What side effects are associated with this type of intervention?

Common treatments for bladder cancer, such as the chemotherapy regimen AMVAC (methotrexate, vinblastine, adriamycin, cisplatin) and the immunotherapy drug nivolumab, have notable side effects. Chemotherapy can cause neutropenic sepsis, anemia, and febrile neutropenia, while nivolumab may lead to skin reactions, endocrine issues, and other immune-related adverse events. Combining these therapies can increase the risk of severe side effects, including pneumonia, diarrhea, and acute kidney injury.

What prior FDA approvals exist?

The FDA has approved several treatments for bladder cancer that involve chemotherapy and immunotherapy. Atezolizumab, an anti-PD-L1 therapy, was approved for patients with metastatic urothelial carcinoma who progressed after platinum-based chemotherapy. Enfortumab vedotin, an antibody-drug conjugate, received accelerated approval for patients with locally advanced or metastatic urothelial carcinoma previously treated with platinum and a checkpoint inhibitor. These treatments are similar to the neoadjuvant AMVAC (methotrexate, vinblastine, adriamycin, cisplatin) and nivolumab combination currently under evaluation.

What other types of research exist?

Promising novel alternatives for bladder cancer treatment include: 1) Atezolizumab, which has shown sustained responses in metastatic urothelial carcinoma, especially when combined with platinum-based chemotherapy. 2) Enfortumab Vedotin, an antibody-drug conjugate targeting nectin-4, approved for platinum-refractory and immune checkpoint blockade-refractory urothelial carcinoma. 3) Sacituzumab Govitecan, another antibody-drug conjugate, targeting Trop-2, showing efficacy in patients progressing after platinum-based chemotherapy and checkpoint inhibitors.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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).

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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.