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TRACTION: Lorigerlimab in Advanced Cervical Cancer
NCT05475171Phase 2
Key facts
- Status
- Recruiting
- Start
- Dec 2022
- Primary completion
- Jun 2028
- Countries
- 1
- Sponsor
- University of Texas MD Anderson Cancer Center
- Modality
- Bispecific Antibodies, Recombinant Proteins and Enzymes, Monoclonal Antibodies
- Drugs
- lorigerlimab
- Conditions
- Cervical Cancer (CC)
01
Overview
Phase 2, open-label, single-arm trial of lorigerlimab in Cervical Cancer (CC), sponsored by University of Texas MD Anderson Cancer Center. Primary endpoints: Overall Survival at 1 year and Disease Control Rate. Started Dec 2022; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Lorigerlimab
Participants will receive Lorigerlimab by vein over about 30 minutes on Day 1 of each cycle
03
Who it enrols
Adults with recurrent, metastatic, or persistent cervical cancer (squamous, adenosquamous, or adenocarcinoma) not amenable to curative treatment, with no prior systemic chemotherapy or immune checkpoint inhibitors, and adequate organ function.
04
Endpoints
Primary
Overall Survival
Disease Control Rate
Secondary
Progression-Free Survival
Objective Response Rate
Duration of Response
Adverse Events
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