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Mirvetuximab Soravtansine Combined With Suvemcitug in Platinum-Resistant Recurrent Ovarian Cancer

ConditionPROC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPeking University Third Hospital

About this trial

his is an open-label, single-center, single-arm, prospective Phase II trial evaluating the efficacy and safety of Mirvetuximab Soravtansine (MIRV) combined with Suvemcitug (SV) in patients with folate receptor alpha (FRα)-positive, platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. A total of 20 eligible patients will receive MIRV (6 mg/kg AIBW IV Q3W) and Suvemcitug (1.5 mg/kg IV Q2W) until disease progression or intolerable toxicity. The primary endpoint is investigator-assessed Progression-Free Survival (PFS) per RECIST v1.1.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Mirvetuximab soravtansine

    Drug

    6 mg/kg adjusted ideal body weight (AIBW), administered intravenously (IV) once every 3 weeks (Q3W).

  • Suvemcitug

    Drug

    1.5 mg/kg, administered intravenously (IV) once every 2 weeks (Q2W).

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Experimental ArmExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

PFS is defined as the time from the date of the first dose of study treatment until the date of first documented radiological disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause, whichever occurs first.

Time frame
Up to approximately 20 months (assessed every 6-8 weeks during treatment).

Secondary outcomes

1

Objective Response Rate (ORR)

Defined as the proportion of participants who achieve a confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) assessed by the investigator according to RECIST v1.1. Confirmation of response is required at least 4 weeks after initial criteria for response are met.

Time frame
Up to approximately 20 months.
2

Duration of Response (DOR)

Defined as the time from the initial documentation of confirmed objective response (CR or PR) to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.

Time frame
Up to approximately 20 months.
3

Overall Survival (OS)

Defined as the time from the date of the first dose of study treatment until the date of death from any cause.

Time frame
Up to approximately 20 months (survival follow-up every 3 months after treatment discontinuation until EOS).
4

Incidence of Adverse Events

Incidence, severity, and resolution of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (TRAEs), and Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Time frame
From baseline (ICD signing) up to 30 days after the last dose of study treatment.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Peking University Third Hospital

Lead sponsor

Source ClinicalTrials.gov

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