STRO-002 + Bevacizumab for Ovarian Cancer
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Sutro Biopharma, Inc.
Must not be taking: Immunosuppressants, Corticosteroids
Disqualifiers: Low grade ovarian carcinoma, others
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This trial tests the safety and effectiveness of combining STRO-002 and Bevacizumab in patients with advanced ovarian cancer that hasn't responded to standard treatments. STRO-002 targets cancer cells directly, and Bevacizumab stops blood vessel growth to tumors.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, ongoing immunosuppressive therapy and certain conditions like uncontrolled hypertension or active infections may affect eligibility.
What data supports the effectiveness of the drug Bevacizumab (Avastin) for ovarian cancer?
Bevacizumab, when combined with chemotherapy, has been shown to significantly prolong progression-free survival (the time during which the cancer does not get worse) in women with newly diagnosed advanced ovarian cancer and in those with recurrent disease. It is approved for use in combination with other drugs for these conditions, and studies have confirmed its activity in ovarian cancer treatment.
12345Is the combination of STRO-002 and Bevacizumab safe for treating ovarian cancer?
Bevacizumab, also known as Avastin, has been used in treating ovarian cancer and is generally safe, but it can cause side effects like high blood pressure, bleeding, and protein in the urine. Serious but rare side effects include blood clots, wound healing problems, and gastrointestinal issues. These side effects are usually manageable by doctors.
16789How is the drug STRO-002 + Bevacizumab unique for treating ovarian cancer?
The combination of STRO-002 and Bevacizumab is unique because it targets the vascular endothelial growth factor (VEGF) to inhibit tumor blood vessel growth, which is a novel approach compared to traditional chemotherapy. Bevacizumab, already used in combination with other drugs for ovarian cancer, is being explored with STRO-002 to potentially enhance its effectiveness and offer a new treatment option.
12101112Eligibility Criteria
This trial is for adults over 18 with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. They should have a life expectancy of more than 3 months and at least one measurable lesion. Participants need good kidney, bone marrow, and liver function but can't join if they've had certain treatments like FolRα targeting agents or are pregnant/breastfeeding without using barrier contraception.Participant Groups
The study tests STRO-002 combined with Bevacizumab in patients with epithelial ovarian cancer to evaluate safety and early effectiveness. It's a Phase 1 trial where participants' response to the treatment is monitored through various health parameters.
1Treatment groups
Experimental Treatment
Group I: Experimental :STRO-002 treatment in combination with BevacizumabExperimental Treatment2 Interventions
Dose Escalation: STRO-002 at increasing dose levels plus bevacizumab at 15 mg/kg
Dose Expansion: STRO-002 at RP2D plus bevacizumab at 15 mg/kg
Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:
🇪🇺 Approved in European Union as Avastin for:
- Colorectal cancer
- Breast cancer
- Non-small cell lung cancer
- Renal cell carcinoma
- Ovarian cancer
🇺🇸 Approved in United States as Avastin for:
- Colorectal cancer
- Non-small cell lung cancer
- Glioblastoma
- Renal cell carcinoma
- Cervical cancer
- Ovarian cancer
🇯🇵 Approved in Japan as Avastin for:
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
🇨🇦 Approved in Canada as Avastin for:
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of South Florida,Tampa, FL
Thomas Jefferson UniversityPhiladelphia, PA
University of PennsylvaniaPhiladelphia, PA
Tennessee OncologyNashville, TN
More Trial Locations
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Who is running the clinical trial?
Sutro Biopharma, Inc.Lead Sponsor
References
Bevacizumab combination therapy: a review of its use in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. [2019]Bevacizumab (Avastin®) is a recombinant, humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody that neutralizes the biological activity of VEGF and inhibits tumor angiogenesis. In the EU, in adult patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, bevacizumab (in combination with carboplatin and paclitaxel) is approved for the first-line treatment of advanced disease and (in combination with carboplatin and gemcitabine) is approved for the treatment of patients with first recurrence of platinum-sensitive disease who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. This article summarizes the pharmacology of bevacizumab and reviews the efficacy and tolerability of bevacizumab combination therapy in well-designed clinical studies in these indications. The addition of bevacizumab to first-line carboplatin plus paclitaxel, followed by bevacizumab maintenance therapy significantly prolonged progression-free survival in women with newly-diagnosed advanced disease (GOG-0218 and ICON7 studies). Progression-free survival was also significantly prolonged after second-line treatment with bevacizumab in combination with carboplatin and gemcitabine, followed by maintenance treatment with bevacizumab alone in women with recurrence (≥ 6 months after front-line platinum-based therapy) of platinum-sensitive disease (OCEANS study). Bevacizumab combination therapy had a generally acceptable tolerability profile in these studies, with the nature of adverse events generally similar to that observed in previous clinical trials in patients with other solid tumors. Although several unanswered questions remain, such as the optimal dosage and duration of treatment, current evidence suggests that bevacizumab combination therapy extends the treatment options available for patients with ovarian cancer.
