RECRUITING

Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study

Conditions

Muscle Invasive Bladder Urothelial Carcinoma Muscle Invasive Renal Pelvis Urothelial Carcinoma Muscle Invasive Ureter Urothelial Carcinoma Muscle Invasive Urethral Urothelial Carcinoma Stage II Bladder Urothelial Carcinoma AJCC v6 and v7 Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 Stage IV Bladder Urothelial Carcinoma AJCC v7

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of urothelial cancer patients who have undergone surgical removal of their bladder, kidney, ureter or urethra.

Official Title

MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer

Quick Facts

Study Start:2024-02-02

Study Completion:2030-09-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05987241

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* PRE-REGISTRATION: Histologically confirmed muscle-invasive urothelial carcinoma of the urethra, bladder, ureter or renal pelvis * PRE-REGISTRATION: Variant histology, including neuroendocrine differentiation, sarcomatoid, micropapillary, glandular, trophoblastic, Mullerian, is allowed if urothelial cancer is predominant histology (any amount of squamous differentiation is allowed provided the tumor is not a pure squamous cell cancer) * PRE-REGISTRATION: Patient must have had radical surgery (i.e., cystectomy and lymph node dissection or nephroureterectomy or ureterectomy) ≥ 3 weeks, but ≤ 12 weeks prior to pre-registration. Patients who have had a partial cystectomy as definitive therapy are not eligible * PRE-REGISTRATION: No gross cancer at the surgical margins. Microscopic invasive urothelial carcinoma at the surgical margins (i.e., "positive margins") are allowed. Carcinoma in situ (CIS) at margins is considered negative margins * PRE-REGISTRATION: No evidence of residual cancer or metastasis after radical cystectomy or nephroureterectomy or ureterectomy (imaging is not required prior to pre-registration but is required prior to registration) * PRE-REGISTRATION: Have undergone a radical cystectomy nephroureterectomy, or ureterectomy with pathological evidence of urothelial carcinoma at high risk of recurrence as described in one of the two scenarios below (i or ii). The 7th edition of American Joint Committee on Cancer (AJCC) staging will be utilized.: * (i) Patients who have not received neoadjuvant systemic therapy: pT3-pT4\* or pT0/x-pT4/N+ on radical surgery (i.e., cystectomy, nephroureterectomy, or ureterectomy) and are not eligible for adjuvant cisplatin chemotherapy * (i) Patients ineligible for cisplatin due to at least one of the following criteria and reason for ineligibility should be documented: * (i) Creatinine Clearance (using Cockcroft-Gault): \< 60 mL/min * (i) Common Terminology Criteria for Adverse Events (CTCAE) version 5, grade \>= 2 audiometric hearing loss * (i) CTCAE version 5, grade \>= 2 or above peripheral neuropathy * New York Heart Association Class III heart failure * (i) Eastern Cooperative Oncology Group (ECOG) performance status = 2 * (i) Patients who are eligible for cisplatin may be candidates if they refuse adjuvant cisplatin-based chemotherapy, despite being informed by the investigator about the treatment options. The patient's refusal must be documented. * (i) Patients with pT2N0 urothelial cancer on radical surgery specimen (without prior neoadjuvant systemic therapy) with ctDNA(+) Signatera results based on an assay performed post-radical surgery as part of routine care outside of the study may proceed with pre-registration but require confirmation of ctDNA(+) Signatera testing on repeat "central testing" in the context of A032103 testing. Patients with pT2N0 with central testing not confirming ctDNA(+) will not be eligible for A032103 (Note: this is distinct from patients with ypT2N0 who are eligible based on ii). * (ii) Patients who received neoadjuvant systemic therapy: ypT2-T4a and/or ypN+ on radical surgery (i.e., cystectomy. , nephroureterectomy, or ureterectomy) pathology specimen. Neoadjuvant systemic therapy may have included cisplatin-based chemotherapy, cisplatin-based chemotherapy plus PD-1/PD-L1 blockade, or enfortumab vedotin plus PD-1/PD-L1 blockade * PRE-REGISTRATION: Available tumor tissue for central Signatera testing to be submitted at pre-registration. Central testing is defined as testing performed as part of the A032103 study prior to registration and is provided by the study and not routine standard commercial testing. Patients who have already had local Signatera testing performed as part of routine care will require repeat central testing as part of the A032103 study to be eligible for registration/randomization. Tumor tissue from the radical surgery specimen is preferred over tissue from prior diagnostic biopsy specimen (e.g., transurethral resection of bladder tumor specimen) * PRE-REGISTRATION: Age \>= 18 years * PRE-REGISTRATION: ECOG Performance Status 0-2 * PRE-REGISTRATION: Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects * PRE-REGISTRATION: No