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Anti-tumor antibiotic, Anti-metabolites

Immunochemotherapy for Bladder Cancer

Phase 2
Waitlist Available
Led By Pooja Ghatalia, MD
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a combination of chemotherapy and immune therapy for patients with muscle invasive bladder cancer. It aims to help these patients keep their bladders and improve their quality of life by effectively targeting and killing cancer cells while boosting the immune system.

Who is the study for?
This trial is for adults with muscle invasive bladder cancer (MIBC) without prior chemotherapy or radiation for urothelial carcinoma, no autoimmune diseases, and not on significant immunosuppressive medications. Participants must have normal organ function, no evidence of metastasis or lymph node positive disease unless biopsy-proven negative, and a good performance status.
What is being tested?
The study tests neoadjuvant accelerated methotrexate/vinblastine/adriamycin/cisplatin (AMVAC) combined with nivolumab in MIBC patients. Those responding well may preserve their bladders and enter active surveillance instead of undergoing radical surgery.
What are the potential side effects?
Potential side effects include typical reactions to chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to lowered blood counts; plus immune-related effects from Nivolumab like rash or inflammation in organs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Metastasis-free survival (MFS)
Secondary study objectives
Number of days of Overall survival
Number of days of Progression free survival
Number of patients erporting Toxicity of neoadjuvant nivolumab and AMVAC therapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AMVAC + nivolumabExperimental Treatment1 Intervention
This will be a single-arm, open-label, multicenter phase 2 study of neoadjuvant nivolumab with AMVAC. Approximately 70 evaluable patients will be enrolled into this study. Eligible patients will be those with diagnosis of muscle invasive urothelial carcinoma of the bladder who are cT2 or cT3 but not clinical N1 at diagnosis. Clinical stage is confirmed by transurethral resection of bladder tumor (TURBT#1).

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Chemotherapy, such as the AMVAC regimen, kills rapidly dividing cancer cells by targeting different phases of the cell cycle, which helps reduce tumor size and eliminate cancer cells that may have spread. Immunotherapy, like Nivolumab, enhances the body's immune response against cancer by blocking the PD-1 pathway, preventing cancer cells from evading immune detection. These mechanisms are crucial for bladder cancer patients as they inform treatment strategies that can improve outcomes and preserve quality of life.
Rationale and Outcomes for Neoadjuvant Immunotherapy in Urothelial Carcinoma of the Bladder.

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
233 Previous Clinical Trials
39,097 Total Patients Enrolled
Pooja Ghatalia, MDPrincipal InvestigatorFox Chase Cancer Center
1 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

AMVAC + Nivolumab (Anti-tumor antibiotic, Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04506554 — Phase 2
Bladder Cancer Research Study Groups: AMVAC + nivolumab
Bladder Cancer Clinical Trial 2023: AMVAC + Nivolumab Highlights & Side Effects. Trial Name: NCT04506554 — Phase 2
AMVAC + Nivolumab (Anti-tumor antibiotic, Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04506554 — Phase 2
~22 spots leftby May 2026