NCT03866382ClinicalTrials.gov

Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors

A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.

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Kurz gefasst

Phase 2314 Teilnehmende gesucht581 Studienzentren2 Länder

Kategorien

Onkologie70%Nephrologie und Urologie28%Immunologie und Rheumatologie1%Endokrin und metabolisch1%Geburtshilfe und Gynäkologie0%

In 1 Register registriert

ClinicalTrials.govNCT03866382Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 6 Tagen

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2019-03-07; recorded start 2019-05-13
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1548 other studies in this databaseCounted from the lead sponsor named in the record (National Cancer Institute (NCI))
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 45 conditions.
Lead sponsor type recorded as: US National Institutes of Health.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 582 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 314 participants (target), run at 581 sites, across 2 countries.

How this score is built

Enrolment24/40
314 participants (target)
Site count25/25
582 sites
Country count7/15
2 countries
Planned duration10/10
Planned over about 95 months
Sponsor scale10/10
National Cancer Institute (NCI) has led 1,534 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Zusammenfassung

This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.

PRIMARY OBJECTIVE: I. To evaluate the efficacy of cabozantinib s-malate (cabozantinib) combined with nivolumab and ipilimumab in the first or second-line (and beyond) setting for patients within each of the rare genitourinary (GU) variant histology group of interest, as measured by objective response rate (ORR). SECONDARY OBJECTIVES: I. To estimate the progression-free survival (PFS) for patients treated with cabozantinib combined with nivolumab and ipilimumab within each rare variant histology. II. To estimate the overall survival (OS) for patients treated with cabozantinib combined with nivolumab and ipilimumab within each rare variant histology. III. To estimate the clinical benefit rate (defined as complete response \[CR\] or partial response \[PR\] or stable disease \[SD\]) for patients treated with cabozantinib combined with nivolumab and ipilimumab within each rare variant histology. IV. To assess the safety of treating patients with rare variant histologies with cabozantinib combined with nivolumab and ipilimumab. V. To support tissue banking and collection of clinical follow-up data for GU tract rare histological variants. EXPLORATORY OBJECTIVE: I. To assess effects of treatment in patients with bone-only disease by bone scan. OUTLINE: Patients receive cabozantinib orally (PO) once daily (QD) on days 1-21 of cycles 1-4 and on days 1-28 of subsequent cycles. Patients also receive nivolumab intravenously (IV) over 30 minutes on day 1 and ipilimumab IV over 90 minutes on day 1 of cycles 1-4. Patients then receive nivolumab IV over 30 minutes on day 1 of subsequent cycles. Treatment repeats every 21 days for cycles 1-4 and every 28 days for subsequent cycles for 2 years in the absence of disease progression or unacceptable toxicity. Patients may undergo echocardiography during screening and undergo computed tomography (CT) or magnetic resonance imaging (MRI), bone scan and blood and urine sample collection throughout the trial and may undergo positron emission tomography (PET)/CT throughout the trial. After completion of study treatment, patients are followed up every 2 months for up to 5 years.

Erkrankungen

Bladder Adenocarcinoma
Bladder Clear Cell Adenocarcinoma
Bladder Mixed Adenocarcinoma
Bladder Neuroendocrine Carcinoma
Bladder Small Cell Neuroendocrine Carcinoma
Bladder Squamous Cell Carcinoma
Chromophobe Renal Cell Carcinoma
Collecting Duct Carcinoma
Invasive Bladder Giant Cell Urothelial Carcinoma
Invasive Bladder Lymphoepithelioma-Like Carcinoma
Invasive Bladder Nested Urothelial Carcinoma
Invasive Bladder Plasmacytoid Urothelial Carcinoma
Invasive Bladder Sarcomatoid Urothelial Carcinoma
Invasive Bladder Urothelial Carcinoma
Kidney Medullary Carcinoma
Large Cell Neuroendocrine Carcinoma
Malignant Testicular Leydig Cell Tumor
Malignant Testicular Sertoli Cell Tumor
Metastatic Bladder Carcinoma
Metastatic Bladder Clear Cell (Glycogen-Rich) Urothelial Carcinoma
Metastatic Bladder Giant Cell Urothelial Carcinoma
Metastatic Bladder Large Cell Neuroendocrine Carcinoma
Metastatic Bladder Lipid-Rich Urothelial Carcinoma
Metastatic Bladder Micropapillary Urothelial Carcinoma
Metastatic Bladder Plasmacytoid Urothelial Carcinoma
Metastatic Bladder Sarcomatoid Urothelial Carcinoma
Metastatic Bladder Small Cell Neuroendocrine Carcinoma
Metastatic Bladder Squamous Cell Carcinoma
Metastatic Chromophobe Renal Cell Carcinoma
Metastatic Kidney Medullary Carcinoma
Metastatic Malignant Genitourinary System Neoplasm
Metastatic Papillary Renal Cell Carcinoma
Metastatic Penile Carcinoma
Metastatic Prostate Small Cell Neuroendocrine Carcinoma
Metastatic Sarcomatoid Renal Cell Carcinoma
Metastatic Urethral Carcinoma
Papillary Renal Cell Carcinoma
Sarcomatoid Renal Cell Carcinoma
Stage IV Bladder Cancer AJCC v8
Stage IV Penile Cancer AJCC v8
Stage IV Renal Cell Cancer AJCC v8
Stage IV Urethral Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8
Urachal Adenocarcinoma
Urethral Clear Cell Adenocarcinoma

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

Inclusion Criteria: * Metastatic disease defined as new or progressive lesions on cross-sectional imaging or bone scan. Patients must have at least: * One measurable site of disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 * One bone lesion on bone scan (tec99 or sodium fluoride \[NaF\] PET/CT, CT or MRI) for the bone-only cohort. * Histologically confirmed diagnosis of one of the following metastatic cohorts: * Small cell/ neuroendocrine carcinoma of the bladder (Cohort A)- All urothelial carcinomas with any amount of neuroendocrine differentiation (including small cell differentiation) will be included. If the tumor is purely neuroendocrine, metastasis from another site of origin should be clinically excluded * Adenocarcinoma of the bladder, or urachal adenocarcinoma, or bladder/urethra clear cell adenocarcinoma (Cohort B) - must be pure (per World Health Organization \[WHO\] definition), (i.e. urothelial carcinoma with glandular differentiation is not considered a pure adenocarcinoma * Squamous cell carcinoma of the bladder (Cohort C) - must be pure (i.e. urothelial carcinoma with squamous differentiation is not considered a pure squamous cell carcinoma) * Plasmacytoid urothelial carcinoma (Cohort D) - Tumor should show predominantly \> or equal \~ 50% plasmacytoid histology (including all types of discohesive growth, such as tumors with signet-ring and/or rhabdoid features as well) * Any penile cancer (Cohort E) * Sarcomatoid renal cell carcinoma (Cohort F) - Tumor should be predominantly sarcomatoid \~ 50% (including rhabdoid differentiation) is also unclassified renal cell carcinomas (RCCs): all (assuming they are high grade with metastasis) malignant angiomyolipomas are allowed * Other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to (Cohort G) : Micropapillary (Tumor should show predominantly \> or equal 50% micropapillary architecture), giant cell, lipid-rich, clear cell and nested variants (Tumor should predominantly \> or equal 50% show these features), large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer (Only treatment-naïve primary small cell of prostate with any amount of small cell component allowed. Post-treatment small cell prostatic carcinomas are not allowed), Malignant testicular Sertoli or Leydig cell tumors, and papillary and chromophobe RCC * Note: Translocation positive renal cell carcinoma patients are eligible. However, AREN1721 should be considered before this trial * Sarcomatoid urothelial carcinoma (Cohort H) - Tumor should show predominantly \~ 50% sarcomatoid differentiation * Renal medullary carcinoma (Cohort I) - Per World Health Organization (WHO) definition, ideally confirmed with immunostains * Bone-only metastatic GU tumors (non-prostate) (Cohort J) - All genitourinary histologies, except prostate are eligible * Renal Collecting Duct Carcinoma (Cohort K) - Per WHO definition (medullary involvement, predominant tubular morphology, desmoplastic stromal reaction, high grade cytology, infiltrative growth pattern, and absence of other renal cell carcinoma subtype or urothelial carcinoma) * Urethra carcinoma (Cohort L) - May be of any histology but if urothelial carcinoma then must be isolated to the urethra and not have metachronous or synchronous urothelial carcinoma of the bladder * H\&E slides from diagnostic tumor tissue for retrospective central pathology review * Patients may have received up to 2 systemic anti-cancer treatments or be treatment naive. Patients with small cell carcinoma should have received a platinum-based combination regimen either as neoadjuvant, adjuvant or first-line treatment). Patients in the bone-only cohort may be urothelial carcinoma histology but must receive standard cisplatin-based chemotherapy (if cisplatin-eligible) * Age \>= 18 years * Patients must be able to swallow oral formulation of the tablets * Karnofsky performance status \>= 80% * Absolute neutrophil count (ANC) \>= 1,000/mcL * Platelet count \>= 75,000/mcL * Total bilirubin =\< 1.5 x upper limit of normal (ULN). For subjects with known Gilbert's disease or similar syndrome with slow conjugation of bilirubin, total bilirubin =\< 3.0 mg/dL * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3.0 x institutional upper limit of normal (ULN) (or =\< 5 x ULN for patients with liver metastases or Gilbert's disease) * Creatinine =\< 1.5 x upper limit of normal (ULN) OR creatinine clearance \>= 40 mL/min/1.73 m\^2 (calculated using the Chronic Kidney Disease Epidemiology \[CKD-EPI\] equation or Cockcroft-Gault formula) for patients with creatinine levels above institutional normal * Hemoglobin \>= 9 g/dL (transfusion of packed red blood cells \[PRBCs\] allowed) * Serum albumin \>= 3.2 g/dL * Lipase and amylase =\< 2.0 x ULN and no radiologic (on baseline anatomical imaging) or clinical evidence of pancreatitis * Prior treatment with MET or VEGFR inhibitors is allowed. However, prior cabozantinib will not be allowed. Also, patients that have received both prior MET or VEGF and prior PD-1/PD-L1/CTLA-4 (sequentially or in combination) are also not allowed * No prior treatment with any therapy on the PD-1/PD-L1 axis or anti- CTLA-4/CTLA-4 inhibitors with the exception of patients with "urothelial carcinoma" histology (cohorts D, H, J, L) * Human immunodeficiency virus (HIV)-positive patients are eligible if on stable dose of highly active antiretroviral therapy (HAART), no clinically significant drug-drug interactions are anticipated with the current HAART regimen, CD4 counts are greater than 350 and viral load is undetectable * Patients with rheumatoid arthritis and other rheumatologic arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication only and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies etc. are eligible but should be considered for rheumatologic evaluation for the presence of target organ involvement and potential need for systemic treatment * Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones or medications (e.g. thyroiditis managed with propylthiouracil \[PTU\] or methimazole) including physiologic oral corticosteroids are eligible * Patients who have evidence of active or acute diverticulitis, intra-abdominal abscess, and gastrointestinal (GI) obstruction, within 12 months are not eligible * Women of childbearing potential must have a negative pregnancy test =\< 7 days prior to registration * Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Post menopause is defined as amenorrhea \>= 12 consecutive months. Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason * Pregnant women may not participate in this study because with cabozantinib, nivolumab, and ipilimumab have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cabozantinib, nivolumab, and ipilimumab, breastfeeding should be discontinued if the mother is treated with these agents * The patient has received no cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 2 weeks before the first dose of study treatment * The patient has received no radiation therapy: * To the lungs and mediastinum or abdomen within 4 weeks before the first dose of study treatment, or has ongoing complications, or is healing from prior radiation therapy * To brain metastasis within 3 weeks for whole-brain radiotherapy (WBXRT), and 2 weeks for stereotactic body radiation therapy (SBRT) before the first dose of study treatment * To the abdomen within 4 weeks before the first dose of study treatment, or has ongoing complications, or is healing from prior radiation therapy * To any other site(s) within 2 weeks before the first dose of study treatment * The patient has received no radionuclide treatment within 6 weeks of the first dose of study treatment * The patient has received no prior treatment with a small molecule kinase inhibitor within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment * The patient has received no prior treatment with hormonal therapy within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment. Subjects receiving gonadotropin-releasing hormone (GnRH) agonists and antagonists are allowed to participate * The patient has not received any other type of investigational agent within 14 days before the first dose of study treatment * The patient must have recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =\< grade 1 from toxicity due to all prior therapies except alopecia, neuropathy and other non-clinically significant adverse events (AEs) defined as lab elevation with no associated symptoms or sequelae * The patient may not have active brain metastases or epidural disease. Patients with brain metastases previously treated with whole brain radiation or radiosurgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible. Neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment. Baseline brain imaging with contrast-enhanced CT or MRI scans for subjects with known brain metastases is required to confirm eligibility * No concomitant treatment with warfarin. Aspirin (up to 325 mg/day), thrombin or factor Xa inhibitors, low-dose warfarin (=\< 1 mg/day), prophylactic and therapeutic low molecular weight heparin (LMWH) are permitted * No chronic concomitant treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort) or strong CYP3A4 inhibitors * Because the lists of these agents are constantly changing, it is important to regularly consult medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product * The patient has not experienced any of the following: * Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment * Hemoptysis of \>= 0.5 teaspoon (2.5 mL) of red blood per day within 1 months before the first dose of study treatment * Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment * The patient has no tumor invading any major blood vessels * The patient has no evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib. Patients with rectal tumor masses are not eligible * The patient has no uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: * Cardiovascular disorders including: * Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening. * Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) \> 150 mm Hg systolic, or \> 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment * The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) \> 500 ms within 28 days before randomization. Note: if initial QTcF is found to be \> 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is =\< 500 ms, the subject meets eligibility in this regard * Any history of congenital long QT syndrome * Any of the following within 6 months before registration of study treatment: * Unstable angina pectoris * Clinically-significant cardiac arrhythmias (patients with atrial fibrillation are eligible) * Stroke (including transient ischemic attack \[TIA\], or other ischemic event) * Myocardial infarction * Cardiomyopathy * No significant gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including: * Any of the following that have not resolved within 28 days before the first dose of study treatment: * Active peptic ulcer disease * Acute diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or malabsorption syndrome * None of the following within 2 years before the first dose of study treatment: * Abdominal fistula or genitourinary fistula * Gastrointestinal perforation * Bowel obstruction or gastric outlet obstruction * Intra-abdominal abscess. Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 2 years before the first dose of study treatment * Disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement are not eligible * No other clinically significant disorders such as: * Severe active infection requiring IV systemic treatment within 14 days before the first dose of study treatment * Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment * History of organ or allogeneic stem cell transplant * Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment (for asymptomatic patients with an elevated thyroid-stimulating hormone \[TSH\], thyroid replacement may be initiated if clinically indicated without delaying the start of study treatment) * No history of major surgery as follows: * Major surgery within 3 months of the first dose of cabozantinib; however, if there were no wound healing complications, patients with rapidly growing aggressive cancers, may start as soon as 6 weeks if wound has completely healed post-surgery * Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications excluding core biopsies and mediport placement * Complete wound healing from prior surgery must be confirmed before the first dose of cabozantinib irrespective of the time from surgery * No history of severe hypersensitivity reaction to any monoclonal antibody * No evidence of active malignancy, requiring systemic treatment within 2 years of registration * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib, nivolumab, ipilimumab or other agents used in study * No positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. If HBV sAG is positive, subsequent ribonucleic acid (RNA) polymerase chain reaction (PCR) must be negative * No patients with 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 should be excluded because of the risk of recurrence or exacerbation of disease

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 2
Zuteilung	Nicht zutreffend
Interventionsmodell	SINGLE_GROUP
Primäres Ziel	TREATMENT
Verblindung	NONE (0)
Teilnahme	314 Teilnehmende gesucht

Sponsor und Mitwirkende

National Cancer Institute (NCI) Sponsor

Studienarme und Interventionen

Treatment (cabozantinib, nivolumab, ipilimumab)EXPERIMENTAL
Patients receive cabozantinib PO QD on days 1-21 of cycles 1-4 and on days 1-28 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 90 minutes on day 1 of cycles 1-4. Patients then receive nivolumab IV over 30 minutes on day 1 of subsequent cycles. Treatment repeats every 21 days for cycles 1-4 and every 28 days for subsequent cycles for 2 years in the absence of disease progression or unacceptable toxicity. Patients may undergo echocardiography during screening and undergo CT or MRI, bone scan and blood and urine sample collection throughout the trial and may undergo PET/CT throughout the trial.

Interventionen

Eingriff Biospecimen Collection
Undergo blood and urine sample collection
Eingriff Bone Scan
Undergo bone scan
Arzneimittel Cabozantinib S-malate
Given PO
Eingriff Computed Tomography
Undergo CT and/or PET/CT scan
Eingriff Echocardiography Test
Undergo echocardiography
Biologikum Ipilimumab
Given IV
Eingriff Magnetic Resonance Imaging
Undergo MRI
Biologikum Nivolumab
Given IV
Eingriff Positron Emission Tomography
Undergo PET/CT scan

Endpunkte

Primärer Endpunkt
Objective response rate (ORR)
An objective response is defined as a confirmed complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Will be estimated by the number of confirmed objective responses divided by the total number of evaluable patients. Confidence intervals for the true ORR will be calculated.
Zeitrahmen Up to 5 years
Sekundärer Endpunkt
Duration of response
Defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.
Zeitrahmen From time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years
Sekundärer Endpunkt
Progression-free survival (PFS)
The median its 95% confidence interval will be determined and will be summarized using the Kaplan-Meier estimator.
Zeitrahmen From start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years
Sekundärer Endpunkt
Overall survival
The median its 95% confidence interval will be determined and will be summarized using the Kaplan-Meier estimator.
Zeitrahmen Up to 5 years
Sekundärer Endpunkt
Clinical benefit rate (CBR)
A confirmed clinical benefit is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart or a confirmed stable disease at two consecutive tumor assessments at least 3 months apart. The CBR will be estimated by the number of patients with confirmed clinical benefit divided by the total number of evaluable patients. Confidence intervals for the true CBR will be calculated using exact binomial confidence intervals.
Zeitrahmen Up to 5 years
Sekundärer Endpunkt
Incidence of adverse events (AE)
Will be assessed using Common Terminology Criteria for Adverse Events version 5.0. The maximum of a particular AE will be determined for each patient. Tables will summarize the number and relative frequency of patients observing an AE as well as the number and relative frequency of patients experiencing any AE of grade 3 or greater.
Zeitrahmen Up to 5 years
Sonstiger Endpunkt
Effects of treatment in patients with bone-only disease
The bone-only tumor patients will be evaluated in an exploratory fashion (if no RECIST measurements are available). A maximum of 15 patients with bone-only disease will be enrolled and evaluated using PFS for a descriptive analysis of the effect of treatment.
Zeitrahmen Up to 5 years

Daten

Daten
Startdatum	13. Mai 2019 (tatsächlich)
Primärer Abschluss	28. Februar 2027 (geschätzt)
Abschluss	28. Februar 2027 (geschätzt)
Erstveröffentlichung	7. März 2019 (tatsächlich)
Zuletzt aktualisiert	16. September 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	August 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

219 Studienzentren rekrutieren

Puerto Rico

Puerto Rico
Einrichtung	Stadt	Bundesland oder Region	Status
Pan American Center for Oncology Trials LLC	San Juan		Aktiv, rekrutiert nicht

United States

United States
Einrichtung	Stadt	Bundesland oder Region	Status
Providence Regional Cancer System-Aberdeen	Aberdeen	Washington	Ausgesetzt
Riverwood Healthcare Center	Aitkin	Minnesota	Ausgesetzt
University Cancer Specialists - Alcoa	Alcoa	Tennessee	Aktiv, rekrutiert nicht
Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	Rekrutiert
OSF Saint Anthony's Health Center	Alton	Illinois	Ausgesetzt
McFarland Clinic - Ames	Ames	Iowa	Rekrutiert
Mary Greeley Medical Center	Ames	Iowa	Rekrutiert
Community Hospital of Anaconda	Anaconda	Montana	Rekrutiert
Anchorage Associates in Radiation Medicine	Anchorage	Alaska	Ausgesetzt
Anchorage Oncology Centre	Anchorage	Alaska	Ausgesetzt
Alaska Women's Cancer Care	Anchorage	Alaska	Ausgesetzt
Alaska Oncology and Hematology LLC	Anchorage	Alaska	Ausgesetzt
Alaska Breast Care and Surgery LLC	Anchorage	Alaska	Ausgesetzt
Anchorage Radiation Therapy Center	Anchorage	Alaska	Ausgesetzt
Providence Alaska Medical Center	Anchorage	Alaska	Ausgesetzt
Katmai Oncology Group	Anchorage	Alaska	Ausgesetzt
UI Health Care Mission Cancer and Blood - Ankeny Clinic	Ankeny	Iowa	Rekrutiert
Trinity Health Saint Joseph Mercy Hospital Ann Arbor	Ann Arbor	Michigan	Rekrutiert
Mission Hope Medical Oncology - Arroyo Grande	Arroyo Grande	California	Aktiv, rekrutiert nicht
PCR Oncology	Arroyo Grande	California	Ausgesetzt
Northwest Wisconsin Cancer Center	Ashland	Wisconsin	Ausgesetzt
Duluth Clinic Ashland	Ashland	Wisconsin	Rekrutiert
Emory University Hospital Midtown	Atlanta	Georgia	Rekrutiert
Emory Saint Joseph's Hospital	Atlanta	Georgia	Ausgesetzt
Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia	Rekrutiert
Rush-Copley Medical Center	Aurora	Illinois	Ausgesetzt
Mount Sinai Comprehensive Cancer Center at Aventura	Aventura	Florida	Aktiv, rekrutiert nicht
Saint Alphonsus Cancer Care Center-Baker City	Baker City	Oregon	Ausgesetzt
Mercy Oncology and Hematology - Clayton-Clarkson	Ballwin	Missouri	Ausgesetzt
Greater Baltimore Medical Center	Baltimore	Maryland	Ausgesetzt
CommonSpirit Saint Joseph Hospital - Bardstown	Bardstown	Kentucky	Aktiv, rekrutiert nicht
Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	Rekrutiert
Ochsner High Grove	Baton Rouge	Louisiana	Aktiv, rekrutiert nicht
Louisiana Hematology Oncology Associates LLC	Baton Rouge	Louisiana	Rekrutiert
Hematology/Oncology Clinic PLLC	Baton Rouge	Louisiana	Ausgesetzt
Indu and Raj Soin Medical Center	Beavercreek	Ohio	Ausgesetzt
Nebraska Medicine-Bellevue	Bellevue	Nebraska	Rekrutiert
Overlake Medical Center	Bellevue	Washington	Ausgesetzt
PeaceHealth Saint Joseph Medical Center	Bellingham	Washington	Ausgesetzt
Strecker Cancer Center-Belpre	Belpre	Ohio	Rekrutiert
Saint Charles Health System	Bend	Oregon	Ausgesetzt
National Institutes of Health Clinical Center	Bethesda	Maryland	Rekrutiert
Lehigh Valley Hospital - Muhlenberg	Bethlehem	Pennsylvania	Rekrutiert
University of Iowa Healthcare Cancer Services Quad Cities	Bettendorf	Iowa	Rekrutiert
Billings Clinic Cancer Center	Billings	Montana	Rekrutiert
University of Alabama at Birmingham Cancer Center	Birmingham	Alabama	Aktiv, rekrutiert nicht
Illinois CancerCare-Bloomington	Bloomington	Illinois	Ausgesetzt
Saint Elizabeth Boardman Hospital	Boardman	Ohio	Ausgesetzt
Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho	Rekrutiert

531 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

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Änderungen im Zeitverlauf

5. August 2026
Studienzentrum entfernt
1 site removed (581 total)
582581

https://xmedica.io/trials/ctgov/NCT03866382