Combining AK104 and Axitinib for Advanced Renal Cell Carcinoma

A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma

This study tests whether combining two medications, AK104 and axitinib, can help people with advanced kidney cancer feel better and live longer.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: West China Hospital (other)
• Drugs / interventions: axitinib
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT05808608 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of AK104 in combination with axitinib as a first-line treatment for advanced or metastatic special pathological subtypes of renal cell carcinoma. It is an open-label, single-arm trial where participants will receive the treatment until disease progression or unacceptable side effects occur. The primary endpoints include overall response rate (ORR) and progression-free survival (PFS) as assessed by investigators using established criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with specific subtypes of metastatic renal cell carcinoma who have not received prior systemic therapy.

Not a fit: Patients with non-metastatic renal cell carcinoma or those who have previously undergone systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced renal cell carcinoma who have limited treatment choices.

How similar studies have performed: While this approach is novel for these specific subtypes of renal cell carcinoma, similar combinations have shown promise in other cancer types.

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.

Where this trial is running

Chengdu, Sichuan

• West China Hospital — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Principal investigator: Hao Zeng, Professor — West China Hospital
• Study coordinator: Hao Zeng, Professor

Conditions: Renal Cell Carcinoma, First-line Treatment, Non Clear Cell Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma