutando
        • UMC Utrecht
        • Contacto:
        • Investigador principal:
          • I. O. Baas
      • Zwolle, Países Bajos
        • Aún no reclutando
        • Isala Klinieken
        • Contacto:
        • Investigador principal:
          • W. A. van der Steeg

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion criteria for the observation cohort:

- Persistent, recurrent, or metastatic cervical cancer commencing treatment or currently treated with a pembrolizumab containing regimen.

Inclusion criteria for the early discontinuation cohort:

  • Previous inclusion in the observation cohort

  • Choice made to stop pembrolizumab for one of the following reasons:

    1. Confirmed complete response if they had received at least 8 cycles of 3- weekly pembrolizumab, including at least 9 weeks beyond a CR (consistent with KEYNOTE-826 criteria) OR
    2. Immune-related toxicity grade ≥ 3 OR
    3. Patient's preference (e.g. chronic or invalidating grade 1-2 immune-related toxicity) OR
    4. Confirmed partial response if they had received at least 8 cycles of 3- weekly pembrolizumab, including at least 9 weeks beyond a PR (timing consistent with KEYNOTE-826 criteria)
  • Eligible and willing to discontinue pembrolizumab (with or without discontinuing bevacizumab)

Exclusion criteria for all cohorts are:

  • Malignant other disease other than cervical carcinoma that required active treatment in the past 2 years: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or any carcinoma in situ that have undergone potentially curative therapy are not excluded
  • Any psychological, familial, sociological or geographical condition or a known psychiatric or substance abuse disorder potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. This comprises each and every condition or circumstance preventing the patient from showing up to the outpatient controls and/or undergoing the CT-scans, or preventing the patient from (adequately) filling out the questionnaires.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Observation cohort
The observation cohort will consist of all participants who receive standard of care treatment and are not eligible for the discontinuation cohort or do not wish to discontinue treatment. Patients will be asked to complete questionnaires every 12 weeks.
Experimental: Discontinuation cohort
The discontinuation cohort will consist of participants who discontinue pembrolizumab (with or without discontinuation of bevacizumab) therapy early according to the inclusion criteria listed in the study protocol. Additionally, will be asked to complete questionnaires every 12 weeks.
Droga: Early discontinuation of Pembrolizumab with or without Bevacizumab
  1. Keytruda, (L01XC18), pembrolizumab, intravenous administration (administered as standard of care).
  2. Avastin, (L01FG01), bevacizumab, intravenous administration (administered as standard of care).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Evaluate the progression-free survival (PFS) and compare to the KEYNOTE-826 trial
Periodo de tiempo: 12 months; for all patients

To evaluate the progression PFS at 12 months and compare it to the historical PFS at 12 months of the KEYNOTE-826 trial.

PFS is defined as the time from start of first line treatment to the first documented disease progression or death due to any cause, whichever occurs first.
12 months; for all patients

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Evaluate progression-free survival (PFS) at 12- and 24 months
Periodo de tiempo: 12 and 24 months; for all patients

To evaluate the PFS at 12- and 24 months for the complete cohort; the observation cohort and the discontinuation cohort separately and per the different response outcomes (SD/PR/CR).

PFS is defined as the time from start of first line treatment to the first documented disease progression or death due to any cause, whichever occurs first.
12 and 24 months; for all patients
To evaluate Overall Survival (OS)
Periodo de tiempo: From enrollment till the end of survival follow-up of ten years or death. Median OS is estimated to be available at the half of total inclusion period (1,5 of 3 years) + median OS from registration trial, so expected at 56 months from trial start

To evaluate the OS, OS is defined as: the time from start of first line treatment to death due to any cause.

Survival curves will be plotted, the OS rate at different time points will be estimated using the Kaplan-Meier method and the median OS wil be evaluated.

