Ovarian, Cervical CancerOpen to EnrollmentPhase 3

CERVICAL: METASTATIC: 2nd Line: TroFuse-020

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)

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Study snapshot

Title: Merck MK-2870-020 Cervical 2nd Line Met TroFuse 020
Malignancy: Cervical
Stage: Stage 4
Disease setting: Metastatic/Palliative
Line of therapy: 2nd Line
Investigational agent: Sacituzumab tirumotecan
Drug class: TROP-2 ADC
Principal investigator: Mackenzie Harbin, MD
Sponsor: Merck Sharp and Dohme
Path: squamous cell, adenocarcinoma, or adenosquamous
Randomized: Yes
ClinicalTrials.gov ID: NCT06459180

Eligibility and objectives

Key eligibility criteria details

Histologicall confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
Must have recurrent or metastatic cervical cancer that has progressed on or after treatment with exactly 1 prior line of systemic platinum doublet chemotherapy (with or without bevacizumab) AND must have received anti-PD1/anti-PD-L1 therapy as part of prior cervical cance regimens
Measurable disease
ECOG PS 0-1
No Grade 2 or higher peripheral neuropathy
No active IBD
No uncontrolled cardiovascular disease
No known additional malignancy requiring care in past 3 years
No known CNS mets

Objective

Primary
- OS
Secondary
- PFS
- ORR
- DoR
- AEs
- TTD
- QoL

Study snapshot

Eligibility and objectives

Key eligibility criteria details

Objective

Treatment details