A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder

Studien-Informationen

Ein-/Ausschlusskriterien

Studien-Rationale

Studien-Arme

• Experimental: TAR-200 + Cetrelimab
  Participants will receive intravesical TAR-200 every 3 weeks (21 days indwelling) for first 18 weeks and thereafter from Week 24 every 12 weeks through study Year 3 in combination with intravenous (IV) Cetrelimab.
• Active Comparator: Chemotherapy (cisplatin or gemcitabine) + Radiation Therapy
  Participants will receive chemotherapy based on investigator's choice from either cisplatin intravenously once weekly for 4 to 6 treatment weeks or gemcitabine intravenously twice weekly for 4 to 6 treatment weeks as Standard of Care (SOC) along with radiation therapy from either conventional radiotherapy (64 Gray [Gy], bladder only) for up to 6.5 treatment weeks or hypo-fractionated radiotherapy (55 Gy, bladder only) for up to 4 weeks.

Geprüfte Regime

• Cetrelimab (JNJ-63723283):
  Participants will receive intravenous Cetrelimab.
• TAR-200 (JNJ-17000139):
  Participants will receive intravesical TAR-200.
• Cisplatin:
  Participants will receive cisplatin intravenously.
• Gemcitabine:
  Participants will receive gemcitabine intravenously.
• Conventional radiation therapy:
  Participants will receive conventional radiation therapy for bladder (64 gy).
• Hypo-fractioned radiation therapy:
  Participants will receive hypo-fractioned radiation therapy for bladder (55 gy).

Quelle: ClinicalTrials.gov