To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma
NCT ID:
NCT05808608
Condition:
Renal Cell Carcinoma
First-line Treatment
Non Clear Cell Renal Cell Carcinoma
Sarcomatoid Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Axitinib
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AK104
Description:
Anti-PD-1/CTLA-4 bi-specific antibody drug; RP2D intravenously (IV)
Arm group label:
Combination treatment group
Intervention type:
Drug
Intervention name:
Axitinib
Description:
An oral, small molecule, TKI selective for VEGFRs; 5mg bid orally
Arm group label:
Combination treatment group
Summary:
This is a Phase Ib/II, open-label, single arm trial to evaluate the efficacy and safety
of AK104 in combination with axitinib as a first-line treatment for advanced/metastatic
special pathological subtypes of renal cell carcinoma (ssRCC). Subjects will receive
AK104 plus axitinib until disease progression, development of unacceptable toxic effects,
death, a decision by the physician or patient to withdraw from the trial. The primary
endpoint is ORR and PFS per RECIST v1.1 and imRECIST as assessed by investigators.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. age≥18, ≤75;
2. histology characteristics accord with special pathological subtypes of RCC:
papillary renal cell carcinoma, chromophobic cell carcinoma, TFE3 rearrangement
renal cell carcinoma, FH-deficient renal cell carcinoma, collecting duct carcinoma,
medullary carcinoma, sarcomatoid carcinoma (>10%), unclassified renal cell carcinoma
;
3. metastatic renal cell carcinoma (TNM IV stage according to the 2009 TNM Staging
system).
4. Patients who have not previously received systemic therapy, ECOG (Eastern
Cooperative Oncology Group)≤2;
5. expected survival >3 months;
6. all patients signed informed consent.
7. blood routine indexes: neutrophils ≥1.5*109, platelets ≥100*109, hemoglobin ≥90g/L;
8. liver function: bilirubin ≤ normal upper limit 1.5 times, ALT/AST≤ normal upper
limit 2.5 times;Serum creatinine ≤ 1.5 times of normal upper limit
9. the following diseases did not appear within 12 months: myocardial infarction,
severe or unstable angina pectoris, asymptomatic heart failure, cardiovascular and
cerebrovascular accident or transient ischemic attack, etc.
Exclusion Criteria:
1. other malignancies previously or at the same time that are different from the
primary site or histology of the tumor assessed in this study, except cervical
carcinoma in situ, basal-cell carcinoma that has been fully treated, superficial
bladder tumor (Ta, Tis, T1) or other malignancies that occurred before the
enrollment and have been cured for more than 3 years;
2. renal decompensation requires hemodialysis or peritoneal dialysis;
3. arrhythmia need anti-arrhythmic treatment, symptomatic coronary artery disease or
myocardial ischemia (myocardial infarction), nearly six months, or congestive heart
failure than NYHA Ⅱ level; Hypertension (systolic blood pressure >160 mmHg or
diastolic blood pressure >100 mmHg) that has been treated with 2 or more
antihypertensive treatments and still cannot be controlled;
4. severe active clinical infection;
5. patients with coagulation disorder or bleeding constitution;
6. major surgery or severe trauma was performed within 4 weeks before enrollment;
7. a history of allogeneic organ transplantation or bone marrow transplantation;
8. drug abuse and medical, psychological or social conditions that may interfere with
patients' participation in research or affect the evaluation of results;
9. known or suspected allergy to the study drug;
10. those who received treatment other than this study within 4 weeks prior to and
during the study period.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Contact:
Last name:
Hao Zeng, professor
Phone:
8618980602129
Email:
kucaizeng@163.com
Investigator:
Last name:
Hao Zeng, professor
Email:
Principal Investigator
Start date:
September 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Hao Zeng
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05808608
