West Cancer Center

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)

Title

Merck MK-2870-020 Cervical 2nd Line Met TroFuse 020

Study Title

Site Link

NCT06459180

Malignancy

Cervical

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd Line

Investigational Agent

Sacituzumab tirumotecan

Drug Class

TROP-2 ADC

Mackenzie Harbin, MD

Sponsor

Merck Sharp and Dohme

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

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

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

squamous cell, adenocarcinoma, or adenosquamous

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes