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Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma

Primary Purpose

Advanced Renal Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
fruquintinib+sintilimab
axitinib / everolimus
fruquintinib
Sponsored by
Hutchison Medipharma Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Renal Cell Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 18 to 75 (inclusive) years of age on the date when ICF was signed;
  2. Histologically or cytologically confirmed renal clear cell carcinoma;
  3. Patients with locally advanced/metastatic renal carcinoma;
  4. Patients with renal carcinoma who progressed during or after or intolerant to previous first-line VEGFR-TKI therapy for advanced/metastatic disease;
  5. At least 1 measurable lesion according to RECIST 1.1;
  6. ECOG PS of 0 or 1;
  7. Adequate organ function.

Exclusion Criteria:

  1. For patients in the first part of the randomized controlled study: has previously received therapy targeting immune modulatory receptors or related pathways;
  2. Receiving approved systemic anti-tumor therapy within 2 weeks prior to the first dose;
  3. Toxicities caused by prior anti-tumor therapy before the first dose that did not recover to Grade 0 or 1 per the NCI CTCAE v5.0 or to the level specified in the enrollment criteria (excluding alopecia and peripheral neurotoxicity ≤ CTCAE Grade 2);
  4. Immunosuppression medication within 4 weeks prior to randomization;
  5. Patients with active autoimmune or inflammatory diseases;
  6. Known central nervous system (CNS) metastasis;
  7. History of pneumonitis requiring corticosteroid therapy, or history of or current interstitial lung disease, or current active pulmonary infection, etc.;
  8. Known clinically significant history of hepatopathy, including active hepatitis virus infection, or other active hepatitis, clinically significant moderate to severe liver cirrhosis;
  9. Human Immunodeficiency Virus (HIV) Infection (HIV 1/2 Antibody positive);
  10. Uncontrolled hypertension despite standard therapy;
  11. Patient with evidence or history of haemorrhagic tendency within 2 months prior to the first dose, regardless of severity.

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Investigational arm

Control arm (comparator)

Fruquintinib monotherapy factorial study

Arm Description

fruquintinib, 5 mg, QD, PO, 2 weeks on/1 week off, 3 weeks/cycle; sintilimab, 200 mg, IV infusion, Q3W, 3 weeks/cycle.

axitinib, 5 mg, twice daily (BID), PO, 3 weeks/cycle, dose escalation will be at the investigator 's discretion ;Everolimus, 10 mg, QD, PO, 3 weeks/cycle.

fruquintinib, 5 mg, QD, PO, 3 weeks on/ 1 week off, 4 weeks/cycle.

Outcomes

Primary Outcome Measures

Progression free survival (PFS) in Part I
PFS per RECIST 1.1 by BIRC
Objective response rate (ORR) in Part II
ORR per RECIST 1.1 by investigator

Secondary Outcome Measures

PFS
PFS per RECIST 1.1
Safety in Part I
Severity and Incidence of Adverse event (AEs) and findings in Laboratory test, vital signs, 12-lead Electrocardiogram (ECG), etc. in Part I
Quality of life in Part I
Quality of life Questionnare analysis in Part I
Safety in Part II
Severity and incidence of AEs and findings in such as Laboratory test, vital signs, 12-lead ECG, etc. in Part II.
Disease control rate (DCR)
PFS per RECIST 1.1
ORR
ORR per RECIST 1.1
Duration of response (DoR)
DoR per RECIST 1.1
Time to Response (TTR)
TTR per RECIST 1.1
OS
OS

Full Information

First Posted
August 16, 2022
Last Updated
July 9, 2023
Sponsor
Hutchison Medipharma Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05522231
Brief Title
Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma
Official Title
A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Fruquintinib in Combination With Sintilimab Versus Axitinib or Everolimus as Second-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hutchison Medipharma Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study consists of two parts, the first part is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus montherapy as second-line treatment for locally advanced or metastatic renal cell carcinoma. The second part is a fruquintinib montherapy factorial cohort study to evaluate the efficacy and safety of fruquintinib monotherapy as for second-line treatment of locally advanced or metastatic renal cell carcinoma.
Detailed Description
The target populations for this study were patients with histologically or cytologically confirmed, locally advanced/ metastatic renal cell carcinoma who progressed during or after or intolerant to previous first-line VEGFR-TKI therapy. A total of about 249-264 patients are planned to be enrolled in the study, among whom about 234 patients are planned to be enrolled in the first part. The patients who are successfully enrolled will be randomly assigned into the investigational arm or the control arm in a 1:1 ratio. The enrollment of part 2 will be started after that of part 1 is completed. About 15~30 patients are planned to be enrolled in the second part. The patients who are successfully enrolled will receive fruquintinib monotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Renal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational arm
Arm Type
Experimental
Arm Description
fruquintinib, 5 mg, QD, PO, 2 weeks on/1 week off, 3 weeks/cycle; sintilimab, 200 mg, IV infusion, Q3W, 3 weeks/cycle.
Arm Title
Control arm (comparator)
Arm Type
Active Comparator
Arm Description
axitinib, 5 mg, twice daily (BID), PO, 3 weeks/cycle, dose escalation will be at the investigator 's discretion ;Everolimus, 10 mg, QD, PO, 3 weeks/cycle.
Arm Title
Fruquintinib monotherapy factorial study
Arm Type
Other
Arm Description
fruquintinib, 5 mg, QD, PO, 3 weeks on/ 1 week off, 4 weeks/cycle.
Intervention Type
Drug
Intervention Name(s)
fruquintinib+sintilimab
Other Intervention Name(s)
HMPL-013 + IBI308
Intervention Description
fruquintinib, 5 mg, QD, PO, 2 weeks on/1 week off, 3 weeks/cycle; sintilimab, 200 mg, IV infusion, Q3W, 3 weeks/cycle.
Intervention Type
Drug
Intervention Name(s)
axitinib / everolimus
Intervention Description
axitinib, 5 mg, twice daily (BID), PO, 3 weeks/cycle, dose escalation will be at the investigator 's discretion based on clinical; everolimus, 10 mg, QD, PO, 3 weeks/cycle.
Intervention Type
Drug
Intervention Name(s)
fruquintinib
Other Intervention Name(s)
HMPL-013
Intervention Description
fruquintinib, 5 mg, QD, PO, 3 weeks on/ 1 week off, 4 weeks/cycle.
Primary Outcome Measure Information:
Title
Progression free survival (PFS) in Part I
Description
PFS per RECIST 1.1 by BIRC
Time Frame
Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
Title
Objective response rate (ORR) in Part II
Description
ORR per RECIST 1.1 by investigator
Time Frame
Time from the date of first treatment administration until disease progression or the introduction of a new treatment, assessed up to 20 months.
Secondary Outcome Measure Information:
Title
PFS
Description
PFS per RECIST 1.1
Time Frame
Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
Title
Safety in Part I
Description
Severity and Incidence of Adverse event (AEs) and findings in Laboratory test, vital signs, 12-lead Electrocardiogram (ECG), etc. in Part I
Time Frame
Through study completion, assessed up to 20 months.
Title
Quality of life in Part I
Description
Quality of life Questionnare analysis in Part I
Time Frame
Through study completion, assessed up to 20 months.
Title
Safety in Part II
Description
Severity and incidence of AEs and findings in such as Laboratory test, vital signs, 12-lead ECG, etc. in Part II.
Time Frame
Through study completion, assessed up to 20 months.
Title
Disease control rate (DCR)
Description
PFS per RECIST 1.1
Time Frame
Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
Title
ORR
Description
ORR per RECIST 1.1
Time Frame
Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
Title
Duration of response (DoR)
Description
DoR per RECIST 1.1
Time Frame
Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
Title
Time to Response (TTR)
Description
TTR per RECIST 1.1
Time Frame
Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
Title
OS
Description
OS
Time Frame
Time from date of randomization until the date of death from any cause, assessed up to 20 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 to 75 (inclusive) years of age on the date when ICF was signed; Histologically or cytologically confirmed renal clear cell carcinoma; Patients with locally advanced/metastatic renal carcinoma; Patients with renal carcinoma who progressed during or after or intolerant to previous first-line VEGFR-TKI therapy for advanced/metastatic disease; At least 1 measurable lesion according to RECIST 1.1; ECOG PS of 0 or 1; Adequate organ function. Exclusion Criteria: Had previously received therapy targeting immune modulatory receptors or related pathways; Receiving approved systemic anti-tumor therapy within 2 weeks prior to the first dose; Toxicities caused by prior anti-tumor therapy before the first dose that did not recover to Grade 0 or 1 per the NCI CTCAE v5.0 or to the level specified in the enrollment criteria (excluding alopecia and peripheral neurotoxicity ≤ CTCAE Grade 2); Immunosuppression medication within 4 weeks prior to randomization; Patients with active autoimmune or inflammatory diseases; Known central nervous system (CNS) metastasis; History of pneumonitis requiring corticosteroid therapy, or history of or current interstitial lung disease, or current active pulmonary infection, etc.; Known clinically significant history of hepatopathy, including active hepatitis virus infection, or other active hepatitis, clinically significant moderate to severe liver cirrhosis; Human Immunodeficiency Virus (HIV) Infection (HIV 1/2 Antibody positive); Uncontrolled hypertension despite standard therapy; Patient with evidence or history of haemorrhagic tendency within 2 months prior to the first dose, regardless of severity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Wang
Phone
18058125909
Email
yuwang@hutch-med.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dingwei Ye
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dingwei Ye

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma

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