Bevacizumab Clinical Trials

What Is Bevacizumab?

Bevacizumab is an FDA-approved medication for metastatic colorectal cancer, recurrent glioblastoma multiforme, and unresectable, locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer. It is a monoclonal antibody that works by targeting Vascular Endothelial Growth Factor (VEGF). VEGF is a protein in the body that plays a crucial role in forming new blood vessels, which tumors need to grow and spread. By blocking VEGF, bevacizumab helps to cut off the blood supply to tumors, thereby preventing or slowing their growth.

Beyond its approved uses, bevacizumab is also being investigated in a wide range of other cancers and various eye conditions. Researchers are studying its potential to improve outcomes when used alone or in combination with other therapies.

Uses and Conditions Under Study

Bevacizumab has been extensively studied in clinical trials for various conditions, with a total of 2548 trials involving 402,741 participants. The earliest trial began in 2001, and the latest is projected to conclude in 2026.

• Colorectal Cancer: This includes Colorectal Cancer (224 trials), Metastatic Colorectal Cancer (127 trials), and Colorectal Neoplasms (48 trials). Bevacizumab is approved for metastatic colorectal cancer and is studied to inhibit the growth of new blood vessels that feed these tumors.
• Ovarian and Fallopian Tube Cancer: Ovarian Cancer (94 trials) and Fallopian Tube Cancer (49 trials) are being investigated. Bevacizumab is explored for its ability to enhance the effectiveness of chemotherapy and PARP inhibitors in these gynecologic cancers by targeting tumor blood supply.
• Breast Cancer: Breast Cancer (122 trials) is another significant area of study. Bevacizumab is being evaluated in combination with chemotherapy regimens, including for advanced or high-risk cases, to prevent tumor growth and spread.
• Liver Cancer: Hepatocellular Carcinoma (84 trials) is a focus for bevacizumab research. It is studied alone or in combination with immunotherapies and locoregional treatments to improve response rates and patient prognosis for advanced liver cancer.
• Brain Cancer: Glioblastoma (64 trials) and Glioblastoma Multiforme (46 trials) are actively researched. Bevacizumab is FDA-approved for recurrent glioblastoma and is being studied to reduce tumor-related swelling and enhance the delivery of other treatments to brain tumors.
• Lung Cancer: Lung Cancer (60 trials), including Non-Small Cell Lung Cancer (NSCLC), is a key area. Bevacizumab is approved for certain types of NSCLC and is investigated in various combinations to improve survival and manage complications like brain metastases.
• Other Cancers: Bevacizumab is also being studied in trials for Head and Neck Squamous Cell Carcinoma, Renal Cell Carcinoma, Melanoma, Kaposi's sarcoma, Neuroblastoma, Pancreatic Cancer, Esophageal and Gastric Cancer, Malignant Pleural Mesothelioma, Sarcoma, and Lymphoma (Non-Hodgkin's lymphoma, Classical Hodgkin's lymphoma). Its anti-angiogenic properties are being explored across these diverse tumor types.
• Eye Conditions: Bevacizumab is being investigated for various eye conditions such as Diabetic Macular Edema, Choroidal Neovascularization, Proliferative Diabetic Retinopathy, Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, and Retinopathy of Prematurity. In these conditions, it aims to reduce abnormal blood vessel growth and associated swelling in the retina that can lead to vision loss.
• Other Non-Cancer Conditions: Research also includes Hereditary Hemorrhagic Telangiectasia, Recurrent Respiratory Papillomatosis, Chronic Subdural Hematoma, COVID-19, Sepsis, Myelodysplastic Syndromes, and Glaucoma, exploring its potential to modulate blood vessel formation or inflammation.

Dosing

Bevacizumab is primarily administered as an intravenous (IV) infusion. The specific dose and frequency vary depending on the condition being treated and whether it is used alone or in combination with other medications.

For cancer treatments, common intravenous doses studied include 5 mg/kg, 7.5 mg/kg, 10 mg/kg, and 15 mg/kg. These infusions are typically given over approximately 30 minutes to 1 hour, with frequencies ranging from once every 2 weeks (Q2W) to every 21-day or 28-day cycles. It is frequently combined with various chemotherapy regimens such as FOLFIRI, FOLFOX, carboplatin, paclitaxel, and other targeted therapies like atezolizumab or pembrolizumab.