Survival follow-up is for up to ten years after commencement of treatment. To give an indication: median OS in the KEYNOTE-826 trial for CPS≥1 (trial population) cohort was 28.6 months and 24-months OS 53.5%.
From enrollment till the end of survival follow-up of ten years or death. Median OS is estimated to be available at the half of total inclusion period (1,5 of 3 years) + median OS from registration trial, so expected at 56 months from trial start
Evaluate objective response rate (ORR)
Periodo de tiempo: The ORR will be evaluated if all patients have had all response evaluations, this will be estimated at around 5 years (3 year inclusion + 2 year follow-up) after start of study.

To evaluate the ORR, ORR is defined as the proportion of patients with CR and PR.

Response for the individual patient will be measured/assessed every 12-18 (±1) weeks starting from baseline till two years of treatment, progression or death.
The ORR will be evaluated if all patients have had all response evaluations, this will be estimated at around 5 years (3 year inclusion + 2 year follow-up) after start of study.
Evaluate duration of response (DoR)
Periodo de tiempo: from enrollement till disease progression, follow-up or death assesed up to about 48 months since commencement of treatment.
To evaluate the DoR, which is defined as the time from the first documented evidence of CR or PR until the first documented disease progression or death due to any cause, whichever occurs assesed up to about 48 months since commencement of treatment.
from enrollement till disease progression, follow-up or death assesed up to about 48 months since commencement of treatment.
To describe the percentage of patients that develop immune-related endocrinopathies
Periodo de tiempo: from commencement of treatment to the end of regular follow-up (+/- 48 months) or disease progression.

The percentage of patients that develop immune-related endocrinopathies

Ir(S)AEs are collected until end of standard follow-up (2 years or disease progression).
from commencement of treatment to the end of regular follow-up (+/- 48 months) or disease progression.
To evaluate the treatment related Immune-Related (Serious) Adverse Events (ir(S)AEs) which led to discontinuation or interruption of systemic treatment.
Periodo de tiempo: from commencement of treatment to the end of regular follow-up (+/- 48 months) or disease progression.

To describe the percentage of patients which irAEs led to discontinuation or interruption (≥12 weeks) of treatment during (rechallenge of) PD-1 blockade.

Ir(S)AEs are collected until end of standard follow-up (2 years or disease progression).
from commencement of treatment to the end of regular follow-up (+/- 48 months) or disease progression.
The Health-Related Quality of Life in patients with recurrent, persistent or metastatic cervical cancer treated with a pembrolizumab-containing regimen
Periodo de tiempo: from enrollment till the end of treatment (two years from commencing treatment), every three months both questionnaires will be sent.
The European Organisation For Research And Treatment Of Cancer (EORTC) QLQ-C30. The tool is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status/QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, a high score for a symptom scale/item represents a high level of symptomatology/problems
from enrollment till the end of treatment (two years from commencing treatment), every three months both questionnaires will be sent.
The anxiety and depression symptoms in patients with recurrent, persistent or metastatic cervical cancer treated with a pembrolizumab-containing regimen
Periodo de tiempo: From enrollment till the end of treatment (two years from commencing treatment), every three months both questionnaires will be sent.
Hospital Anxiety and Depression Scale (HADS) is designed to assess symptoms of anxiety and depression in clinical and research settings. It consists of 14 items divided into two subscales: anxiety (HADS-A) and depression (HADS-D), each containing seven items scored on a 4-point Likert scale. Scores from 0-21 for each subscale, higher scores means greater distress.
From enrollment till the end of treatment (two years from commencing treatment), every three months both questionnaires will be sent.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University Medical Center Groningen

Investigadores

  • Investigador principal: M. Jalving, University Medical Center Groningen

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de mayo de 2026

Finalización primaria (Estimado)

1 de mayo de 2030

Finalización del estudio (Estimado)

1 de febrero de 2039

Fechas de registro del estudio

Enviado por primera vez

5 de enero de 2026

Primero enviado que cumplió con los criterios de control de calidad

11 de junio de 2026

Publicado por primera vez (Actual)

12 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 22590

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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