Toripalimab Combined With Axitinib as Neoadjuvant Therapy for Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma

NCT04385654 | Unknown Phase 2 FDA Drug

• 1 other identifier: TORAXI
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-arm phase II clinical trial to evaluate the initial efficacy and safety of toripalimab combined with axitinib as neoadjuvant therapy for advanced/metastatic non-clear cell renal cell carcinoma

Conditions

Neoadjuvant Therapy; Advanced Cancer; Metastatic Kidney Cancer

Keywords

Toripalimab; Axitinib; Neoadjuvant; Advanced/Metastatic; Non-clear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• Major Pathologic Response (MPR)

  The residual tumor cells (% RVT) were calculated according to immune related pathologic response criteria (irPRC), MPR is defined as %RVT\<10%

  6 week

• Pathologic Complete Response (pCR)

  The residual tumor cells (% RVT) were calculated according to immune related pathologic response criteria (irPRC), pCR is defined as %RVT\<0%

  6 week

• Pathologic No Response (pNR)

  The residual tumor cells (% RVT) were calculated according to immune related pathologic response criteria (irPRC), pCR is defined as %RVT\>90%

  6 week

Secondary Outcomes (10)

• Objective response rate (ORR)

  6 week

• Disease-free survival(DFS)

  Up to 24 months

• Progression-free survival(PFS)

  Up to 24 months

• Overall survival(OS)

  Up to 24 months

• Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19 (FKSI-19)

  Up to 24 months

Study Arms (1)

Neoadjuvant toripalimab plus axitinib

EXPERIMENTAL

Toripalimab (240 mg,ivgtt,q3w) combined with Axitinib (5 mg,po,bid) was treated for 6 weeks and underwent surgery within 2-4 weeks

Drug: Toripalimab; Drug: Axitinib

Interventions

Toripalimab DRUG

Toripalimab (240 mg,ivgtt,q3w) was administered to patients for 6 weeks and underwent surgery within 2-4 weeks

Also known as: anti-PD-1 antibody

Neoadjuvant toripalimab plus axitinib

Axitinib DRUG

Axitinib (5 mg,po,qd) was administered to patients for 6 weeks and underwent surgery within 2-4 weeks

Also known as: TKIs

Neoadjuvant toripalimab plus axitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) age ≥18,\<75; 2) histopathological evidence of renal cell carcinoma , histological type is non-clear cell renal cell carcinoma, and meet one of the following conditions :(1) clinical T stage ≥2, or lymph node positive, or nuclear grading ≥3; (2) confirmed by imaging or pathology that distant metastasis has occurred; 3) sections with formalin-fixed paraffin blocks or at least 10 um of tissue tumor biopsy samples for biomarker exploration studies; 4) ECOG score ≤1; 5) life expectancy above 6 months; 6) sign informed consent, and be able to follow the visit and related procedures stipulated in the program; 7) agree to collect tumor tissue, blood and other specimens required by this study and apply them to relevant studies; 8)important organs and bone marrow functions meet the following requirements: absolute neutrophil count (ANC) ≥1.5×109/L, platelet (PLT) ≥100×109/L, hemoglobin (HGB) ≥9g/dL;Liver function: serum total bilirubin (TBIL) ≤1.5 times normal upper limit (ULN), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤2.5 times ULN, serum albumin (ALB) ≥ 2.8g /dL. Renal function: serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥40 mL/min; 9) cardiac function met the following conditions: baseline electrocardiogram (ECG) had no evidence of PR prolongation or AV block;

You may not qualify if:

• \) patients with other malignant tumors with different primary sites or histology from the tumor evaluated in this study within 2 years of personal history, except those with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or cervical carcinoma in situ under good control; 2) major surgery or severe trauma within 4 weeks before enrollment; 3) immunosuppressive drugs were used within 4 weeks prior to the first dose of study therapy, excluding local glucocorticoids, inhaled or otherwise, or systemic glucocorticoids at physiological doses (i.e., no more than 10mg/ d prednisone or equivalent doses of other glucocorticoids); 4) known or suspected active autoimmune diseases (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroiditis, etc. Patients with type 1 diabetes with good insulin control can also be enrolled.
• \) known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 6) allergic to any component of monoclonal antibody; 7) suffering from other uncontrolled serious diseases, including but not limited to: A) severe infection in the active phase or clinically poorly controlled; B) HIV infection (HIV antibody positive); C) acute or chronic active hepatitis b (HBsAg positive and HBV DNA\>1\*103/ml) or acute or chronic active hepatitis c (HCV antibody positive and HCV RNA\>15IU/ml); D) active tuberculosis, etc.; 8) class iii-iv congestive heart failure (New York heart association classification), poorly controlled and clinically significant arrhythmia; 9) uncontrolled arterial hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg); 10) had any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, etc. within 6 months before the selected treatment; 11) diseases requiring the use of warfarin (coumarin) for anticoagulant treatment; 12) uncontrolled hypercalcemia (more than 1.5 mmol/L of calcium or calcium greater than 12 mg/dL or adjusted serum calcium greater than ULN), or symptomatic hypercalcemia requiring continued bisphosphate treatment; 13) accompanied by other malignant tumors (except those that have been cured, such as cervical carcinoma in situ, non-melanoma skin cancer, etc.); 14) other acute or chronic diseases, psychiatric disorders, or laboratory abnormalities that may result in increased risk associated with study participation or study drug administration, or interference with the interpretation of study results, and ineligibility to participate in the study as determined by the investigator; 15) pregnant or lactating women.

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Kidney Neoplasms; Neoplasm Metastasis

Interventions

toripalimab; spartalizumab; Axitinib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 13, 2020
• Study Start: June 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share