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Immunotherapy combo aims to stall advanced bladder cancer

NCT ID NCT04568304

Disease control Sponsor: Shanghai Junshi Bioscience Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests whether adding the immunotherapy drug toripalimab to standard chemotherapy helps people with advanced bladder cancer that has not been treated before. Participants have a type of bladder cancer that has spread or cannot be removed by surgery and shows a protein called PD-L1. The trial compares toripalimab plus chemo against a placebo plus chemo to see if the combination delays cancer growth and is safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
toripalimab (an immunotherapy drug) plus standard chemotherapy (gemcitabine and cisplatin or carboplatin)
What this could lead to
If successful, this combination could become a new first-line standard of care for people with advanced bladder cancer that expresses PD-L1, potentially extending the time before the cancer worsens.
What could go wrong
This is a phase 3 trial, but results are not yet known. Immunotherapies can cause immune-related side effects, and not all patients respond. The benefit over chemotherapy alone may be modest or absent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Started

Sep 2022

Finished

Sep 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria 1. Have full knowledge on this study and are willing to sign informed consent form (ICF); 2. Age 18-75 years at time of signing ICF, male or female; 3. The investigator judged that the subject is eligible for platinum-based chemotherapy; 4. Presence of histopathologically confirmed unresectable locally advanced (T4, any N; or any T, N2-3) or metastatic urothelial carcinoma; 5. No prior systemic anti-tumor therapy; 6. Subjects who are able to provide tumor tissue slides (≥ 5 slides) for PD-L1 test and the corresponding pathology report and whose PD-L1 test must be positive before randomization; 7. With at least one measurable lesion as per RECIST 1.1 criteria; 8. ECOG performance status score of 0-1; 9. Adequate function of vital organs. Exclusion criteria 1. Have received anti-tumor treatments, including chemotherapy, radiotherapy or investigational product within 28 days before randomization; 2. Have received traditional Chinese medicines with anti-tumor activity or immunomodulators (eg. Interferon and Interleukin) within 14 days before randomization; 3. Previous use of anti-PD-1/PD-L1 agent or a drug acting on another co-inhibitory T cell receptor; 4. Subjects who are currently participating in or have participated in a study with investigational product within 4 weeks before administration; 5. Having received systemic corticosteroid therapy (dose equivalent to prednisone \> 10 mg/day) within 14 days before randomization; 6. Subjects with active central nervous system (CNS) metastasis; 7. Grade 2 or higher peripheral neuropathy or hearing loss.

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Conditions

The condition(s) this trial relates to.

transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced or metastatic urothelial carcinoma

Contacts and locations

Locations

  • Peking University Cancer Hospital

    Beijing, China

  • Peking University First Hospital

    Beijing, China

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, China

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