postoperative/adjuvant systemic therapy after radical surgery * PRE-REGISTRATION: No adjuvant radiation after radical surgery * PRE-REGISTRATION: No treatment with any other type of investigational agent =\< 4 weeks before pre-registration * PRE-REGISTRATION: Not have ever received prior treatment with LAG-3 blockade * PRE-REGISTRATION: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * PRE-REGISTRATION: Absolute Neutrophil Count (ANC) \>= 1,200/mm\^3 * PRE-REGISTRATION: Platelet count \>= 100,000/mm\^3 * PRE-REGISTRATION: Hemoglobin \>= 8 g/dL * PRE-REGISTRATION: Creatinine =\< 1.5 x upper limit of normal (ULN) or calculated (calc.) creatinine clearance \> 30 mL/min (using either Cockcroft-Gault formula or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation * PRE-REGISTRATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x ULN * PRE-REGISTRATION: Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except in patients with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL) * PRE-REGISTRATION: For women of childbearing potential only: A negative urine or serum pregnancy test done =\< 14 days prior to pre-registration is required * PRE-REGISTRATION: Not currently requiring hemodialysis * PRE-REGISTRATION: No current or prior history of myocarditis * PRE-REGISTRATION: No grade ≥ 3 immune related adverse event with prior PD-1/PD-L1 blockade * PRE-REGISTRATION: No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens- Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease. * PRE-REGISTRATION: Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. * PRE-REGISTRATION: Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible. * PRE-REGISTRATION: No current pneumonitis or prior history of non-infectious pneumonitis that required steroids within the previous 5 years. * PRE-REGISTRATION: No known active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected). * PRE-REGISTRATION: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * PRE-REGISTRATION: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible. * PRE-REGISTRATION: No concurrent antineoplastic therapy. * PRE-REGISTRATION: No current immunosuppressive agents (with the exception of corticosteroids as described below). * PRE-REGISTRATION: No condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of pre-registration (with the exception of steroid pre-medications for contrast allergies). Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * REGISTRATION: Patient must have had radical cystectomy and lymph node dissection or nephroureterectomy or ureterectomy =\< 18 weeks prior to registration. * REGISTRATION: Must have evaluable ctDNA Signatera assay result (i.e., ctDNA\[+\]or ctDNA\[-\]) based on test performed as part of central testing at pre-registration to A032103. Central testing is defined as testing performed as part of the A032103. Local/commercial testing results may not be used for registration to A032103 * Cisplatin-ineligible (or cisplatin-declining) patients with a pT2N0 urothelial cancer on cystectomy or nephroureterectomy or ureterectomy who were pre-registered based on routine standard care ctDNA(+) Signatera testing must have confirmed ctDNA(+) Signatera testing on central testing. If central Signatera testing yields a ctDNA(-) result, these patients are ineligible. NOTE: This is a distinct consideration from patients with ypT2-4 and/or ypN+ urothelial cancer (i.e., patients who had received neoadjuvant cisplatin-based chemotherapy) who are eligible with either ctDNA(+) or ctDNA(-) central Signatera testing * REGISTRATION: All patients must have confirmed disease-free status defined as no measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or definitive non-measurable radiographic metastatic disease, within 60 days prior to registration. Patients with equivocal nodes less than 15 mm in short axis, or \< 10 mm in long axis for non-lymph node lesions, not considered by the investigator to represent malignant disease will be eligible. Attempts should be made to resolve the etiology of equivocal lesions with complementary imaging (e.g., PET scan) or biopsy. * REGISTRATION: No major surgery =\< 3 weeks before registration. * REGISTRATION: No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette- Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed. Coronavirus disease 2019 (COVID-19) vaccines are not live vaccines and are allowed * REGISTRATION: No change since registration in clinical condition and/or laboratory tests that would impact the safety of nivolumab +/- relatlimab administration in the opinion of the treating investigator * COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+): * Patient must have converted to ctDNA(+) during serial monitoring performed centrally in the setting of the A032103 study * COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+): * No evidence of metastatic disease on the most recent scheduled imaging assessment as outlined in the study calendar (no repeat imaging is necessary specifically at the time of the conversion from ctDNA\[-\] to ctDNA\[+\]). * COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+): * No change in clinical condition and/or laboratory tests that would impact the safety of nivolumab administration in the opinion of the treating investigator * COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+): * =\< 6 weeks from reporting of ctDNA(+) result to site (not from the date sample was drawn).	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* PRE-REGISTRATION: Histologically confirmed muscle-invasive urothelial carcinoma of the urethra, bladder, ureter or renal pelvis
