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RecruitingNCT05987241Updated Oct 7, 2026

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

A Phase 2/3 interventional study of Biospecimen Collection and cfDNA or ctDNA Measurement in Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma and Muscle Invasive Ureter Urothelial Carcinoma, sponsored by National Cancer Institute (NCI). Recruiting at 501 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by National Cancer Institute (NCI) · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 8 months later.
Updated Oct 6, 2026Site recruiting status changed1 site added+1 moreGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
992
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

PRIMARY OBJECTIVES:

I. To compare the ctDNA clearance proportion (i.e., ctDNA positive [+] --> ctDNA negative [-]) at 12 weeks in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 2 portion).

II. To compare overall survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 3 portion).

III. To compare disease-free survival in patients enrolled in Cohort B randomized to immediate treatment with nivolumab to those randomized to surveillance with subsequent treatment with nivolumab only upon converting to ctDNA(+)

SECONDARY OBJECTIVES:

I. To compare disease-free survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab.

II. To define the association between ctDNA clearance and disease-free survival and overall survival for Cohort A patients.

III. To compare overall survival in patients enrolled in Cohort B randomized to immediate treatment with nivolumab to those randomized to surveillance with subsequent treatment with nivolumab only upon converting to ctDNA(+).

IV. To determine the lead time from a ctDNA(+) assay to radiographic recurrence in patients initially ctDNA(-) post-definitive surgery enrolled in Cohort B.

V. To estimate the proportion of Cohort B patients on Arm 4 who become ctDNA(+) and receive nivolumab.

VI. To compare the cumulative incidence of Cohort B patients who become ctDNA(+) between Arms 3 and 4.

VII. To determine the safety of adjuvant nivolumab plus relatlimab. VIII. To compare disease-free survival and overall survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab according to receipt of neoadjuvant immune checkpoint blockade-containing therapy versus no neoadjuvant immune checkpoint blockade-containing therapy.

IX. To compare disease-free survival and overall survival in patients enrolled in Cohort B treated with adjuvant nivolumab versus nivolumab + relatlimab according to receipt of neoadjuvant immune checkpoint blockade-containing therapy versus no neoadjuvant immune checkpoint blockade-containing therapy.

EXPLORATORY OBJECTIVES:

I. To explore the kinetics of quantitative ctDNA levels (mean number of tumor molecules observed per mL of plasma or MTM/ml) over time and the association between ctDNA kinetics and time-to-event outcomes.

II. To estimate the costs and value of care in patients with a ctDNA(+) assay post-radical surgery treated with adjuvant nivolumab versus nivolumab + relatlimab.

III. To estimate the costs and value of care in patients with a ctDNA(-) assay post-radical surgery treated with adjuvant nivolumab versus surveillance with subsequent treatment with nivolumab at the time of conversion to ctDNA(+).

QUALITY OF LIFE OBJECTIVES:

I. Within each cohort, to compare quality-adjusted survival among randomized arms using European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L).

II. Within Cohort B, to compare overall quality of life (QOL) as measured by the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) between baseline and 42 months (calculated as the area under the curve) among randomized arms.

III. Within each cohort, to compare overall QOL as measured by the EORTC QLQ-C30 at each time point among randomized arms.

IV. Within each cohort, to compare bladder cancer-specific QOL as measured by the EORTC Bladder Cancer Muscle-Invasive 30 Questionnaire (QLQ-BLM30) at each time point among randomized arms.

V. Within each cohort, to compare patient-reported fatigue as measured by Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue at each time point among randomized arms.

OUTLINE: Patients are assigned to 1 of 2 cohorts based on ctDNA results.

COHORT A: Patients who are ctDNA(+) are randomized to 1 of 2 arms:

ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) and may undergo cystoscopy throughout the trial.

ARM II: Patients receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.

COHORT B: Patients who are ctDNA(-) are randomized to 1 of 2 arms:

ARM III: Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.

ARM IV: Patients undergo ctDNA surveillance consisting of collection of tissue and blood during screening and collection of blood only on study and during follow up. Patients who convert to ctDNA(+) during surveillance then receive nivolumab IV over 30 minutes day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.

After completion of study treatment, patients are followed up at weeks 48, 60, 72, 84, 96, 120, 144, 196, and 248.

02

Conditions studied

  • 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
03

In context

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • PRE-REGISTRATION (STEP 0): Histologically confirmed muscle-invasive urothelial carcinoma of the urethra, bladder, ureter or renal pelvis
  • PRE-REGISTRATION (STEP 0): 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 (STEP 0): Radical surgery (cystectomy with lymph node dissection or nephroureterectomy or ureterectomy) must be ≥ 3 weeks and ≤ 12 weeks (central Signatera pathway) or ≤ 16 weeks (commercial Signatera pathwary) prior to pre-registration. Patients who have had a partial cystectomy as definitive therapy are not eligible
  • PRE-REGISTRATION (STEP 0): Patients who have had a partial cystectomy as definitive therapy are not eligible
  • PRE-REGISTRATION (STEP 0): 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 (STEP 0): 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 (STEP 0): 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: pT4N0 or pTanyN+ on radical surgery pathology specimen (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 adjuvant 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 are eligible only if the result was obtained via commercial testing (central testing is not permitted for this population) (Note: this is distinct from patients with ypT2N0 who are eligible based on ii).
    • (ii) Patients who received neoadjuvant systemic therapy: ypT2-T4N0 or Nx or ypTanyN+ 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 (STEP 0): Patients are required to meet criteria for one of two criteria:

    • 1) Commercial Signatera pathway:

      • Available commercial Signatera testing result (i.e., ctDNA+ or ctDNA-) from blood sample obtained ≥ 3 weeks and ≤ 16 weeks from time of radical surgery performed as part of standard care

        • Sites are required to verify that the commercial Signatera report demonstrates a complete 16 target assay design and that the test was designed on exome. This verification is conducted at the site level during the eligibility review. OR

    • Central Signatera pathway:

      • Pre-registration samples are to be submitted after pre-registration, at ≥ 3 weeks but ≤ 12 weeks from the time of radical surgery

        • Ineligible patients for the commercial pathway must use the central Signatera pathway and provide tumor tissue as part of the A032103 study
        • For patients who have not had neoadjuvant chemotherapy, tumor tissue is preferred from the radical surgery specimen
        • For patients who have had neoadjuvant therapy, tissue is preferred from the pre-chemotherapy specimen diagnosing muscle-invasive disease (e.g., transurethral resection of bladder tumor specimen)
  • PRE-REGISTRATION (STEP 0): Age >= 18 years
  • PRE-REGISTRATION (STEP 0): ECOG performance status 0-2
  • PRE-REGISTRATION (STEP 0): Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
  • PRE-REGISTRATION (STEP 0): No postoperative adjuvant systemic therapy after radical surgery
  • PRE-REGISTRATION (STEP 0): No adjuvant radiation after radical surgery
  • PRE-REGISTRATION (STEP 0): No treatment with any other type of investigational agent =\< 4 weeks before pre-registration
  • PRE-REGISTRATION (STEP 0): No previous treatment with LAG-3 blockade therapy
  • PRE-REGISTRATION (STEP 0): 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 (STEP 0): Absolute neutrophil count (ANC) >= 1,200/mm\^3
  • PRE-REGISTRATION (STEP 0): Platelet count >= 100,000/mm\^3
  • PRE-REGISTRATION (STEP 0): Hemoglobin >= 8 g/dL
  • PRE-REGISTRATION (STEP 0): 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 (STEP 0): Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x ULN
  • PRE-REGISTRATION (STEP 0): 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 (STEP 0): For women of childbearing potential only: A negative urine or serum pregnancy test done =\< 14 days prior to pre-registration is required
  • PRE-REGISTRATION (STEP 0): Not currently requiring hemodialysis
  • PRE-REGISTRATION (STEP 0): No current or prior history of myocarditis
  • PRE-REGISTRATION (STEP 0): No history of a grade ≥ 3 immune related adverse event with prior PD-1/PD-L1 blockade in the neoadjuvant setting
  • PRE-REGISTRATION (STEP 0): 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 (STEP 0): Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.
  • PRE-REGISTRATION (STEP 0): 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 (STEP 0): No current pneumonitis or prior history of non-infectious pneumonitis that required steroids within the previous 5 years.
  • PRE-REGISTRATION (STEP 0): 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 (STEP 0): 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 (STEP 0): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible.
  • PRE-REGISTRATION (STEP 0): No concurrent antineoplastic therapy including anti-hormonal treatments used for cancer therapy (e.g., leuprolide, antiandrogens)
  • PRE-REGISTRATION (STEP 0): No current immunosuppressive agents (except for corticosteroids as described below).
  • PRE-REGISTRATION (STEP 0): 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 (STEP 1): Patient must have had radical cystectomy and lymph node dissection or nephroureterectomy or ureterectomy =\< 18 weeks prior to registration.

