A Study to Evaluate AVB-S6-500 with Paclitaxel vs Paclitaxel in Patients with Platinum-resistant Recurrent Ovarian Cancer

Overview

About this study

The purpose of this study is to evaluate AVB-S6-500 in combination with paclitaxel (Pac) in patients with platinum resistant recurrent ovarian cancer to compare the effectiveness and of AVB-S6-500 in combination with Pac versus placebo plus Pac.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Histologically confirmed and documented recurrent ovarian, fallopian tube, or
peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are
eligible.

- Aged 18 years or older

- Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1

- Platinum-resistant disease (defined as progression within ≤6 months from completion of
most recent platinum-containing regimen and calculated from the date of the last
administered dose of platinum therapy).Subject may have been treated with additional
regimen(s) subsequent to determination of platinum resistance.

- Available archived tumor tissue or if archived tissue is not available, a fresh tumor
biopsy.

- Received at least 1 but not more than 4 prior therapy regimens.

Note: Maintenance therapy OR hormonal therapies should not be counted as a separate
therapy.

Note: Patients who have not received prior bevacizumab must be deemed medically
inappropriate OR ineligible to receive bevacizumab, refused to receive bevacizumab, or been
unable to receive bevacizumab due to lack of access.

- Measurable disease according to RECIST v1.1 criteria

- Normal gastrointestinal function.

- At least 28 days between termination of prior anticancer or hormonal therapy and first
administration of batiraxcept.

- Full recovery from all treatment-related toxicities to Grade 1 or less, except
alopecia.

Exclusion Criteria:

- Tumors in the breast or bone

- Untreated central nervous system (CNS) metastases. Subjects requiring corticosteroid
therapy for the management of their treated CNS metastases may not be on >10 mg/day
prednisone or equivalent or have demonstrated signs or symptoms of neurologic
instability for 28 days or less prior to randomization.

- Primary platinum-refractory disease (defined as progression during or within 4 weeks
after completion of the first platinum regimen)

- Is being treated with concurrent anticancer therapy or other interventional treatments
administered for their underlying ovarian cancer.

- Received prior therapy with PAC in the platinum-resistant recurrent setting

- Evidence of clinically significant third spacing (e.g., pleural effusions, ascites,
anasarca, etc.) that requires therapeutic intervention within 28 days prior to first
dose of batiraxcept/placebo

Eligibility last updated 8/9/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Andrea Wahner Hendrickson, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions