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NCT03587311Active, not recruitingPhase 2

Bevacizumab and Anetumab Ravtansine or Paclitaxel in Treating Patients With Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Randomized Phase 2 Study of Bevacizumab and Either Weekly Anetumab Ravtansine or Weekly Paclitaxel in Platinum-Resistant or Platinum Refractory Ovarian Cancer

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

This phase II trial studies the side effects of bevacizumab and anetumab ravtansine or paclitaxel in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that does not respond to treatment (refractory). Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Anetumab ravtansine is a drug that targets a protein in the body called mesothelin, which can be found in some ovarian, pancreatic and other tumors. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving bevacizumab and anetumab ravtansine or paclitaxel may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
96 (estimated)
First submitted
13 Jul 2018
Start date
12 Oct 2018
Primary completion date
15 Dec 2027
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT03587311

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 96
  • From 12 Oct 2018 to the primary completion date, 15 Dec 2027
  • 23 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
  • Patients who are receiving any other investigational agents
  • Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list or medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. Strong inhibitors and inducers of CYP3A4 are prohibited within 2 weeks before the start of and during treatment. Strong inhibitors and inducers of CYP2C8 should be used with caution; the PI of the study is to be consulted regarding their use
  • Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued during the study and for at least 6 months after last dose of study drugs. These potential risks may also apply to other agents used in this study. Women of child-bearing potential who do not agree to use adequate contraceptive measures during study therapy and for at least 6 months after the completion of study therapy will be excluded. Should a patient become pregnant or suspect she is pregnant while she is participating in this study, the patient should inform the treating physician immediately
  • History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to day 1
  • Invasive procedures defined as follows:
    • Major surgical procedure or significant traumatic injury within 28 days prior to day 1 therapy, or open biopsy within 7 days prior to day 1 therapy
    • Anticipation of need for major surgical procedures during the course of the study
  • Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to day 1
  • History or evidence of arterial thrombotic or hemorrhagic disorders within 3 months before proposed start of treatment, non-healing wound, ulcer, or bone fracture
  • Prior use of weekly paclitaxel or bevacizumab in the platinum resistant (disease progression within 6 months of platinum based chemotherapy)/refractory (disease progression during or following the 3 months of the first line platinum based chemotherapy) setting

Other illness

  • History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, anetumab ravtansine or paclitaxel
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, or psychiatric illness/social situations that would limit compliance with study requirements
  • Serious or non-healing wound, ulcer or bone fracture
  • Patients with clinically significant cardiovascular disease are excluded
    • Inadequately controlled hypertension (HTN) (systolic blood pressure \[SBP\] \> 160 mmHg and/or diastolic blood pressure \[DBP\] \> 90 mmHg despite antihypertensive medication)
    • History of cerebrovascular accident (CVA) within 6 months
    • Myocardial infarction or unstable angina within 6 months
    • Serious and inadequately controlled cardiac arrhythmia
    • Significant vascular disease (e.g. aortic aneurysm, history of aortic dissection)
    • Clinically significant peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • History of bowel obstruction within 28 days from proposed start of treatment
  • Known active human immunodeficiency virus (HIV) or hepatitis B or C infection

Lab values

  • Resting electrocardiogram (ECG) with corrected QT interval by Fridericia (QTcF) \> 470 msec or family history of long QT syndrome

Other

  • Current symptom of keratitis or retinopathy at \>= grade 2

Who the study is looking for

  • Patients must have histologically or cytologically confirmed high grade serous or high grade endometrioid ovarian, fallopian tube, primary peritoneal cancer
  • Patients must have platinum resistant (platinum-free interval \< 6 months) or platinum refractory disease as per Gynecological Cancer Intergroup (GCIC) criteria
  • Patients must have radiologic evidence of disease progression
  • Criteria only for the randomized phase 2 part: patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
  • Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
  • Leukocytes \>= 3 x 10\^9/L
  • Absolute neutrophil count \>= 1.5 x 10\^9/L
  • Platelets \>= 100 x 10\^9/L
  • Total bilirubin =\< upper limit of normal (ULN) (except in Gilbert's syndrome)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal (ULN)
  • Serum creatinine =\< 1.5 x ULN OR creatinine clearance \>= 50 mL/min/1.73 m\^2 for patients with creatinine levels above 1.5 x institutional normal (using the Cockcroft Gault formula)
  • Urine protein / creatinine ratio (UPCR) =\< 1
  • Ongoing prior toxicities related to previous treatments must be recovered to \< grade 2 at the time of registration (with the exception of alopecia, grade 2 peripheral neuropathy or lymphopenia)
  • Criteria only for the randomized phase 2 part: mesothelin screen positive determined from archival tumor tissue and to be performed centrally. MSLN-positive is defined as \>= 30% of tumor cells with membrane staining intensities \>= 2+. If an archival tumor specimen is unavailable, or unsuitable for mesothelin testing, a pre-treatment fresh tumor biopsy is required
    • For the run-in-phase 1, patients will not be selected based on the mesothelin expression
  • Patients with known brain metastases are not excluded from this clinical trial. Patients who received palliative radiation (for brain metastases) are eligible if they have been asymptomatic for at least 4 weeks without use of maintenance steroid therapy, and last received radiation at least 4 weeks prior to proposed start of therapy
  • Ability to understand and the willingness to sign a written informed consent document. Patients with Impaired Decision Making Capacity (IDMC) can have a Legally Authorized Representative sign on their behalf. Documentation, such as a Power of Attorney, must be presented in order for a substitute decision maker to be allowed

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Health Network, Princess Margaret Hospital
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TorontoCanadaUnknown status
UCHealth University of Colorado Hospital
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AuroraUnited StatesUnknown status
University of Virginia Cancer Center
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CharlottesvilleUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesUnknown status
UM Sylvester Comprehensive Cancer Center at Coral Gables
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Coral GablesUnited StatesUnknown status
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Deerfield BeachUnited StatesUnknown status
Wayne State University/Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
Weisberg Cancer Treatment Center
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Farmington HillsUnited StatesUnknown status
HaysMed
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HaysUnited StatesUnknown status
University of Wisconsin Carbone Cancer Center - University Hospital
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MadisonUnited StatesUnknown status
University of Miami Miller School of Medicine-Sylvester Cancer Center
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MiamiUnited StatesUnknown status
Vanderbilt University/Ingram Cancer Center
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NashvilleUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey
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New BrunswickUnited StatesUnknown status
The University of Kansas Cancer Center - Olathe
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OlatheUnited StatesUnknown status
UC Irvine Health- Chao Family Comprehensive Cancer Center
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OrangeUnited StatesUnknown status
Mercy Hospital Pittsburg
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PittsburgUnited StatesUnknown status
UM Sylvester Comprehensive Cancer Center at Plantation
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PlantationUnited StatesUnknown status
Salina Regional Health Center
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SalinaUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
Moffitt Cancer Center
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TampaUnited StatesUnknown status
University of Kansas Health System Saint Francis Campus
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TopekaUnited StatesUnknown status
University of Kansas Hospital-Westwood Cancer Center
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WestwoodUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.