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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05327686
Other study ID # NRG-GU012
Secondary ID NCI-2022-02189NR
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 30, 2022
Est. completion date June 15, 2032

Study information

Verified date March 2024
Source NRG Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.


Description:

PRIMARY OBJECTIVE: I. To determine whether the addition of stereotactic ablative radiotherapy (SABR) to the primary tumor in combination with immunotherapy improves outcomes compared to immunotherapy alone in patients with metastatic, unresected, renal cell carcinoma (RCC). The primary endpoint is nephrectomy and radiographic progression-free survival (nrPFS) with progression determined as per iRECIST criteria. SECONDARY OBJECTIVES: I. To assess the safety, toxicity and tolerability of the two treatment strategies as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5 in each treatment arm. II. To assess the objective response rate (ORR) by Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) in each treatment arm. III. Nephrectomy and radiographic progression-free survival excluding nephrectomies that were performed for non-protocol specified indications (nephrectomy and radiographic progression-free survival [nrPFS]2). IV. Radiographic progression-free survival (rPFS). V. To assess overall survival (OS) in each treatment arm. VI. To assess the time to subsequent second-line therapy or death in each treatment arm. VII. To assess the rate of cytoreductive nephrectomy in each treatment arm. VIII. To assess treatment-free survival in patients who discontinue therapy for reason other than radiographic disease progression. IX. To assess the ORR by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and iRECIST in the primary renal mass. EXPLORATORY OBJECTIVES: I. To assess composite nrPFS in the predefined histological subgroups below: Ia. Clear cell versus non-clear cell histology. Ib. International Metastatic RCC database consortium (IMDC) intermediate versus poor risk group. Ic. Systemic treatment with immunotherapy-immunotherapy combination versus immunotherapy-vascular endothelial growth factor (VEGF) targeted therapy combination. Id. Sarcomatoid versus non sarcomatoid variant. II. To identify prognostic and predictive biomarkers of response to SABR in the context of immunotherapy based treatment via assessment of tissue and blood based biomarkers. III. To evaluate the abscopal effect of SABR with systemic therapy. IIIa. Compare ORR in non-irradiated target lesions in the control arm patients undergoing immunotherapy alone to the experimental arm undergoing SABR + immunotherapy. IV. To evaluate the impact of treatment on level of inferior vena cava (IVC) thrombus. V. To compare accruing center identified iRECIST progression and centrally identified iRECIST progression events on computed tomography (CT). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive one of the following immunotherapy regimens per physician discretion: nivolumab intravenously (IV) over 30 minutes and ipilimumab IV over 30 minutes every 3 weeks for 4 doses followed by nivolumab IV over 30 minutes every 2 or 4 weeks; pembrolizumab IV over 30 minutes every 3 or 6 weeks and axitinib orally (PO) twice daily (BID); avelumab IV over 60 minutes every 2 weeks and axitinib PO BID; nivolumab IV over 30 minutes every 2 or 4 weeks and cabozantinib PO once daily (QD); OR pembrolizumab IV over 30 minutes every 3 or 6 weeks and lenvatinib PO QD. Treatment with immunotherapy continues in the absence of disease progression or unacceptable toxicity. ARM II: Patients undergo SABR on 3 different days over 1-3 weeks and receive immunotherapy as in Arm I. After completion of study treatment, patients are followed up every 6 months for 5 years, and then annually for 3 years.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date June 15, 2032
Est. primary completion date June 15, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma prior to registration - Node-positive unresectable (TxN1Mx) or metastatic (TxNxM1) based on the following diagnostic workup: - History/physical examination within 45 days prior to registration - CT/magnetic resonance imaging (MRI) of the chest/abdomen/pelvis within 45 days prior to registration - Patients must have IMDC intermediate (1-2 factors) or poor risk disease (>= 3 factors) - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial - Patients with measurable disease (node positive or metastatic) as defined by RECIST version 1.1 excluding the primary renal tumor - Patient not recommended for or refused immediate cytoreductive nephrectomy - Candidate for standard of care therapy with either immuno-oncology (IO)-IO or IO-VEGF combination regimen - Primary renal tumor measuring 20 cm or less in anterior to posterior dimension only on axial imaging - Age >= 18 - Karnofsky performance status >= 60 within 45 days prior to registration - Hemoglobin >= 8 g/dL (transfusions are allowed) (within 45 days prior to registration) - Platelet count >= 50,000/mm^3 (within 45 days prior to registration) - Absolute neutrophil count (ANC) >= 1500/mm^3 (within 45 days prior to registration) - Calculated (Calc.) creatinine clearance >= 30 mL/min (within 45 days prior to registration) - For African American patients specifically whose renal function is not considered adequate by the formula above, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) should be used for calculating the related estimated glomerular filtration rate (GFR) with a correction factor for African American race creatinine clearance for trial eligibility, where GFR >= 30 mL/min/1.73m^2 will be considered adequate - Total bilirubin =< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) (within 45 days prior to registration) - Aspartate aminotransferase and alanine aminotransferase (AST and ALT) =< 3 x upper limit of normal (ULN) or < 5 x ULN if hepatic metastases present (within 45 days prior to registration) - Patients with known human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing is not required for entry into protocol - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated - Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load - The patient must agree to use a highly effective contraception, including men with vasectomies if they are having sex with a woman of childbearing potential or with a woman who is pregnant, while on study drug and for 6 months following the last dose of study drug. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal - The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information Exclusion Criteria: - Patients with planned treatment of all metastatic disease with definitive therapy including either surgery, ablative (non-palliative) doses of radiation, or intervention of some type (definitive interventional radiology techniques) to ALL metastatic sites rendering the patient without extra-renal measurable disease. Patients NOT planned for definitive treatment of all metastatic sites are eligible. Lesions radiated palliatively are not eligible for response assessment - Patients with untreated or unstable brain metastases or cranial epidural disease - Note: Patients who have been adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator are eligible. Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator - Prior radiotherapy to the kidney that would result in overlap of radiation therapy fields treatment of the primary tumor - Any systemic therapy for metastatic renal cell carcinoma (RCC) that was initiated > 90 days before registration, note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration) - Severe, active comorbidity defined as follows: - Active autoimmune disease requiring ongoing therapy including systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications daily. Inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease - History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies - Active tuberculosis (purified protein derivative [PPD] response without active tuberculosis [TB] is allowed) - Uncontrolled hypertension (systolic blood pressure [BP] > 190 mmHg or diastolic BP > 110 mmHg) - Major surgery requiring hospital admission = 28 days prior to registration. - Any serious (requiring hospital stay or long-term rehab) non-healing wound, ulcer, or bone fracture within 45 days prior to registration - Any arterial thrombotic (ST elevation myocardial infarction [STEMI], non-ST elevation myocardial infarction [NSTEMI], cerebrovascular accident [CVA], etc) events within 180 days prior to registration - Active New York (NY) Heart Association class 3-4 heart failure symptoms - Moderate or severe hepatic impairment (Child-Pugh B or C) - Any history of untreated pulmonary embolism or deep venous thrombosis (DVT) within 180 days prior to registration. (Any asymptomatic or treated pulmonary embolism or asymptomatic treated deep venous thrombosis > 30 days prior to registration is allowed) - Unstable cardiac arrhythmia within 180 days prior to registration - History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to registration - History of or active inflammatory bowel disease - Malabsorption syndrome within 45 days prior to registration - Pregnancy and individuals unwilling to discontinue nursing. For women of child bearing potential must have a negative pregnancy test =< 45 days prior to registration

