Clinical trial · Interventional
A Study of Navicixizumab in Patients With Platinum Resistant Ovarian Cancer
An Open Label Randomized Study of Navicixizumab Plus Paclitaxel and Navicixizumab Monotherapy in Comparison to Paclitaxel Monotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 3, randomized, open-label, 2-stage, multicenter study of navicixizumab with or without paclitaxel compared with paclitaxel monotherapy in patients with platinum-resistant advanced epithelial ovarian cancer and specific biomarkers, as measured by the proprietary and validated Xerna™ TME Panel biomarker assay. Eligible patients must have received at least 2 prior regimens but not more than 5 prior regimens, including treatment with a monoclonal antibody angiogenesis inhibitor (e.g., bevacizumab), must be considered platinum-resistant, and must be considered appropriate to receive single-agent paclitaxel chemotherapy as a next line of therapy. All patients must be willing and able to provide a formalin-fixed paraffin embedded (FFPE) archive or core tumor sample collected during screening for classification as B+ or B- biomarker status based on RNA expression data from the Xerna™ TME Panel biomarker assay. The co-primary efficacy endpoints are ORR by RECIST v1.1 and PFS (as assessed by blinded independent radiological review \[BIRR\]) analyzed at different timepoints. Analysis of the ORR primary efficacy endpoints will occur at the end of Stage 1 and at the end of Stage 2; the PFS primary efficacy endpoint will be analyzed at the end of Stage 2.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| navicixizumab | Drug | — | UNRESOLVED |
| Xerna™ TME Panel | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Combination navicixizumab + paclitaxel
- description
- Combination navicixizumab + paclitaxel: navicixizumab 3 mg/kg Q2W of a 28 day cycle (i.e., Days 1 and 15); paclitaxel 80 mg/m2 on Days 1, 8 and 15 of a 28 day cycle
- interventionNames
- Drug: navicixizumab
- Device: Xerna™ TME Panel
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel monotherapy
- description
- Paclitaxel monotherapy: paclitaxel 80 mg/m2 on Days 1, 8 and 15 of a 28-day cycle
- interventionNames
- Device: Xerna™ TME Panel
- type
- EXPERIMENTAL
- label
- Navicixizumab monotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must have epithelial ovarian, fallopian tube, or primary peritoneal cancer * Patients must have received ≥2 and not more than 5 prior therapies, including at least 1 line of therapy containing bevacizumab (or biosimilar). * Patients must be considered platinum-resistant, defined as progression within 6 months from completion of a platinum-containing therapy * Patient must be considered appropriate for treatment with weekly paclitaxel monotherapy as the next line of therapy. * Patient must be willing and able to provide an FFPE archival or core tumor sample for determination of biomarker status on the Xerna™ TME Panel biomarker assay (positive or negative) prior to study treatment. * Presence of at least one measurable lesion, as defined by RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 Adequate organ function Exclusion Criteria: * Non-epithelial ovarian carcinoma. * Ovarian tumors with low malignant potential (i.e., borderline tumors). * Primary platinum-refractory disease (defined as progression during or within 4 weeks after completion of the first platinum regimen). * Patient has received an anti-angiogenic product other than bevacizumab or biosimilar. * Patient has congestive heart failure * Patient has a history of myocardial infarction, cerebral vascular accident, or transient ischemic attacks within 6 months * Patient has a history of cardiac ischemia or heart failure within 6 months * Baseline B-type natriuretic peptide (BNP) value \>100 pg/mL or N-terminal-proBNP (NT-proBNP) value of \> 125 pg/mL. * LVEF \<50%. * Peak tricuspid velocity \>3.0 m/s on Doppler ECHO. * Clinically significant ECG abnormality, as assessed by the investigator * Blood pressure (BP) \>140/90 mmHg * History of bowel obstruction, including sub-occlusive disease, related to the underlying disease * Hemoptysis \>2.5 mL within 8 weeks prior * Major surgical procedure, or significant traumatic injury within 28 days * Uncontrolled seizure disorder or active neurologic disease * Patients with a cardiac aneurysm.
References
Publications (1)
- DERIVEDGaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3. PMID 37185961