  • REGISTRATION (STEP 1): Must have evaluable ctDNA Signatera assay result (i.e., ctDNA+ or ctDNA-) based on either:

    • Commercial Signatera result OR
    • Central Signatera testing result (i.e. testing that was performed as part of A032103.)
  • REGISTRATION (STEP 1): 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 lymph 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 (STEP 1): No major surgery =\< 3 weeks before registration.
  • REGISTRATION (STEP 1): 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 (STEP 1): No change since Step 0 pre-registration in clinical condition and/or laboratory tests that would impact the safety of nivolumab +/- relatlimab administration in the opinion of the treating investigator
  • REGISTRATION (STEP 1): No evidence of high grade urothelial cancer in the bladder for patients with primary urothelial cancers of the upper urinary tract

  • RE-REGISTRATION (STEP 2) 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 as part of A032103

  • RE-REGISTRATION (STEP 2) 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[+]).

  • RE-REGISTRATION (STEP 2) COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):

    • In the opinion of the treating investigator, patient clinical condition and laboratory tests would not impact the safety of nivolumab administration in the opinion of the treating investigator
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
992 participants (estimated)

Study arms

  • Active comparator
    Cohort A, Arm I (nivolumab)

    Patients in Cohort A, Arm I receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.

    Procedure: Biospecimen Collection · Procedure: Computed Tomography · Procedure: Cystoscopy · Procedure: Magnetic Resonance Imaging · Biological: Nivolumab · Other: Questionnaire Administration

  • Experimental
    Cohort A, Arm II (nivolumab, relatlimab)

    Patients in Cohort A, Arm II receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.

    Procedure: Biospecimen Collection · Procedure: Computed Tomography · Procedure: Cystoscopy · Procedure: Magnetic Resonance Imaging · Biological: Nivolumab · Other: Questionnaire Administration · Biological: Relatlimab

  • Active comparator
    Cohort B, Arm III (nivolumab)

    Patients in Cohort B, Arm III receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.

    Procedure: Biospecimen Collection · Procedure: Computed Tomography · Procedure: Magnetic Resonance Imaging · Biological: Nivolumab · Other: Questionnaire Administration

  • Experimental
    Cohort B, Arm IV (ctDNA surveillance, nivolumab)

    Patients in Cohort B, Arm IV undergo ctDNA surveillance consisting of collection of tissue and blood during screening and collection of blood only on study and during follow up. Patients who convert to ctDNA(+) during surveillance then receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.

    Procedure: Biospecimen Collection · Other: cfDNA or ctDNA Measurement · Procedure: Computed Tomography · Procedure: Cystoscopy · Procedure: Magnetic Resonance Imaging · Biological: Nivolumab · Other: Questionnaire Administration

Interventions

  • ProcedureBiospecimen Collection

    Undergo collection of tissue and blood

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • OthercfDNA or ctDNA Measurement

    Undergo ctDNA surveillance

    Also known as: Cell-Free DNA/Circulating Tumor DNA Measurement, cfDNA/ctdDNA Measurement, cfDNA/ctDNA, cfDNA/ctDNA Measurement, Circulating Cell-Free DNA/Circulating Tumor-Derived DNA Measurement

  • ProcedureComputed Tomography

    Undergo CT

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

  • ProcedureCystoscopy

    Undergo cystoscopy

    Also known as: CS

  • ProcedureMagnetic Resonance Imaging

    Undergo MRI

    Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

  • BiologicalNivolumab

    Given IV

    Also known as: ABP 206, BCD-263, BMS 936558, BMS-936558, BMS936558, CMAB819, MDX 1106, MDX-1106, MDX1106, NIVO, Nivolumab Biosimilar ABP 206, Nivolumab Biosimilar BCD-263, Nivolumab Biosimilar CMAB819, ONO 4538, ONO-4538, ONO4538, Opdivo

  • OtherQuestionnaire Administration

    Ancillary studies

  • BiologicalRelatlimab

    Given IV

    Also known as: BMS 986016, BMS-986016, BMS986016, Immunoglobulin G4, Anti-(human Lymphocyte Activation Gene-3 Protein) (Human Heavy Chain), Disulfide with Human Light Chain, Dimer

06

What researchers measure

Primary outcomes

  1. Proportion of patients who are circulating tumor DNA negative (ctDNA[-]) (Cohort A Phase II)

    Will be determined for each treatment arm as the number of patients who are ctDNA(-) after 12 weeks of treatment divided by the total number of patients on the treatment arm. Patients who do not have a 12-week ctDNA result will be deemed to be ctDNA(+). The comparison of the proportions of patients who are ctDNA(-) after 12 weeks of treatment between the two arms will be performed with a chi-square test.

    Time frame: At week 12 from treatment start date

  2. Overall survival (OS) (Cohort A Phase III)

    The analysis will be performed using a stratified log-rank test that uses the specified stratification variables. An additional analysis will be perform using a stratified Cox regression model to generate the point estimate and 90% confidence interval for the hazard ratio (HR) (comparing Arm 2 to Arm 1).

    Time frame: From randomization until death due to any cause, assessed up to 5 years after completion of study treatment

  3. Disease-Free Survival (DFS) (Cohort B)

    A stratified Cox model (using the randomization stratification variables will be used to generate a 90% confidence interval (CI) for the HR. If the 90% CI does not contain 1.39, Arm 4 (surveillance with ctDNA serial testing to determine whether patient is treated with nivolumab) will be deemed to be non-inferior to treating patients immediately with nivolumab.

    Time frame: From randomization until confirmed disease recurrence as assessed by the treating physician or death due to any cause, assessed up to 5 years after completion of study treatment

Secondary outcomes

  1. Proportion of patients who are ctDNA(-) (Cohort A Phase III) from treatment start date

    Will be determined for each treatment arm as the number of patients who are ctDNA(-) after 12 weeks of treatment divided by the total number of patients on the treatment arm. Patients who do not have a 12-week ctDNA result will be deemed to be ctDNA(+).

    Time frame: At week 12

  2. OS (Cohort A Phase II)

    If the trial does not continue to phase III, OS will be a secondary endpoint.

    Time frame: From randomization until death due to any cause, assessed up to 5 years after completion of study treatment

  3. DFS (Cohort A Phase II or III)

    This will be a secondary endpoint for the phase III trial, if completed, or for the phase II trial if the phase III trial is not performed.

    Time frame: From randomization until confirmed disease recurrence as assessed by the treating physician or death due to any cause, assessed up to 5 years after completion of study treatment

  4. Incidence of adverse events (Cohort A)

    Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Adverse events (AEs) will be summarized with frequencies and relative frequencies. The maximum grade for an AE will be recorded for each patient by treatment arm. The number (percent) of patients that experience each observed adverse event will be summarized by treatment arm. In addition, the proportion of patients that experience a grade 3+, grade 4+, and grade 5 adverse event will be summarized as the number and percent of patients by treatment arm. The primary summary will be regardless of attribution.

    Time frame: Up to 5 years after completion of study treatment

  5. OS (Cohort B)

    Time frame: From randomization until death due to any cause, assessed up to 5 years after completion of study treatment

  6. Cumulative incidence of ctDNA(+) conversion (Cohort B)

    Time frame: From randomization until a patient becomes ctDNA(+), assessed up to 5 years after completion of study treatment

  7. Lead time for ctDNA(+) conversion (Cohort B)

    Time frame: From when a patient becomes ctDNA(+) until a confirmed radiographic disease recurrence, assessed up to 5 years after completion of study treatment

  8. Incidence of adverse events (Cohort B)

    Will be assessed using CTCAE v5.0. Adverse events will be summarized with frequencies and relative frequencies. The maximum grade for an AE will be recorded for each patient by treatment arm. The number (percent) of patients that experience each observed adverse event will be summarized by treatment arm. In addition, the proportion of patients that experience a grade 3+, grade 4+, and grade 5 adverse event will be summarized as the number and percent of patients by treatment arm. The primary summary will be regardless of attribution.

    Time frame: Up to 5 years after completion of study treatment

07

Study locations

451 of 501 sites recruiting
  • Cancer Center at Saint Joseph's
    Phoenix, Arizona 85004, United States
    Recruiting
  • Mayo Clinic Hospital in Arizona
    Phoenix, Arizona 85054, United States
    • Site Public Contact · Contact · 855-776-0015
    • Arnab Basu · Principal investigator
    Recruiting
  • University of Arizona Cancer Center-Orange Grove Campus
    Tucson, Arizona 85704, United States
    Suspended
  • Banner University Medical Center - Tucson
    Tucson, Arizona 85719, United States
    Recruiting
  • University of Arizona Cancer Center-North Campus
    Tucson, Arizona 85719, United States
    Recruiting
  • Highlands Oncology Group - Fayetteville
    Fayetteville, Arkansas 72703, United States
    • Site Public Contact · Contact · research@hogonc.com · 479-872-8100
    • Joseph T. Beck · Principal investigator
    Recruiting
  • Highlands Oncology Group - Rogers
    Rogers, Arkansas 72758, United States
    • Site Public Contact · Contact · research@hogonc.com · 479-872-8130
    • Joseph T. Beck · Principal investigator
    Recruiting
  • Highlands Oncology Group
    Springdale, Arkansas 72762, United States
    • Site Public Contact · Contact · research@hogonc.com · 479-872-8130
    • Joseph T. Beck · Principal investigator
    Recruiting
  • Kaiser Permanente-Anaheim
    Anaheim, California 92806, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Kaiser Permanente-Baldwin Park
    Baldwin Park, California 91706, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Kaiser Permanente-Bellflower
    Bellflower, California 90706, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Kaiser Permanente Dublin
    Dublin, California 94568, United States
    • Site Public Contact · Contact · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • Kaiser Permanente-Fontana
    Fontana, California 92335, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Kaiser Permanente-Fremont
    Fremont, California 94538, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • Kaiser Permanente Fresno Orchard Plaza
    Fresno, California 93720, United States
    • Site Public Contact · Contact · 833-574-2273
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • Kaiser Permanente-Fresno
    Fresno, California 93720, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • Kaiser Permanente South Bay
    Harbor City, California 90710, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Kaiser Permanente-Irvine
    Irvine, California 92618, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • UC San Diego Moores Cancer Center
    La Jolla, California 92093, United States
    • Site Public Contact · Contact · cancercto@ucsd.edu · 858-822-5354
    • Tyler Stewart · Principal investigator
    Recruiting
  • Keck Medicine of USC Koreatown
    Los Angeles, California 90020, United States
    Active, not recruiting
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California 90027, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Los Angeles General Medical Center
    Los Angeles, California 90033, United States
    Active, not recruiting
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
    Active, not recruiting
  • Kaiser Permanente West Los Angeles
    Los Angeles, California 90034, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • UCLA / Jonsson Comprehensive Cancer Center
    Los Angeles, California 90095, United States
    • Site Public Contact · Contact · 888-798-0719
    • Alexandra Drakaki · Principal investigator
    Recruiting
  • Kaiser Permanente- Modesto MOB II
    Modesto, California 95356, United States
    • Site Public Contact · Contact · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • Kaiser Permanente-Modesto
    Modesto, California 95356, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • USC Norris Oncology/Hematology-Newport Beach
    Newport Beach, California 92663, United States
    Active, not recruiting
  • Kaiser Permanente-Oakland
    Oakland, California 94611, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • Kaiser Permanente-Ontario
    Ontario, California 91761, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Stanford Cancer Institute Palo Alto
    Palo Alto, California 94304, United States
    Recruiting
  • Kaiser Permanente - Panorama City
    Panorama City, California 91402, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Kaiser Permanente-Riverside
    Riverside, California 92505, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Kaiser Permanente-Roseville
    Roseville, California 95661, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • Kaiser Permanente Downtown Commons
    Sacramento, California 95814, United States
    • Site Public Contact · Contact · kpoct@kp.org · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
    • Site Public Contact · Contact · 916-734-3089
    • Mamta Parikh · Principal investigator
    Recruiting
  • Kaiser Permanente-South Sacramento
    Sacramento, California 95823, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • Kaiser Permanente-San Diego Zion
    San Diego, California 92120, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Kaiser Permanente-San Francisco
    San Francisco, California 94115, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • Kaiser Permanente-Santa Teresa-San Jose
    San Jose, California 95119, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • Kaiser Permanente San Leandro
    San Leandro, California 94577, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • Kaiser Permanente-San Marcos
    San Marcos, California 92078, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Kaiser San Rafael-Gallinas
    San Rafael, California 94903, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • Kaiser Permanente Medical Center - Santa Clara
    Santa Clara, California 95051, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • Saint John's Cancer Institute
    Santa Monica, California 90404, United States
    Suspended
  • Kaiser Permanente-Santa Rosa
    Santa Rosa, California 95403, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • Kaiser Permanente-South San Francisco
    South San Francisco, California 94080, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • Kaiser Permanente-Vallejo
    Vallejo, California 94589, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • Kaiser Permanente-Walnut Creek
    Walnut Creek, California 94596, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Andrea L. Harzstark · Principal investigator
    Recruiting
  • Kaiser Permanente-Woodland Hills
    Woodland Hills, California 91367, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • UCHealth University of Colorado Hospital
    Aurora, Colorado 80045, United States
    • Site Public Contact · Contact · 720-848-0650
    • Elizabeth R. Kessler · Principal investigator
    Recruiting
  • Kaiser Permanente-Franklin
    Denver, Colorado 80205, United States
    Recruiting
  • Poudre Valley Hospital
    Fort Collins, Colorado 80524, United States
    • Site Public Contact · Contact · 970-297-6150
    • Elizabeth R. Kessler · Principal investigator
    Recruiting
  • Cancer Care and Hematology-Fort Collins
    Fort Collins, Colorado 80528, United States
    Recruiting
  • UCHealth Greeley Hospital
    Greeley, Colorado 80631, United States
    Recruiting
  • UCHealth Highlands Ranch Hospital
    Highlands Ranch, Colorado 80129, United States
    • Site Public Contact · Contact · 720-848-0650
    • Elizabeth R. Kessler · Principal investigator
    Recruiting
  • Kaiser Permanente-Rock Creek
    Lafayette, Colorado 80026, United States
    Recruiting
  • Kaiser Permanente-Lone Tree
    Lone Tree, Colorado 80124, United States
    Recruiting
  • UCHealth Lone Tree Health Center
    Lone Tree, Colorado 80124, United States
    Recruiting
  • Medical Center of the Rockies
    Loveland, Colorado 80538, United States
    • Site Public Contact · Contact · 970-203-7083
    • Elizabeth R. Kessler · Principal investigator
    Recruiting
  • Hartford HealthCare - Avon
    Avon, Connecticut 06001, United States
    • Site Public Contact · Contact · 860-972-4700
    • Michael Sun · Principal investigator
    Recruiting
  • Hartford HealthCare - Saint Vincent's Medical Center
    Bridgeport, Connecticut 06606, United States
    • Site Public Contact · Contact · 860-972-4700
    • Michael Sun · Principal investigator
    Recruiting
  • Smilow Cancer Hospital-Derby Care Center
    Derby, Connecticut 06418, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Joseph W. Kim · Principal investigator
    Recruiting
  • Hartford Healthcare - Fairfield
    Fairfield, Connecticut 06824, United States
    Recruiting
  • Smilow Cancer Hospital Care Center-Fairfield
    Fairfield, Connecticut 06824, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Joseph W. Kim · Principal investigator
    Recruiting
  • Smilow Cancer Hospital Care Center at Glastonbury
    Glastonbury, Connecticut 06033, United States
    Suspended
  • Smilow Cancer Hospital Care Center at Greenwich
    Greenwich, Connecticut 06830, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Joseph W. Kim · Principal investigator
    Recruiting
  • Smilow Cancer Hospital Care Center - Guilford
    Guilford, Connecticut 06437, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Joseph W. Kim · Principal investigator
    Recruiting
  • Hartford Hospital
    Hartford, Connecticut 06102, United States
    • Site Public Contact · Contact · 860-545-5363
    • Michael Sun · Principal investigator
    Recruiting
  • Smilow Cancer Hospital Care Center at Saint Francis
    Hartford, Connecticut 06105, United States
    Suspended
  • Hartford HealthCare - Manchester
    Manchester, Connecticut 06042, United States
    • Site Public Contact · Contact · 860-972-4700
    • Michael Sun · Principal investigator
    Recruiting
  • Midstate Medical Center
    Meriden, Connecticut 06451, United States
    • Site Public Contact · Contact · 866-662-5678
    • Michael Sun · Principal investigator
    Recruiting
  • The Hospital of Central Connecticut
    New Britain, Connecticut 06050, United States
    • Site Public Contact · Contact · 860-224-5660
    • Michael Sun · Principal investigator
    Recruiting
  • Yale University
    New Haven, Connecticut 06520, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Joseph W. Kim · Principal investigator
    Recruiting
  • Yale-New Haven Hospital North Haven Medical Center
    North Haven, Connecticut 06473, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Joseph W. Kim · Principal investigator
    Recruiting
  • Smilow Cancer Hospital Care Center at Long Ridge
    Stamford, Connecticut 06902, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Joseph W. Kim · Principal investigator
    Recruiting
  • Smilow Cancer Hospital-Torrington Care Center
    Torrington, Connecticut 06790, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Joseph W. Kim · Principal investigator
    Recruiting
  • Smilow Cancer Hospital Care Center-Trumbull
    Trumbull, Connecticut 06611, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Joseph W. Kim · Principal investigator
    Recruiting
  • Smilow Cancer Hospital-Waterbury Care Center
    Waterbury, Connecticut 06708, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Joseph W. Kim · Principal investigator
    Recruiting
  • Smilow Cancer Hospital Care Center - Waterford
    Waterford, Connecticut 06385, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Joseph W. Kim · Principal investigator
    Recruiting
  • Helen F Graham Cancer Center
    Newark, Delaware 19713, United States
    Recruiting
  • Medical Oncology Hematology Consultants PA
    Newark, Delaware 19713, United States
    Recruiting
  • MedStar Georgetown University Hospital
    Washington D.C., District of Columbia 20007, United States
    • Site Public Contact · Contact · 202-444-2223
    • Nicholas I. Simon · Principal investigator
    Recruiting
  • MedStar Washington Hospital Center
    Washington D.C., District of Columbia 20010, United States
    • Site Public Contact · Contact · 202-877-8839
    • Nicholas I. Simon · Principal investigator
    Recruiting
  • Sibley Memorial Hospital
    Washington D.C., District of Columbia 20016, United States
    • Site Public Contact · Contact · jquiver1@jhmi.edu · 202-243-2373
    • Jean H. Hoffman-Censits · Principal investigator
    Recruiting
  • George Washington University Medical Center
    Washington D.C., District of Columbia 20037, United States
    • Site Public Contact · Contact · 202-741-2210
    • Pavani Chalasani · Principal investigator
    Recruiting
  • Mount Sinai Comprehensive Cancer Center at Aventura
    Aventura, Florida 33180, United States
    • Site Public Contact · Contact · yenrique@msmc.com · 305-674-2625
    • Oleg Gligich · Principal investigator
    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Aventura
    Aventura, Florida 33180, United States
    Suspended
  • UM Sylvester Comprehensive Cancer Center at Coral Gables
    Coral Gables, Florida 33146, United States
    • Site Public Contact · Contact · 305-243-2647
    • Janaki N. Sharma · Principal investigator
    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
    Deerfield Beach, Florida 33442, United States
    • Site Public Contact · Contact · 305-243-2647
    • Janaki N. Sharma · Principal investigator
    Recruiting
  • Malcom Randall Veterans Administration Medical Center
    Gainesville, Florida 32610, United States
    • Site Public Contact · Contact · trials@cancer.ufl.edu · 352-273-8675
    • Jess DeLaune · Principal investigator
    Recruiting
  • UF Health Cancer Institute - Gainesville
    Gainesville, Florida 32610, United States
    • Site Public Contact · Contact · cancer-center@ufl.edu · 352-273-8010
    • Daniel V. Araujo · Principal investigator
    Recruiting
  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
    Hollywood, Florida 33021, United States
    • Site Public Contact · Contact · OHR@mhs.net · 954-265-1847
    • Matthew P. Salzberg · Principal investigator
    Recruiting
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224-9980, United States
    • Site Public Contact · Contact · 855-776-0015
    • Arnab Basu · Principal investigator
    Recruiting
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
    Miami, Florida 33136, United States
    • Site Public Contact · Contact · 305-243-2647
    • Janaki N. Sharma · Principal investigator
    Recruiting
  • Miami Cancer Institute
    Miami, Florida 33176, United States
    • Site Public Contact · Contact · 786-596-2000
    • Rohan Garje · Principal investigator
    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Kendall
    Miami, Florida 33176, United States
    • Site Public Contact · Contact · 305-243-2647
    • Janaki N. Sharma · Principal investigator
    Recruiting
  • Mount Sinai Medical Center
    Miami Beach, Florida 33140, United States
    Recruiting
  • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
    North Miami, Florida 33181, United States
    Recruiting
  • AdventHealth Orlando
    Orlando, Florida 32803, United States
    Recruiting

