BGOG-cx20/Trofuse-020

A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer

Open
Prior lines
1
Histology
Squamous, Adeno
Phase
III
IMP
MK-2870
principal investigator
Prof. Dr. Toon Van Gorp

Treatment

This trial consists of two different treatment options:

  • MK-2870 (Sacituzumab Tirumotecan)
  • Physician's choice (pemetrexed, tisotumab vedotin, topotecan, vinorelbine, gemcitabine or irinotecan)

Patients are randomized to one of either treatment groups.

Treatment duration

The treatment can continue until disease progression, unacceptable toxicity or withdrawal of consent.

Eligibility

Main inclusion criteria:

  • Has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
  • Must have recurrent or metastatic cervical cancer that has progressed on or after treatment with 1 prior line of systemic platinum doublet chemotherapy (with or without bevacizumab) AND must have received anti-PD-1/anti-PD-L1 therapy as part of prior cervical cancer regimens
  • Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

Main exclusion criteria:

  • Received prior systemic anticancer therapy

Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT06459180). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.

Contact

In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be