Safety and Efficacy of Ubamatamab With First-line Chemotherapy in Ovarian Cancer
ConditionOvarian Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorARCAGY/ GINECO GROUP
About this trial
The purpose of this clinical trial is to assess the safety and efficacy of ubamatamab in combination with first-line chemotherapy in patients with ovarian cancer. The main questions it aims to answer are:
* What is the safety profile of ubamatamab when administered with carboplatin-paclitaxel ± bevacizumab? * What is the objective response rate after three cycles of ubamatamab in combination with carboplatin-paclitaxel ± bevacizumab?
Participants will:
* Receive three cycles of ubamatamab in combination with carboplatin-paclitaxel ± bevacizumab, followed by maintenance therapy with ubamatamab ± bevacizumab for up to 15 months, depending on HRD status and disease response after the initial treatment cycles. * Attend regular clinic visits throughout the treatment period for checkups and tests
Eligibility criteria
Qualifiers
Histologically confirmed high-grade epithelial (serous, endometrioid, or carcinosarcoma with a ≥30% epithelial tumor component) ovarian, primary peritoneal, or fallopian-tube carcinoma
Adult patient aged ≥ 18 years old
Advanced stage III or IV
A poorly chemosensitive disease defined by an unfavorable standardized KELIM score < 1.0 calculated on CA-125 KELIM™ calculator for patients treated with neo-adjuvant chemotherapy
Disqualifiers
None
Trial design
Treatments tested in this trial
- Ubamatamab
- Chemotherapy
- Bevacizumab
- GCSF
Treatment groups
43 Participants
are divided into 1 treatment groupSponsors and collaborators
ARCAGY/ GINECO GROUP
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
Source ClinicalTrials.gov