Bevacizumab and its use in epithelial ovarian cancer. [2019]Bevacizumab is a monoclonal antibody that binds to VEGF, a circulating protein involved in the promotion of angiogenesis and probably tumor growth and progression. Bevacizumab has demonstrated anticancer activity in several cancers, either combined with chemotherapy or when used as a single agent, and has been approved by the US FDA as a treatment for several cancers. As VEGF has been implicated in ovarian cancer progression and ascites formation, and high levels of VEGF have been found in plasma and ascites in women with ovarian cancer, bevacizumab has been tested as an anticancer therapy in ovarian cancer. Documented single-agent activity of bevacizumab in recurrent ovarian cancer has led to combination studies with both biologic agents as well as other chemotherapy agents in both recurrent and newly diagnosed cancer. One trial in patients with recurrent, heavily pretreated ovarian cancer demonstrated a higher than predicted risk of gastrointestinal perforation, and although a lower incidence of gastrointestinal perforation has been reported in less heavily pretreated patients, patients and their physicians must be aware of this risk. Upfront studies testing the impact of adding bevacizumab to carboplatin and paclitaxel chemotherapy for the treatment of newly diagnosed cancer are currently underway, and one Phase III randomized study (Gynecologic Oncology Group study 218) was recently presented and will be discussed in this article.
Anti-angiogenic agents in ovarian cancer: past, present, and future. [2023]Angiogenesis plays a pivotal role in normal ovarian physiology as well as in the progression of ovarian cancer through ascites formation and metastatic spread. Bevacizumab (Avastin(®), Genentech; South San Francisco, CA, USA), a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody, is the most widely studied anti-angiogenesis agent both across tumor types and specifically in epithelial ovarian cancer. In 2005, single-agent bevacizumab at 15 mg/kg (IV) every 3 weeks was first reported to be active in a case of recurrent high-grade serous ovarian cancer after failing 11th line cytotoxic treatment. Since then, many case series, phase II and phase III trials have confirmed these results leading to regulatory approval in most countries including the US Food and Drug Administration in 2014. Guidelines now give clear recommendations as to when and how bevacizumab should be integrated into the ovarian cancer treatment paradigm. Other anti-VEGF agents such as the VEGF receptor (VEGFR) tyrosine kinase inhibitors have not shown increased activity or reduced toxicity relative to bevacizumab. However, anti-angiogenics other than anti-VEGF/VEGFR agents such as those targeting Angiopoietin-1 and -2 are in development as well as novel combinations with vascular disrupting agents (VDAs), PARP inhibitors and immune checkpoint inhibitors. Clearly, the benefits of anti-angiogenic agents such as bevacizumab must be carefully weighed against the cost and associated toxicities. Although almost all patients with ovarian cancer will receive an anti-angiogenic compound, cures are not increased. Predictive biomarkers are an urgent unmet need.
Integrating bevacizumab into the management of epithelial ovarian cancer: the controversy of front-line versus recurrent disease. [2020]Angiogenesis plays a fundamental role in the pathogenesis of ovarian cancer. Vascular endothelial growth factor (VEGF) expression has been associated with the development of malignant ascites and tumor progression. Bevacizumab (Avastin(®); Genentech, South San Francisco, CA, USA), a humanized anti-VEGF monoclonal antibody, is the most widely studied antiangiogenesis agent across tumor types and specifically in epithelial ovarian cancer (EOC). With the recent reporting of four consecutive positive randomized trials adding bevacizumab to chemotherapy in the treatment of both front-line (GOG 218 and ICON7) and recurrent EOC ['platinum-resistant' (AURELIA Trial) or 'platinum-sensitive' (OCEANS Trial)], the most debatable question today is thus not IF we should treat ovarian cancer patients with bevacizumab, but WHEN. As bevacizumab is active in both settings, it seems appropriate to carefully consider this clinical controversy: 'what is the optimal setting for bevacizumab treatment?' A fine balance of efficacy, toxicity, quality of life, and symptom control is the main crux of this controversy. The cost effectiveness of bevacizumab in EOC is also controversial.
