Active — Not RecruitingPhase 3

A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

United States367 participantsStarted 2023-12-14

Plain-language summary

This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Recurrent LG Ta within 12 months of prior LG or HG (HG Ta ≤ 3 cm) tumor
✓. Solitary LG Ta \>3 cm tumor
✓. Multifocal LG Ta tumors
✓. Primary and solitary HG Ta ≤3 cm tumor
✓. LG T1 tumor

What they're measuring

Recurrence Free Survival (RFS)

Timeframe: 29 months

Trial details

NCT IDNCT06111235

SponsorCG Oncology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

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