Bladder Cancer: TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical BCG

What is the Purpose of this Study?

This study focuses on individuals who have a diagnosis of high-risk, non-muscle invasive bladder cancer (also referred to as HR-NMIBC or urothelial cancer). The purpose of the study is to compare the effects of an investigational drug delivery system called TAR-200 in combination with cetrelimab or TAR-200 alone to the effects of intravesical (medicine that is put directly into the bladder) Bacillus Calmette Guérin (BCG) in patients with HR-NMIBC. Investigational means that TAR-200 with or without cetrelimab has not been approved by the U.S. Food and Drug Administration (FDA). TAR-200 is a drug delivery system that is placed into the bladder and releases a drug called gemcitabine (an anti-cancer chemotherapy drug) into the bladder. Cetrelimab is a medicine that may treat certain cancers by working with the immune system (also known as immunotherapy). Participants will be randomly assigned to 1 of 3 treatment groups to receive either TAR-200 in combination with cetrelimab, TAR-200 alone, or intravesical BCG therapy alone.


Eligibility

  • Histologically confirmed initial diagnosis by local pathology (within 90 days of the most recent signed informed consent) of high grade non-muscle invasive bladder cancer (HR-NMIBC) (high-grade Ta, any T1 or carcinoma in-situ [CIS]), in participants who are Bacillus Calmette Guérin (BCG)-naïve
  • BCG-naïve (participants who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before date of randomization are eligible)
  • All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy. Local urine cytology at screening must be negative or atypical (for high-grade urothelial carcinoma [HGUC]) for patients with papillary only disease (without CIS)
  • Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
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Where can I participate?

Cedars-Sinai Cancer at SOCC

More about this Clinical Trial

What is the full name of this clinical trial?

17000139BLC3002: A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and 17000139BLC3002 Safety of TAR-200 in Combination with Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin in Participants with BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer

Study Details
Disease Type/Condition

Urinary Bladder

Principal Investigator

Ahdoot, Michael

Co-Investigators

Edwin Posadas, Hyung Kim, Jun Gong, Mitra Anirban

Age Group

Adult

Phase

III

IRB Number

Study00002713

ClinicalTrials.gov ID

NCT05714202

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Urinary Bladder

Principal Investigator

Ahdoot, Michael

Age Group

Adult

Phase

III

IRB Number

17000139BLC3002

ClinicalTrials.gov ID

NCT05714202

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org