進行乳頭状腎がん患者におけるアテゾリズマブ併用または非併用のカボザンチニブの試験、PAPMET2 試験
進行乳頭状腎細胞癌（PAPMET2）患者におけるアテゾリズマブ（NSC #783608）の有無にかかわらず、カボザンチニブ（NSC #761968）の第II相ランダム化試験
This phase II trial compares the effect of atezolizumab in combination with usual treatment with cabozantinib to cabozantinib alone in patients with papillary renal cell carcinoma that has spread from where it first started (primary site) to other places in the body (metastatic). Papillary renal cell carcinoma (PRCC) is a type of kidney cancer that forms in the lining of the tiny tubes in the kidney that return filtered substances that the body needs back to the blood and remove extra fluid and waste as urine. Most papillary tumors look like long, thin finger-like growths under a microscope. It is also called papillary kidney cancer or PRCC. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the tumor and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply and may also prevent the growth of new blood vessels that tumors need to grow. By these actions it may help slow or stop the spread of tumor cells. Combination therapy with atezolizumab and cabozantinib may shrink the tumor and allow a longer survival time in patients with metastatic renal cell carcinoma.
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVE:
I. To compare progression-free survival in participants with metastatic papillary renal cell carcinoma (mPRCC) randomized to cabozantinib (cabozantinib S-malate) with atezolizumab versus cabozantinib alone.
SECONDARY OBJECTIVES:
I. To compare overall survival in participants with mPRCC randomized to cabozantinib with atezolizumab versus cabozantinib alone.
II. To compare Response Evaluation Criteria in Solid Tumors (RECIST) objective response rate (confirmed and unconfirmed, complete and partial response) in participants with mPRCC randomized to cabozantinib with atezolizumab versus cabozantinib alone.
III. To evaluate the quantitative and qualitive adverse events observed in each treatment arm.
BANKING OBJECTIVE:
I. To bank biospecimens for future correlative studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive cabozantinib S-malate orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) and blood and urine sample collection throughout the trial. Patients may also undergo bone scan throughout the trial.
ARM II: Patients receive cabozantinib S-malate PO QD on days 1-21 and atezolizumab intravenously (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI and blood and urine sample collection throughout the trial. Patients may also undergo bone scan throughout the trial.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for up to 5 years.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Arizona
-
Gilbert、Arizona、アメリカ、85234
- Banner MD Anderson Cancer Center
-
Phoenix、Arizona、アメリカ、85004
- Cancer Center at Saint Joseph's
-
-
Arkansas
-
Little Rock、Arkansas、アメリカ、72205
- University of Arkansas for Medical Sciences
-
-
California
-
Anaheim、California、アメリカ、92806
- Kaiser Permanente-Anaheim
-
Baldwin Park、California、アメリカ、91706
- Kaiser Permanente-Baldwin Park
-
Bellflower、California、アメリカ、90706
- Kaiser Permanente-Bellflower
-
Duarte、California、アメリカ、91010
- City of Hope Comprehensive Cancer Center
-
Dublin、California、アメリカ、94568
- Epic Care-Dublin
-
Emeryville、California、アメリカ、94608
- Epic Care Partners in Cancer Care
-
Fontana、California、アメリカ、92335
- Kaiser Permanente-Fontana
-
Harbor City、California、アメリカ、90710
- Kaiser Permanente South Bay
-
Irvine、California、アメリカ、92618
- Kaiser Permanente-Irvine
-
Los Angeles、California、アメリカ、90027
- Kaiser Permanente Los Angeles Medical Center
-
Los Angeles、California、アメリカ、90034
- Kaiser Permanente West Los Angeles
-
Martinez、California、アメリカ、94553-3156
- Contra Costa Regional Medical Center
-
Ontario、California、アメリカ、91761
- Kaiser Permanente-Ontario
-
Panorama City、California、アメリカ、91402
- Kaiser Permanente - Panorama City
-
Riverside、California、アメリカ、92505
- Kaiser Permanente-Riverside
-
Sacramento、California、アメリカ、95817
- University of California Davis Comprehensive Cancer Center
-
San Diego、California、アメリカ、92120
- Kaiser Permanente-San Diego Zion
-
San Marcos、California、アメリカ、92078
- Kaiser Permanente-San Marcos
-
Walnut Creek、California、アメリカ、94597
- Epic Care Cyberknife Center
-
Woodland Hills、California、アメリカ、91367
- Kaiser Permanente-Woodland Hills
-
-
District of Columbia
-
Washington D.C.、District of Columbia、アメリカ、20007
- MedStar Georgetown University Hospital
-
-
Idaho
-
Boise、Idaho、アメリカ、83706
- Saint Alphonsus Cancer Care Center-Boise
-
Boise、Idaho、アメリカ、83712
- Saint Luke's Cancer Institute - Boise
-
Caldwell、Idaho、アメリカ、83605
- Saint Alphonsus Cancer Care Center-Caldwell
-
Coeur d'Alene、Idaho、アメリカ、83814
- Kootenai Health - Coeur d'Alene
-
Fruitland、Idaho、アメリカ、83619
- Saint Luke's Cancer Institute - Fruitland
-
Meridian、Idaho、アメリカ、83642
- Saint Luke's Cancer Institute - Meridian
-
Nampa、Idaho、アメリカ、83687
- Saint Alphonsus Cancer Care Center-Nampa
-
Nampa、Idaho、アメリカ、83687
- Saint Luke's Cancer Institute - Nampa
-
Post Falls、Idaho、アメリカ、83854
- Kootenai Clinic Cancer Services - Post Falls
-
Sandpoint、Idaho、アメリカ、83864
- Kootenai Clinic Cancer Services - Sandpoint
-
Twin Falls、Idaho、アメリカ、83301
- Saint Luke's Cancer Institute - Twin Falls
-
-
Illinois
-
Bloomington、Illinois、アメリカ、61704
- Illinois CancerCare-Bloomington
-
Canton、Illinois、アメリカ、61520
- Illinois CancerCare-Canton
-
Carthage、Illinois、アメリカ、62321
- Illinois CancerCare-Carthage
-
Chicago、Illinois、アメリカ、60611
- Northwestern University
-
Danville、Illinois、アメリカ、61832
- Carle at The Riverfront
-
DeKalb、Illinois、アメリカ、60115
- Northwestern Medicine Cancer Center Kishwaukee
-
Decatur、Illinois、アメリカ、62526
- Decatur Memorial Hospital
-
Decatur、Illinois、アメリカ、62526
- Cancer Care Specialists of Illinois - Decatur
-
Dixon、Illinois、アメリカ、61021
- Illinois CancerCare-Dixon
-
Effingham、Illinois、アメリカ、62401
- Crossroads Cancer Center
-
Effingham、Illinois、アメリカ、62401
- Carle Physician Group-Effingham
-
Eureka、Illinois、アメリカ、61530
- Illinois CancerCare-Eureka
-
Galesburg、Illinois、アメリカ、61401
- Illinois CancerCare-Galesburg
-
Geneva、Illinois、アメリカ、60134
- Northwestern Medicine Cancer Center Delnor
-
Glenview、Illinois、アメリカ、60026
- Northwestern Medicine Glenview Outpatient Center
-
Grayslake、Illinois、アメリカ、60030
- Northwestern Medicine Grayslake Outpatient Center
-
Kewanee、Illinois、アメリカ、61443
- Illinois CancerCare-Kewanee Clinic
-
Lake Forest、Illinois、アメリカ、60045
- Northwestern Medicine Lake Forest Hospital
-
Macomb、Illinois、アメリカ、61455
- Illinois CancerCare-Macomb
-
Mattoon、Illinois、アメリカ、61938
- Carle Physician Group-Mattoon/Charleston
-
Maywood、Illinois、アメリカ、60153
- Loyola University Medical Center
-
O'Fallon、Illinois、アメリカ、62269
- Cancer Care Center of O'Fallon
-
Orland Park、Illinois、アメリカ、60462
- Northwestern Medicine Orland Park
-
Ottawa、Illinois、アメリカ、61350
- Illinois CancerCare-Ottawa Clinic
-
Pekin、Illinois、アメリカ、61554
- Illinois CancerCare-Pekin
-
Peoria、Illinois、アメリカ、61615
- Illinois CancerCare-Peoria
-
Peru、Illinois、アメリカ、61354
- Illinois CancerCare-Peru
-
Princeton、Illinois、アメリカ、61356
- Illinois CancerCare-Princeton
-
Rockford、Illinois、アメリカ、61114
- UW Health Carbone Cancer Center Rockford
-
Shiloh、Illinois、アメリカ、62269
- Memorial Hospital East
-
Springfield、Illinois、アメリカ、62702
- Southern Illinois University School of Medicine
-
Springfield、Illinois、アメリカ、62702
- Springfield Clinic
-
Springfield、Illinois、アメリカ、62781
- Springfield Memorial Hospital
-
Urbana、Illinois、アメリカ、61801
- Carle Cancer Center
-
Warrenville、Illinois、アメリカ、60555
- Northwestern Medicine Cancer Center Warrenville
-
Washington、Illinois、アメリカ、61571
- Illinois CancerCare - Washington
-
-
Iowa
-
Ames、Iowa、アメリカ、50010
- Mary Greeley Medical Center
-
Ames、Iowa、アメリカ、50010
- McFarland Clinic - Ames
-
Ankeny、Iowa、アメリカ、50023
- UI Health Care Mission Cancer and Blood - Ankeny Clinic
-
Boone、Iowa、アメリカ、50036
- McFarland Clinic - Boone
-
Clive、Iowa、アメリカ、50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
-
Des Moines、Iowa、アメリカ、50314
- Mercy Medical Center - Des Moines
-
Des Moines、Iowa、アメリカ、50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
-
Des Moines、Iowa、アメリカ、50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
-
Fort Dodge、Iowa、アメリカ、50501
- McFarland Clinic - Trinity Cancer Center
-
Jefferson、Iowa、アメリカ、50129
- McFarland Clinic - Jefferson
-
Marshalltown、Iowa、アメリカ、50158
- McFarland Clinic - Marshalltown
-
Waukee、Iowa、アメリカ、50263
- UI Health Care Mission Cancer and Blood - Waukee Clinic
-
-
Kansas
-
Topeka、Kansas、アメリカ、66606
- Cotton O'Neil Cancer Center / Stormont Vail Health
-
-
Louisiana
-
Metairie、Louisiana、アメリカ、70006
- East Jefferson General Hospital
-
Metairie、Louisiana、アメリカ、70006
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
-
Metairie、Louisiana、アメリカ、70002
- Mary Bird Perkins Cancer Center - Metairie
-
New Orleans、Louisiana、アメリカ、70112
- University Medical Center New Orleans
-
New Orleans、Louisiana、アメリカ、70115
- Touro Infirmary
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
-
Michigan
-
Ann Arbor、Michigan、アメリカ、48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
-
Battle Creek、Michigan、アメリカ、49017
- Bronson Battle Creek
-
Brighton、Michigan、アメリカ、48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
-
Brighton、Michigan、アメリカ、48114
- Trinity Health Medical Center - Brighton
-
Canton、Michigan、アメリカ、48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
-
Canton、Michigan、アメリカ、48188
- Trinity Health Medical Center - Canton
-
Caro、Michigan、アメリカ、48723
- Caro Cancer Center
-
Chelsea、Michigan、アメリカ、48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
-
Chelsea、Michigan、アメリカ、48118
- Chelsea Hospital
-
Detroit、Michigan、アメリカ、48201
- Wayne State University/Karmanos Cancer Institute
-
Farmington Hills、Michigan、アメリカ、48334
- Weisberg Cancer Treatment Center
-
Flint、Michigan、アメリカ、48503
- Hurley Medical Center
-
Flint、Michigan、アメリカ、48503
- Genesee Hematology Oncology PC
-
Flint、Michigan、アメリカ、48503
- Genesys Hurley Cancer Institute
-
Flint、Michigan、アメリカ、48503
- Cancer Hematology Centers - Flint
-
Grand Rapids、Michigan、アメリカ、49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Kalamazoo、Michigan、アメリカ、49007
- West Michigan Cancer Center
-
Kalamazoo、Michigan、アメリカ、49007
- Bronson Methodist Hospital
-
Kalamazoo、Michigan、アメリカ、49009
- Beacon Kalamazoo Cancer Center
-
Lansing、Michigan、アメリカ、48912
- University of Michigan Health - Sparrow Lansing
-
Livonia、Michigan、アメリカ、48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Marlette、Michigan、アメリカ、48453
- Saint Mary's Oncology/Hematology Associates of Marlette
-
Muskegon、Michigan、アメリカ、49444
- Trinity Health Muskegon Hospital
-
Niles、Michigan、アメリカ、49120
- Corewell Health Lakeland Hospitals - Niles Hospital
-
Norton Shores、Michigan、アメリカ、49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
-
Pontiac、Michigan、アメリカ、48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Saginaw、Michigan、アメリカ、48604
