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

  • STATUS
    Recruiting
  • End date
    Jul 27, 2027
  • participants needed
    200
  • sponsor
    Janssen Research & Development, LLC
Updated on 22 July 2021
Investigator
The Medical Research Network, LLC
Primary Contact
Hospital da Senhora da Oliveira (9.4 mi away) Contact
+176 other location
radical cystectomy
carcinoma
carcinoma in situ
invasive bladder cancer
transurethral resection
cystoscopy
bladder tumor
transurethral bladder excision
intravesical bcg

Summary

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.

Description

Bladder cancer is the tenth most common malignancy worldwide. The natural history of high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) is unpredictable; rates of recurrence vary from 15 percent (%) to 78%, and rates of progression to muscle invasion and metastasis vary from less than (<) 1 to 45%. The TAR-200/gemcitabine (JNJ-17000139-AAC) product (hereafter, TAR-200) is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine minitablets, and osmotic minitablets containing urea as the osmotic agent. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds PD-1. This study consists 3 periods: screening phase (up to 30 days); treatment phase (up to 2 years); follow up phase (up to 5 years). Total duration of study is up to 5 years. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specified time points during this study.

Details
Condition urinary tract neoplasm, bladder cancer, bladder disorder, Urothelial Cancer, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, bladder tumor
Treatment Cetrelimab, TAR-200
Clinical Study IdentifierNCT04640623
SponsorJanssen Research & Development, LLC
Last Modified on22 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed diagnosis of high-risk, non-muscle invasive urothelial carcinoma in situ (CIS; Tis), with or without papillary disease (T1, high-grade Ta) within 12 months of completion of adequate Bacillus Calmette-Guerin (BCG) therapy. Mixed histology tumours are allowed if urothelial differentiation (transitional cell histology) is predominant (example, less than (<) 20 percent (%) variant histologic subtype). However, the presence of neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible. For participants with lamina propria invasion (T1) on the screening biopsy/ transurethral resection of bladder tumor (TURBT), muscularis propria must be present in order to rule out Muscle Invasive Bladder Cancer (MIBC)
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
Concurrent extra-vesical (that is, urethra, ureter, or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium
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
Known active hepatitis B or C infection (for example, participants with history of hepatitis C infection but normal hepatitis C virus polymerase chain reaction test and participants with hepatitis B with positive hepatitis B surface antigen (HBsAg) antibody 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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