New hope for Platinum-Resistant ovarian cancer: targeted drug combo enters phase 2 trial
NCT ID NCT03587311
First seen Jun 25, 2026 · Last updated Jul 09, 2026 · Updated 3 times
Summary
This phase 2 trial tests whether combining bevacizumab (a drug that blocks blood vessel growth) with anetumab ravtansine (a targeted therapy) works better than standard paclitaxel chemotherapy for women with ovarian, fallopian tube, or primary peritoneal cancer that no longer responds to platinum-based treatment. About 96 participants will be randomly assigned to one of the two combinations. The main goal is to see which combo delays cancer progression longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bevacizumab (Avastin) and anetumab ravtansine
- What this could lead to
- If successful, this could offer a new treatment option for women with ovarian cancer that no longer responds to platinum-based chemotherapy.
- What could go wrong
- This is a mid-stage trial with only 96 participants, so results may not apply to all patients. The experimental drug may not work better than the standard paclitaxel, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2018
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, anetumab ravtansine or paclitaxel * 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 * 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 * 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 * Serious or non-healing wound, ulcer or bone fracture * 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 * 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 * Current symptom of keratitis or retinopathy at \>= grade 2 * Resting electrocardiogram (ECG) with corrected QT interval by Fridericia (QTcF) \> 470 msec or family history of long QT syndrome * History of bowel obstruction within 28 days from proposed start of treatment * 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 * Known active human immunodeficiency virus (HIV) or hepatitis B or C infection
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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HaysMed
Hays, Kansas, 67601, United States
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Mercy Hospital Pittsburg
Pittsburg, Kansas, 66762, United States
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
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Salina Regional Health Center
Salina, Kansas, 67401, United States
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The University of Kansas Cancer Center - Olathe
Olathe, Kansas, 66061, United States
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UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
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UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
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UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146, United States
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UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
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UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324, United States
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University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
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University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606, United States
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University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205, United States
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University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
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University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
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University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
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Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
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Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
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