REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: REGN7508, Placebo.
- Who it may be relevant to
- Registry conditions: Cancer-Associated Thrombosis (CAT). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Georgia, Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against FXI, for Primary Prophylaxis of Cancer-Associated Thrombosis for Participants With Solid Tumors Undergoing Cancer Treatment (ROXI-CAT-I)
Overview
This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on the prevention of Cancer-Associated Thrombosis (CAT) in participants. The aim of the study is to see how effective the study drug is in preventing blood clots in participants with solid tumors who are currently receiving anticancer treatment or planning to start anticancer treatment within a month of being assigned to a study treatment, or recovering from surgery, and how the study drug compares to placebo for CAT. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
Interventions
- Drug REGN7508
Administered per the protocol - Drug Placebo
Administered per the protocol
Primary outcome measures
- Time-to-first event of centrally adjudicated VTE (DVT, PE) or ATE, or thromboembolism- or ATE-related death [Time frame: Through 6 months]
- Time-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH) major bleeding or Clinically Relevant Non-Major (CRNM) bleeding [Time frame: Through 6 months]
Secondary outcome measures (12)
- Time-to-first event of the centrally adjudicated symptomatic or incidental VTE (DVT, PE) or ATE and thromboembolism- or ATE-related death [Time frame: Through 6 months]
- Time-to-first event of symptomatic VTE [Time frame: Through 6 months]
- Time-to-first event of symptomatic DVT [Time frame: Through 6 months]
- Time-to-first event of symptomatic non-fatal PE [Time frame: Through 6 months]
- Time-to-first event of thromboembolism-related death [Time frame: Through 6 months]
- Time-to-first event of incidental VTE [Time frame: Through 6 months]
- Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT [Time frame: Through 6 months]
- Time-to-first event of incidental non-fatal PE (in a segmental or larger pulmonary artery) [Time frame: Through 6 months]
- Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by lower extremities ultrasound) [Time frame: Through 6 months]
- Time-to-first event of ATE [Time frame: Through 6 months]
- Time-to-first event of ATE-related death [Time frame: Through 6 months]
- Time-to-first event of centrally adjudicated VTE (DVT, PE), or thromboembolism-related death [Time frame: Through 6 months]
Eligibility criteria
Inclusion criteria
- Has a histologically confirmed diagnosis of malignant solid tumors which are locally advanced or metastatic as described in the protocol
- Has a Khorana thromboembolic risk score ≥2 during screening period or harbors a somatic documented tumor genetic variant known to be associated with a similar increased risk of VTE as described in the protocol
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2 at the time of screening and day 1 prior to the first dose of study intervention
Exclusion criteria
- Has known bleeding conditions (eg, Hemophilia A or B, von Willebrand's disease), hemorrhagic tumor sites, or other conditions with a high risk for bleeding (eg, hepatic disease associated with coagulopathy)
- Has a cancer diagnosis consisting solely of basal cell or squamous cell skin carcinoma
- Has a primary brain tumor or brain metastases as described in the protocol
- Has proximal lower extremity DVT locally detected by Compression Ultrasound (CUS) during screening period
- Has any condition that, as judged by the investigator, may confound the results of the study or would place the participant at increased risk of harm if he/she participated in the study
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Georgia · 9 centers
- LTD High Technology Hospital Medcenter — Batumi
- Krystyna Kiel Oncology Center — Kutaisi
- American Hospital Tbilisi — Tbilisi
- Llc Todua Clinic — Tbilisi
- Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic — Tbilisi
- Institute of Clinical Oncology — Tbilisi
- JSC Evex Hospitals - Caraps Medline — Tbilisi
- LTD Cancer Research Centre — Tbilisi
- … and 1 more center
United States · 3 centers
- Bioresearch Partner- Hialeah Hospital — Hialeah
- Helios Clinical Research — North Miami Beach
- El Paso Medical Research Institute (Medresearch Inc) — El Paso
Japan · 1 center
- Yamaguchi University Hospital — Ube
Identifiers
NCT: NCT07410117 · R7508-CAT-2392 · 2024-519298-21-00