A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer (OVAL)

VBL Therapeutics

Status and phase: Completed; Phase 3

Conditions: Recurrent Platinum Resistant Ovarian Cancer

Treatments: Drug: Placebo + Paclitaxel; Drug: VB-111 + Paclitaxel

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT03398655

VB-111-701/GOG-3018

Details and patient eligibility

About

The purpose of this phase 3, randomized, multicenter study is to compare VB-111 and paclitaxel to placebo and paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer.

Enrollment: 408 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female patients ≥18 years of age

2. Histologically confirmed epithelial ovarian cancer and documented disease.

3. Patients must have platinum-resistant disease

4. Patients must have disease that is measurable according to RECIST 1.1 and require chemotherapy treatment.

5. ECOG PS 0-1.

6. Adequate hematological functions:

   • ANC ≥ 1000/mm3
   • PLT ≥ 100,000/mm3
   • PT and PTT (seconds) < 1.2 X ULN. Patients who are anticoagulated do not need to meet criteria for PT and PTT.

7. Patients who are known to carry a BRCA mutation may be enrolled only after (following PARP inhibitor treatment failure, or being intolerant of, or ineligible for PARP inhibitor treatment).

Exclusion criteria

1. Non-epithelial tumors (Carcino-sarcomas are excluded)

2. Ovarian tumors with low malignant potential (i.e. borderline tumors) clear cell carcinomas, grade 1 serous tumors or mucinous tumors.

3. History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma, adequately controlled, non-metastatic squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.

4. Previous ovarian cancer treatment with >5 anticancer regimens.

5. Any prior radiotherapy to the pelvis or whole abdomen.

6. Inadequate liver function, defined as serum creatinine > ULN, unless calculated creatinine clearance > 50ml/min (by Cockroft & Gault formula):

   • Serum (total) bilirubin > ULN (Exception: documented Gilbert's disease patients can be enrolled)
   • Alkaline phosphatase, AST/SGOT or ALT/SGPT ≥2.5 x ULN (or ≥ 5 x ULN in the presence of liver metastases).

7. Inadequate renal function, defined as:

   • Serum creatinine > ULN OR
   • Calculated creatinine clearance < 50ml/min (by Cockroft & Gault formula)

8. New York Heart Association (NYHA) Grade II or greater congestive heart failure

9. History of myocardial infarction or unstable angina within 6 months prior to day of randomization.

10. History of stroke or transient ischemic attack within 6 months prior to day of randomization.

11. Patient with proliferative and/or vascular retinopathy

12. Known brain metastases

13. History of hemoptysis or active GI bleeding within 6 month prior to day of randomization

14. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).

15. History of abdominal fistula or gastrointestinal perforation.

16. Current signs and symptoms of bowel obstruction

17. Uncontrolled active infection

18. Patients who had evidence of disease progression during or up to 90 days from the last dose of the first line of platinum based therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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408 participants in 2 patient groups

Arm 1

Experimental group

Description:

VB-111 + Paclitaxel

Treatment:

Drug: VB-111 + Paclitaxel

Arm 2

Active Comparator group

Description:

Placebo + Paclitaxel

Treatment:

Drug: Placebo + Paclitaxel