Testing Cabozantinib With or Without Atezolizumab in Patients With Advanced Papillary Kidney Cancer, PAPMET2 Trial
A Phase II Randomized Trial of Cabozantinib (NSC #761968) With or Without Atezolizumab (NSC #783608) in Patients With Advanced Papillary Renal Cell Carcinoma (PAPMET2)
3 other identifiers
interventional
200
1 country
199
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2023
Typical duration for phase_2
199 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2022
CompletedFirst Posted
Study publicly available on registry
June 9, 2022
CompletedStudy Start
First participant enrolled
March 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
May 1, 2026
March 1, 2026
4.3 years
June 7, 2022
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival
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
Secondary Outcomes (3)
Overall survival
From date of registration to date of death due to any cause, assessed up to 5 years
Objective response rate
Up to 5 years
Incidence of adverse events
Day 1 of each cycle
Study Arms (2)
Arm I (cabozantinib S-malate)
ACTIVE COMPARATORPatients 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.
Arm II (cabozantinib S-malate, atezolizumab)
EXPERIMENTALPatients 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.
Interventions
Undergo collection of blood and urine samples
Given PO
Given IV
Undergo bone scans
Undergo CT scans
Undergo MRI
Eligibility Criteria
You may qualify if:
- 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
- +37 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (199)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Kaiser Permanente-Anaheim
Anaheim, California, 92806, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706, United States
Kaiser Permanente-Bellflower
Bellflower, California, 90706, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Epic Care-Dublin
Dublin, California, 94568, United States
Epic Care Partners in Cancer Care
Emeryville, California, 94608, United States
Kaiser Permanente-Fontana
Fontana, California, 92335, United States
Kaiser Permanente South Bay
Harbor City, California, 90710, United States
Kaiser Permanente-Irvine
Irvine, California, 92618, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Kaiser Permanente West Los Angeles
Los Angeles, California, 90034, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
Kaiser Permanente-Ontario
Ontario, California, 91761, United States
Kaiser Permanente - Panorama City
Panorama City, California, 91402, United States
Kaiser Permanente-Riverside
Riverside, California, 92505, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Kaiser Permanente-San Diego Zion
San Diego, California, 92120, United States
Kaiser Permanente-San Marcos
San Marcos, California, 92078, United States
Epic Care Cyberknife Center
Walnut Creek, California, 94597, United States
Kaiser Permanente-Woodland Hills
Woodland Hills, California, 91367, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Northwestern University
Chicago, Illinois, 60611, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026, United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
UW Health Carbone Cancer Center Rockford
Rockford, Illinois, 61114, United States
Memorial Hospital East
Shiloh, Illinois, 62269, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023, United States
McFarland Clinic - Boone
Boone, Iowa, 50036, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263, United States
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, 66606, United States
Mary Bird Perkins Cancer Center - Metairie
Metairie, Louisiana, 70002, United States
East Jefferson General Hospital
Metairie, Louisiana, 70006, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, 70006, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Touro Infirmary
New Orleans, Louisiana, 70115, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188, United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188, United States
Caro Cancer Center
Caro, Michigan, 48723, United States
Chelsea Hospital
Chelsea, Michigan, 48118, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Cancer Hematology Centers - Flint
Flint, Michigan, 48503, United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, 49009, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, 48453, United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444, United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120, United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, 48764, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
Huron Gastroenterology PC
Ypsilanti, Michigan, 48106, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127, United States
Community Hospital of Anaconda
Anaconda, Montana, 59711, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Logan Health Medical Center
Kalispell, Montana, 59901, United States
Community Medical Center
Missoula, Montana, 59804, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89183, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Duke Cancer Center Cary
Cary, North Carolina, 27518, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
Duke Cancer Center Raleigh
Raleigh, North Carolina, 27609, United States
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Premier Blood and Cancer Center
Dayton, Ohio, 45409, United States
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104, United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, 75080, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Farmington Health Center
Farmington, Utah, 84025, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
West Virginia University Charleston Division
Charleston, West Virginia, 25304, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin L Maughan
SWOG Cancer Research Network
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2022
First Posted
June 9, 2022
Study Start
March 24, 2023
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
May 1, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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