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Avelumab
Given IV
Drug:
Axitinib
Given PO
Cabozantinib
Given PO
Biological:
Ipilimumab
Given IV
Drug:
Lenvatinib
Given PO
Biological:
Nivolumab
Given IV
Pembrolizumab
Given IV
Radiation:
Stereotactic Ablative Radiotherapy
42 Gy in 3 fractions

Locations

Country Name City State
United States Lovelace Medical Center-Saint Joseph Square Albuquerque New Mexico
United States Lovelace Radiation Oncology Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Alton Memorial Hospital Alton Illinois
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic - Ames Ames Iowa
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States UH Seidman Cancer Center at UH Avon Health Center Avon Ohio
United States University of Maryland/Greenebaum Cancer Center Baltimore Maryland
United States MaineHealth Coastal Cancer Treatment Center Bath Maine
United States UHHS-Chagrin Highlands Medical Center Beachwood Ohio
United States UPMC-Heritage Valley Health System Beaver Beaver Pennsylvania
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Brigham and Women's Hospital Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Saint Joseph Mercy Brighton Brighton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States University of Vermont and State Agricultural College Burlington Vermont
United States University of Vermont Medical Center Burlington Vermont
United States Cooper Hospital University Medical Center Camden New Jersey
United States Saint Joseph Mercy Canton Canton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Carlisle Regional Cancer Center Carlisle Pennsylvania
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States West Virginia University Charleston Division Charleston West Virginia
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Northwestern University Chicago Illinois
United States Case Western Reserve University Cleveland Ohio
United States Central Maryland Radiation Oncology in Howard County Columbia Maryland
United States MU Health - University Hospital/Ellis Fischel Cancer Center Columbia Missouri
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States UT Southwestern Simmons Cancer Center - RedBird Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Carle at The Riverfront Danville Illinois
United States Dayton Blood and Cancer Center Dayton Ohio
United States Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Beaumont Hospital - Dearborn Dearborn Michigan
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois
United States City of Hope Comprehensive Cancer Center Duarte California
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States UC San Diego Health System - Encinitas Encinitas California
United States UPMC Hillman Cancer Center Erie Erie Pennsylvania
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Beaumont Hospital - Farmington Hills Farmington Hills Michigan
United States UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth Texas
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie Maryland
United States Glens Falls Hospital Glens Falls New York
United States Miami Valley Cancer Care and Infusion Greenville Ohio
United States UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania
United States Mayo Clinic in Florida Jacksonville Florida
United States UC San Diego Moores Cancer Center La Jolla California
United States Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin
United States Northwestern Medicine Lake Forest Hospital Lake Forest Illinois
United States Monmouth Medical Center Southern Campus Lakewood New Jersey
United States Sparrow Hospital Lansing Michigan
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Monmouth Medical Center Long Branch New Jersey
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg Pennsylvania
United States Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin
United States UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio
United States East Jefferson General Hospital Metairie Louisiana
United States LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie Louisiana
United States Miami Cancer Institute Miami Florida
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Cooper CyberKnife Center Mount Laurel New Jersey
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States Marshfield Medical Center - Neillsville Neillsville Wisconsin
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States UPMC Hillman Cancer Center - New Castle New Castle Pennsylvania
United States Louisiana State University Health Science Center New Orleans Louisiana
United States University Medical Center New Orleans New Orleans Louisiana
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Drexel Town Square Health Center Oak Creek Wisconsin
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States University Hospitals Parma Medical Center Parma Ohio
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States UPMC-Magee Womens Hospital Pittsburgh Pennsylvania
United States UPMC-Passavant Hospital Pittsburgh Pennsylvania
United States UPMC-Saint Clair Hospital Cancer Center Pittsburgh Pennsylvania
United States UPMC-Saint Margaret Pittsburgh Pennsylvania
United States UPMC-Shadyside Hospital Pittsburgh Pennsylvania
United States Maine Medical Center-Bramhall Campus Portland Maine
United States University Hospitals Portage Medical Center Ravenna Ohio
United States Ascension Saint Mary's Hospital Rhinelander Wisconsin
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States UT Southwestern Clinical Center at Richardson/Plano Richardson Texas
United States Mayo Clinic in Rochester Rochester Minnesota
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Siteman Cancer Center at Christian Hospital Saint Louis Missouri
United States Siteman Cancer Center-South County Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri
United States UC San Diego Medical Center - Hillcrest San Diego California
United States Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
United States MaineHealth Cancer Care Center of York County Sanford Maine
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine
United States Maine Medical Center- Scarborough Campus Scarborough Maine
United States Memorial Hospital East Shiloh Illinois
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Maine Medical Partners - South Portland South Portland Maine
United States Memorial Medical Center Springfield Illinois
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Ascension Saint Michael's Hospital Stevens Point Wisconsin
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Stony Brook University Medical Center Stony Brook New York
United States Community Medical Center Toms River New Jersey
United States Upper Valley Medical Center Troy Ohio
United States William Beaumont Hospital - Troy Troy Michigan
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States UW Cancer Center at ProHealth Care Waukesha Wisconsin
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States Froedtert West Bend Hospital/Kraemer Cancer Center West Bend Wisconsin
United States Reading Hospital West Reading Pennsylvania
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Divine Providence Hospital Williamsport Pennsylvania
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States UPMC Memorial York Pennsylvania
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan

Sponsors (2)

Lead Sponsor Collaborator
NRG Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nephrectomy and radiographic progression-free survival (nrPFS) Nephrectomy and radiographic progression-free survival time is defined as time from randomization to the date of first radiographic progression, nephrectomy, death, or last negative evaluation (censored). nrPFS rates are estimated using the Kaplan-Meier method. Progression is determined by the Response Evaluation Criteria in Solid Tumors version 1.1 criteria modified for immunotherapy trials (iRECIST). From randomization to last follow-up, up to 8 years
Secondary Percentage of participants with complete or partial response Best overall response is determined by the Response Evaluation Criteria in Solid Tumors version 1.1 criteria modified for immunotherapy trials (iRECIST). From randomization to last follow-up, up to 8 years
Secondary Percentage of participants with complete or partial response in the primary renal mass Best overall response is determined by the Response Evaluation Criteria in Solid Tumors version 1.1 criteria modified for immunotherapy trials (iRECIST). From randomization to last follow-up, up to 8 years
Secondary Radiographic progression-free survival (rPFS) Radiographic progression-free survival time is defined as time from randomization to the date of first radiographic progression, death, or last negative evaluation (censored). rPFS rates are estimated using the Kaplan-Meier method. Radiographic progression is determined by the Response Evaluation Criteria in Solid Tumors version 1.1 criteria modified for immunotherapy trials (iRECIST). From randomization to last follow-up, up to 8 years
Secondary Nephrectomy and radiographic progression-free survival excluding nephrectomies that were performed for non-protocol specified reasons (nrPFS2) Nephrectomy and radiographic progression-free survival time (excluding nephrectomies that were performed for non-protocol specified reasons) is defined as time from randomization to the date of first radiographic progression, nephrectomy performed for protocol-stated reasons, death, or last negative evaluation (censored). nrPFS2 rates are estimated using the Kaplan-Meier method. Progression is determined by the Response Evaluation Criteria in Solid Tumors version 1.1 criteria modified for immunotherapy trials (iRECIST). From randomization to last follow-up, up to 8 years
Secondary Overall survival Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. From randomization to last follow-up, up to 8 years
Secondary Second-line therapy-free survival Second-line therapy-free survival time is defined as time from randomization to the date of the initiation of second-line therapy, death, or last known follow-up (censored). Second-line therapy-free survival rates are estimated using the Kaplan-Meier method. From randomization to last follow-up, up to 8 years
Secondary Percentage of participants who undergo cytoreductive nephrectomy From randomization to last follow-up, up to 8 years
Secondary Treatment-free survival Treatment-free survival time is defined as time from the discontinuation of protocol therapy to the date of death or last follow-up (censored). Treatment-free survival rates are estimated using the Kaplan-Meier method. From randomization to last follow-up, up to 8 years
Secondary Percentage of participants with grade 3+ and with grade 4+ treatment-related adverse events Common Terminology Criteria for Adverse Events (CTCAE) 5.0 grades adverse event severity from 1=mild to 5=death. Adverse events recorded as possibly, probably, or definitely related to protocol treatment will be considered to be treatment-related. From randomization to last follow-up, up to 8 years
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