What side effects are associated with this type of intervention?

Common treatments for bladder cancer, such as chemotherapy with gemcitabine and carboplatin or oxaliplatin, can cause side effects including neutropenia, anemia, thrombocytopenia, nausea, vomiting, fatigue, and increased risk of infection. Immunotherapy with PD-1 inhibitors like nivolumab can lead to immune-related adverse events such as skin reactions, endocrine disorders, pneumonitis, colitis, hepatitis, and nephritis. Combining these treatments may increase the likelihood of experiencing these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for bladder cancer that combine chemotherapy and immunotherapy. Gemcitabine, often used with cisplatin or carboplatin, is a standard chemotherapy agent for bladder cancer. Immunotherapy options include PD-1 inhibitors like nivolumab and pembrolizumab. Nivolumab has been approved for use in patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy. Pembrolizumab is approved for similar indications, including as a first-line treatment in cisplatin-ineligible patients. These approvals highlight the evolving landscape of bladder cancer treatment, integrating both chemotherapy and immunotherapy to improve patient outcomes.

What other types of research exist?

Promising novel alternatives for bladder cancer treatment in 2024 include: 1) Enfortumab Vedotin, particularly after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients, as shown in the EV-201 trial. 2) Pembrolizumab, either as monotherapy or in combination with chemotherapy, as demonstrated in the KEYNOTE-045 and KEYNOTE-062 trials. 3) Cabozantinib in combination with Nivolumab, which has shown efficacy in patients refractory to immune checkpoint inhibitors. 4) Sacituzumab Govitecan, as explored in the TROPHY-U-01 study for patients progressing after platinum-based chemotherapy and checkpoint inhibitors.

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Platinum-based Chemotherapy

Chemotherapy Combinations with Nivolumab for Bladder Cancer

Phase 2

Waitlist Available

Led By Matthew Galsky, M.D.

Research Sponsored by Matthew Galsky

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically documented, locally advanced or metastatic urothelial carcinoma

No prior chemotherapy for inoperable locally advanced or mUC

Must not have

Prior malignancy active within the previous 3 years except for locally curable cancers

Evidence of interstitial lung disease or active, non-infectious pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to a maximum of 53 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing two combinations of drugs for patients with advanced bladder cancer who can't use a common chemotherapy drug. The treatment includes drugs to kill cancer cells and another to help the immune system fight the cancer.

Who is the study for?

Adults with advanced bladder cancer that can't be treated with cisplatin and haven't had chemotherapy for it. They must have a certain level of kidney, liver, and blood cell function, not be pregnant or breastfeeding, use contraception if needed, and have no serious health issues or recent other cancers. People who've had immune system treatments or suffer from autoimmune diseases (except mild forms), severe heart problems, transplants, active infections requiring treatment, HIV/AIDS or hepatitis are excluded.

What is being tested?

This phase 2 trial is testing two combinations: Gemcitabine + Carboplatin + Nivolumab versus Gemcitabine + Oxaliplatin + Nivolumab in patients who cannot receive cisplatin for their metastatic urothelial cancer. Participants will be randomly assigned to one of these treatment groups considering their lymph node status.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs; infusion reactions; fatigue; nausea; low blood counts leading to increased infection risk; liver enzyme changes suggesting liver stress; nerve damage causing numbness or pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced bladder cancer confirmed by a biopsy.

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I have not had chemotherapy for my advanced urinary cancer.

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I cannot receive cisplatin due to certain health reasons.

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I can perform daily activities with slight limitations.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had any cancer except for treatable local cancers in the past 3 years.

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I have a lung condition not caused by an infection.

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I am currently on medication for an infection.

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I am on steroids or other drugs that affect my immune system.

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I have moderate to severe nerve pain or damage.

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I have been treated with drugs that target the immune system.

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I have had a solid organ or tissue transplant, including stem cell transplant.

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I have an autoimmune disease.

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I have a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to a maximum of 53 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to a maximum of 53 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to a maximum of 53 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Adverse Events

Duration of Response (DOR)

Overall Survival (OS)

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment3 Interventions

Gemcitabine plus oxaliplatin plus nivolumab

Group II: Arm AExperimental Treatment3 Interventions

Gemcitabine plus carboplatin plus nivolumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

FDA approved

Gemcitabine

FDA approved

Carboplatin

FDA approved

Oxaliplatin

FDA approved

0 / 13Eligibility criteria met

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 and immunotherapy are common treatments for bladder cancer. Chemotherapy, using drugs like Gemcitabine, Carboplatin, and Oxaliplatin, targets rapidly dividing cancer cells by causing DNA damage and inhibiting cell division, leading to cell death. Immunotherapy, particularly PD-1 inhibitors like Nivolumab, blocks the PD-1 receptor on T-cells, preventing cancer cells from evading the immune system and allowing T-cells to destroy the cancer. These mechanisms are important for bladder cancer patients as they provide targeted approaches to eliminate cancer cells and improve treatment outcomes.

[Immunological biomarker research in uro-oncology-using the example of urothelial cancer].[The role of immunotherapy in the modern treatment of urothelial carcinoma].

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Who is running the clinical trial?

Matthew GalskyLead Sponsor

10 Previous Clinical Trials

372 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,691 Previous Clinical Trials

4,097,539 Total Patients Enrolled

Hoosier Cancer Research NetworkOTHER

68 Previous Clinical Trials

3,707 Total Patients Enrolled

Matthew Galsky, M.D.5.02 ReviewsPrincipal Investigator - Icahn School of Medicine at Mount Sinai; Tisch Cancer Institute

Hoosier Cancer Research Network

4 Previous Clinical Trials

180 Total Patients Enrolled

5Patient Review

Dr. Smith is one of the best physicians I have ever had the pleasure of knowing. He cares for his patients like they are family and I would (and have) recommend him to anyone. His staff is also wonderful and accommodating.