* PRE-REGISTRATION: Variant histology, including neuroendocrine differentiation, sarcomatoid, micropapillary, glandular, trophoblastic, Mullerian, is allowed if urothelial cancer is predominant histology (any amount of squamous differentiation is allowed provided the tumor is not a pure squamous cell cancer)
* PRE-REGISTRATION: Patient must have had radical surgery (i.e., cystectomy and lymph node dissection or nephroureterectomy or ureterectomy) ≥ 3 weeks, but ≤ 12 weeks prior to pre-registration. Patients who have had a partial cystectomy as definitive therapy are not eligible
* PRE-REGISTRATION: No gross cancer at the surgical margins. Microscopic invasive urothelial carcinoma at the surgical margins (i.e., "positive margins") are allowed. Carcinoma in situ (CIS) at margins is considered negative margins
* PRE-REGISTRATION: No evidence of residual cancer or metastasis after radical cystectomy or nephroureterectomy or ureterectomy (imaging is not required prior to pre-registration but is required prior to registration)
* PRE-REGISTRATION: Have undergone a radical cystectomy nephroureterectomy, or ureterectomy with pathological evidence of urothelial carcinoma at high risk of recurrence as described in one of the two scenarios below (i or ii). The 7th edition of American Joint Committee on Cancer (AJCC) staging will be utilized.:
* (i) Patients who have not received neoadjuvant systemic therapy: pT3-pT4\* or pT0/x-pT4/N+ on radical surgery (i.e., cystectomy, nephroureterectomy, or ureterectomy) and are not eligible for adjuvant cisplatin chemotherapy
* (i) Patients ineligible for cisplatin due to at least one of the following criteria and reason for ineligibility should be documented:
* (i) Creatinine Clearance (using Cockcroft-Gault): \< 60 mL/min
* (i) Common Terminology Criteria for Adverse Events (CTCAE) version 5, grade \>= 2 audiometric hearing loss
* (i) CTCAE version 5, grade \>= 2 or above peripheral neuropathy
* New York Heart Association Class III heart failure
* (i) Eastern Cooperative Oncology Group (ECOG) performance status = 2
* (i) Patients who are eligible for cisplatin may be candidates if they refuse adjuvant cisplatin-based chemotherapy, despite being informed by the investigator about the treatment options. The patient's refusal must be documented.
* (i) Patients with pT2N0 urothelial cancer on radical surgery specimen (without prior neoadjuvant systemic therapy) with ctDNA(+) Signatera results based on an assay performed post-radical surgery as part of routine care outside of the study may proceed with pre-registration but require confirmation of ctDNA(+) Signatera testing on repeat "central testing" in the context of A032103 testing. Patients with pT2N0 with central testing not confirming ctDNA(+) will not be eligible for A032103 (Note: this is distinct from patients with ypT2N0 who are eligible based on ii).
* (ii) Patients who received neoadjuvant systemic therapy: ypT2-T4a and/or ypN+ on radical surgery (i.e., cystectomy. , nephroureterectomy, or ureterectomy) pathology specimen. Neoadjuvant systemic therapy may have included cisplatin-based chemotherapy, cisplatin-based chemotherapy plus PD-1/PD-L1 blockade, or enfortumab vedotin plus PD-1/PD-L1 blockade
* PRE-REGISTRATION: Available tumor tissue for central Signatera testing to be submitted at pre-registration. Central testing is defined as testing performed as part of the A032103 study prior to registration and is provided by the study and not routine standard commercial testing. Patients who have already had local Signatera testing performed as part of routine care will require repeat central testing as part of the A032103 study to be eligible for registration/randomization. Tumor tissue from the radical surgery specimen is preferred over tissue from prior diagnostic biopsy specimen (e.g., transurethral resection of bladder tumor specimen)
* PRE-REGISTRATION: Age \>= 18 years
* PRE-REGISTRATION: ECOG Performance Status 0-2
* PRE-REGISTRATION: Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
* PRE-REGISTRATION: No postoperative/adjuvant systemic therapy after radical surgery
* PRE-REGISTRATION: No adjuvant radiation after radical surgery
* PRE-REGISTRATION: No treatment with any other type of investigational agent =\< 4 weeks before pre-registration
* PRE-REGISTRATION: Not have ever received prior treatment with LAG-3 blockade
* PRE-REGISTRATION: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* PRE-REGISTRATION: Absolute Neutrophil Count (ANC) \>= 1,200/mm\^3
