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

September 21, 2023 updated by: Hao Zeng
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital
        • Contact:
        • Principal Investigator:
          • Hao Zeng, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination treatment group
Subjects in this group will receive AK104 (RP2D, administered intravenously) plus Axitinib 5 mg bid, administered orally.
Drug: AK104
Anti-PD-1/CTLA-4 bi-specific antibody drug; RP2D intravenously (IV)
Drug: Axitinib
An oral, small molecule, TKI selective for VEGFRs; 5mg bid orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR per RECIST v1.1 and imRECIST as assessed by investigators
Time Frame: 3 years
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1 and imRECIST
3 years
12-month PFS rate per RECIST v1.1 and imRECIST as assessed by investigators
Time Frame: 12 months
Progression is assessed by investigators based on RECIST v1.1 and imRECIST, including disease progression or death from any cause.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DCR per RECIST v1.1 and imRECIST as assessed by investigators
Time Frame: 3 years
ORR is the proportion of subjects with complete response(CR), partial response(PR) or stable disease (SD) based on RECIST v1.1 and imRECIST
3 years
OS
Time Frame: 3 years
OS is the time from the first use of a therapeutic drug to death from any cause
3 years
PFS per RECIST v1.1 and imRECIST as assessed by investigators
Time Frame: 3 years
PFS is the time from the first use of a therapeutic drug to disease progression or death from any cause, progression is assessed by investigators based on RECIST v1.1 and imRECIST
3 years
Life quality Questionnaire composite
Time Frame: 3 years

Evaluate life quality using EuroQol Five Dimensions Questionnaire (EQ-5D). EQ-5D included two aspects: EQ-5D Descriptive System and the EQ-5D visual analogue scale (EQ-VAS).

In the description system, health status will be evaluated in 5 aspects: Mobility, Self-care, Usual Activities, Pain/Discomfort, Anxiety/Depression.

EQ-VAS ranges from 0 to 100, higher scores indicate better health.
3 years
Pain score
Time Frame: 3 years
Evaluate pain using visual analogue scale (VAS), range from 0 to 10, higher scores predict a poor prognosis.
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-related adverse events
Time Frame: 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, also types and degree
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hao Zeng

Investigators

  • Principal Investigator: Hao Zeng, Professor, West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK104AXI-ssRCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There is a plan to make IPD and related data dictionaries available

IPD Sharing Time Frame

Data would be available starting from the time when summary data are published or otherwise made available, for 3 years.

IPD Sharing Access Criteria

Other researchers access the data by sending an email to our PI.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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