Phase 2Recruiting

Comparing Avelumab with Stereotactic Ablative Radiotherapy 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

Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

Condition: Metastatic Renal Cell CarcinomaSponsor: NRG OncologyTarget enrollment: 240

Phase 2
2 groups
Sites in Toronto and Québec
Recruiting

Interventions (12)

Biological therapy
Avelumab
Given IV
Medication
Axitinib
Given PO
Medical procedure
Biospecimen Collection
Undergo collection of blood
Medical procedure
Bone Scan
Undergo bone scan
Medication
Cabozantinib
Given PO
Medical procedure
Computed Tomography
Undergo CT
Biological therapy
Ipilimumab
Given IV
Medication
Lenvatinib
Given PO
Medical procedure
Magnetic Resonance Imaging
Undergo MRI
Biological therapy
Nivolumab
Given IV
Biological therapy
Pembrolizumab
Given IV
Radiation therapy
Stereotactic Ablative Radiotherapy
42 Gy in 3 fractions

Canadian Sites (2)

1 of 2 recruiting

CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Québec, Quebec
Recruiting
University Health Network-Princess Margaret Hospital
Toronto, Ontario
Paused

See who this study is looking for46 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

+Patients must have IMDC intermediate (1-2 factors) or poor risk disease (\>= 3 factors)
+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
+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 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)
+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 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)
+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
+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

Exclusion

−Active New York (NY) Heart Association class 3-4 heart failure symptoms
−History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies
−Patients with untreated or unstable brain metastases or cranial epidural disease
−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
−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)
−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
−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
−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
−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)
−Major surgery requiring hospital admission =\< 28 days prior to registration

5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning

What this study is

This study is testing a treatment for a condition.

Phase 2 — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effects.

From the trial registry

Built from these fields:

designModule.designInfo.primaryPurpose
designModule.phases

Who receives what

There are 2 groups in this study.

Group A, the comparison group, receives one or more of: Avelumab, Axitinib, Biospecimen Collection, Bone Scan, Cabozantinib, Computed Tomography, Ipilimumab, Lenvatinib, Magnetic Resonance Imaging, Nivolumab and Pembrolizumab.

Registry label: A: Arm I (standard of care immunotherapy)

Group B receives one or more of: Avelumab, Axitinib, Biospecimen Collection, Bone Scan, Cabozantinib, Computed Tomography, Ipilimumab, Lenvatinib, Magnetic Resonance Imaging, Nivolumab, Pembrolizumab and Stereotactic Ablative Radiotherapy.

Registry label: B: Arm II (SABR, standard of care immunotherapy)

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].label
armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-label: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

designModule.designInfo.allocation
designModule.designInfo.maskingInfo.masking

Is there a placebo?

This study does not list a placebo group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteers.

These are the criteria the study lists. Only the trial site can decide whether someone can take part.

From the trial registry

Built from these fields:

eligibilityModule.minimumAge
eligibilityModule.sex
eligibilityModule.healthyVolunteers

How big and how long

The study aims to enrol about 240 people.

The study is currently expected to finish around June 2033.

The main measurement is taken over: From randomization to last follow-up, up to 8 years.

From the trial registry

Built from these fields:

designModule.enrollmentInfo.count
statusModule.completionDateStruct.date
outcomesModule.primaryOutcomes[].timeFrame

What the study measures

Nephrectomy and radiographic progression-free survival (nrPFS) — measured over From randomization to last follow-up, up to 8 years.

From the trial registry

Built from these fields:

outcomesModule.primaryOutcomes[].measure
outcomesModule.primaryOutcomes[].timeFrame

Source: NCT05327686 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?