* PRE-REGISTRATION: Platelet count \>= 100,000/mm\^3
* PRE-REGISTRATION: Hemoglobin \>= 8 g/dL
* PRE-REGISTRATION: Creatinine =\< 1.5 x upper limit of normal (ULN) or calculated (calc.) creatinine clearance \> 30 mL/min (using either Cockcroft-Gault formula or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
* PRE-REGISTRATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x ULN
* PRE-REGISTRATION: Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except in patients with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
* PRE-REGISTRATION: For women of childbearing potential only: A negative urine or serum pregnancy test done =\< 14 days prior to pre-registration is required
* PRE-REGISTRATION: Not currently requiring hemodialysis
* PRE-REGISTRATION: No current or prior history of myocarditis
* PRE-REGISTRATION: No grade ≥ 3 immune related adverse event with prior PD-1/PD-L1 blockade
* PRE-REGISTRATION: No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens- Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease.
* PRE-REGISTRATION: Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.
* PRE-REGISTRATION: Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
* PRE-REGISTRATION: No current pneumonitis or prior history of non-infectious pneumonitis that required steroids within the previous 5 years.
* PRE-REGISTRATION: No known active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected).
* PRE-REGISTRATION: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* PRE-REGISTRATION: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible.
* PRE-REGISTRATION: No concurrent antineoplastic therapy.
* PRE-REGISTRATION: No current immunosuppressive agents (with the exception of corticosteroids as described below).
* PRE-REGISTRATION: No condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of pre-registration (with the exception of steroid pre-medications for contrast allergies). Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
* REGISTRATION: Patient must have had radical cystectomy and lymph node dissection or nephroureterectomy or ureterectomy =\< 18 weeks prior to registration.
* REGISTRATION: Must have evaluable ctDNA Signatera assay result (i.e., ctDNA\[+\]or ctDNA\[-\]) based on test performed as part of central testing at pre-registration to A032103. Central testing is defined as testing performed as part of the A032103. Local/commercial testing results may not be used for registration to A032103
* Cisplatin-ineligible (or cisplatin-declining) patients with a pT2N0 urothelial cancer on cystectomy or nephroureterectomy or ureterectomy who were pre-registered based on routine standard care ctDNA(+) Signatera testing must have confirmed ctDNA(+) Signatera testing on central testing. If central Signatera testing yields a ctDNA(-) result, these patients are ineligible. NOTE: This is a distinct consideration from patients with ypT2-4 and/or ypN+ urothelial cancer (i.e., patients who had received neoadjuvant cisplatin-based chemotherapy) who are eligible with either ctDNA(+) or ctDNA(-) central Signatera testing
* REGISTRATION: All patients must have confirmed disease-free status defined as no measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or definitive non-measurable radiographic metastatic disease, within 60 days prior to registration. Patients with equivocal nodes less than 15 mm in short axis, or \< 10 mm in long axis for non-lymph node lesions, not considered by the investigator to represent malignant disease will be eligible. Attempts should be made to resolve the etiology of equivocal lesions with complementary imaging (e.g., PET scan) or biopsy.
* REGISTRATION: No major surgery =\< 3 weeks before registration.
* REGISTRATION: No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette- Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed. Coronavirus disease 2019 (COVID-19) vaccines are not live vaccines and are allowed
* REGISTRATION: No change since registration in clinical condition and/or laboratory tests that would impact the safety of nivolumab +/- relatlimab administration in the opinion of the treating investigator
* COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):
* Patient must have converted to ctDNA(+) during serial monitoring performed centrally in the setting of the A032103 study
* COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):
* No evidence of metastatic disease on the most recent scheduled imaging assessment as outlined in the study calendar (no repeat imaging is necessary specifically at the time of the conversion from ctDNA\[-\] to ctDNA\[+\]).
* COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):
* No change in clinical condition and/or laboratory tests that would impact the safety of nivolumab administration in the opinion of the treating investigator
* COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):
* =\< 6 weeks from reporting of ctDNA(+) result to site (not from the date sample was drawn).

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Matthew D Galsky

PRINCIPAL_INVESTIGATOR

Alliance for Clinical Trials in Oncology

Study Locations (Sites)

Cancer Center at Saint Joseph's

Phoenix, Arizona, 85004

United States

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, 85704

United States

Banner University Medical Center - Tucson

Tucson, Arizona, 85719

United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719

United States

Highlands Oncology Group - Fayetteville

Fayetteville, Arkansas, 72703

United States

Highlands Oncology Group - Rogers

Rogers, Arkansas, 72758

United States

Highlands Oncology Group

Springdale, Arkansas, 72762

United States

Kaiser Permanente-Anaheim

Anaheim, California, 92806

United States

Kaiser Permanente-Baldwin Park

Baldwin Park, California, 91706

United States

Kaiser Permanente-Bellflower

Bellflower, California, 90706

United States

Kaiser Permanente-Fontana

Fontana, California, 92335

United States

Kaiser Permanente South Bay

Harbor City, California, 90710

United States

Kaiser Permanente-Irvine

Irvine, California, 92618

United States

UC San Diego Moores Cancer Center

La Jolla, California, 92093

United States

Keck Medicine of USC Koreatown

Los Angeles, California, 90020

United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027

United States

Los Angeles General Medical Center

Los Angeles, California, 90033

United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

Kaiser Permanente West Los Angeles

Los Angeles, California, 90034

United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, 92663

United States

Kaiser Permanente-Ontario

Ontario, California, 91761

United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304

United States

Kaiser Permanente - Panorama City

Panorama City, California, 91402

United States

Kaiser Permanente-Riverside

Riverside, California, 92505

United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817

United States

Kaiser Permanente-San Diego Zion

San Diego, California, 92120

United States

Kaiser Permanente-San Marcos

San Marcos, California, 92078

United States

Kaiser Permanente-Woodland Hills

Woodland Hills, California, 91367

United States

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045

United States

Kaiser Permanente-Franklin

Denver, Colorado, 80205

United States

Poudre Valley Hospital

Fort Collins, Colorado, 80524

United States

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, 80528

United States

UCHealth Greeley Hospital

Greeley, Colorado, 80631

United States

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129

United States

Kaiser Permanente-Rock Creek

Lafayette, Colorado, 80026

United States

Kaiser Permanente-Lone Tree

Lone Tree, Colorado, 80124

United States

UCHealth Lone Tree Health Center

Lone Tree, Colorado, 80124

United States

Medical Center of the Rockies

Loveland, Colorado, 80538

United States

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, 06418

United States

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, 06824

United States

Smilow Cancer Hospital Care Center at Glastonbury

Glastonbury, Connecticut, 06033

United States

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, 06830

United States

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, 06437

United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105

United States

Yale University

New Haven, Connecticut, 06520

United States

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, 06473

United States

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, Connecticut, 06902

United States

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, 06790

United States

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611

United States

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, 06708

United States

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385

United States

Helen F Graham Cancer Center

Newark, Delaware, 19713

United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713

United States

MedStar Georgetown University Hospital

Washington, District of Columbia, 20007

United States

MedStar Washington Hospital Center

Washington, District of Columbia, 20010

United States

George Washington University Medical Center

Washington, District of Columbia, 20037

United States

Mount Sinai Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180

United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180

United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146

United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442

United States

Malcom Randall Veterans Administration Medical Center

Gainesville, Florida, 32610

United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610

United States

Mount Sinai Medical Center

Miami Beach, Florida, 33140

United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

United States

Miami Cancer Institute

Miami, Florida, 33176

United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, 33176

United States

AdventHealth Orlando

Orlando, Florida, 32803

United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324

United States

Emory University Hospital Midtown

Atlanta, Georgia, 30308

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342

United States

Northside Hospital

Atlanta, Georgia, 30342

United States

Northside Hospital - Duluth

Duluth, Georgia, 30096

United States

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097

United States

Northside Hospital - Gwinnett

Lawrenceville, Georgia, 30046

United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706

United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605

United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814

United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687

United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854

United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864

United States

Advocate Good Shepherd Hospital

Barrington, Illinois, 60010

United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704

United States

Illinois CancerCare-Canton

Canton, Illinois, 61520

United States

Illinois CancerCare-Carthage

Carthage, Illinois, 62321

United States

Northwestern University

Chicago, Illinois, 60611

United States

University of Illinois

Chicago, Illinois, 60612

United States

Swedish Covenant Hospital

Chicago, Illinois, 60625

United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657

United States

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, 60014

United States

Carle at The Riverfront

Danville, Illinois, 61832

United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

United States

Decatur Memorial Hospital

Decatur, Illinois, 62526

United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115

United States

Illinois CancerCare-Dixon

Dixon, Illinois, 61021

United States

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515

United States

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Advocate Sherman Hospital

Elgin, Illinois, 60123

United States

Elmhurst Memorial Hospital

Elmhurst, Illinois, 60126

United States

Illinois CancerCare-Eureka

Eureka, Illinois, 61530

United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201

United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401

United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134

United States

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, 60026

United States

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, 60026

United States

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030

United States

Ingalls Memorial Hospital

Harvey, Illinois, 60426

United States

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, 60035

United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443

United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045

United States

AMG Libertyville - Oncology

Libertyville, Illinois, 60048

United States

Condell Memorial Hospital

Libertyville, Illinois, 60048

United States

Illinois CancerCare-Macomb

Macomb, Illinois, 61455

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

Edward Hospital/Cancer Center

Naperville, Illinois, 60540

United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451

United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

United States

Northwestern Medicine Oak Brook

Oak Brook, Illinois, 60523

United States

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453-2699

United States

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462

United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, 60462

United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350

United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068

United States

Illinois CancerCare-Pekin

Pekin, Illinois, 61554

United States

Illinois CancerCare-Peoria

Peoria, Illinois, 61615

United States

Illinois CancerCare-Peru

Peru, Illinois, 61354

United States

Edward Hospital/Cancer Center?Plainfield

Plainfield, Illinois, 60585

United States

Illinois CancerCare-Princeton

Princeton, Illinois, 61356

United States

UW Health Carbone Cancer Center Rockford

Rockford, Illinois, 61114

United States

Memorial Hospital East

Shiloh, Illinois, 62269

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Springfield Clinic

Springfield, Illinois, 62702

United States

Springfield Memorial Hospital

Springfield, Illinois, 62781

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555

United States

Illinois CancerCare - Washington

Washington, Illinois, 61571

United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202

United States

Mary Greeley Medical Center

Ames, Iowa, 50010

United States

McFarland Clinic - Ames

Ames, Iowa, 50010

United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023

United States

McFarland Clinic - Boone

Boone, Iowa, 50036

United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, 50325

United States

Iowa Methodist Medical Center

Des Moines, Iowa, 50309

United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309

United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314

United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314

United States

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, 50501

United States

McFarland Clinic - Jefferson

Jefferson, Iowa, 50129

United States

McFarland Clinic - Marshalltown

Marshalltown, Iowa, 50158

United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263

United States

HaysMed

Hays, Kansas, 67601

United States

University of Kansas Cancer Center

Kansas City, Kansas, 66160

United States

Lawrence Memorial Hospital

Lawrence, Kansas, 66044

United States

The University of Kansas Cancer Center - Olathe

Olathe, Kansas, 66061

United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210

United States

Salina Regional Health Center

Salina, Kansas, 67401

United States

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, 66606

United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205

United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

United States

Baptist Health Louisville

Louisville, Kentucky, 40207

United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121

United States

Lafayette Family Cancer Center-EMMC

Brewer, Maine, 04412

United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

United States

UPMC Western Maryland

Cumberland, Maryland, 21502

United States

Beverly Hospital

Beverly, Massachusetts, 01915

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Steward Saint Elizabeth's Medical Center

