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Study Name

GOG 3101

Study 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 as Second-line Treatment for Participants with Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20)

Start Date

July 24, 2024

Enrollment Status

Enrolling new patients

Sponsor

Merck Sharp & Dohme LLC

Study Type

Interventional

Location

Willis Knighton Cancer Center
2600 Kings Hwy Shreveport, LA 71107
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Main Inclusion

Recurrent or metastatic cervical cancer that:

Has progressed on or after 1 prior line ofsystemic platinum doublet treatment (with or without bevacizumab)

AND

Has received anti-PD-1/anti-PD-L1 therapy as part of prior cervical cancer regimens

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Exclusion Criteria

grade ≥2 peripheral neuropathy

history of dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease

active inflammatory bowel disease requiring immunosuppressive medication or previous h/o inflammatory bowel disease

uncontrolled, significant cardiovascular disease or cerebrovascular disease

two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7days before the first dose of study intervention

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Treatment Information

There are 2 parts to this trial. The trial drugs you receive will depend on which part is open for enrollment when you join the trial. The trial doctor and trial staff can tell you whether you are joining the trial during the first or second part.

Part 1: If you are in this part, you will get MK-2870. The first part will include up to 20 people.
Part 2: This part of the trial has 2 groups. If you are in this part, the trial treatment you get will depend on which group you are in. A computer will randomly decide which group you are assigned to. You have an equal chance of being assigned to Group 1 or Group 2. This part will have about 666 participants.
Group 1: MK-2870 once every 2 weeks.
Group 2: Standard treatment. The trial doctor will decide which treatment you will get, based on standard treatments at the trial site, and discuss this with you. You will get one of the trial drugs.

All trial drugs are given by a needle in a vein. This is called intravenous (IV) infusion.

You, your trial doctor, and the clinical trial staff will know which group you are assigned to and which trial drug you are getting.

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Costs & Stipend Details

You will receive $50.00 per completed visit. If you do not complete the trial, you will be paid for each trial visit you complete.

Reasonable travel expenses for trial related visits may be covered. The patient will need to discuss this with the trial doctor and the clinical trial staff.

This clinical trial will cover the cost of research related drugs, tests and procedures that are not considered standard medical care. Procedures including, but not limited to, routine physical exams, routine lab tests and routine tests such as imaging and ECGs.

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General Information

This study will have two phases: a sacituzumab tirumotecan safety run-in and a Phase 3 portion. The safety run-in phase will be used to evaluate the efficacy and safety of sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion. The purpose of this study is to compare the efficacy and safety of sacituzumab tirumotecan versus treatment of physician’s choice as second-line treatment for participants with recurrent or metastatic cervical cancer in the Phase 3 portion.

The primary study hypotheses are that, in the Phase 3 portion, sacituzumab tirumotecan results in a superior overall survival compared to TPC in participants with high trophoblast cell surface antigen 2 (TROP2) expression level and in all participants.

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