Do you have adult patients with non-muscle invasive bladder cancer?

CIS with active disease is defined as CIS (± Ta/T1) present on the most recent tumor evaluation (≤ 3 months) prior to signing the ICF. The specimen containing CIS should be submitted for central review to determine eligibility. If re-staging TURBT was performed prior to signing informed consent, CIS with active disease may be determined from ANY specimen during this tumor evaluation period (ie, staging or re-staging).

Note: Historic tumor specimen may be used for pathological confirmation of BCG unresponsive CIS (+/- Ta) eligibility provided the sample is ≤ 3 months old, unless otherwise approved by the Sponsor. Historic tumor specimen may be used for pathological confirmation of BCG unresponsive CIS with T1 as long as muscle is present in the sample and is not involved (submission of re-staging TURBT sample is not necessary provided pathology remains consistent with first TURBT pathology. Historic tumor specimen from restaging tissue may be submitted if the first sample did not have muscle in specimen and should be ≤ 3 months old).

Note: Sites are encouraged to ensure that pathological specimens have been specifically evaluated by the local pathologist for the presence or absence of CIS. There should be documentation by the local pathologist in the medical record that this evaluation has been performed as well as documentation of the findings prior to submitting the samples for central confirmation.

All papillary disease must be completely resected and obvious areas of CIS should be fulgurated or cauterized if technically feasible prior to study treatment initiation, see Section 8.1.3, Transurethral Resection and Biopsy for further details.

Participants with CIS+T1 without muscle present in the specimen should undergo a re-staging TURBT to confirm eligibility, regardless of whether they had a repeat resection within 6 weeks of their initial TURBT. Participants with CIS+T1 with muscle present in the specimen should undergo a re-staging TURBT to confirm eligibility if they did not have a repeat resection within 6 weeks of their initial TURBT. If re-staging was not completed prior to signing ICF, re-staging cystoscopy/cytology/TURBT can be performed in the same clinical setting during Screening. Local interpretation of re-staging is acceptable to confirm eligibility. Study visits may be delayed by up to 28 days after TURBT/biopsy procedure only if required per the site’s standard of care.

In instances of significant discrepancies between local and central pathological reads, a central adjudication process may be implemented.

At Screening, if TURBT/biopsy shows worsening stage of disease per local/Investigator’s assessment (eg, ≥ T2), the participant is no longer eligible for study treatment.

Treatment for NMIBC (other than single-dose post-operative chemotherapy) administered between most recent CIS diagnosis and planned TARA-002 therapy is not permitted.

The simultaneous use of stable hormonal contraception in conjunction with a double-barrier method (eg, condom with spermicide or diaphragm with spermicide), or;

The use of an intrauterine device in place for at least 12 weeks, in conjunction with a double barrier method, or;

Abstinence if this is the participant’s usual lifestyle and preferred contraception.

The simultaneous use of stable hormonal contraception by the female partner in conjunction with a double-barrier method (eg, condom with spermicide or diaphragm with spermicide), or;

The female partner’s use of an intrauterine device in place for at least 12 weeks, in conjunction with a double barrier method, or;

The female partner is surgically sterile for at least 6 weeks or is at least 12 months postmenopausal, or;

Abstinence if this is the participant’s usual lifestyle and preferred contraception.