Treatment
This trial consists of two different treatment options:
- MK-2870
- Standard chemotherapy (Doxorubicin or Paclitaxel)
MK-2870 is administered intravenously once every fortnight.
Doxorubicin is administered intravenously once every three weeks.
Paclitaxel is administered intravenously for three subsequent weeks followed by a week off treatment.
Patients are assigned randomly to one of the treatment groups. In case the patient is randomized to the arm with standard chemotherapy, it's up to the investigator to decide whether Doxorubicin or Paclitaxel will be administered.
Treatment duration
MK-2870, Doxorubicin and Paclitaxel are administered until disease progression, unacceptable toxicity or withdrawal of consent.
Eligibility
Main inclusion criteria:
- Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma
- Has radiographically evaluable disease, either measurable or nonmeasurable per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR)
- Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination
Main exclusion criteria:
- Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas
- Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- Has had a recurrence of endometrial carcinoma or carcinosarcoma more than 180 days after completing platinum-based therapy administered in the curative-intent or adjuvant setting without any additional platinum-based therapy received in the metastatic or recurrent setting
- Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma
Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT06132958). 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