Health TrialsbyHealthPanel

Trastuzumab Rezetecan and Carboplatin ± Bevacizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-sensitive Recurrent Ovarian Cancer

ConditionsOvarian CancerPlatinum Sensitive Ovarian Cancer (PSOC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorSun Yat-sen University

About this trial

This study is a randomized, open-label, controlled phase II clinical trial.

It is planned to enroll 176 subjects with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer previously treated with Poly (ADP-ribose) polymerase inhibitors (PARPi).

Subjects will be randomly assigned in a 1:1 ratio to receive either the experimental treatment group (trastuzumab Rezetecan + carboplatin ± bevacizumab) or the control treatment group (investigator's choice chemotherapy ± bevacizumab).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance.

Aged 18 to 75 years.

Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Have received 1-3 prior lines of platinum-based chemotherapy and have experienced disease progression or recurrence ≥6 months after the last platinum-based treatment (platinum-sensitive relapse).

Disqualifiers

Ovarian cancer with pathological types of clear cell carcinoma, low-grade serous adenocarcinoma, or mucinous adenocarcinoma.

Known allergy to any component of trastuzumab rezetecan; known allergy to carboplatin.

Prior treatment with anti-HER2 therapy, an antibody-drug conjugate (ADC) containing a topoisomerase I inhibitor, or a topoisomerase I inhibitor alone.

Untreated or active central nervous system (CNS) metastases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trastuzumab Rezetecan (SHR-A1811)

    Drug

    Administered intravenously on Day 1 of each 3-week treatment cycle.

  • Carboplatin

    Drug

    Administered intravenously on Day 1 of each 3-week treatment cycle.

  • Bevacizumab

    Drug

    Administered intravenously on Day 1 of each 3-week treatment cycle.

  • Bevacizumab

    Drug

    Administered intravenously.

  • Carboplatin + Paclitaxel

    Drug

    Administered intravenously.

  • Carboplatin + pegylated liposomal doxorubicin

    Drug

    Administered intravenously.

  • Carboplatin + Gemcitabine

    Drug

    Administered intravenously

Treatment groups

176 Participants
are divided into 2 treatment groups
Group A: Trastuzumab rezetecan + Carboplatin ± BevacizumabExperimental treatment 3 interventions
Group B: Investigator Choice of Chemotherapy ± BevacizumabActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as determined by investigators.

Time frame
Up to approximately 3 years

Secondary outcomes

1

Objective Response Rate (ORR)

Defined as the proportion of subjects who achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) as assessed by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). For responses categorized as CR or PR, confirmation is required through a subsequent evaluation performed no less than 4 weeks (≥28 days) after the initial assessment.

Time frame
Up to approximately 3 years
2

Disease Control Rate (DCR)

Defined as the proportion of subjects with a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as assessed by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Time frame
Up to approximately 3 years
3

Duration of Response (DoR)

Defined as the time from the first date a subject is assessed as having a confirmed Complete Response (CR) or Partial Response (PR) to the first date of either Progressive Disease (PD) or death due to any cause, whichever occurs first.

Time frame
Up to approximately 3 years
4

Overall Survival (OS)

Defined as the time from the randomization date to death due to any cause in subjects.

Time frame
Up to approximately 5 years

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

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