Metastatic Renal Cell Carcinoma Clinical Trial
— SAMURAIOfficial title:
Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)
Verified date | March 2024 |
Source | NRG Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
NRG Oncology | National Cancer Institute (NCI) |
United States,
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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