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Can immunotherapy plus chemo spare bladders in cancer patients?
NCT ID NCT04506554
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers test whether giving nivolumab with AMVAC chemotherapy before surgery helps people with muscle-invasive bladder cancer. The trial enrolls adults with bladder cancer that has grown into the muscle wall. Some participants whose tumors shrink completely may keep their bladder and go on active surveillance instead of having it removed. The main goal is to see how long patients live without the cancer spreading.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab combined with AMVAC chemotherapy (methotrexate, vinblastine, doxorubicin, and cisplatin)
- What this could lead to
- If it works, some people with muscle-invasive bladder cancer could keep their bladder and avoid major surgery. The approach might also lower the chance of the cancer spreading.
- What could go wrong
- This is a phase II trial with 81 participants, so results may not hold in larger groups. Chemotherapy and immunotherapy can cause serious side effects, and not everyone will respond enough to skip surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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81 people
The number who actually took part.
- Started
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Dec 2020
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female patients ≥18 years * Primary urothelial or predominantly urothelial carcinoma of the bladder confirmed from pathology report. Patients with some component of variant histology mixed with predominant urothelial carcinoma will be allowed. Upper tract urothelial carcinoma patients are not allowed. * Urothelial carcinoma of the prostatic urethra in men is allowed * Histologic evidence of muscularis propria invasion. * AJCC23 clinical stage T2-T3 N0M0. * No radiographic evidence of lymph node positive disease as per RECIST 1.1 (≥15 mm short axis diameter). Lymph node positive disease is defined as clinical lymphadenopathy on staging CT or MRI greater than 1.4 cm in the short axis. If a lymph node is greater than 1.4 cm, it has to be biopsy proven negative for the patient to be eligible. * No metastatic disease (M0). * ECOG performance status 0, or 1. * Left ventricular ejection fraction ≥ 50% by MUGA or ECHO within 6 months of study entry. * Negative pregnancy test in women of child bearing potential within 24 hours of study registration. If the pregnancy test is positive, the patient must not receive protocol treatment and must not be enrolled in the study. * Normal organ and bone marrow function (Leukocytes ≥ 3,000/mcL, Absolute neutrophil count ≥ 1,500/mcL, Platelets ≥ 100,000/mcL, Total bilirubin ≤ institutional upper limit of normal (ULN) unless patient has known Gilbert's disease, in which case an elevated bilirubin is allowed, AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional ULN, Creatinine Clearance ≥ 50 mL/min calculated using the Cockroft-Gault formula or measured with 24 hour urine collection) Exclusion Criteria: * Any component of small cell histology. * Prior systemic chemotherapy or radiation therapy for urothelial carcinoma or cytotoxic chemotherapy for another malignancy within 1 year of study entry are ineligible. Patients who received immunotherapy for non-muscle invasive bladder cancer will be excluded * Has a known additional malignancy that has had progression or has required active treatments in the last three years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. A history of prostate cancer that was treated with surgery is acceptable, provided that the following criteria are met: Stage T2N0M0 or lower; PSA undetectable for 1 year while off androgen deprivation therapy. Patients on active surveillance for low grade prostate cancer are allowed to participate. * Patients who have received experimental agents within 4 weeks of study entry. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Methotrexate, Vinblastine, Doxorubicin or Cisplatin or other agents used in the study * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (defined by current oral or intravenous antibiotic therapy), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study due to the potential for teratogenic or abortifacient effects of cytotoxic chemotherapy. * Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with cytotoxic chemotherapy. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. * Patients with hydronephrosis that has not been addressed with a documented assessment (i.e. normal GFR, no intervention necessary) or an intervention such as placement of a stent or nephrostomy tube. * Any condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled or topical steroids and adrenal replacement steroid doses \> 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease. Use of steroids as pre-medication for contrast allergy prior to CT scans is permitted. It is acceptable to use steroids as pre-medication for AMVAC. * History of autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. * Prior treatment with CD137 agonists, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents. * Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin \[IL\]-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrolment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497, United States
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
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UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
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UT Southwestern Medical Center
Dallas, Texas, 75390, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New strategy aims to eliminate residual bladder cancer after drug combo
- Keytruda may let some bladder cancer patients avoid bladder removal
- Scientists hunt for clues in bladder Cancer's surrounding tissue
- New Drug-Radiation combo aims to spare bladders in cancer patients