RightFit
RecruitingPhase 3

Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers

A 2-Part, Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against Factor XI, for the Treatment and Secondary Prevention of Venous Thromboembolism in Participants With Solid and Hematologic Cancers (ROXI-CAT-II)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests an experimental drug, REGN7508, against apixaban to see how safely and well it treats blood clots and prevents new ones. Part 1 is for adults with or without cancer who have a clot in a deep leg vein. Part 2 is for adults with cancer who have a clot in a deep vein or the lungs.

This study is researching an experimental drug called REGN7508 (called "study drug") and will consist of 2 parts: Part 1 and Part 2. The study is focused on participants with or without cancer who develop blood clots in certain veins (called Deep Vein Thrombosis \[DVT\]) that block blood flow (Part 1) or focused on participants with cancer who develop blood clots in certain veins (DVT) or the lungs (also called Pulmonary Embolism \[PE\]) (Part 2). The aim of the study is to see how safe and effective the study drug is at treating and preventing further blood clots in participants with or without cancer (Part 1) or in participants with cancer (Part 2) compared with another treatment (apixaban). 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 drug less effective or could lead to side effects)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be able to care for yourself and be up and about at least half of your waking hours (ECOG score 0–2).
  • If you have cancer in Part 1, or join Part 2, a tissue test must confirm a solid tumor or an allowed type of blood cancer. Having only basal-cell or squamous-cell skin cancer does not qualify.
  • Part 1: A scan must confirm a new deep leg vein clot within 5 days before you are assigned to a treatment group. The clot must cause symptoms or, if found by chance, be in a vein near the knee or higher.
  • Part 1: You must need a treatment dose of an oral blood thinner called a DOAC for at least 3 months.
  • Part 2: A scan must confirm a new blood clot in a vein or the lungs within 5 days before you are assigned to a treatment group.
  • Part 2: You must need a treatment dose of a DOAC blood thinner for at least 6 months.
  • Other study rules also apply.

Who can't join

  • The study doctor thinks you have a high risk of bleeding inside your skull.
  • You have a bleeding disorder, a tumor site that bleeds, or another condition that raises your bleeding risk.
  • The study doctor thinks blood thinners are not safe for you.
  • You are expected to live less than 6 months.
  • If you have cancer in Part 1, or join Part 2: You have acute leukemia or myelodysplastic syndrome, which are blood or bone marrow cancers.
  • If you have cancer in Part 1, or join Part 2: You have a tumor that started in the brain, or cancer that spread to the brain as defined by the study rules.
  • Part 1: You have a lung clot that causes symptoms, or a clot found by chance in a lung artery of a certain size or larger.
  • Part 2: You have a lung clot that makes your blood pressure or blood flow unstable.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: 1. 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 2. 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 3. Part 1 additional criteria: 1. 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) 2. 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 4. Part 2 additional criteria: 1. Newly diagnosed VTE within 5 days (120 hours) of randomization (with imaging confirmation) as described in the protocol 2. Anticoagulation therapy with a therapeutic dose of a DOAC for at least 6 months is indicated for newly diagnosed VTE Key Exclusion Criteria: 1. Is at high risk of intracranial bleeding in the opinion of the investigator 2. 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) 3. Contraindication to anticoagulation in the opinion of the investigator 4. Life expectancy of \< 6 months 5. Part 1 participants with cancer and Part 2 additional exclusion criteria: 1. Has acute leukemia or myelodysplastic syndrome 2. Has primary brain tumor 3. Has brain metastases as described in the protocol 6. Part 1 additional exclusion criteria: 1. Has a symptomatic PE 2. Has an asymptomatic (incidentally-diagnosed) PE in a segmental or larger pulmonary artery 7. Part 2 additional exclusion criteria: PE leading to hemodynamic instability as described in the protocol Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Study sites (3)

FL

NY

TX