Tislelizumab Plus Lenvatinib in Stage III-IV RCC

NCT05485883 | Unknown Phase 2 DMC

• 1 other identifier: TILUR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II study to determine the efficacy and safety of Tislelizumab when given in combination with Lenvatinib as treatment for patients with the advanced kidney cancer . Patients will receive treatment with Tislelizumab in combination with Lenvatinib every 3 weeks unitl tumor progression or serious side effects

Conditions

Advanced Kidney Cancer

Keywords

Tislelizumab Lenvatinib

Outcome Measures

Primary Outcomes (2)

• PFS

  Duration from patient enrollment to disease progression

  assessed up to 4 years

• DCR

  PerPercentage of evaluable cases in which patients were in remission or stable after treatmen

  assessed up to 4 years

Study Arms (1)

Advanced Renal Cell

EXPERIMENTAL

Patients will receive treatment with Tislelizumab every 3 weeks,and take Lenvatinib 8mg every day

Drug: Tislelizumab Lenvatinib

Interventions

Tislelizumab Lenvatinib DRUG

Patients will receive treatment with Tislelizumab in combination with Lenvatinib every 3 weeks unitl tumor progression or serious side effects

Advanced Renal Cell

Eligibility Criteria

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

You may qualify if:

• Willing and able to provide written informed consent
• Age ≥ 18 years
• Subjects with pathologically and radiologically confirmed renal cell carcinoma: Stage III/IV
• There are no suspected brain metastases
• There are lesions that can be measured by imaging
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
• Organ function level must meet the following requirements:
• Hematological indexes: neutrophil count \>= 1.5x10\^9/L, platelet count \>= 100x10\^9/L, hemoglobin \>= 9.0 g/dl (can be maintained by blood transfusion); Liver function: total bilirubin \<=1.5 ULN, alanine aminotransferase and aspartate aminotransferase \<=1.5 ULN
• Women were required to use an effective contraceptive method for three months after the end of the study, and men were required to consent to use an effective contraceptive method with their spouse during and for three months after the end of the study
• The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up

You may not qualify if:

• Prior treatment with radiation, chemotherapy, long-term or high-dose hormone therapy, or immune checkpoint inhibitors
• Previous or concurrent other malignancy
• Previous PD-L1 or PD-L1 treatment, or allergy to PD-L1
• History of primary immunodeficiency
• Active, known or suspected autoimmune diseases
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
• Pregnant or lactating female patients;
• Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions;
• Have a clear history of active tuberculosis;
• Participating in other clinical researchers;
• Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures;
• Uncontrolled concurrent diseases, including but not limited to:
• HIV infected (HIV antibody positive); Severe infection in active stage or poorly controlled; Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension \[i.e. hypertension greater than or equal to CTCAE grade 2 after drug treatment\]); Patients with active bleeding or new thrombotic disease

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Changyi Quan

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

Study Officials

• Changyi Quan, MD,PhD

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changyi Quan, MD,PhD

CONTACT

13388067990; 345920147@qq.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: July 25, 2022
• First Posted: August 3, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: August 8, 2022

Record last verified: 2022-07

Locations

CN (1)