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Trial Title:
Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2)
NCT ID:
NCT05522231
Condition:
Advanced Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Everolimus
Axitinib
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
fruquintinib+sintilimab
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 group label:
Investigational arm
Other name:
HMPL-013 + IBI308
Intervention type:
Drug
Intervention name:
axitinib / everolimus
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.
Arm group label:
Control arm (comparator)
Intervention type:
Drug
Intervention name:
fruquintinib
Description:
fruquintinib, 5 mg, QD, PO, 3 weeks on/ 1 week off, 4 weeks/cycle.
Arm group label:
Fruquintinib monotherapy factorial study
Other name:
HMPL-013
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.
Criteria for eligibility:
Criteria:
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. Had previously received therapy targeting immune modulatory receptors or related
pathways (including but not limited to therapy targeting PD-1, CTLA-4, IDO, PD-L1,
LAG-3, TIGIT, IL-2R and GITR, etc, but excluding related cytokine therapy such as
IL2), excluding patients who had received immunotherapy such as anti-PD- (L) 1
antibody in adjuvant/neoadjuvant therapy setting and did not progress within 6
months after discontinuation;
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. Toxicities caused by prior anti-tumor therapy before the first dose that did not
recover to Grade 0 or 1 per the National Cancer Institute Common Terminology
Criteria for Adverse events (NCI CTCAE) v5.0 or to the level specified in the
enrollment criteria (excluding alopecia and peripheral neurotoxicities ≤CTCAE Grade
2 caused by platinum-based chemotherapy; thyroid dysfunction with stable disease
control after symptomatic treatment);
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Dingwei Ye
Start date:
October 27, 2022
Completion date:
March 2025
Lead sponsor:
Agency:
Hutchison Medipharma Limited
Agency class:
Industry
Source:
Hutchmed
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05522231