Brighton, Massachusetts, 02135

United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805

United States

Dana-Farber Cancer Institute at Foxborough

Foxboro, Massachusetts, 02035

United States

Addison Gilbert Hospital

Gloucester, Massachusetts, 01930

United States

Lahey Medical Center-Peabody

Peabody, Massachusetts, 01960

United States

Dana-Farber/Brigham and Women's Cancer Center at South Shore

South Weymouth, Massachusetts, 02190

United States

Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care

Winchester, Massachusetts, 01890

United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

United States

Bronson Battle Creek

Battle Creek, Michigan, 49017

United States

McLaren Cancer Institute-Bay City

Bay City, Michigan, 48706

United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114

United States

University of Michigan - Brighton Center for Specialty Care

Brighton, Michigan, 48116

United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188

United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118

United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038

United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Henry Ford Hospital

Detroit, Michigan, 48202

United States

OSF Saint Francis Hospital and Medical Group

Escanaba, Michigan, 49829

United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334

United States

Cancer Hematology Centers - Flint

Flint, Michigan, 48503

United States

Genesee Hematology Oncology PC

Flint, Michigan, 48503

United States

Genesys Hurley Cancer Institute

Flint, Michigan, 48503

United States

Hurley Medical Center

Flint, Michigan, 48503

United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503

United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503

United States

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007

United States

West Michigan Cancer Center

Kalamazoo, Michigan, 49007

United States

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, 48910

United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912

United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

United States

Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444

United States

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, 49120

United States

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, 49444

United States

Henry Ford Medical Center-Columbus

Novi, Michigan, 48377

United States

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, 49770

United States

Corewell Health Reed City Hospital

Reed City, Michigan, 49677

United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601

United States

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, 48604

United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085

United States

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, 49085

United States

MyMichigan Medical Center Tawas

Tawas City, Michigan, 48764

United States

Munson Medical Center

Traverse City, Michigan, 49684

United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322

United States

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, 48661

United States

University of Michigan Health - West

Wyoming, Michigan, 49519

United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197

United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601

United States

Mercy Hospital

Coon Rapids, Minnesota, 55433

United States

Fairview Southdale Hospital

Edina, Minnesota, 55435

United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407

United States

United Hospital

Saint Paul, Minnesota, 55102

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

United States

MU Health - University Hospital/Ellis Fischel Cancer Center

Columbia, Missouri, 65212

United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141

United States

Parkland Health Center - Farmington

Farmington, Missouri, 63640

United States

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, 65109

United States

University Health Truman Medical Center

Kansas City, Missouri, 64108

United States

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, 64128

United States

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154

United States

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064

United States

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, 64116

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Veteran's Affairs Medical Center - Saint Louis

Saint Louis, Missouri, 63125

United States

Mercy Hospital South

Saint Louis, Missouri, 63128

United States

Siteman Cancer Center-South County

Saint Louis, Missouri, 63129

United States

Missouri Baptist Medical Center

Saint Louis, Missouri, 63131

United States

Siteman Cancer Center at Christian Hospital

Saint Louis, Missouri, 63136

United States

Mercy Hospital Saint Louis

Saint Louis, Missouri, 63141

United States

Siteman Cancer Center at Saint Peters Hospital

Saint Peters, Missouri, 63376

United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670

United States

Mercy Hospital Springfield

Springfield, Missouri, 65804

United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080

United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127

United States

Community Hospital of Anaconda

Anaconda, Montana, 59711

United States

Billings Clinic Cancer Center

Billings, Montana, 59101

United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715

United States

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405

United States

Logan Health Medical Center

Kalispell, Montana, 59901

United States

Community Medical Center

Missoula, Montana, 59804

United States

Nebraska Medicine-Bellevue

Bellevue, Nebraska, 68123

United States

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, 89052

United States

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, 89102

United States

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, 89148

United States

New Hampshire Oncology Hematology PA-Concord

Concord, New Hampshire, 03301

United States

Solinsky Center for Cancer Care

Manchester, New Hampshire, 03103

United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920

United States

Jefferson Cherry Hill Hospital

Cherry Hill, New Jersey, 08002

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Monmouth Medical Center Southern Campus

Lakewood, New Jersey, 08701

United States

Monmouth Medical Center

Long Branch, New Jersey, 07740

United States

Southern Ocean County Medical Center

Manahawkin, New Jersey, 08050

United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

Sidney Kimmel Cancer Center Washington Township

Sewell, New Jersey, 08080

United States

Community Medical Center

Toms River, New Jersey, 08755

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106

United States

Presbyterian Kaseman Hospital

Albuquerque, New Mexico, 87110

United States

Presbyterian Rust Medical Center/Jorgensen Cancer Center

Rio Rancho, New Mexico, 87124

United States

Montefiore Medical Center-Einstein Campus

Bronx, New York, 10461

United States

Maimonides Medical Center

Brooklyn, New York, 11219

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Memorial Sloan Kettering Commack