Showing the first 100 of 501 sites across 2 countries.

08

References and documents

Individual participant data

Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

No publications or documents are linked to this record.

09

Updates

4 registry updates since Sep 25, 2026
Sites
1 site added, 1 site removed. 6 sites changed recruiting status
Show site
  • Vandalia Health/CAMC Institute for Academic Medicine · Charleston, United States
Show 1 removed
  • West Virginia University Charleston Division · Charleston, United States
across 3 updates, Sep 30, 2026 – Oct 6, 2026
Show all 4 updates
  1. Oct 6, 2026
    4 sites changed recruiting status
    + 1 other change: contact details
  2. Oct 1, 2026
    1 site added, 1 site removed
    Show site
    • Vandalia Health/CAMC Institute for Academic Medicine · Charleston, United States
    Show 1 removed
    • West Virginia University Charleston Division · Charleston, United States
  3. Sep 30, 2026
    2 sites changed recruiting status
    + 1 other change: contact details
  4. Sep 29, 2026
    Minor edits only
    + 1 other change: contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05987241
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 14, 2023
Start date
Feb 2, 2024
Primary completion
Sep 2, 2030 (estimated)
Completion
Sep 2, 2030 (estimated)
Last update
Oct 7, 2026

Study contacts

Matthew D Galsky
principal investigator · Alliance for Clinical Trials in Oncology

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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