A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)

Condition(s) studied

Investigational drug(s) / intervention(s)

Pembrolizumab: Intravenous (IV) Infusion

Sacituzumab Tirumotecan: IV Infusion

Bevacizumab: IV Infusion

Paclitaxel: IV Infusion

Cisplatin: IV Infusion

Carboplatin: IV Infusion

Rescue Medications: Participants will receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent, prophylactic steroid mouthwash (dexamethasone or equivalent), and granulocyte colony-stimulating factor (G-CSF).

Study summary

Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body.

Researchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells.

The goals of this study are to learn:

* About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and
* If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment

Eligibility

Primary outcome measure(s)

• Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs) — Up to approximately 69 months
  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
• Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AE — Up to approximately 66 months
  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
• Part 2 Maintenance Treatment: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) — Up to approximately 48 months
  PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first, as assessed by RECIST 1.1 as evaluated by BICR. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
• Part 2 Maintenance Treatment: Overall Survival (OS) — Up to approximately 60 months
  OS is defined as time from randomization to death due to any cause. OS will be presented.

Trial sites (172)

+ 132 more sites — see the full list on the official registry below.