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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Ubamatamab

    Drug

    Dosage form: Solution for perfusion Dosage: 5 mg/mL; 50 mg/mL Frequency: administration every three weeks Treatment duration: 15 months

  • Chemotherapy

    Drug

    Carboplatin + Paclitaxel administered at each cycle of 21 days (in total 3 cycles).

  • Bevacizumab

    Drug

    Bevacizumab administered at each cycle of 21 days (3 cycles in total) then during maintenance therapy every 3 weeks.

  • GCSF

    Drug

    Administered at each cycle during the 3 first cycles of the drug combination (chemotherapy + bevacizumab + ubamatamab).

Treatment groups

43 Participants
are divided into 1 treatment group
Group A: Carboplatin-paclitaxel-bevacizumab + ubamatamabExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Safety run-in phase I : Safety and recommended dose for phase II trial during the Dose-limiting toxicities monitoring period

Incidence of Treatment emergent adverse events according to NCI CTCAE version 6.0 (Safety and Tolerability)

Time frame
Up to 4 weeks of treatment
2

Safety run-in phase I : Safety and recommended dose for phase II trial during the Dose-limiting toxicities monitoring period

Dose-limiting toxicities (DLT) occurring during the DLT period (Safety and Tolerability)

Time frame
Up to 4 weeks of treatment
3

Safety run-in phase I : Safety and recommended dose for phase II trial during the Dose-limiting toxicities monitoring period

The recommended dose for phase II trial (RP2D) of ubamatamab in combination with carboplatin-paclitaxel + bevacizumab

Time frame
From Cycle 1 Day 1 of the first patient included to Cycle 3 Day 1 of the sixth patient included (each cycle is 21 days) (Safety and Tolerability)
4

Efficacy phase II part

Objective response rate (ORR): Percentage of patients experiencing complete (CR) or partial response (PR) as the best overall radiological response after 3 cycles of ubamatamab in combination with carboplatin-paclitaxel-bevacizumab based on RECIST 1.1 criteria

Time frame
1 month after Cycle 3 Day 1 of the sixth patient included (each cycle is 21 days).

Secondary outcomes

1

Safety during the whole treatment period

Incidence of Treatment emergent Adverse events according to NCI CTCAE version 6.0 during the whole treatment period (Safety and Tolerability)

Time frame
From study treatment start to 90 days after the last dose of ubamatamab
2

Objective response rate (ORR)

Percentage of patients experiencing complete (CR) or partial response (PR) as the best overall radiological response during the whole study treatment period based on RECIST 1.1 criteria.

Time frame
Through study treatment completion, an average of 15 months.
3

Duration of response in patients experiencing an objective response

Time from first objective response to first objective documented disease progression (based on RECIST v1.1 criteria), or to death (regardless of the cause in the absence of disease progression).

Time frame
From study treatment start to disease progression or death whichever occurs first assessed up to 48 months.
4

Disease control rate (DCR)

Percentage of patients experiencing complete (CR) or partial response (PR) or stable disease (SD) as the best overall radiological response during the whole treatment period based on RECIST 1.1 criteria.

Time frame
From study treatment start to end of treatment, an average of 15 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ARCAGY/ GINECO GROUP

Lead sponsor

Regeneron Pharmaceuticals

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: