A Study to Evaluate Efficacy and Safety of Lenvatinib Combined With Tislelizumab in Patients With FHRCC

NCT05877820 | Unknown Phase 2

• 1 other identifier: LENTIS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

FHRCC is a rare kind of renal cell carcinoma with a morbidity of 1/2000000 per year.Although several combination therapies demonstrated possible efficacy in this population. No standard treatment has been approved. The purpose of this study is to evaluate the efficacy and safety of Lenvatinib in combination with tislelizumab in the first line treatment of patients with locally advanced/metastatic FHRCC.

Conditions

Fumarate Hydratase Deficient Renal Cell Carcinoma

Keywords

PD-1 checkpoint inhibitor; FHRCC

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1.

  Up to approximately 24 months

Secondary Outcomes (7)

• Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  Up to approximately 24 months

• Overall Survival (OS)

  Up to approximately 24 months

• Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  Up to approximately 24 months

• Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  Up to approximately 24 months

• Overall Survival (OS) Rate at Month 12 in All Participants

  Month 12

Study Arms (1)

Tislelizumab+Lenvatinib combination therapy

EXPERIMENTAL

Participants receive tislelizumab 200 mg intravenously every 3 weeks PLUS lenvatinib 20mg orally once daily.

Biological: Tislelizumab; Drug: Lenvatinib

Interventions

Tislelizumab BIOLOGICAL

Intravenous infusion

Tislelizumab+Lenvatinib combination therapy

Lenvatinib DRUG

Oral tablet

Tislelizumab+Lenvatinib combination therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand and voluntarily sign the informed consent form and agree to receive treatment, examination and follow-up as required by the study protocol;
• Age ≥ 18, \< 80 years, male or female;
• ECOG score ≤2;
• unresectable or recurrent metastatic FH-deficient renal cell carcinoma not previously treated with systemic antitumor therapy, as confirmed by histology. Prior cytokine therapy is allowed;
• At least 1 measurable tumor lesion according to RECIST 1.1 criteria. The lesion that has received prior radiotherapy and progressed again is allowed as a target lesion;
• agree to provide blood and urine samples and previous archived or fresh tumor tissue samples.
• Demonstrates adequate organ function.
• Female subjects of childbearing potential must have a negative serum pregnancy test result within 7 days prior to the first dose. participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of study drug.

You may not qualify if:

• Prior treatment with agents targeting VEGF, VEGFR, or mTOR, including but not limited to sunitinib, axitinib, pazopanib, sorafenib, cabozantinib, lenvatinib, bevacizumab, anlotinib, or everolimus;
• Prior treatment with anti-PD-1, PD-L1 or CTLA-4 antibodies;
• Participants who are using other investigational agents or who had received investigational drugs \<=4 weeks prior to study treatment start;
• Received major surgery or is recovering from surgery (as judged by the investigator) within 4 weeks;
• Received Chinese herbal or proprietary Chinese medicine preparation with an antitumor indication within 2 weeks;
• Requirement of adrenocorticosteroids (\>10 mg prednisone or equivalent daily) or other immunosuppressive systemic therapy within 2 week; inhalation of \>10 mg prednisone or equivalent daily, but without active autoimmune disease may participate in this study;
• History of organ transplantation or conditions requiring long-term adrenocorticosteroid or immunosuppressive therapy
• Hypothyroidism, adrenal or pituitary gland function that can be controlled with hormone replacement therapy, type I diabetes mellitus, psoriasis or vitiligo that do not require systemic therapy may be enrolled in the study;
• The presence of other malignancies that have progressed or require treatment within 5 years (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or cured carcinoma in situ, such as carcinoma in situ of the breast, prostate cancer: subjects with limited low-risk prostate cancer (≤ T2a, Gleason score ≤ 6, PSA \< 10ng/ml) who have received radical treatment and no PSA biochemical (those with recurrence may participate in this study);
• History of active central nervous system (CNS) metastases or baseline phase imaging showing CNS metastases within 30 days prior to the first dose. Subjects with prior surgical or radiation treatment for brain or meningeal metastases who have maintained clinical stability for ≥ 3 months by screening and have discontinued systemic hormone therapy (dose \> 10 mg/day of prednisone or other equivalent hormone) for \> 4 weeks may be enrolled. Subjects may be enrolled in this study if the subject's CNS metastases can be treated to meet the requirements of the enrollment criteria and if the subject's CNS symptoms have returned to ≤ grade 1 for at least 2 weeks prior to enrollment (except for residual signs or symptoms related to CNS treatment);
• Poorly controlled hypertension: SBP ≥ 150 mmHg and/or DBP ≥ 90 mmHg;
• Any one or more of the following cardiovascular disease states within the last 6 months: myocardial infarction; unstable angina; endoluminal angioplasty or coronary stenting; coronary/peripheral artery bypass graft; NYHA cardiac function class 3-4; congestive heart failure; cerebrovascular accident including transient ischemic attack;
• Heart rate corrected QT interval (QTc) ≥ 480 ms;
• History of active bleeding or other severe bleeding within 1 month;
• Deep vein thrombosis or pulmonary embolism within 6 months;

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Ethics Committee of Shanghai Renji Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Interventions

tislelizumab; lenvatinib

Central Study Contacts

Yunze Xu, PhD

CONTACT

+8618801967501; rjxuyunze@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 26, 2023
• Study Start: June 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)