The use of bevacizumab in the management of ovarian cancer: an argument for single-agent rather than combination therapy. [2020]Bevacizumab is a biologically and clinically active antineoplastic agent in the management of epithelial ovarian cancer. While phase III trial data have revealed the favorable impact on progression-free survival associated with combining the agent with cytotoxic chemotherapy, at the current time a strong argument can be made (based on both efficacy and cost-effectiveness considerations) that a more rational approach to utilizing bevacizumab in ovarian cancer would be to administer the drug as a single agent in the platinum-resistant setting.
Experience with bevacizumab in the management of epithelial ovarian cancer. [2015]Müllerian duct adenocarcinomas, in particular epithelial ovarian cancers, continue to represent a major source of female cancer-related morbidity and mortality, despite advances in surgical management and innovations in cytotoxic chemotherapy. Angiogenesis-targeted therapy seems to be appropriate for exploration in these disease processes based on a wealth of evidence from preclinical and molecular epidemiology studies. Bevacizumab is a prototypical agent neutralizing vascular endothelial growth factor (VEGF), a critical angiogenic promoter related to tumor progression, malignant effusions, and prognosis in ovarian cancer. Phase II trials have demonstrated the activity of bevacizumab as a single agent and in combination with other modalities such as low-dose metronomic cyclophosphamide. Historical studies have supported these observations. Unique toxicities have been ascribed to the administration of bevacizumab and other anti-VEGF molecules for patients with this disease and other solid tumors. Although most of these toxicities (such as proteinuria, hypertension, and bleeding) are generally mild, and are either self-limiting or controllable, other adverse effects, though uncommon, may be serious (these include arterial thromboembolism, wound healing complications, and GI perforation or fistulae). Phase III trials are now in progress to determine the role of this drug in primary therapy as an adjunct to platinum-taxane chemotherapy. This article reviews the background and rationale for anti-VEGF therapy of ovarian cancer, summarizes efficacy and safety data from phase II trials and historical studies of bevacizumab in this disease, introduces the implementation of bevacizumab in phase III front-line trials, examines controversial aspects related to anti-VEGF therapy, and proposes future directions regarding bevacizumab and other angiogenic growth factor-targeted therapeutics.
Critical appraisal of bevacizumab in the treatment of ovarian cancer. [2018]Bevacizumab is the first molecular-targeted agent to be used for the treatment of ovarian cancer. Bevacizumab is a humanized monoclonal antibody targeting vascular endothelial growth factor. Two randomized Phase III trials evaluated the combination of bevacizumab plus standard cytotoxic chemotherapy for first-line treatment of advanced ovarian cancer. Additional Phase III trials evaluated bevacizumab combined with cytotoxic chemotherapy in platinum-sensitive and platinum-resistant recurrent ovarian cancer. All these trials reported a statistically significant improvement in progression-free survival but not in overall survival. Furthermore, bevacizumab effectively improved the quality of life with regard to abdominal symptoms in recurrent ovarian cancer patients. Bevacizumab is associated with adverse events not commonly observed with cytotoxic agents used to treat gynecological cancers, such as hypertension, bleeding, thromboembolism, proteinuria, delayed wound healing, and gastrointestinal events. However, most of these events can be adequately managed by gynecologists. The clinical trial results with bevacizumab have supported its recent approval in Europe and the United States as a treatment for ovarian cancer. This review presents the latest evidence for bevacizumab therapy of ovarian cancer and describes selection of patients for personalized treatment.
Adverse Events Associated With Long-term Treatment of Epithelial Ovarian Cancer With Bevacizumab and Chemotherapy. [2022]Adverse events associated with long-term bevacizumab administration for ovarian cancer have been poorly documented in Japan. This study aimed to evaluate the adverse events of bevacizumab combined with chemotherapy for treating primary and recurrent epithelial ovarian cancer in Japan.
