Venous Thromboembolism study: REGN7508 vs Apixaban
Official title Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
ClinicalTrials.gov ID: NCT07493304
What this study is testing
What is REGN7508?
This is an investigational medicine being studied to treat and prevent blood clots in the veins or lungs.
Also referred to as cenvacibart.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a new drug works as well as a standard medicine. It also checks how safe the new drug is for people with cancer.
- Who it's for
- You may be able to join if you have cancer and have a blood clot in a vein.
- What's involved
- You would take a new medicine or a standard medicine. You would get regular blood tests to check your health.
- Time commitment
- The study lasts for a set time with regular visits to the clinic.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 at the time of screening and day 1 prior to first dose of study...
- In Part 1 participants with cancer and Part 2 participants: Histologically confirmed diagnosis of malignant solid or select hematologic tumor (other...
- Has newly diagnosed symptomatic lower extremity DVT or incidentally-detected proximal lower extremity DVT (eg, popliteal or femoral) within 5 days...
- Anticoagulation therapy with a therapeutic dose of a Direct Oral Anticoagulant (DOAC) for at least 3 months is indicated for the newly diagnosed...
- Newly diagnosed VTE within 5 days (120 hours) of randomization (with imaging confirmation) as described in the protocol
You likely can't join if
- Is at high risk of intracranial bleeding in the opinion of the investigator
- Known bleeding conditions (eg, Hemophilia A or B, von Willebrand's disease), hemorrhagic tumor sites, or other conditions with a high risk for...
- Contraindication to anticoagulation in the opinion of the investigator
- Life expectancy of \< 6 months
- Has acute leukemia or myelodysplastic syndrome
- Has primary brain tumor
See the full eligibility criteria
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 at the time of screening and day 1 prior to first dose of study intervention
- In Part 1 participants with cancer and Part 2 participants: Histologically confirmed diagnosis of malignant solid or select hematologic tumor (other than basal-cell or squamous-cell carcinoma of the skin alone) as...
- Has newly diagnosed symptomatic lower extremity DVT or incidentally-detected proximal lower extremity DVT (eg, popliteal or femoral) within 5 days (120 hours) of randomization (with imaging confirmation)
- Anticoagulation therapy with a therapeutic dose of a Direct Oral Anticoagulant (DOAC) for at least 3 months is indicated for the newly diagnosed proximal lower extremity DVT
- Newly diagnosed VTE within 5 days (120 hours) of randomization (with imaging confirmation) as described in the protocol
- Anticoagulation therapy with a therapeutic dose of a DOAC for at least 6 months is indicated for newly diagnosed VTE Key
- Is at high risk of intracranial bleeding in the opinion of the investigator
- 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)
- Contraindication to anticoagulation in the opinion of the investigator
- Life expectancy of \< 6 months
- Has acute leukemia or myelodysplastic syndrome
- Has primary brain tumor
- Has brain metastases as described in the protocol
- Has a symptomatic PE
- Has an asymptomatic (incidentally-diagnosed) PE in a segmental or larger pulmonary artery
- Part 2 additional exclusion criteria: PE leading to hemodynamic instability as described in the protocol Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
- Sofia, Bulgaria
- Isehara-Shi, Kanagawa, Japan
- Shinjuku, Tokyo, Japan
- Ube, Yamaguchi, Japan
- Bucharest, Bucharest, Romania
- Cluj-Napoca, Cluj, Romania
- Yongin-si, Gyeonggi-do, South Korea
- Busan, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States; Sofia, Bulgaria; Isehara-Shi, Kanagawa, Japan; Shinjuku, Tokyo, Japan; Ube, Yamaguchi, Japan; Bucharest, Bucharest, Romania and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.