Health TrialsbyHealthPanel

9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer

ConditionUrothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMabwell (Shanghai) Bioscience Co., Ltd.

About this trial

This is a randomized, controlled, open-label, multicenter phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of 9MW2821 combined with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign the informed consent form approved by IEC.

Male or female subjects aged 18 to 80 years.

ECOG status: 0 or 1.

Histologically confirmed local advanced or metastatic urothelial cancer

Disqualifiers

History of another malignancy within 3 years.

History of autoimmune disease requiring systemic treatment within 2 years.

History of clinically significant cardiac/cerebrovascular diseases or thrombosis within 6 months.

Major surgery treated within 28 days; Any live vaccines got within 28 days; Radiotherapy or Intravesical therapy treated within 21 days; Traditional Chinese medicine or any potent CYP3A4 inducers/inhibitors taken within 14 days.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 9MW2821

    Drug

    9MW2821, 1.25mg/kg, intravenous (IV) infusion

  • Toripalimab

    Drug

    Toripalimab, 240mg, intravenous (IV) infusion

  • Gemcitabine

    Drug

    Gemcitabine: 1000mg/m2, intravenous (IV) infusion

  • Cisplatin/Carboplatin

    Drug

    Cisplatin: 70mg/m2 or Carboplatin: AUC=4.5/5, intravenous (IV) infusion.

Treatment groups

460 Participants
are divided into 2 treatment groups
Group A: 9MW2821+ToripalimabExperimental treatment 2 interventions
Group B: Gemcitabine+Cisplatin/CarboplatinActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

BICR-PFS

Progression-free survival, assessed by BICR

Time frame
up to 50 months
2

OS

Overall Survival

Time frame
up to 50 months

Secondary outcomes

1

ORR

Objective response rate, assessed by BICR or investigator

Time frame
Up to 50 months
2

DCR

Disease control rate, assessed by BICR or investigator

Time frame
Up to 50 months
3

DoR

Duration of response, assessed by BICR or investigator

Time frame
Up to 50 months
4

PFS

Progression-free survival, assessed by investigator

Time frame
Up to 50 months

Other outcomes

Sponsors and contacts

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

Mabwell (Shanghai) Bioscience Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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