A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)

Conditions

• Cervical Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sacituzumab Tirumotecan — BIOLOGICAL
  IV infusion
• Pemetrexed — DRUG
  IV infusion
• Tisotumab Vedotin — BIOLOGICAL
  IV infusion
• Topotecan — DRUG
  IV infusion
• Vinorelbine — DRUG
  IV infusion
• Gemcitabine — DRUG
  IV infusion
• Irinotecan — DRUG
  IV infusion

Study Details

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.

Key Dates

Start date

Jul 24, 2024

Status verified

May 2026

Primary completion

Jun 15, 2028

Completion

Jun 15, 2028

Study Design

Enrollment

686 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sacituzumab Tirumotecan
  Participants will receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.
• Active Comparator: Treatment of Physician's Choice (TPC)
  At the physician's discretion, participants will receive 500 mg/m\^2 of pemetrexed on day 1 of every 3-week cycle via IV infusion OR 2 mg/kg of tisotumab vedotin on day 1 of every 3-week cycle via IV infusion OR 1 mg/m\^2 (or 1.25 mg/m\^2 if tolerating well) topotecan on days 1, 2, 3, 4, and 5 of every 3-week cycle via IV infusion OR 30 mg/m\^2 of vinorelbine on days 1 and 8 of every 3-week cycle via IV infusion OR 1000 mg/m\^2 of gemcitabine on day 1 and 8 of every 3-week cycle via IV infusion OR 100 mg/m\^2 (or 125 mg/m\^2 if tolerating well) of irinotecan on days 1, 8, 15, and 22 of every 6 week cycle via IV infusion, until progressive disease or discontinuation.

Primary Outcome Measure

Objective Response Rate (ORR) in Sacituzumab Tirumotecan Run-in [ Time Frame: Up to approximately 46 months ]

Locations (38)

Find similar trials in Mobile, AL

Related Studies

• Cervical Cancer Detection Using Optical Spectroscopy
  Recruiting · Duke University · Durham, North Carolina
• 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