NCT06146777

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
468

participants targeted

Target at P50-P75 for phase_3

Timeline
55mo left

Started Dec 2023

Longer than P75 for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Dec 2023Dec 2030

First Submitted

Initial submission to the registry

November 20, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

7 years

First QC Date

November 20, 2023

Last Update Submit

November 24, 2023

Conditions

Papillary Renal Cell Carcinoma

Keywords

Papillary renal cell carcinomapembrolizumabAdjuvant therapy

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    Disease free survival (DFS) was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death.

    From the date of registration to up to 7 years

Secondary Outcomes (1)

  • Overall survival

    From the date of registration to up to 7 years

Study Arms (2)

Pembrolizumab

EXPERIMENTAL

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

Drug: Pembrolizumab

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

PembrolizumabDRUG

Intravenous infusion

Also known as: KEYTRUDA®, MK-3475, SCH 900475
Pembrolizumab
PlaceboDRUG

Intravenous infusion

Also known as: saline solution
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

pembrolizumabSaline Solution

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Jun-Hang Luo, M.D.

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun-Hang Luo, M.D.

CONTACT

+862087755766luojunh@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 27, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

November 29, 2023

Record last verified: 2023-11