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New treatment option for Metastatic Renal Cell Carcinoma
Official title Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial
ClinicalTrials.gov ID: NCT05327686
What this study is testing
What is Avelumab?
Avelumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for metastatic renal cell carcinoma.
Also referred to as Bavencio, MSB 0010718C.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 from where it first started (primary site) to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- Patients with planned treatment of all metastatic disease with definitive therapy including either surgery, ablative (non-palliative) doses of...
- 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...
- 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...
- Severe, active comorbidity defined as follows:
See the full eligibility criteria
Who can join
- 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 how well it works assessment of the investigational regimen are eligible for...
- 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)
- Creatinine clearance (CrCl) \>= 30 mL/min estimated by Cockcroft-Gault Equation
- 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...
- Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except people 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...
- 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...
What rules you out
- 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 treatment radiology...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Kingman, Arizona, United States
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Arroyo Grande, California, United States
- Beverly Hills, California, United States
- Burlingame, California, United States
- Duarte, California, United States
- Encinitas, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Modesto, California, United States
- Orange, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- San Luis Obispo, California, United States
- San Mateo, California, United States
+ 235 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Kingman, Arizona, United States; Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Arroyo Grande, California, United States; Beverly Hills, California, United States and 249 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.