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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
Study Summary
This trial is testing a new combination of drugs to treat bladder cancer. If it is successful, it could help people preserve their Bladders and avoid surgery.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Metastasis-free survival (MFS)
Secondary outcome measures
Number of days of Overall survival
Number of days of Progression free survival
Number of patients erporting Toxicity of neoadjuvant nivolumab and AMVAC therapy
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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Who is running the clinical trial?
Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,467 Total Patients Enrolled
Pooja Ghatalia, MDPrincipal InvestigatorFox Chase Cancer Center
1 Previous Clinical Trials
70 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had chemotherapy or radiation for urothelial carcinoma within the past year, or you have had immunotherapy for non-muscle invasive bladder cancer.You have a type of cancer called small cell histology.You have a history of certain autoimmune diseases like rheumatoid arthritis or lupus.There is evidence that the cancer has invaded the muscle layer of the organ.Your cancer is at a specific stage called T2 or T3 and has not spread to nearby lymph nodes or other parts of the body.You are taking strong medications that suppress your immune system, except for specific situations like asthma inhalers or pre-medications for certain medical procedures.If you have HIV and are taking medication for it, you cannot participate in the study because the drugs you are taking might not work well with the chemotherapy, and you may be at higher risk of serious infections.You have a kidney condition called hydronephrosis that has not been checked or treated by a doctor.You have received treatment with certain types of medications that target the immune system.You have taken certain medications that boost your immune system within the last 4 weeks.You have been diagnosed with bladder cancer that is mostly made up of urothelial cells. If there are other types of cells mixed in, it's okay, but if the cancer is in the upper urinary tract, you cannot participate.Men with urothelial carcinoma of the prostatic urethra are allowed to participate.Your heart is pumping blood effectively, as measured by a test done within the past 6 months.You do not have swollen lymph nodes larger than 1.4 cm in diameter, unless a biopsy shows they are not cancerous.You are able to perform daily activities without any problems or with minimal limitations.You have had another type of cancer that has gotten worse or needed treatment in the last three years, except for a few specific types of skin or cervical cancer. If you had prostate cancer, it must have been at an early stage and treated with surgery, and your PSA levels must have been undetectable for at least 1 year without needing hormone therapy.You had allergic reactions to drugs similar to Methotrexate, Vinblastine, Doxorubicin, or Cisplatin.You have a serious illness or infection that is not under control, or you have heart problems or mental health issues that could make it hard to follow the study rules.You do not have cancer that has spread to other parts of your body.Your blood and organ functions are all within normal ranges, except for bilirubin if you have Gilbert's disease.
Research Study Groups:
This trial has the following groups:- Group 1: AMVAC + nivolumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the combination of AMVAC and Nivolumab been given regulatory clearance?
"Currently, there is a limited amount of data demonstrating the safety of AMVAC + Nivolumab; for this reason, our team has assigned it a rating of 2."
Answered by AI
Are volunteers currently enrolling in this research endeavor?
"Affirmative. Per the listing on clinicaltrials.gov, this medical research is actively recruiting participants. It was initially published on December 1st 2020 and last updated on November 8th 2022. There are 71 places available at a single site."
Answered by AI
To what purpose is the AMVAC + Nivolumab combination typically prescribed?
"AMVAC + Nivolumab is an effective treatment for malignant tumours, unresectable melanomas and squamous cell carcinomas."
Answered by AI
How many people have enrolled in this research program?
"Affirmative. Information available on clinicaltrials.gov reveals that this medical experiment, which was first launched in December 1st 2020, is actively enrolling participants. 71 patients are required to participate from a single site."
Answered by AI
Could you please list any other experiments that have used AMVAC and Nivolumab together?
"Currently, 718 studies have been conducted that investigate the combination of AMVAC and Nivolumab. Of these trials, 82 are in Phase 3. Interestingly, despite being based out of Zürich BE., there are 40285 other sites running research for this medication regime."
Answered by AI
Is this an unprecedented trial in its field?
"The research into AMVAC + Nivolumab began in 2012, with the first clinical trial being funded by Ono Pharmaceutical Co. Ltd and involving 659 patients. Following this initial study it was approved for Phase 1 & 2 trials, which has resulted in 718 active studies across 2356 cities and 49 countries."
Answered by AI
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