NCT04430036

AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer

A Phase II Trial of Neoadjuvant AGEN1884 Plus AGEN2034 in Combination With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer Prior to Radical Cystectomy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II trial to evaluate the tolerability, efficacy, and immune outcomes of AGEN1884 plus AGEN2034 concurrent with cisplatin and gemcitabine in the neoadjuvant treatment of muscle-invasive, non-metastatic bladder cancer prior to radical cystectomy.

Detailed description

We will begin with an initial safety run-in to establish the safety of the combination prior to expansion to the full planned phase II. The overall phase II will be an open-label, single arm study in two stages to evaluate the efficacy of the combination in pathologic downstaging of MIBC. Patients will receive four 21-day cycles of neoadjuvant therapy consisting of cisplatin and gemcitabine plus AGEN2034 in all 4 cycles and AGEN1884 in cycles 1 and 3. Patients will proceed to radical cystectomy within 10 weeks after the final dose of this therapy. The primary endpoint of pathologic tumor downstaging will be assessed at the time of cystectomy.

Conditions

• Urinary Bladder Neoplasms

Interventions

Type	Name	Description
DRUG	AGEN1884	A fully human monoclonal Anti-PD-1 Antibody
DRUG	AGEN2034	A fully human monoclonal Anti-PD-1 Antibody
DRUG	Cisplatin	Alkylating antineoplastic agent
DRUG	Gemcitabine	Antimetabolite antineoplastic agent

Timeline

• Start date: 2020-10-14
• Primary completion: 2021-10-18
• Completion: 2022-03-14
• First posted: 2020-06-12
• Last updated: 2024-04-04
• Results posted: 2024-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study