Pembrolizumab Plus Lenvatinib in Stage III-IV RCC

Advanced Kidney Cancer Clinical Trial

Official title:

A Prospective Single-arm Clinical Study of Pembrolizumab Combined With Lenvatinib Neoadjuvant Therapy in Patients With Advanced Renal Cance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485896
• Other study ID #: PELUR
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2022
• Source: Tianjin Medical University Second Hospital
• Contact: Changyi Quan, MD,PhD
• Phone: 13388067990
• Email: 345920147[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase II study to determine the efficacy and safety of Pembrolizumab when given in combination with Lenvatinib as treatment for patients with the advanced kidney cancer. Further evaluate whether the treatment plan is beneficial to the patient's operation. Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles pre-operation and patients need to continue taking the drug for a year after surgery.

Description:

This is a phase II study to determine the efficacy and safety of Pembrolizumab when given in combination with Lenvatinib as treatment for patients with the advanced kidney cancer . Further evaluate whether the treatment plan is beneficial to the patient's operation.Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles pre-operation and patients need to continue taking the drug for a year after surgery. The main objective of the study was to evaluate whether the treatment was beneficial to patients undergoing surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Willing and able to provide written informed consent

2. Age = 18 years and age =75years

3. Patients with pathologically and radiographically confirmed renal cell carcinoma:

Clinical staging:cT3N0-1M0-1,cT4N0-1M0-1(III/IV stage)

4. Preoperative imaging evaluation can be performed radical excision or tumor reduction surgery

5. There are no suspected brain metastases

6. The presence of measurable lesions was assessed according to RECISTv1.1 criteria

7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

8. 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

9. 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

10. The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up

Exclusion Criteria:

1. Prior treatment with radiation, chemotherapy, long-term or high-dose hormone therapy, or immune checkpoint inhibitors

2. Previous or concurrent other malignancy

3. Previous PD-L1 or PD-L1 treatment, or allergy to PD-L1

4. History of primary immunodeficiency

5. Active, known or suspected autoimmune diseases

6. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation

7. Pregnant or lactating female patients;

8. 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;

9. Have a clear history of active tuberculosis;

10. Participating in other clinical researchers;

11. Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures;

12. 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

Related Conditions & MeSH terms

• Advanced Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• Pembrolizumab plus Lenvatinib
Pembrolizumab plus Lenvatinib

Locations

Country	Name	City	State
China	Changyi Quan	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Second Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	The proportion of patients whose tumors shrink by a certain amount and remain so for a certain amount of time	through study completion, an average of 3 year