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RecruitingLast updated: 6 February 2024

MK-2870-005: This study is comparing how safe and effective a new antibody-drug conjugate (called MK-2870) is compared to treatment of the physician's choice in people with endometrial cancer who have had prior platinum-based chemotherapy and immunotherapyA 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)

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 patients with endometrial cancer who have received prior platinum-based chemotherapy and immunotherapy

Cancer

Female Reproductive System Cancers Gynaecological

Age

People18+

Phase

III

Trial Acronym

MK-2870-005

More information

Trial Identifiers

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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)

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 a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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