Trial purpose
Cancer treatment
Tumor type
Gynaecological
Age
18+
Clinical summary
Summary
Eligible participants will be randomly allocated to one of two treatment arms.
In Arm A (Experimental), participants will receive the investigational drug, called MK-2870. MK-2870 will be given via intravenous (IV) infusion on Day 1 of each 14-day cycle. Additionally, participants receive diphenhydramine (or equivalent), an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of MK-2870. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.
In Arm B (Active Comparator), participants will receive treatment of physician's choice. This will either be doxorubicin chemotherapy or paclitaxel chemotherapy. Doxorubicin will be given via IV infusion on Day 1 of each 21-day cycle. Paclitaxel will be given by IV infusion on Days 1, 8 and 15 of each 28-day cycle.
Conditions
This trial is treating people with endometrial cancer who have received prior platinum-based chemotherapy and immunotherapy
Eligibility
Inclusion
- Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
- Has radiographically evaluable disease, either measurable or nonmeasurable per RECIST 1.1, as assessed by 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.
Exclusion
- 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.
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Merck Sharp & Dohme LLC
Scientific Title
A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (MK-2870-005/ENGOT-en23/GOG-3095)
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