Commack, New York, 11725

United States

Glens Falls Hospital

Glens Falls, New York, 12801

United States

Memorial Sloan Kettering Westchester

Harrison, New York, 10604

United States

NYU Langone Hospital - Long Island

Mineola, New York, 11501

United States

Mount Sinai Chelsea

New York, New York, 10011

United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016

United States

Mount Sinai Hospital

New York, New York, 10029

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Rochester General Hospital

Rochester, New York, 14621

United States

Unity Park Ridge Campus

Rochester, New York, 14626

United States

University of Rochester

Rochester, New York, 14642

United States

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553

United States

Wilmot Cancer Institute at Webster

Webster, New York, 14580

United States

Duke Cancer Center Cary

Cary, North Carolina, 27518

United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, 28374

United States

Duke Cancer Center Raleigh

Raleigh, North Carolina, 27609

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501

United States

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122

United States

OhioHealth O'Bleness Hospital

Athens, Ohio, 45701

United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, 43214

United States

Riverside Methodist Hospital

Columbus, Ohio, 43214

United States

Grant Medical Center

Columbus, Ohio, 43215

United States

Doctors Hospital

Columbus, Ohio, 43228

United States

Delaware Health Center-Grady Cancer Center

Delaware, Ohio, 43015

United States

Grady Memorial Hospital

Delaware, Ohio, 43015

United States

Columbus Oncology and Hematology Associates

Dublin, Ohio, 43016

United States

Dublin Methodist Hospital

Dublin, Ohio, 43016

United States

OhioHealth Mansfield Hospital

Mansfield, Ohio, 44903

United States

OhioHealth Marion General Hospital

Marion, Ohio, 43302

United States

OhioHealth Pickerington Methodist Hospital

Pickerington, Ohio, 43147

United States

ProMedica Flower Hospital

Sylvania, Ohio, 43560

United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069

United States

OhioHealth Westerville Medical Campus/Westerville Cancer Center

Westerville, Ohio, 43082

United States

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, 73505

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, 74146

United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, 97914

United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045

United States

Providence Portland Medical Center

Portland, Oregon, 97213

United States

Providence Saint Vincent Medical Center

Portland, Oregon, 97225

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103

United States

UPMC Altoona

Altoona, Pennsylvania, 16601

United States

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017

United States

Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301

United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505

United States

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601

United States

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, 17109

United States

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, 17050

United States

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, 15146

United States

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

United States

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, 19114

United States

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, 15215

United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232

United States

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237

United States

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, 15243

United States

Reading Hospital

West Reading, Pennsylvania, 19611

United States

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 19090

United States

Smilow Cancer Hospital Care Center - Westerly

Westerly, Rhode Island, 02891

United States

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640

United States

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605

United States

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605

United States

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605

United States

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615

United States

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650

United States

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672

United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

United States

The West Clinic - Wolf River

Germantown, Tennessee, 38138

United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232

United States

UT Southwestern Simmons Cancer Center - RedBird

Dallas, Texas, 75237

United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

United States

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, 76104

United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030

United States

Ben Taub General Hospital

Houston, Texas, 77030

United States

Michael E DeBakey VA Medical Center

Houston, Texas, 77030

United States

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, 75080

United States

Central Vermont Medical Center/National Life Cancer Treatment

Berlin, Vermont, 05602

United States

University of Vermont Medical Center

Burlington, Vermont, 05401

United States

University of Vermont and State Agricultural College

Burlington, Vermont, 05405

United States

University of Virginia Cancer Center

Charlottesville, Virginia, 22908

United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

United States

VCU Community Memorial Health Center

South Hill, Virginia, 23970

United States

Virginia Mason Medical Center

Seattle, Washington, 98101

United States

West Virginia University Charleston Division

Charleston, West Virginia, 25304

United States

Aurora Saint Luke's South Shore

Cudahy, Wisconsin, 53110

United States

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024

United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301

United States

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303

United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311

United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718

United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792

United States

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, 54143

United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233

United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149

United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066

United States

Saint Vincent Hospital Cancer Center at Oconto Falls

Oconto Falls, Wisconsin, 54154

United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904

United States

Saint Vincent Hospital Cancer Center at Sheboygan

Sheboygan, Wisconsin, 53081

United States

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081

United States

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235-1495

United States

Aurora Medical Center in Summit

Summit, Wisconsin, 53066

United States

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241

United States

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188

United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188

United States

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226

United States

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Matthew D Galsky, PRINCIPAL_INVESTIGATOR, Alliance for Clinical Trials in Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-02

Study Completion Date2030-09-02

Study Record Updates

Study Start Date2024-02-02

Study Completion Date2030-09-02

Terms related to this study

Additional Relevant MeSH Terms

Muscle Invasive Bladder Urothelial Carcinoma
Muscle Invasive Renal Pelvis Urothelial Carcinoma
Muscle Invasive Ureter Urothelial Carcinoma
Muscle Invasive Urethral Urothelial Carcinoma
Stage II Bladder Urothelial Carcinoma AJCC v6 and v7
Stage III Bladder Urothelial Carcinoma AJCC v6 and v7
Stage IV Bladder Urothelial Carcinoma AJCC v7