RECRUITING

A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)

Conditions

Venous Thromboembolism Anti-factor XI (FXI) monoclonal antibody Peripherally inserted central catheter

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in the vein, also called a 'PICC line'. The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement. 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)

Official Title

A Master Protocol for a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of REGN9933 and REGN7508, Monoclonal Antibodies Against Factor XI for Prevention of Venous Thromboembolism in Patients With a Peripherally Inserted Central Catheter (ROXI-CATH)

Quick Facts

Study Start:2024-09-20

Study Completion:2026-06-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06299111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. PICC is anticipated to remain in place for at least 14 days 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol 3. Body weight ≥50 kg and ≤130 kg during the screening period 4. International normalized ratio (INR) and aPTT values at or below the upper limit of normal as defined by the local lab during the screening period 5. Platelet count ≥100 x 10\^9/L during the screening period as described in the protocol	1. Unsuccessful PICC placement or any other complication associated with this procedure that in the opinion of the study investigator may present any safety concerns to the participant 2. History of prior venous thrombosis in the arm in which the PICC is to be placed 3. Peripheral catheter(s) in the same arm in which the PICC is to be placed or expected need for peripheral catheter(s) placement in the same arm the PICC is to be placed as described in the protocol 4. History of known thromboembolic disease or thrombophilia 5. Participants requiring therapeutic or prophylactic anticoagulation and/or antiplatelet therapy as described in the protocol 6. Expected to receive cancer therapy or other medication associated with a prior episode of Grade 4 thrombocytopenia as described in the protocol 7. Any history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, traumatic spinal or epidural anesthesia, or history of bleeding diathesis (such as but not limited to Hemophilia A or B, von Willebrand's disease, fibrinogen deficiency, and other inherited or acquired bleeding disorders)

Inclusion Criteria

Exclusion Criteria

1. PICC is anticipated to remain in place for at least 14 days
2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol
3. Body weight ≥50 kg and ≤130 kg during the screening period
4. International normalized ratio (INR) and aPTT values at or below the upper limit of normal as defined by the local lab during the screening period
5. Platelet count ≥100 x 10\^9/L during the screening period as described in the protocol

1. Unsuccessful PICC placement or any other complication associated with this procedure that in the opinion of the study investigator may present any safety concerns to the participant
2. History of prior venous thrombosis in the arm in which the PICC is to be placed
3. Peripheral catheter(s) in the same arm in which the PICC is to be placed or expected need for peripheral catheter(s) placement in the same arm the PICC is to be placed as described in the protocol
4. History of known thromboembolic disease or thrombophilia
5. Participants requiring therapeutic or prophylactic anticoagulation and/or antiplatelet therapy as described in the protocol
6. Expected to receive cancer therapy or other medication associated with a prior episode of Grade 4 thrombocytopenia as described in the protocol
7. Any history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, traumatic spinal or epidural anesthesia, or history of bleeding diathesis (such as but not limited to Hemophilia A or B, von Willebrand's disease, fibrinogen deficiency, and other inherited or acquired bleeding disorders)

Contacts and Locations

Study Contact

Clinical Trials Administrator

CONTACT

844-734-6643

clinicaltrials@regeneron.com

Principal Investigator

Clinical Trial Management

STUDY_DIRECTOR

Regeneron Pharmaceuticals

Study Locations (Sites)

Memorial Sloan Kettering

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-20

Study Completion Date2026-06-29

Study Record Updates

Study Start Date2024-09-20

Study Completion Date2026-06-29

Terms related to this study

Keywords Provided by Researchers

Anti-factor XI (FXI) monoclonal antibody
Venous Thromboembolism
Peripherally inserted central catheter

Additional Relevant MeSH Terms

Venous Thromboembolism