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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guerin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease.
Bladder
Phase II
Adults
Not Available
Not Available
Luckenbaugh, Amy
International
Vanderbilt University
09-15-2021
Treatment
VICCURO2106
NCT04640623

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

Histologically confirmed diagnosis of persistent or recurrent high-risk, Non-muscle Invasive Bladder Cancer (HR-NMIBC) (carcinoma in situ [CIS]; Tumour in situ [Tis]), with or without papillary disease (T1, high-grade Ta) within 12 months of completion (last dose) of adequate Bacillus Calmette-Guerin (BCG) therapy. Mixed histology tumours are allowed if urothelial differentiation (transitional cell histology) is predominant (example, less than (
Visible papillary disease must be fully resected (absent) prior to randomization (residual CIS acceptable) and documented at screening cystoscopy

Participants must be ineligible for or have elected not to undergo radical cystectomy

BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy defined as a minimum of 5 of 6 doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or 2 of 6 doses of a second induction course

Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2



Exclusion Criteria:

Histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV

Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephrouretrectomy more than 24 months prior to initiating study

Participants with an active, known or suspected autoimmune disease. Participants with autoimmune disorders not requiring systemic treatment (example, skin conditions such as vitiligo, psoriasis, alopecia) or conditions requiring hormonal replacement therapies such as type 1 diabetes mellitus or hypothyroidism are permitted to enroll

Active hepatitis B or C infection (for example, participants with history of hepatitis C infection but undetectable hepatitis C virus polymerase chain reaction (PCR) test and participants with history of hepatitis B infection with positive hepatitis B surface antigen (HBsAg) antibody and undetectable PCR are allowed)

Prior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor

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