PROTECx - Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Groningen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-05-11

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

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

Secondary objectives 6

1. To evaluate the 12- and 24 month PFS
2. To evaluate the OS
3. To evaluate objective response rate (ORR)
4. To evaluate the duration of response (DOR)
5. To describe the treatment related ir(S)AEs
6. To describe the QoL of patients over time

Conditions and MedDRA coding

Metastatic cervical cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Inclusion criteria for the observation cohort: Persistent, recurrent, or metastatic cervical cancer commencing treatment or currently treated with a pembrolizumab containing regimen.
2. Inclusion criteria for the early discontinuation cohort: • Previous inclusion in the observation cohort • Choice made to stop pembrolizumab for one of the following reasons: o 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 o Immune-related toxicity grade ≥ 3 OR o Patient’s preference (e.g. chronic or invalidating grade 1-2 immune-related toxicity) OR o 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 3

1. 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
2. Any condition, in opinion of the investigator, that may hamper compliance to the study procedures.
3. Insufficient proficiency in written and spoken Dutch to understand the study information, complete Dutch language questionnaires, or provide informed consent will be excluded

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. PFS: The time from start of first line treatment to the first documented disease progression or death due to any cause, whichever occurs first.

Secondary endpoints 6

1. PFS-12 & PFS-24: The proportion of participants that are PFS event-free at 12 and 24 months for the complete cohort; the observation cohort and the discontinuation cohort separately and the different response outcomes (SD/PR/CR).
2. The time from start of first line treatment to death due to any cause for the complete cohort and separately for the observation cohort and the discontinuation cohort.
3. The ORR is defined as the proportion of patients with CR and PR. This will be assessed for the complete cohort and separately for the observation cohort and the discontinuation cohort
4. The DoR 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. It will be evaluated for the total cohort and separately for the observation cohort and the discontinuation cohort
5. • The percentage of patients of which irAEs led to discontinuation or interruption (≥12 weeks) of treatment during (rechallenge of) PD-1 blockade separately for the observation cohort and discontinuation cohort • The percentage of patients that develop immune-related endocrinopathies separately for the observation cohort and discontinuation cohort
6. The change in QoL will be assessed at different time points (according to Table 1.) and will be reported in a descriptive manner

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Groningen

Sponsor organisation

Universitair Medisch Centrum Groningen

Address

Hanzeplein 1

City

Groningen

Postcode

9713 GZ

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

M. Jalving

Public contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

M. Jalving

Locations

1 EU/EEA country · 11 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications