Treatment for Muscle Invasive Bladder Cancer

Phase-Based Estimates
Fudan University Shanghai Cancer Center, Shanghai, China
+1 More
All Sexes
Eligible conditions
Muscle Invasive Bladder Cancer

Study Summary

A Study to Evaluate the Safety and Efficacy of Oral APL-1202 in Combination With Tislelizumab Compared to Tislelizumab Alone as Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer

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Eligible Conditions

  • Urinary Bladder Cancer
  • Muscle Invasive Bladder Cancer
  • Urinary Bladder Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 3 primary outcomes and 11 secondary outcomes in patients with Muscle Invasive Bladder Cancer. Measurement will happen over the course of 9 weeks.

26 months
Cumulative amount in urinary excretion (Ae)
PD-L1 protein expression levels in pre- and post-treatment tumor tissues.
Radiological response (RR).
The rate of pathologic complete response (pCR) in Phase 2.
Tumor mutation burdens (TMB) in pre- and post-treatment plasma ctDNA (circulating tumor DNA).
Tumor mutation burdens (TMB) in pre- and post-treatment tumor tissues.
Tumor mutation burdens (TMB) in pre- and post-treatment urine cfDNA (cell free DNA).
cumulative fraction of dose in urinary excretion (Ae%)
9 weeks
Adverse events (AE) and serious adverse events (SAE).
The RP2D of APL-1202 in combination with tislelizumab.

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Tislelizumab alone
Placebo group

This trial requires 79 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Tislelizumab alone
APL-1202 in combination with tislelizumab

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 26 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 26 months for reporting.

Closest Location

Mount Sinai Medical Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Muscle Invasive Bladder Cancer or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Willing and able to provide written informed consent.
Age ≥ 18 years.
Histopathologically confirmed transitional cell carcinoma of the bladder. Patients with mixed histologies are required to have a dominant (i.e. > 50%) transitional cell pattern.
Radical cystectomy is planned (according to local guidelines).
Impaired renal function with calculated CrCl 30 to 59 mL/min (by Cockcroft-Gault equation).
Eastern Cooperative Oncology Group (ECOG) Performance Status 2.
CTCAE v.5 Grade ≥2 audiometric hearing loss.
In the clinical judgement of the investigator, potential adverse effects from cisplatin-based neoadjuvant chemotherapy outweighs its benefits.
Clinical stage T2-T4a N0 M0 disease by CT (or MRI) (within 4 weeks of randomization).
Residual disease after transurethral resection of bladder (TURB) (surgical opinion, cystoscopy or radiological presence).

Patient Q&A Section

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Muscle Invasive Bladder Cancer by sharing your contact details with the study coordinator.