Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05043402 |
| Other study ID # |
ONCX-NAV-G301 |
| Secondary ID |
2021-001933-38 |
| Status |
Not yet recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
November 30, 2022 |
| Est. completion date |
August 15, 2024 |
Study information
| Verified date |
August 2022 |
| Source |
OncXerna Theraputics, Inc. |
| Contact |
OncXerna Therapeutics |
| Phone |
781-907-7810 |
| Email |
medical[@]oncxerna.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
Patients will be stratified by Xerna™ TME Panel status and region and randomized to the
following treatment arms according to the corresponding study stage randomization ratios.
Enrollment will proceed from Stage 1 to Stage 2 without interruption:
Stage 1 treatment arms (4:4:1 randomization):
- Combination navicixizumab + paclitaxel: navicixizumab 3 mg/kg once every 2 weeks (Q2W)
of a 28-day cycle (i.e., on Days 1 and 15); paclitaxel 80 mg/m2 on Days 1, 8 and 15 of a
28-day cycle
- Paclitaxel monotherapy: paclitaxel 80 mg/m2 on Days 1, 8 and 15 of a 28-day cycle
- Navicixizumab monotherapy: navicixizumab 3 mg/kg Q2W of a 28-day cycle (i.e., on Days 1
and 15)
• Stage 2 treatment arms (2:2:3 randomization):
- Combination navicixizumab + paclitaxel: navicixizumab 3 mg/kg Q2W of a 28-day cycle
(i.e., on Days 1 and 15); paclitaxel 80 mg/m2 on Days 1, 8 and 15 of a 28-day cycle
- Paclitaxel monotherapy: paclitaxel 80 mg/m2 on Days 1, 8 and 15 of a 28-day cycle
- Navicixizumab monotherapy: navicixizumab 3 mg/kg Q2W of a 28-day cycle (i.e., on Days 1
and 15) Within each treatment arm, patients will be stratified to a B+ or B- cohort
based on their Xerna™ TME Panel biomarker assay results during screening.
Patients in both stages will have radiologic tumor assessments every 8 weeks (±1 week),
regardless of treatment delays, until objective disease progression, initiation of subsequent
anticancer therapy, withdrawal of consent, death, or end of study, whichever occurs first.
All patients will continue to receive study treatment until progressive disease (PD) per
RECIST v1.1 (as assessed by the investigator), the development of unacceptable toxicity,
withdrawal of consent, or another protocol-defined discontinuation criteria is met, whichever
occurs first, or until the sponsor terminates the study.
Treatment decisions (i.e., whether to continue or discontinue the study medication) should
not be made based on CA-125 levels. Progression during protocol treatment cannot be declared
on the basis of CA 125 alone.
All patients who discontinue study treatment for any reason will be followed for survival at
3-month intervals until death or withdrawal of consent, whichever occurs first. Survival
follow-up will continue for 12 months after the last patient is enrolled or approximately 75%
of the population has died, whichever is later.
