BGOG-EN31/RAINFOL-3

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy

Open
Grade
High grade, Low grade, Other / unknown
Prior lines
1, 2, 3
Histology
Endometrioid, Mucinous Serous Clear-cell
Phase
III
IMP
Rina-S
principal investigator
Prof. Dr. Toon Van Gorp/IA

Treatment

The study consists of two different treatment options (1:1 randomization):

  • Rina-S
  • Investigator's choice: paclitaxel or doxorubicin

     

Treatment duration

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

Eligibility

Main inclusion criteria:

  • histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) 
  • Participants must have received at least 1, but not more than 3, prior lines of therapy
  • Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination

Main exclusion criteria:

  • Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.

Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT07166094). 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