Cancer-Associated Thrombosis (CAT)
Conditions
Keywords
Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Arterial Thromboembolism (ATE), Solid tumors (cancers), Clinically Relevant Non-Major (CRNM) bleeding, International Society of Thrombosis and Hemostasis (ISTH)
Brief summary
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
DRUGREGN7508
Administered per the protocol
DRUGPlacebo
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Has a histologically confirmed diagnosis of malignant solid tumors which are locally advanced or metastatic as described in the protocol 2. 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 3. 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 Key
Exclusion criteria
1. 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) 2. Has a cancer diagnosis consisting solely of basal cell or squamous cell skin carcinoma 3. Has a primary brain tumor or brain metastases as described in the protocol 4. Has proximal lower extremity DVT locally detected by Compression Ultrasound (CUS) during screening period 5. 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-to-first event of centrally adjudicated VTE (DVT, PE) or ATE, or thromboembolism- or ATE-related death | 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 | Through 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Time-to-first event of the centrally adjudicated symptomatic or incidental VTE (DVT, PE) or ATE and thromboembolism- or ATE-related death | Through 6 months |
| Time-to-first event of symptomatic VTE | Through 6 months |
| Time-to-first event of symptomatic DVT | Through 6 months |
| Time-to-first event of symptomatic non-fatal PE | Through 6 months |
| Time-to-first event of thromboembolism-related death | Through 6 months |
| Time-to-first event of incidental VTE | Through 6 months |
| Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT | Through 6 months |
| Time-to-first event of incidental non-fatal PE (in a segmental or larger pulmonary artery) | Through 6 months |
| Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by lower extremities ultrasound) | Through 6 months |
| Time-to-first event of ATE | Through 6 months |
| Time-to-first event of ATE-related death | Through 6 months |
| Time-to-first event of centrally adjudicated VTE (DVT, PE), or thromboembolism-related death | Through 6 months |
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Up to day 245 |
| Severity of TEAEs | Up to day 245 |
| Occurrence of Anti-Drug Antibody (ADA) to REGN7508 | Up to day 245 |
| Magnitude of ADA to REGN7508 | Up to day 245 |
Countries
Georgia, United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed