Testing Cabozantinib With or Without Atezolizumab in Patients With Advanced Papillary Kidney Cancer, PAPMET2 Trial
Purpose
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 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 body's immune system attack the cancer 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 cancer 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 cancer cells. Combination therapy with atezolizumab and cabozantinib may shrink the cancer and allow a longer survival time in patients with metastatic renal cell carcinoma.
Conditions
- Metastatic Papillary Renal Cell Carcinoma
- Stage IV Renal Cell Cancer AJCC v8
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 magnetic resonance imaging (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, if needed, must receive a stable dose of anti-convulsant therapy - 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 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 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 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 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 for OPEN access instructions) 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
Exclusion Criteria
- 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 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) 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 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 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 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 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator 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 and bone scans throughout the trial. Patients may also undergo collection of blood samples throughout the trial. |
|
|
Experimental 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 and bone scans throughout the trial. Patients may also undergo collection of blood samples throughout the trial. |
|
Recruiting Locations
Cancer Center at Saint Joseph's
Phoenix, Arizona 85004
Phoenix, Arizona 85004
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274
Site Public Contact
501-686-8274
Kaiser Permanente-Anaheim
Anaheim, California 92806
Anaheim, California 92806
Kaiser Permanente-Baldwin Park
Baldwin Park, California 91706
Baldwin Park, California 91706
Kaiser Permanente-Bellflower
Bellflower, California 90706
Bellflower, California 90706
City of Hope Comprehensive Cancer Center
Duarte, California 91010
Duarte, California 91010
Epic Care-Dublin
Dublin, California 94568
Dublin, California 94568
Contact:
Site Public Contact
925-875-1677
Site Public Contact
925-875-1677
Epic Care Partners in Cancer Care
Emeryville, California 94608
Emeryville, California 94608
Contact:
Site Public Contact
510-629-6682
Site Public Contact
510-629-6682
Kaiser Permanente-Fontana
Fontana, California 92335
Fontana, California 92335
Kaiser Permanente - Harbor City
Harbor City, California 90710
Harbor City, California 90710
Kaiser Permanente-Irvine
Irvine, California 92618
Irvine, California 92618
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Los Angeles, California 90027
Kaiser Permanente West Los Angeles
Los Angeles, California 90034
Los Angeles, California 90034
Contra Costa Regional Medical Center
Martinez, California 94553-3156
Martinez, California 94553-3156
Contact:
Site Public Contact
925-957-5400
Site Public Contact
925-957-5400
Kaiser Permanente-Ontario
Ontario, California 91761
Ontario, California 91761
Kaiser Permanente - Panorama City
Panorama City, California 91402
Panorama City, California 91402
Kaiser Permanente-Riverside
Riverside, California 92505
Riverside, California 92505
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089
Site Public Contact
916-734-3089
Kaiser Permanente-San Diego Zion
San Diego, California 92120
San Diego, California 92120
Kaiser Permanente-San Marcos
San Marcos, California 92078
San Marcos, California 92078
Epic Care Cyberknife Center
Walnut Creek, California 94597
Walnut Creek, California 94597
Kaiser Permanente-Woodland Hills
Woodland Hills, California 91367
Woodland Hills, California 91367
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Boise, Idaho 83712
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Fruitland, Idaho 83619
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Meridian, Idaho 83642
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83686
Nampa, Idaho 83686
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
Twin Falls, Idaho 83301
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Bloomington, Illinois 61704
Illinois CancerCare-Canton
Canton, Illinois 61520
Canton, Illinois 61520
Illinois CancerCare-Carthage
Carthage, Illinois 62321
Carthage, Illinois 62321
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
Carle at The Riverfront
Danville, Illinois 61832
Danville, Illinois 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Decatur, Illinois 62526
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
DeKalb, Illinois 60115
Illinois CancerCare-Dixon
Dixon, Illinois 61021
Dixon, Illinois 61021
Contact:
Site Public Contact
815-285-7800
Site Public Contact
815-285-7800
Carle Physician Group-Effingham
Effingham, Illinois 62401
Effingham, Illinois 62401
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Illinois CancerCare-Eureka
Eureka, Illinois 61530
Eureka, Illinois 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Geneva, Illinois 60134
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois 60026
Glenview, Illinois 60026
Contact:
Site Public Contact
312-695-1102
Site Public Contact
312-695-1102
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois 60030
Grayslake, Illinois 60030
Contact:
Site Public Contact
312-695-1102
Site Public Contact
312-695-1102
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Kewanee, Illinois 61443
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
Lake Forest, Illinois 60045
Illinois CancerCare-Macomb
Macomb, Illinois 61455
Macomb, Illinois 61455
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Mattoon, Illinois 61938
Loyola University Medical Center
Maywood, Illinois 60153
Maywood, Illinois 60153
Contact:
Site Public Contact
708-226-4357
Site Public Contact
708-226-4357
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Northwestern Medicine Orland Park
Orland Park, Illinois 60462
Orland Park, Illinois 60462
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Ottawa, Illinois 61350
Illinois CancerCare-Pekin
Pekin, Illinois 61554
Pekin, Illinois 61554
Illinois CancerCare-Peoria
Peoria, Illinois 61615
Peoria, Illinois 61615
Illinois CancerCare-Peru
Peru, Illinois 61354
Peru, Illinois 61354
Illinois CancerCare-Princeton
Princeton, Illinois 61356
Princeton, Illinois 61356
Southern Illinois University School of Medicine
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Springfield Clinic
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541
Site Public Contact
800-444-7541
Memorial Medical Center
Springfield, Illinois 62781
Springfield, Illinois 62781
Carle Cancer Center
Urbana, Illinois 61801
Urbana, Illinois 61801
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Warrenville, Illinois 60555
Illinois CancerCare - Washington
Washington, Illinois 61571
Washington, Illinois 61571
Mary Greeley Medical Center
Ames, Iowa 50010
Ames, Iowa 50010
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
McFarland Clinic - Ames
Ames, Iowa 50010
Ames, Iowa 50010
McFarland Clinic - Boone
Boone, Iowa 50036
Boone, Iowa 50036
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Des Moines, Iowa 50314
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa 50501
Fort Dodge, Iowa 50501
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
McFarland Clinic - Jefferson
Jefferson, Iowa 50129
Jefferson, Iowa 50129
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
McFarland Clinic - Marshalltown
Marshalltown, Iowa 50158
Marshalltown, Iowa 50158
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas 66606
Topeka, Kansas 66606
Contact:
Site Public Contact
785-270-4939
Site Public Contact
785-270-4939
East Jefferson General Hospital
Metairie, Louisiana 70006
Metairie, Louisiana 70006
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana 70006
Metairie, Louisiana 70006
University Medical Center New Orleans
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
Touro Infirmary
New Orleans, Louisiana 70115
New Orleans, Louisiana 70115
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
Baltimore, Maryland 21287
Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
Bronson Battle Creek
Battle Creek, Michigan 49017
Battle Creek, Michigan 49017
Saint Joseph Mercy Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Saint Joseph Mercy Canton
Canton, Michigan 48188
Canton, Michigan 48188
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Canton, Michigan 48188
Caro Cancer Center
Caro, Michigan 48723
Caro, Michigan 48723
Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
Detroit, Michigan 48201
Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
Flint, Michigan 48503
Genesee Hematology Oncology PC
Flint, Michigan 48503
Flint, Michigan 48503
Genesys Hurley Cancer Institute
Flint, Michigan 48503
Flint, Michigan 48503
Hurley Medical Center
Flint, Michigan 48503
Flint, Michigan 48503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
West Michigan Cancer Center
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Ascension Borgess Cancer Center
Kalamazoo, Michigan 49009
Kalamazoo, Michigan 49009
University of Michigan Health - Sparrow Lansing
Lansing, Michigan 48912
Lansing, Michigan 48912
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Livonia, Michigan 48154
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan 48453
Marlette, Michigan 48453
Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
Muskegon, Michigan 49444
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
Norton Shores, Michigan 49444
Ascension Saint Mary's Hospital
Saginaw, Michigan 48601
Saginaw, Michigan 48601
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
Saginaw, Michigan 48604
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Ascension Saint Joseph Hospital
Tawas City, Michigan 48764
Tawas City, Michigan 48764
Munson Medical Center
Traverse City, Michigan 49684
Traverse City, Michigan 49684
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan 48661
West Branch, Michigan 48661
University of Michigan Health - West
Wyoming, Michigan 49519
Wyoming, Michigan 49519
Huron Gastroenterology PC
Ypsilanti, Michigan 48106
Ypsilanti, Michigan 48106
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Mercy Hospital
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
Fairview Southdale Hospital
Edina, Minnesota 55435
Edina, Minnesota 55435
Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Saint Louis Park, Minnesota 55416
Regions Hospital
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
United Hospital
Saint Paul, Minnesota 55102
Saint Paul, Minnesota 55102
University of Mississippi Medical Center
Jackson, Mississippi 39216
Jackson, Mississippi 39216
Contact:
Site Public Contact
601-815-6700
Site Public Contact
601-815-6700
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Hackensack University Medical Center
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Contact:
Site Public Contact
201-996-2879
Site Public Contact
201-996-2879
Duke Cancer Institute Cary
Cary, North Carolina 27518
Cary, North Carolina 27518
Contact:
Site Public Contact
919-781-7070
Site Public Contact
919-781-7070
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina 28328
Clinton, North Carolina 28328
Duke University Medical Center
Durham, North Carolina 27710
Durham, North Carolina 27710
Contact:
Site Public Contact
888-275-3853
Site Public Contact
888-275-3853
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina 27534
Goldsboro, North Carolina 27534
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina 28546
Jacksonville, North Carolina 28546
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina 28374
Pinehurst, North Carolina 28374
Duke Raleigh Hospital
Raleigh, North Carolina 27609
Raleigh, North Carolina 27609
Contact:
Site Public Contact
919-862-5400
Site Public Contact
919-862-5400
Miami Valley Hospital South
Centerville, Ohio 45459
Centerville, Ohio 45459
Dayton Blood and Cancer Center
Dayton, Ohio 45409
Dayton, Ohio 45409
Contact:
Site Public Contact
937-276-8320
Site Public Contact
937-276-8320
Miami Valley Hospital
Dayton, Ohio 45409
Dayton, Ohio 45409
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio 45415
Dayton, Ohio 45415
Miami Valley Hospital North
Dayton, Ohio 45415
Dayton, Ohio 45415
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
Franklin, Ohio 45005-1066
Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
Greenville, Ohio 45331
Contact:
Site Public Contact
937-569-7515
Site Public Contact
937-569-7515
Kettering Medical Center
Kettering, Ohio 45429
Kettering, Ohio 45429
Upper Valley Medical Center
Troy, Ohio 45373
Troy, Ohio 45373
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma 74146
Tulsa, Oklahoma 74146
Contact:
Site Public Contact
918-505-3200
Site Public Contact
918-505-3200
Providence Newberg Medical Center
Newberg, Oregon 97132
Newberg, Oregon 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon 97045
Oregon City, Oregon 97045
Providence Portland Medical Center
Portland, Oregon 97213
Portland, Oregon 97213
Providence Saint Vincent Medical Center
Portland, Oregon 97225
Portland, Oregon 97225
Oregon Health and Science University
Portland, Oregon 97239
Portland, Oregon 97239
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas 75237
Dallas, Texas 75237
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Dallas, Texas 75390
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas 76104
Fort Worth, Texas 76104
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
Richardson, Texas 75080
Farmington Health Center
Farmington, Utah 84025
Farmington, Utah 84025
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
Richmond, Virginia 23235
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
Richmond, Virginia 23298
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Eau Claire, Wisconsin 54701
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Marshfield, Wisconsin 54449
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
Minocqua, Wisconsin 54548
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
Stevens Point, Wisconsin 54482
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Weston, Wisconsin 54476
More Details
- NCT ID
- NCT05411081
- Status
- Recruiting
- Sponsor
- National Cancer Institute (NCI)
Detailed Description
PRIMARY OBJECTIVE: I. To compare progression-free survival in participants with metastatic papillary renal cell carcinoma (mPRCC) randomized to cabozantinib S-malate (cabozantinib) 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) and bone scans throughout the trial. Patients may also undergo collection of blood samples 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 and bone scans throughout the trial. Patients may also undergo collection of blood samples 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.