A Study of Avelumab In Combination with Axitinib Versus Sunitinib In Patients With Advanced Kidney Cancer
- Conditions
- Advanced renal cell carcinoma (aRCC).MedDRA version: 21.0Level: LLTClassification code 10023405Term: Kidney cancer stage IVSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10023404Term: Kidney cancer stage IIISystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002429-20-GB
- Lead Sponsor
- Pfizer Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 830
1. Histological or cytological diagnosis of advanced/metastatic renal cell carcinoma (aRCC) with a clear cell component. A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening will be required. Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided. If an FFPE tissue block cannot be provided as per documented regulations then 15 unstained slides will be acceptable. Availability of an archival FFPE tumor tissue block from primary diagnosis specimen (or 15 unstained slides). At least one measurable lesion defined by RECIST that has not been previously irradiated;
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
3. Estimated life expectancy of at least 3 months;
4. Adequate bone marrow, renal and liver function;
5. No evidence of uncontrolled hypertension documented by 2 baseline blood pressure (BP) readings taken at least 1 hour apart;
6. Left ventricular ejection fraction (LVEF) above or equal to the lower limit of normal (LLN);
7. Negative serum pregnancy test at screening (females of childbearing potential);
8. Male and female patients able to have children must agree to use 2 highly effective methods of contraception throughout the study and for at least 90 days after the last dose of assigned treatment
9. Evidence of a personally signed and dated informed consent;
10. Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures;
11. Age above 18 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 622
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 208
1. Systemic therapy directed at advanced or metastatic RCC prior to study entry, including adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occured during or within 12 months after the last dose of treatment, immunotherapy or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways;
2. Therapy with axitinib and/or sunitinib as well as any prior therapies with other VEGF pathway inhibitors prior to study entry;
3. Patients with newly diagnosed brain metastases or patients with known symptomatic brain metastases requiring steroids;
4. Major surgery within 4 weeks or major radiation therapy within 2 weeks prior to study entry;
5. Persisting toxicity related to prior therapy NCI CTCAE v4.0 Grade >1;
6. Current or prior use of immunosuppressive medication within 7 days prior to study entry;
7. Known prior or suspected hypersensitivity to investigational products, including known severe hypersensitivity reactions to monoclonal antibodies (Grade >= 3) and any history of anaphylaxis;
8. Diagnosis of any other malignancy within 5 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, or low-grade (Gleason 6 or below) prostate cancer on surveillance;
9. Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent;
10. Gastrointestinal abnormalities;
11. Active infection requiring systemic therapy;
12. Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy;
13. Known HIV or AIDS-related illness;
14. Positive HBV or HCV test indicating acute or chronic infection;
15. Administration of live vaccine within 4 weeks prior to study entry and during study participation;
16. Requirement of anticoagulant therapy with oral vitamin K antagonists;
17. Evidence of inadequate wound healing;
18. Grade >= 3 hemorrhage within 4 weeks of patient study entry;
19. Any of the following in the previous 12 months prior to study entry: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, LVEF less than LLN, clinically significant pericardial effusion, cerebrovascular accident, transient ischemic attack;
20. Any of the following in the previous 6 months prior to study entry: deep vein thrombosis or symptomatic pulmonary embolism;
21. Evidence of tumor involvement of the myocardium or pericardium or tumor thrombus extending to the heart;
22. Ongoing cardiac dysrhythmias of NCI CTCAE Grade >= 2 or prolongation of the QTc interval to > 500 msec;
23. Current use or anticipated need for treatment with medicines or foods that are known strong CYP3A4/5 inhibitors, including their administration within 10 days prior to study entry;
24. Current use or anticipated need for drugs that are known strong CYP3A4/5 inducers, including their administration within 10 days prior to study entry;
25. Patients who are site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees directly involved in the conduct of the study;
26. Pregnant female patients and breastfeeding female patients;
27. Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, uncontrolled asthma and pneumonitis or psychiatric condition including
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method