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Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants with Solid and Hematologic Cancers
EU CTIS ID: 2024-519299-16-00
What this study is testing
Part 1: To evaluate the safety and tolerability of REGN7508 in participants with DVT Part 2: To evaluate the effect of REGN7508 compared to standard-of-care anticoagulation (apixaban) in the prevention of recurrent symptomatic or asymptomatic VTE and VTE-related death in participants with cancer associated VTE Part 2: To evaluate the effect of REGN7508 compared to apixaban on clinically important bleeding events
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 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 described in the protocol
- Part 1 additional criteria: a. 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) b. 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
- Part 2 additional criteria: a. Newly diagnosed VTE within 5 days (120 hours) of randomization (with imaging confirmation) as described in the protocol b. Anticoagulation therapy with a therapeutic dose of a DOAC for at least 6 months is indicated for newly diagnosed VTE
- Note: Other Protocol Defined Inclusion Criteria Apply
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 bleeding (eg, hepatic disease associated with coagulopathy)
- Contraindication to anticoagulation in the opinion of the investigator
- Life expectancy of < 6 months
- Part 1 participants with cancer and Part 2 additional exclusion criteria: a. Has acute leukemia or myelodysplastic syndrome b. Has primary brain tumor c. Has brain metastases as described in the protocol
- Part 1 additional exclusion criteria: a. Has a symptomatic PE b. Has an asymptomatic (incidentally-diagnosed) PE in a segmental or larger pulmonary artery
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 described in the protocol
- Part 1 additional criteria: a. 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) b. 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
- Part 2 additional criteria: a. Newly diagnosed VTE within 5 days (120 hours) of randomization (with imaging confirmation) as described in the protocol b. Anticoagulation therapy with a therapeutic dose of a DOAC for at least 6 months is indicated for newly diagnosed VTE
- Note: Other Protocol Defined Inclusion Criteria Apply
- 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
- Part 1 participants with cancer and Part 2 additional exclusion criteria: a. Has acute leukemia or myelodysplastic syndrome b. Has primary brain tumor c. Has brain metastases as described in the protocol
- Part 1 additional exclusion criteria: a. Has a symptomatic PE b. 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 Exclusion Criteria Apply
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Taiwan
- Australia
- Brazil
- Korea, Republic of
- United States
- Georgia
- United Kingdom
- Turkey
- Canada
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 - 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Taiwan; Australia; Brazil; Korea, Republic of; United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.