- Oncology Hematology Associates of Saginaw Valley PC
-
Saginaw、Michigan、アメリカ、48601
- MyMichigan Medical Center Saginaw
-
Saint Joseph、Michigan、アメリカ、49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Tawas City、Michigan、アメリカ、48764
- MyMichigan Medical Center Tawas
-
Traverse City、Michigan、アメリカ、49684
- Munson Medical Center
-
West Branch、Michigan、アメリカ、48661
- Saint Mary's Oncology/Hematology Associates of West Branch
-
Wyoming、Michigan、アメリカ、49519
- University of Michigan Health - West
-
Ypsilanti、Michigan、アメリカ、48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
-
Ypsilanti、Michigan、アメリカ、48106
- Huron Gastroenterology PC
-
-
Minnesota
-
Coon Rapids、Minnesota、アメリカ、55433
- Mercy Hospital
-
Edina、Minnesota、アメリカ、55435
- Fairview Southdale Hospital
-
Maplewood、Minnesota、アメリカ、55109
- Saint John's Hospital - Healtheast
-
Minneapolis、Minnesota、アメリカ、55407
- Abbott-Northwestern Hospital
-
Saint Louis Park、Minnesota、アメリカ、55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Paul、Minnesota、アメリカ、55101
- Regions Hospital
-
Saint Paul、Minnesota、アメリカ、55102
- United Hospital
-
-
Mississippi
-
Jackson、Mississippi、アメリカ、39216
- University of Mississippi Medical Center
-
-
Missouri
-
Cape Girardeau、Missouri、アメリカ、63703
- Saint Francis Medical Center
-
City of Saint Peters、Missouri、アメリカ、63376
- Siteman Cancer Center at Saint Peters Hospital
-
Creve Coeur、Missouri、アメリカ、63141
- Siteman Cancer Center at West County Hospital
-
Farmington、Missouri、アメリカ、63640
- Parkland Health Center - Farmington
-
Sainte Genevieve、Missouri、アメリカ、63670
- Sainte Genevieve County Memorial Hospital
-
St Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
-
St Louis、Missouri、アメリカ、63129
- Siteman Cancer Center-South County
-
St Louis、Missouri、アメリカ、63136
- Siteman Cancer Center at Christian Hospital
-
St Louis、Missouri、アメリカ、63131
- Missouri Baptist Medical Center
-
St Louis、Missouri、アメリカ、63141
- Mercy Hospital Saint Louis
-
St Louis、Missouri、アメリカ、63128
- Mercy Hospital South
-
Sullivan、Missouri、アメリカ、63080
- Missouri Baptist Sullivan Hospital
-
-
Montana
-
Anaconda、Montana、アメリカ、59711
- Community Hospital of Anaconda
-
Billings、Montana、アメリカ、59101
- Billings Clinic Cancer Center
-
Billings、Montana、アメリカ、59102
- Saint Vincent Frontier Cancer Center
-
Bozeman、Montana、アメリカ、59715
- Bozeman Health Deaconess Hospital
-
Great Falls、Montana、アメリカ、59405
- Benefis Sletten Cancer Institute
-
Kalispell、Montana、アメリカ、59901
- Logan Health Medical Center
-
Missoula、Montana、アメリカ、59804
- Community Medical Center
-
-
Nevada
-
Las Vegas、Nevada、アメリカ、89102
- OptumCare Cancer Care at Charleston
-
Las Vegas、Nevada、アメリカ、89183
- OptumCare Cancer Care at Fort Apache
-
-
New Jersey
-
Hackensack、New Jersey、アメリカ、07601
- Hackensack University Medical Center
-
-
North Carolina
-
Cary、North Carolina、アメリカ、27518
- Duke Cancer Center Cary
-
Clinton、North Carolina、アメリカ、28328
- Southeastern Medical Oncology Center-Clinton
-
Durham、North Carolina、アメリカ、27710
- Duke University Medical Center
-
Goldsboro、North Carolina、アメリカ、27534
- Southeastern Medical Oncology Center-Goldsboro
-
Jacksonville、North Carolina、アメリカ、28546
- Southeastern Medical Oncology Center-Jacksonville
-
Pinehurst、North Carolina、アメリカ、28374
- FirstHealth of the Carolinas-Moore Regional Hospital
-
Raleigh、North Carolina、アメリカ、27609
- Duke Cancer Center Raleigh
-
-
Ohio
-
Avon、Ohio、アメリカ、44011
- UH Seidman Cancer Center at UH Avon Health Center
-
Beachwood、Ohio、アメリカ、44122
- UHHS-Chagrin Highlands Medical Center
-
Centerville、Ohio、アメリカ、45459
- Miami Valley Hospital South
-
Cleveland、Ohio、アメリカ、44106
- Case Western Reserve University
-
Dayton、Ohio、アメリカ、45409
- Miami Valley Hospital
-
Dayton、Ohio、アメリカ、45415
- Miami Valley Hospital North
-
Dayton、Ohio、アメリカ、45415
- Dayton Physician LLC - Englewood
-
Dayton、Ohio、アメリカ、45409
- Premier Blood and Cancer Center
-
Franklin、Ohio、アメリカ、45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Greenville、Ohio、アメリカ、45331
- Miami Valley Cancer Care and Infusion
-
Kettering、Ohio、アメリカ、45429
- Kettering Medical Center
-
Troy、Ohio、アメリカ、45373
- Upper Valley Medical Center
-
-
Oklahoma
-
Oklahoma City、Oklahoma、アメリカ、73104
- University of Oklahoma Health Sciences Center
-
Tulsa、Oklahoma、アメリカ、74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
-
-
Oregon
-
Newberg、Oregon、アメリカ、97132
- Providence Newberg Medical Center
-
Ontario、Oregon、アメリカ、97914
- Saint Alphonsus Cancer Care Center-Ontario
-
Oregon City、Oregon、アメリカ、97045
- Providence Willamette Falls Medical Center
-
Portland、Oregon、アメリカ、97239
- Oregon Health and Science University
-
Portland、Oregon、アメリカ、97213
- Providence Portland Medical Center
-
Portland、Oregon、アメリカ、97225
- Providence Saint Vincent Medical Center
-
-
Texas
-
Dallas、Texas、アメリカ、75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Dallas、Texas、アメリカ、75237
- UT Southwestern Simmons Cancer Center - RedBird
-
Fort Worth、Texas、アメリカ、76104
- UT Southwestern/Simmons Cancer Center-Fort Worth
-
Richardson、Texas、アメリカ、75080
- UT Southwestern Clinical Center at Richardson/Plano
-
San Antonio、Texas、アメリカ、78229
- University of Texas Health Science Center at San Antonio
-
-
Utah
-
Farmington、Utah、アメリカ、84025
- Farmington Health Center
-
Salt Lake City、Utah、アメリカ、84112
- Huntsman Cancer Institute/University of Utah
-
-
Virginia
-
Richmond、Virginia、アメリカ、23235
- VCU Massey Cancer Center at Stony Point
-
Richmond、Virginia、アメリカ、23298
- VCU Massey Comprehensive Cancer Center
-
-
West Virginia
-
Charleston、West Virginia、アメリカ、25304
- Vandalia Health/CAMC Institute for Academic Medicine
-
-
Wisconsin
-
Eau Claire、Wisconsin、アメリカ、54701
- Marshfield Medical Center-EC Cancer Center
-
Marshfield、Wisconsin、アメリカ、54449
- Marshfield Medical Center-Marshfield
-
Minocqua、Wisconsin、アメリカ、54548
- Marshfield Medical Center - Minocqua
-
Rice Lake、Wisconsin、アメリカ、54868
- Marshfield Medical Center-Rice Lake
-
Stevens Point、Wisconsin、アメリカ、54482
- Marshfield Medical Center-River Region at Stevens Point
-
Weston、Wisconsin、アメリカ、54476
- Marshfield Medical Center - Weston
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
-
Participants must have a histologically confirmed diagnosis of metastatic papillary renal cell carcinoma (PRCC), either type 1 or type 2. (NOTE: A designation of type 1 or type 2 should be made by the local pathologist if possible but is not required). Mixed histologies which contain type 1 or type 2 along with any other RCC histology/histologies will be allowed provided that they contain a papillary component
-
Participants must have measurable disease per RECIST 1.1 criteria. All measurable lesions must be assessed by CT or MRI within 28 days prior to registration. All non-measurable lesions must be assessed by CT or MRI, or nuclear medicine bone scan within 42 days prior to registration. The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. If there is clinical suspicion for bone metastases at the time of enrollment (at the discretion of the investigator), bone scan must be performed at baseline (within 42 days prior to registration)
-
Participants with new or progressive brain metastases (active brain metastases) must not require immediate central nervous system (CNS) specific treatment at the time of study registration or anticipated during the first cycle of therapy. Patients with leptomeningeal disease are excluded from enrolling
-
Participants with measurable disease, per RECIST version (v)1.1, must be present outside the CNS
-
Participants must have no history of intracranial hemorrhage or spinal cord hemorrhage
-
Participants must not have undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment
-
Participants must not have ongoing requirements for corticosteroids as therapy for CNS disease
-
Participants, if needed, must receive a stable dose of anti-convulsant therapy
-
Participants must not have cavitating pulmonary lesions
-
Participants must not have uncontrolled pleural effusions, pericardial effusions, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Participants with indwelling catheters (e.g., PleurX [registered trademark]) are allowed
-
Participants must not have tumor invading the gastrointestinal (GI) tract or evidence of endotracheal or endobronchial tumor within 28 days prior to registration
-
Participants must not have evidence of tumor invading or encasing any major blood vessels
-
Participants must not have had major surgery within 28 days prior to registration, and participants must have recovered from any adverse effects of surgery
-
Participants must not have had prior treatment with cabozantinib for any reason
-
Participants must not have had prior treatment or adjuvant therapy with PD-1/PD-L1 checkpoint inhibitors for any reason within the past 6 months
-
Participants must not have received more than one prior systemic therapy for advanced or metastatic renal cell carcinoma with the exception of another VEGF inhibitor Food and Drug Administration (FDA)-approved for advanced RCC (i.e., pazopanib, bevacizumab, sorafenib or axitinib). If a participant develops metastatic disease within six months of discontinuation of adjuvant therapy, this will constitute one prior systemic therapy for advanced or metastatic RCC. If a patient develops metastatic disease and more than six months has elapsed since discontinuation of adjuvant therapy, this will not constitute prior systemic therapy for advanced or metastatic RCC
-
Participants must not take within 14 days prior to registration, nor plan to take while on protocol treatment, any strong CYP3A4 inhibitors (e.g. boceprevir, cobicistat, danoprevir, elvitegravir/RIT, fluvoxamine, indinavir, itraconazole, ketoconazole, lopinavir/RIT, nefazodone, nelfinavir, posaconazole, ritonavir, telaprevir, telithromycin, tipranavir/RIT, or voriconazole,); Please refer to https://drug-interactions.medicine.iu.edu/MainTable.aspx for the updated CYP3A4 inhibitors or inducers
-
Participants must not take within 14 days prior to registration, nor plan to take while on protocol treatment, any strong CYP3A4 inducers (e.g. avasimibe, phenytoin, rifampin, rifabutin); Please refer to https://drug-interactions.medicine.iu.edu/MainTable.aspx for the updated CYP3A4 inhibitors or inducers
-
Participants must complete all prior radiation therapy at least 14 days prior to registration. Participants must have recovered to =< grade 1 from all associated toxicities at the time of registration unless the toxicity is determined to be not clinically significant by the registering investigator
-
Participants must not be receiving or planning to receive any other investigational agents at time of registration
-
Participants must not have been diagnosed with a clinically significant autoimmune disease, exceptions such as diabetes, eczema, and vitiligo are allowed. Other non-clinically significant autoimmune diseases are allowed if approved by the registering investigator
-
Participants must not be on steroid doses > 10 mg prednisone equivalent. Replacement steroid doses for adrenal insufficiency will be allowed. Also, short duration steroid therapy to prevent allergic reactions are acceptable (e.g. prior to CT imaging)
-
Participants must be >= 18 years of age
-
Participants must have a complete physical examination and medical history within 28 days prior to registration
-
Participants must have a Zubrod performance status of 0-2
-
White blood count (WBC) >= 2 x 10^3/uL (within 28 days prior to registration)
-
Absolute neutrophil count (ANC) >= 1.5 x 10^3/uL (within 28 days prior to registration)
-
Platelet count >= 100 x 10^3/uL (within 28 days prior to registration)
-
Lymphocyte count >= 0.5 x 10^3/uL (within 28 days prior to registration)
-
Hemoglobin (>= 9 g/dL) (within 28 days prior to registration). Participants may be transfused to meet this criterion
-
Total serum bilirubin =< 1.5 x the institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration). Participants with history of Gilbert's disease must have total bilirubin =< 5 x institutional ULN
-
Aspartate aminotransferase (AST) must be =< 3 x the institutional ULN unless the liver is involved with the tumor, in which case serum transaminase (SGOT) must be =< 5 x the institutional ULN (within 28 days prior to registration)
-
Alanine aminotransferase (ALT), must be =< 3 x the institutional ULN unless the liver is involved with the tumor, in which case serum transaminase (SGPT) must be =< 5 x the institutional ULN (within 28 days prior to registration)
-
Participants must have serum creatinine =< 2 x the institutional ULN OR creatinine clearance (either measured or calculated) > 30 mL/min and obtained within 28 days prior to registration
-
Participants must not have any clinical evidence of congestive heart failure (CHF) (specifically, New York Heart Association [NYHA] class III [moderate] or class IV [severe]) at the time of registration
-
Participants must not have known history of congenital long QT syndrome and must not have experienced unstable angina pectoris, clinically significant cardiac arrhythmias, or stroke (transient ischemic attack [TIA] or other ischemic event) within 90 days prior to registration
-
Participants must not have experienced myocardial infarction or thromboembolic event requiring anticoagulation within 90 days of registration, unless clinically stable with ongoing medical management
-
Participants must have urine protein < 3+ within 28 days prior to registration. If urine protein is 3+ or greater, then urine protein by 24-hour collection must show less than 3 grams of protein
-
Participants must have documented blood pressure of systolic blood pressure (SBP) < 150 mm Hg or diastolic blood pressure (DBP) < 100 mm Hg within 14 days prior to registration
-
Participants with known human immunodeficiency virus (HIV) must be on effective anti-retroviral therapy at registration and have undetectable viral load within 6 months of registration
-
Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy within 6 months prior to registration, if indicated
-
Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load within 6 months prior to registration
-
Participants must be able to take oral medications (i.e., swallow pills whole). Participants must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures that could in the opinion of the treating investigator affect absorption, or active peptic ulcer disease. Participants with intractable nausea or vomiting are not eligible
-
Participants must not have had any clinically-significant GI bleeding within 3 months prior to registration and participants must not have a GI disorder which (at the discretion of the investigator) bears a high risk of perforation or fistula (e.g. Crohn's disease)
-
Participants must not have had hemoptysis of >= (2.5 mL) of red blood, and do not demonstrate any other signs indicative of pulmonary hemorrhage within 3 months prior registration
-
Participants 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
-
Participants must not be pregnant or nursing, due to VEGF therapy being toxic to embryogenesis. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
-
Participants must not be on warfarin, at therapeutic doses. Low dose aspirin for cardio-protection (per local applicable guidelines) and low molecular weight heparin (LMWH) are allowed
-
Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
-
Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- NOTE: For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
-
As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Arm I (cabozantinib S-malate)
Patients receive cabozantinib S-malate PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI and blood and urine sample collection throughout the trial. Patients may also undergo bone scan throughout the trial. |
Undergo MRI
他の名前：
Given PO
他の名前：
Undergo collection of blood and urine samples
他の名前：
Undergo CT scans
他の名前：
Undergo bone scans
他の名前：
|
|
実験的：Arm II (cabozantinib S-malate, atezolizumab)
Patients receive cabozantinib S-malate PO QD on days 1-21 and atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI and blood and urine sample collection throughout the trial. Patients may also undergo bone scan throughout the trial. |
Undergo MRI
他の名前：
Given PO
他の名前：
Given IV
他の名前：
Undergo collection of blood and urine samples
他の名前：
Undergo CT scans
他の名前：
Undergo bone scans
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression free survival
時間枠：From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 5 years
|
A proportional hazards model will be used to evaluate the experimental arm compared to the control arm, adjusted for the stratification factors as covariates in the model. A one-sided p-value =< 0.05 will indicate statistical significance. Participants last known to be alive and progression free are censored at date of last contact. |
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 5 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall survival
時間枠：From date of registration to date of death due to any cause, assessed up to 5 years
|
Will be estimated by the Kaplan-Meier method, and a stratified log-rank test will be used to compare the treatment arms. Participants last known to be alive are censored at date of last contact. |
From date of registration to date of death due to any cause, assessed up to 5 years
|
|
Objective response rate
時間枠：Up to 5 years
|
Will be estimated to within +/- 11% (95% confidence interval). |
Up to 5 years
|
|
Incidence of adverse events
時間枠：Day 1 of each cycle
|
Will be estimated to within +/- 11% (95% confidence interval). Will utilize the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 for toxicity and serious adverse event reporting. |
Day 1 of each cycle
|
協力者と研究者
捜査官
- 主任研究者：Benjamin L Maughan、SWOG Cancer Research Network
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NCI-2022-04668
- U10CA180888 (米国 NIH グラント/契約)
- NCI-2022-04668 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- S2200 (その他の識別子：CTEP)
- S2200 (その他の識別子：SWOG)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。