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)

Conditions

• Cervical Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — BIOLOGICAL
  Intravenous (IV) Infusion
• Sacituzumab Tirumotecan — BIOLOGICAL
  IV Infusion
• Bevacizumab — BIOLOGICAL
  IV Infusion
• Paclitaxel — DRUG
  IV Infusion
• Cisplatin — DRUG
  IV Infusion
• Carboplatin — DRUG
  IV Infusion
• Rescue Medications — DRUG
  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 Details

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

Key Dates

Start date

Jan 19, 2026

Status verified

Jun 2026

Primary completion

Oct 29, 2031

Completion

Oct 29, 2031

Study Design

Enrollment

1,023 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 Safety Run-in: Sac-TMT + Pembrolizumab + Bevacizumab
  Participants will receive sac-TMT 4 mg/kg every 2 weeks (q2w) and pembrolizumab 400 mg every 6 weeks (q6w) for up to 14 cycles (up to approximately 20 months). Bevacizumab 15 mg/kg every 3 weeks (q3w) will be administered until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long.
• Experimental: Part 2: Sac-TMT + Pembrolizumab +/- Bevacizumab
  During induction treatment, participants will receive pembrolizumab 200 mg q3w, paclitaxel 175 mg/m\^2 q3w, and cisplatin 50 mg/m\^2 q3w (or carboplatin area under the curve \[AUC\]5 mg/mL/min q3w). Participants may also receive bevacizumab 15 mg/kg q3w at the investigator's discretion. Each cycle will be 3 weeks long and treatment will continue for up to 6 cycles (up to approximately 4 months). During maintenance treatment, participants will receive sac-TMT 4 mg/kg q2w and pembrolizumab 400 mg q6w for up to 14 cycles (up to approximately 20 months). Participants may also receive bevacizumab 15 mg/kg q3w, at the investigator's discretion, until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long.
• Active Comparator: Part 2: Pembrolizumab +/- Bevacizumab
  During induction treatment, participants will receive pembrolizumab 200 mg q3w, paclitaxel 175 mg/m\^2 q3w, and cisplatin 50 mg/m\^2 q3w (or carboplatin AUC5 mg/mL/min q3w). Participants may also receive bevacizumab 15 mg/kg q3w at the investigator's discretion. Each cycle will be 3 weeks long and treatment will continue for up to 6 cycles (up to approximately 4 months). During maintenance treatment, participants will receive pembrolizumab 400 mg q6w for up to 14 cycles (up to approximately 20 months). Participants may also receive bevacizumab 15 mg/kg q3w, at the investigator's discretion, until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long.

Primary Outcome Measure

Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs) [ Time Frame: Up to approximately 69 months ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (16)

Find similar trials in Miami Beach, FL

Related Studies

• Study of NEO-201 in Solid Tumors Expansion Cohorts
  PHASE1/PHASE2 · Recruiting · Precision Biologics, Inc · Bethesda, Maryland
• FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
  Recruiting · University Health Network, Toronto · Houston, Texas
• Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients
  PHASE1 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer
  Recruiting · GOG Foundation · Goodyear, Arizona