BridgeMD
Pembrolizumab in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma
EU CTIS ID: 2023-507294-18-00
What this study is testing
1. To evaluate and compare PFS per RECIST 1.1 as assessed by BICR in subjects treated with pembrolizumab plus axitinib versus sunitinib monotherapy. 2. To evaluate and compare OS in subjects treated with pembrolizumab plus axitinib versus sunitinib monotherapy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has histologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell component with or without sarcomatoid features
- Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.
- Has locally advanced/metastatic disease (i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer) or has recurrent disease
- Has measurable disease per RECIST 1.1 as assessed by the investigator/site radiologist
- Has received no prior systemic therapy for advanced RCC.
- Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
You likely can't join if
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization.
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has known active Hepatitis B or Hepatitis C infection.
- Has received a live virus vaccine within 30 days of randomization.
See the full eligibility criteria
Who can join
- Has histologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell component with or without sarcomatoid features
- Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.
- Has locally advanced/metastatic disease (i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer) or has recurrent disease
- Has measurable disease per RECIST 1.1 as assessed by the investigator/site radiologist
- Has received no prior systemic therapy for advanced RCC.
- Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
- Has Karnofsky performance status (KPS) ≥ 70% as assessed within 10 days prior to randomization.
- If receiving bone resorptive therapy (including but not limited to bisphosphonate or receptor activator of nuclear factor-kappa B ligand [RANK-L] inhibitor) must have therapy initiated at least 2 weeks prior to randomization.
- Demonstrates adequate organ function.
- Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.
What rules you out
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization.
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has known active Hepatitis B or Hepatitis C infection.
- Has received a live virus vaccine within 30 days of randomization.
- Has a clinically significant gastrointestinal (GI) abnormality including: malabsorption, total gastric resection, or any condition that might affect the absorption of orally taken medication; active GI bleeding, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy; intraluminal metastatic lesion with suspected bleeding, inflammatory bowel disease, ulcerative colitis or other GI condition associated with increased risk of perforation.
- Has QT interval corrected for heart rate (QTc) ≥480 msec.
- Has a history of any of the following cardiovascular conditions within 12 months of randomization: myocardial infarction, unstable angina pectoris, cardiac angioplasty or stenting, coronary/peripheral artery bypass graft, class III or IV congestive heart failure per New York Heart Association, cerebrovascular accident or transient ischemic attack.
- Has a history of deep vein thrombosis or pulmonary embolism within 6 months of screening.
- Has poorly controlled hypertension defined as systolic blood pressure (SBP) ≥150 mm Hg and/or diastolic blood pressure (DBP) ≥90 mm Hg.
- Has had major surgery within 4 weeks, received radiation therapy within 2 weeks prior to randomization, or has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to prior treatment.
- Has evidence of inadequate wound healing.
- Has active bleeding disorder or other history of significant bleeding episodes within 30 days of randomization.
- Has hemoptysis within 6 weeks prior to randomization.
- Has current use (within 7 days of randomization) or anticipated need for treatment with drugs or foods that are known strong cytochrome P450 (CYP3A4/5) inhibitors.
- Has current use (within 7 days of randomization) or anticipated need for treatment with drugs that are known strong CYP3A4/5 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort; or drugs that are known with proarrhythmic potential.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- Has had a prior solid organ transplant.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug.
- Has had prior treatment with any anti-programmed cell death (anti-PD-1), or programmed cell death ligand 1 (PD-L1), or PD-L2 agent or an antibody targeting any other immune-regulatory receptors or mechanisms.
- Has received prior systemic anti-cancer therapy for RCC with vascular endothelial growth factor (VEGF)/VEGF receptors (VEGFR) or mechanistic target of rapamycin (mTOR) targeting agents.
- Has a history of severe hypersensitivity reaction (e.g., generalized rash/erythema, hypotension, bronchospasm, angioedema or anaphylaxis) to axitinib or sunitinib.
- Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy exceeding physiologic corticosteroid dose or any other form of immunosuppressive therapy within 7 days prior to randomization, except in the case of central nervous system (CNS) metastases.
- Has an active autoimmune disease requiring systemic treatment with in the past 2 years OR a documented history of clinically severe autoimmune disease. Note: Participants with vitiligo, Sjøgren's syndrome, Type 1 diabetes, resolved childhood asthma/atopy, hypothyroidism or adrenal or pituitary insufficiency who are stable on hormone replacement, are not excluded.
- Has a known additional malignancy that has progressed or has required active treatment in the last 3 years. Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ such as breast cancer in situ are acceptable if they have undergone potentially curative therapy.
- Has known active CNS metastases and/or carcinomatous meningitis.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Russian Federation
- United Kingdom
- Brazil
- Taiwan
- Japan
- Korea, Republic of
- Ukraine
- Canada
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 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Russian Federation; United Kingdom; Brazil; Taiwan; Japan and 3 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 EU CTIS; the study team decides eligibility.