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New treatment option for Clear Cell Renal Cell Carcinoma
Official title Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer
ClinicalTrials.gov ID: NCT06661720
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for clear cell renal cell carcinoma.
Also referred to as Keytruda.
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 III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
- Phase 3: a large, late-stage study
- Time commitment: about 6 months
- 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
- Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary...
- Note: Patients with microscopically positive soft tissue or vascular margins without gross residual disease are permitted
- Intermediate-high risk RCC:
- pT2 grade 4 or sarcomatoid features, N0M0
- pT3 any grade N0, M0
See the full eligibility criteria
- Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor (radical or partial nephrectomy)
- Note: Patients with microscopically positive soft tissue or vascular margins without gross residual disease are permitted
- Intermediate-high risk RCC:
- pT2 grade 4 or sarcomatoid features, N0M0
- pT3 any grade N0, M0
- High-risk RCC
- pT4, any grade, N0, M0
- pT, any stage., any grade, N+, M0
- cM1 no evidence of disease (NED) RCC
- Participants who have had resection of primary tumor (radical or partial nephrectomy) and resection or definitive radiation or ablation of solid, isolated, soft tissue metastases (excluding brain and bone lesions) at...
- Surgery (radical or partial nephrectomy or metastasectomy or ablation) \> 4 weeks but =\< 16 weeks prior to study registration with no ongoing complications from surgery
- No evidence of disease at time of randomization as assessed by investigator by either CT or MRI scan of the brain and chest, abdomen and pelvis
- No prior systemic treatment for RCC
- Age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status =\ = 60%)
- Absolute neutrophil count (ANC) \>= 1,000/mm\^3
- Platelet count \>= 100,000/mm\^3
- Hemoglobin \>= 8 g/dL
- Total bilirubin =\< 3 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 3 x upper limit of normal (ULN)
- Calculated (calc.) creatinine clearance \>= 30 mL/min (using Cockcroft Gault equation or the estimated glomerular filtration rate from the modification of diet in renal disease trial)
- Urine protein =\< 1+ on urine analysis (UA) or urine protein creatinine ration (UPCR) \< 2mg/mg
- Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test is required...
- HIV status: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Hepatitis
- Hepatitis B: 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 resolved HBV infection, defined as...
- Hepatitis C: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable...
- Cardiac Disease: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart...
- No history of myocarditis
- No history of clinically significant pneumonitis
- No uncontrolled hypertension (systolic blood pressure [BP] \> 150 mm Hg or diastolic BP \> 90 mm Hg) documented on 2 consecutive measurements taken at least 2 hours apart
- No serious non-healing wound, ulcer or bone fracture within 28 days prior to registration
- No serious/active infection requiring parenteral antibiotics
- No moderate or severe hepatic impairment (child-Pugh B or C)
- No significant bleeding disorders within 1 month prior to registration, for example:
- Hematemesis, hematochezia or other gastrointestinal bleeding grade 3 or higher
- Hemoptysis of pulmonary bleeding grade 3 or higher
- Hematuria or other genitourinary bleeding grade 3 or higher
- No history of allogeneic organ transplantation
- No history of allergy of hypersensitivity to study drugs or components
- No condition requiring systemic treatment with either corticosteroid (\> 10 mg daily or prednisone equivalent) within 14 days of treatment initiation or other immunosuppressive medications within 30 days of...
- No active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis or other gastrointestinal condition associated with increased risk of perforation; history of abdominal fistula, gastrointestinal...
- 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...
- No patients with a history of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids \> 10 mg/day, or immunosuppressive drugs) with the...
- Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
- Brief (\<7 days) use of systemic corticosteroids is allowed when use is considered standard of care
- Patients with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma/atopy will not be excluded
- Patients requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded
- Patients with hypothyroidism that is stable with hormone replacement or Sjögren's syndrome will not be excluded Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Jonesboro, Arkansas, United States
- Little Rock, Arkansas, United States
- Auburn, California, United States
- Beverly Hills, California, United States
- Duarte, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Lancaster, California, United States
- Los Angeles, California, United States
- Modesto, California, United States
- Newport Beach, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- San Mateo, California, United States
+ 315 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Phoenix, Arizona, United States; Tucson, Arizona, United States; Jonesboro, Arkansas, United States; Little Rock, Arkansas, United States; Auburn, California, United States; Beverly Hills, California, United States and 329 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.