Multi-classifier System for Stratifying Stage III Papillary Renal Cell Carcinoma of Receiving Adjuvant Therapy

NCT ID: NCT06146777

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 468 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2030-12-01

Brief Summary

The goal of this trial is to test whether patients with stage III papillary renal cell carcinoma (pRCC) could benefit from adjuvant therapy or not. The investigators invented a multi-classifier system that was successfully categorise patients with stage III pRCC into high-risk and low-risk groups. Here the investigators randomly assign classifier-defined high risk patients of stage III pRCC into adjuvant pembrolizumab group placebo group. Disease-free survival and overall survival are the end points of observation.

Detailed Description

kidney cancer represented 4.2% of all new cancer cases, and its incidence has been increasing. Over 90% of kidney cancer cases are renal cell carcinoma (RCC), which includes various subtypes with distinct histologic features, clinical courses, and responses to therapy. Clear cell renal cell carcinoma (ccRCC) and papillary renal cell carcinoma (pRCC) are the most common histologic subtypes of RCC, accounting for approximately 75% and 20% of all cases, respectively. Adjuvant pembrolizumab showed promising efficacy in ccRCC, however, whether high-risk pRCC patients could benefit from adjuvant pembrolizumab remain unknown.

Participants will be assigned to continue with the study treatment until any of the following occurs: the recurrence of the disease; the emergence of unacceptable adverse events (AEs); the presence of an intercurrent illness that precludes further administration of the treatment; the decision of the Investigator to withdraw the participant; noncompliance with the study treatment or procedural mandates; administrative reasons necessitating the discontinuation of treatment; or the completion of 17 treatment cycles (approximately one year), with each cycle 3 weeks long.

Conditions

Papillary Renal Cell Carcinoma

Keywords

Papillary renal cell carcinoma; pembrolizumab; Adjuvant therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pembrolizumab

Participants receive pembrolizumab 200 mg on Day 1 of each 3-week cycle for up to 17 cycles.

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: DRUG

Intravenous infusion

Placebo

Participants receive intravenous placebo on Day 1 of each 3-week cycle for up to 17 cycles.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intravenous infusion

Interventions

Pembrolizumab

Intravenous infusion

Intervention Type: DRUG

Placebo

Intravenous infusion

Intervention Type: DRUG

Other Intervention Names

KEYTRUDA®; MK-3475; SCH 900475; saline solution

Eligibility Criteria

Inclusion Criteria

• Histological confirmation of pRCC
• With confirmed diagnosis of stage III pRCC
• Classified as high-risk by multi-classifier system
• With moderate/good Eastern Cooperative Oncology Group (ECOG) health rating (PS): 0-1 score.
• Receive radical operation for renal cancer with negative margin.
• Receive no anti-cancer treatment before primary surgery.
• The informed consent has been obtained from the patient.

Exclusion Criteria

• Patients with Transcription factor enhancer 3(TFE3) or transcription factor EB (TFEB) translocation proven by cytogenetic analysis or by fluorescence in situ hybridization (FISH)
• Previously received neoadjuvant therapy
• With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
• With bad compliance or contraindication to enrollment.
• Pregnant woman or lactating woman.
• With contraindication to receive pembrolizumab, such as had a prior solid organ transplant, has a known history of human immunodeficiency virus infection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Jun-Hang Luo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun-Hang Luo, M.D.

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Central Contacts

Jun-Hang Luo, M.D.

Role: CONTACT

Phone: +862087755766

Email: luojunh@mail.sysu.edu.cn

Other Identifiers

FirstSunYatSen20231101

Identifier Type: -

Identifier Source: org_study_id