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A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC

ConditionNMIBC
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

This is a multicenter, randomized, open-label phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus investigator-selected chemotherapy in patients with BCG-unresponsive papillary-only non-muscle-invasive bladder cancer (NMIBC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged at least 18 years, gender is not limited;

Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;

Histologic confirmation of high-risk non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ); BCG-unresponsive;

Cystoscopy within 6 weeks before the randomization shows that the lesion has been completely removed; for T1 stage lesions, pathological results must show the presence of bladder muscle tissue;

Disqualifiers

Previous histopathological diagnosis was muscle-invasive, locally advanced or metastatic urothelial carcinoma (T2 or T3 or T4 or N+ or M+);

Received surgery such as TURBT or radiotherapy for bladder lesions within 2 weeks before the randomization; Major surgery was performed within 28 days before randomization;

Those who have previously received the following treatments and have not experienced disease recurrence or progression before enrolment: a) Intravesical infusion of cytotoxic chemotherapy or other drugs (such as oncolytic viruses), etc; b) Immune checkpoint inhibitors; c) Other investigatory drugs for the treatment of NMIBC;

Those who have previously received immunostimulant therapy;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-1501 for Injection

    Drug

    SHR-1501 for injection.

  • BCG for Injection

    Drug

    Bacillus calmette guerin (BCG) for injection.

  • Epirubicin Hydrochloride for Injection

    Drug

    Epirubicin hydrochloride for injection.

  • Pirarubicin Hydrochloride for Injection

    Drug

    Pirarubicin hydrochloride for injection.

  • Gemcitabine Hydrochloride for Injection

    Drug

    Gemcitabine hydrochloride for injection.

  • Hydroxycamptothecin for Injection

    Drug

    Hydroxycamptothecin for injection.

  • Mitomycin for Injection

    Drug

    Mitomycin for injection.

Treatment groups

236 Participants
are divided into 2 treatment groups
Group A: SHR-1501 + BCG GroupExperimental treatment 2 interventions
Group B: Investigator-selected Chemotherapy GroupActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

Disease-Free Survival (DFS) assessed by Blinded Independent Central Review (BICR)

Disease free survival is defined as the time from randomization to date of DFS event assessed by BICR.

Time frame
Up to approximately 5 years.

Secondary outcomes

1

Disease-Free Survival (DFS) assessed by investigator

Disease-free survival (DFS) is defined as the time from randomization to date of DFS event assessed by investigator.

Time frame
Up to approximately 5 years.
2

Overall Survival (OS)

Overall Survival (OS) is defined as the time from randomization to date of death from any cause.

Time frame
Up to approximately 5 years.
3

Number of adverse events (AEs) as assessed by CTCAE v6.0.

Time frame
Up to approximately 5 years.
4

Number of serious adverse events (SAEs) as assessed by CTCAE v6.0.

Time frame
Up to approximately 5 years.

Other outcomes

Sponsors and contacts

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

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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