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Pembrolizumab Plus Lenvatinib in Stage III-IV RCC

Primary Purpose

Advanced Kidney Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pembrolizumab plus Lenvatinib
Sponsored by
Tianjin Medical University Second Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Kidney Cancer focused on measuring Pembrolizumab; Lenvatinib; Advanced Renal Cell Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Changyi QuanRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Advanced Renal Cell

Arm Description

Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles in the preoperation and patients need to continue taking the drug for a year after surgery.

Outcomes

Primary Outcome Measures

ORR
The proportion of patients whose tumors shrink by a certain amount and remain so for a certain amount of time

Secondary Outcome Measures

Full Information

First Posted
July 25, 2022
Last Updated
August 4, 2022
Sponsor
Tianjin Medical University Second Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05485896
Brief Title
Pembrolizumab Plus Lenvatinib in Stage III-IV RCC
Official Title
A Prospective Single-arm Clinical Study of Pembrolizumab Combined With Lenvatinib Neoadjuvant Therapy in Patients With Advanced Renal Cance
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Second Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Kidney Cancer
Keywords
Pembrolizumab; Lenvatinib; Advanced Renal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Advanced Renal Cell
Arm Type
Experimental
Arm Description
Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles in the preoperation and patients need to continue taking the drug for a year after surgery.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab plus Lenvatinib
Intervention Description
Pembrolizumab plus Lenvatinib
Primary Outcome Measure Information:
Title
ORR
Description
The proportion of patients whose tumors shrink by a certain amount and remain so for a certain amount of time
Time Frame
through study completion, an average of 3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing and able to provide written informed consent Age ≥ 18 years and age ≤75years Patients with pathologically and radiographically confirmed renal cell carcinoma: Clinical staging:cT3N0-1M0-1,cT4N0-1M0-1(III/IV stage) Preoperative imaging evaluation can be performed radical excision or tumor reduction surgery There are no suspected brain metastases The presence of measurable lesions was assessed according to RECISTv1.1 criteria 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changyi Quan, MD,PhD
Phone
13388067990
Email
345920147@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changyi Quan, MD,PhD
Organizational Affiliation
Tianjin Medical University Second Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changyi Quan
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300211
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changyi Quan, PhD
Phone
13388067990
Email
345920147@qq.com

12. IPD Sharing Statement

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Pembrolizumab Plus Lenvatinib in Stage III-IV RCC

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