Bevacizumab and ovarian cancer. [2021]Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that targets vascular endothelial growth factor-A, and is indicated in the treatment of various tumors (colon, lung, renal, and glioblastoma). It has been recently approved for the treatment of ovarian cancer in various countries. This review summarizes the activity and toxicity of bevacizumab in the treatment of ovarian cancer, both as single-agent drug and in combination with cytotoxic chemotherapy. As a single-agent drug, it has shown response rates of 16-21% in the treatment of recurrent ovarian cancer. Two phase III randomized trials have been published evaluating the addition of bevacizumab to standard chemotherapy as front-line treatment of advanced ovarian cancer. In addition, trials evaluating the combination with chemotherapy in recurrent ovarian cancer (platinum-sensitive and platinum-resistant disease) have also been reported. All these trials showed a statistically significant improvement in progression-free survival although no improvement in overall survival has been reported. The main adverse event is hypertension. Other serious, but uncommon adverse events include gastrointestinal perforation as well as renal and central nervous system toxicity.
Phase II study of carboplatin, paclitaxel, and bevacizumab with maintenance bevacizumab as first-line chemotherapy for advanced mullerian tumors. [2022]PURPOSE New strategies are needed to improve outcomes for patients with advanced ovarian cancer. Bevacizumab is a recombinant humanized monoclonal antibody that neutralizes vascular endothelial growth factor but is associated with GI perforations (GIPs) in patients with recurrent disease. PATIENTS AND METHODS An open-label, phase II clinical trial was conducted in newly diagnosed patients with stage > or = IC epithelial müllerian tumors. Patients received intravenous (IV) carboplatin (area under the curve = 5), paclitaxel (175 mg/m(2) IV), and bevacizumab (15 mg/kg IV) for six to eight cycles on day 1 every 21 days. Bevacizumab was omitted in the first cycle and continued as a single agent for 1 year. Results Sixty-two women participated in this study. Fifty-one patients (82%) were optimally surgically cytoreduced before treatment. The median age was 58 years (range, 18 to 77 years). Forty-five women (73%) had ovarian cancer, 10 (16%) had peritoneal cancer, four (6%) had fallopian tube cancers, and three (5%) had uterine papillary serous tumors. The majority of patients (90%) had stage III or IV disease. A median of 17 maintenance cycles (range, 0 to 25+ cycles) of bevacizumab (556 cycles) were administered with mild toxicity. Treatment was associated with two pulmonary embolisms and two GIPs, all occurring during the chemotherapy phase of treatment (364 total cycles). No grade 4 toxicities were seen during maintenance bevacizumab treatment. Radiographic responses were documented in 21 (75%) of 28 women with measurable disease (11 complete responses and 10 partial responses), with CA-125 responses in 76% of patients (11 complete responses, 21%; and 35 partial responses, 55%). The progression-free survival rate at 36 months was 58%. CONCLUSION The regimen of carboplatin, paclitaxel, and bevacizumab with maintenance bevacizumab is feasible, safe, and worthy of future study in advanced ovarian cancer.
Low-dose (7.5 mg/kg) bevacizumab may be a viable option in recurrent ovarian cancer: A retrospective study. [2023]Bevacizumab (BEV) is a humanized monoclonal antibody of vascular endothelial growth factor receptors and, as a result of clinical trials, was approved for the treatment of recurrent ovarian cancer (ROC). The aim of this study was to assess the clinical utility of BEV in patients with ROC in real-world practice beyond clinical trials.
Bevacizumab in ovarian cancer: A critical review of phase III studies. [2022]Bevacizumab (BV) is a humanized monoclonal antibody targeting vascular endothelial growth factor and it is the first molecular-targeted agent to be used for the treatment of ovarian cancer (OC). Randomized Phase III trials evaluated the combination of BV plus standard chemotherapy for first-line treatment of advanced OC and for platinum-sensitive and platinum-resistant recurrent OC. These trials reported a statistically significant improvement in progression-free survival but not in overall survival. Furthermore, BV effectively improved the quality of life with regard to abdominal symptoms in recurrent OC patients. Bevacizumab is associated with adverse events such as hypertension, bleeding, thromboembolism, proteinuria, delayed wound healing, and gastrointestinal events. However, most of these events can be adequately managed. This review describes the latest evidence for BV treatment of OC and selection of patients for personalized treatment.