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New drug duo takes on tough cancers: hope for advanced bladder, kidney, and melanoma patients

NCT ID NCT05661955

Disease control Sponsor: BeiGene 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new combination of two immunotherapy drugs (BGB-A445 and tislelizumab) in about 113 people with advanced bladder, kidney, or skin cancer that has spread. The goal is to see if the combo can shrink tumors and how safe it is. Participants must have already tried at least one prior treatment.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

113 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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.

Key Inclusion Criteria: 1. Participants who were histologically or cytologically confirmed advanced and/or metastatic cancer. UC participants (Cohort A and B), RCC patients (Cohort C and D) or melanoma participants (Cohort E and F) who have received at least 1 but no more than 3 lines of prior systemic therapy. Cisplatin ineligible UC participants (Cohort G) who have received no prior systemic therapy and have PD-L1 CPS ≥ 10. Melanoma patients (Cohort H) with non-mucosal melanoma who have no previous systemic treatment. Melanoma participants (Cohort I) with non-mucosal melanoma who were CPI pretreated and have 1 or 2 lines of prior systemic therapy. Participants must not have received prior therapy targeting OX40 or any other T-cell agonists. 2. Has at least 1 measurable lesion as defined per RECIST v1.1. 3. Participants must be able to provide an archived formalin-fixed paraffin embedded (FFPE) tumor tissue sample 4. ECOG PS ≤ 1 (Participants with UC could have an ECOG PS ≤ 2) and a life expectancy of≥ 3 months 5. Adequate organ function as indicated by the laboratory values up to the first dose of study drug(s) Key Exclusion Criteria: 1. Active leptomeningeal disease or uncontrolled brain metastasis 2. Active autoimmune diseases or history of autoimmune diseases that may relapse or history of life-threatening toxicity related to prior immune therapy 3. Any active malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent 4. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s), with the following exceptions: 1. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) 2. Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption 3. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a nonautoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen) 5. With uncontrolled diabetes, or \> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management, or ≥ Grade 3 hypoalbuminemia occurring ≤ 14 days before the first dose of study drug(s) Note: Other protocol defined Inclusion/Exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

melanoma non-cutaneous melanoma renal cell carcinoma transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

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

Melanoma Non-mucosal melanoma Renal cell carcinoma Urothelial carcinoma

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530021, China

  • Jining No1 Peoples Hospital West Branch

    Jining, Shandong, 272000, China

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042, China

  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008, China

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013, China

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Second Hospital and Clinical Medical School, Lanzhou University

    Lanzhou, Gansu, 730030, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.