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This study is designed as a phase-II proof of clinical trial to investigate if a treatment strategy where stereotactic body radiation therapy (SBRT) is given with pembrolizumab is sufficiently active to warrant further investigation in randomized phase II or III studies. Metastatic renal cell cancer (mRCC) patients with PD-1 expressing immune cells are more likely to have larger more aggressive tumours and reduced survival. Pembrolizumab is designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. SBRT will be given to the 1-5 most clinically significant lesions after the 1nd course of pembrolizumab treatment in an effort to improve the activity of pembrolizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab + RT (5 fractions, 8 Gy) + Pembrolizumab | Experimental | Pembrolizumab will be started. Stereotactic Body Radiation Therapy will be given before the 2nd course of pembrolizumab and pembrolizumab will be continued. Pembrolizumab will continue until progression as per immune related response criteria (irRC). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: Pembrolizumab | Combination Product | 200mg(body weight >75kg) or 100mg(body weight≤75kg) given intravenously over 30 minutes day 1 of every 3 week cycle until progression as per immune related response criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate by immune related response criteria (irRC), and RECIST 1.1 criteria | Approximately 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | up to 24 months | |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | up to 24 months | |
| The disease control rate |
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Inclusion Criteria:
Age> 18 years at the time of signing informed consent;
ECOG score of 0 or 1;
Histologically confirmed, advanced ccRCC of stage IV (AJCC 8);
Life expectancy of more than 12 weeks;
Evidence of measurable metastatic kidney cancer according to RECIST 1.1 criteria. Patients should have an adequate number of non-irradiated metastatic sites in order to adequately assess the activity of the pembrolizumab therapy;
If central nervous system (CNS) metastases are treated before inclusion and the patient's neurological system is present Return of symptoms to baseline levels (except for signs or symptoms associated with CNS therapy)At least 14 days, such patients may be included. In addition, patients must stop taking glucocorticoids or prednisone in a stable dose and ≤ 10 mg per day;
Main organ function meets the following criteria within 7 days before treatment:
Women of childbearing age should agree to use contraception (e. g. intrauterine device, contraceptive or condom) within 6 months after study completion, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative;
Men should agree that contraception must be used during and within 6 months of the end of the study period;
With consent and have signed the informed consent, willing and able to comply with the planned visits, research treatment, laboratory tests, and other experimental procedures.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guozhu Xie | Contact | 13242801662 | xieguozhu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guozhu,Xie | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| C538445 | Clear-cell metastatic renal cell carcinoma |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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| up to 24 months |
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | China |
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