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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-17

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Cell Carcinoma First-line Treatment Non Clear Cell Renal Cell Carcinoma Sarcomatoid Renal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combination treatment group

Subjects in this group will receive AK104 (RP2D, administered intravenously) plus Axitinib 5 mg bid, administered orally.

Group Type EXPERIMENTAL

AK104

Intervention Type DRUG

Anti-PD-1/CTLA-4 bi-specific antibody drug; RP2D intravenously (IV)

Axitinib

Intervention Type DRUG

An oral, small molecule, TKI selective for VEGFRs; 5mg bid orally

Interventions

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AK104

Anti-PD-1/CTLA-4 bi-specific antibody drug; RP2D intravenously (IV)

Intervention Type DRUG

Axitinib

An oral, small molecule, TKI selective for VEGFRs; 5mg bid orally

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No