For eye conditions, bevacizumab is often given as an intravitreal injection directly into the eye. Doses studied for these indications are much smaller, including 0.002 mg, 0.004 mg, 0.008 mg, 0.016 mg, 0.031 mg, 0.063 mg, 0.125 mg, 0.25 mg, 0.3125 mg, 0.625 mg, and 1.25 mg. These injections are sometimes required monthly.

Investigational uses also include specific formulations for molecular imaging, such as bevacizumab-800CW at doses of 15 mg or 25 mg, administered intravenously before bronchoscopy. Pediatric patients have also been included in studies, for example, in neuroblastoma, where bevacizumab is combined with other chemotherapy drugs.

Side Effects

When taking Bevacizumab, patients may experience various side effects. In clinical trials involving thousands of patients, the most common side effect was fatigue, affecting 45.4% of patients taking Bevacizumab, which was similar to the 45.9% of patients on placebo. Nausea was also commonly reported by 40.0% of Bevacizumab patients, compared to 39.4% on placebo.

Other frequently reported side effects that occurred more often in patients receiving Bevacizumab than those on placebo include:

• Diarrhea, experienced by 35.5% of Bevacizumab patients compared to 30.4% on placebo.
• Alopecia (hair loss), affecting 31.5% of Bevacizumab patients versus 28.5% on placebo.
• Rash, seen in 25.0% of Bevacizumab patients compared to 19.7% on placebo.
• Epistaxis (nosebleeds), reported by 23.5% of Bevacizumab patients, a notable increase compared to 11.3% on placebo.
• Headache, occurring in 23.3% of Bevacizumab patients versus 19.9% on placebo.
• Hypertension (high blood pressure), affecting 20.8% of Bevacizumab patients compared to 15.1% on placebo.

Some side effects were reported at similar or lower rates in patients taking Bevacizumab compared to placebo, such as constipation (28.5% vs 29.2%), vomiting (22.8% vs 22.2%), anemia (23.9% vs 26.0%), and neutropenia (19.6% vs 22.0%).

Clinical Trial Results

Ovarian Epithelial Cancer or Primary Peritoneal Cancer

In a study (NCT00022659) of patients with persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer, Bevacizumab treatment showed a median progression-free survival of 4.7 months. The median overall survival for patients in this trial was 16.9 months. At 6 months, 40.3% of participants were progression-free, and 21% of participants experienced a tumor response.

Persistent or Recurrent Cancer of the Cervix

A trial (NCT00025233) investigating Bevacizumab in patients with persistent or recurrent cancer of the cervix reported a median progression-free survival of 3.40 months. The median overall survival was 7.3 months. Approximately 23.9% of participants achieved progression-free survival lasting longer than 6 months, and 10.9% of participants showed a tumor response.

Metastatic Malignant Melanoma

A study (NCT00026221) evaluated Bevacizumab with or without interferon alfa in patients with metastatic malignant melanoma. The median progression-free survival varied by treatment arm:

• Patients receiving Bevacizumab with interferon-alpha-2b had a median progression-free survival of 3 months.
• Patients receiving Bevacizumab alone had a median progression-free survival of 8.5 months.
• Patients receiving monoclonal antibody and biological therapy (control arm) had a median progression-free survival of 4.8 months.

Regarding objective response rates, 1 patient in the Bevacizumab with interferon-alpha-2b arm and 0 patients in the Bevacizumab alone arm had an objective response, while 6 patients in the control arm showed an objective response.

Liver Cancer That Cannot Be Removed With Surgery

In a study (NCT00049322) of patients with unresectable liver cancer, the combination of chemoembolization and Bevacizumab (TACE-BEV arm) was compared to chemoembolization alone (TACE-O arm). The probability of progression-free survival at 16 weeks was 0.79 for the TACE-BEV arm, significantly higher than the 0.19 for the TACE-O arm. Neovessel formation, as measured by angiogram at 14 weeks, was observed in 2 participants in the TACE-BEV arm and 3 participants in the TACE-O arm.

Stage IV Breast Cancer

A trial (NCT00054132) investigated Erlotinib Hydrochloride and Bevacizumab in patients with Stage IV breast cancer. Among 38 participants evaluated for toxicity, the median time to progression was 11 weeks. The duration of response was reported as 52 months. For tumor response, 17 participants achieved a complete response and 19 participants achieved a partial response, meaning 94.7% of evaluated patients had a complete or partial response.

Currently Recruiting Trials

Bevacizumab is a medication frequently studied in clinical trials, often in combination with other therapies, to explore new ways to treat various cancers and other conditions. Researchers are actively seeking participants for a wide range of studies, from early-stage investigations to large-scale comparative trials.

One ongoing Phase 4 study, NCT07059494, sponsored by the Icahn School of Medicine at Mount Sinai, is evaluating atezolizumab and Bevacizumab alongside Y^90 radioembolization for hepatocellular carcinoma (HCC). This trial is designed for up to 40 participants and includes cohorts for those beyond Milan Criteria or within Milan Criteria with elevated AFP levels. For metastatic colorectal cancer (mCRC), a large Phase 3 study, NCT07549412, aims to enroll 1020 participants. Sponsored by EMD Serono, it compares a new drug, precemtabart tocentecan, with or without Bevacizumab, against trifluridine/tipiracil plus Bevacizumab in previously treated patients.

Another Phase 2 study, NCT07446322, from Oncolytics Biotech, is investigating FOLFIRI and Bevacizumab with or without pelareorep for RAS-mutated, microsatellite-stable mCRC, targeting 60 participants. In advanced gynecological malignancies, Sichuan Kelun-Biotech Biopharmaceutical is running a Phase 2 trial, NCT07448922, for 280 participants, exploring SKB518 as a monotherapy or in combination with carboplatin and/or Bevacizumab. For recurrent or advanced endometrial cancer, the National Cancer Institute is sponsoring a Phase 3 study, NCT07198074, with an enrollment goal of 255 participants, testing Bevacizumab with chemotherapy (carboplatin and paclitaxel) and immunotherapy (pembrolizumab).

Beyond cancer, Bevacizumab is also being studied for other conditions. A Phase 2/3 trial, NCT06264531, is assessing the safety and efficacy of intravenous Bevacizumab in 54 participants with symptomatic cerebral arteriovenous malformations. Additionally, a Phase 3 study, NCT06888817, sponsored by The Netherlands Cancer Institute, is comparing Bevacizumab to corticosteroids as a first-line treatment for symptomatic cerebral radiation necrosis after radiation for high-grade glioma or brain metastases, enrolling 408 participants.

Where to Participate

Clinical trials involving Bevacizumab are conducted globally, with study sites spanning 2235 locations across 805 cities in 50 states. This broad reach helps ensure diverse participation and accessibility for patients interested in contributing to medical research.

Some of the top cities with the most recruiting sites include:

• New York, New York (76 sites)
• Houston, Texas (71 sites)
• Nashville, Tennessee (54 sites)
• Los Angeles, California (54 sites)
• Chicago, Illinois (43 sites)
• Boston, Massachusetts (42 sites)
• Portland, Oregon (42 sites)
• Columbus, Ohio (38 sites)
• St Louis, Missouri (36 sites)
• Atlanta, Georgia (36 sites)

Eligibility for these trials is broad, welcoming participants aged 1 to 130 years, of all genders. Many studies also include healthy volunteers and children, depending on the specific research objectives.

Development Timeline

The journey of Bevacizumab in clinical research began on May 17, 2001, marking the start of its extensive development. Since then, a remarkable 2548 trials have been initiated, enrolling over 402,741 participants to date, with the latest trial starting on May 13, 2026. This robust pipeline reflects continuous efforts to understand and expand the therapeutic potential of Bevacizumab.

Early in its development, Bevacizumab was explored for conditions like breast cancer, ovarian cancer, hepatocellular carcinoma, glioblastoma, and lung cancer. Over time, its application expanded significantly to include a wide array of conditions such as colorectal neoplasms, diabetic macular edema, and even acute respiratory distress syndrome, demonstrating its versatility and the broad impact of its anti-angiogenic mechanism. The majority of studies have been in Phase 2 (1309 trials), followed by Phase 3 (336 trials) and Phase 1 (311 trials), indicating a strong progression through the clinical development stages.

Leading the research efforts are prominent institutions and pharmaceutical companies, including the National Cancer Institute (NCI), Hoffmann-La Roche, M.D. Anderson Cancer Center, and Genentech, Inc. Other significant contributors include Sun Yat-sen University, Fudan University, Pfizer, AbbVie, AstraZeneca, Eli Lilly and Company, Merck Sharp & Dohme LLC, and Bristol-Myers Squibb. These sponsors have been instrumental in driving the investigation of Bevacizumab, exploring its efficacy and safety across a diverse range of medical needs.