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Perioperative TORIPALIMAB Plus LENVATINIB in Patients With Renal Cell Carcinoma Undergoing Nephrectomy (PLUTO)

NCT06114940 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-03-05

No results posted yet for this study

Summary

The PLUTO-trial is a single-center, open-label, phase II trial investigating Toripalimab plus Lenvatinib in patients with multi-stage clear-cell renal cell carcinoma. In this trial, patients will be enrolled in one of three cohorts according to the stage of their clear-cell renal-cell carcinoma: localized, locally advanced and metastatic RCC. Patients in all cohorts will receive four to five cycles of preoperative Toripalimab (240mg Q3W IV) plus Lenvatinib (20mg QD PO) and will undergo nephrectomy within four weeks after the last cycle. Patients in cohort 1 who are considered to be at high risk according to pathology results of surgery specimen, and all the patients in cohort 2 are supposed to receive postoperative doses of Toripalimab (240mg Q3W IV) for at most 17 doses. Patients in cohort 3 are supposed to continue Toripalimab plus Lenvatinib after surgery.

The primary clinical endpoint of the study is immune-related pathological response to tumorigenesis, defined as the extent of tumor cell reduction in the tumor bed. Simon's two-stage design is used in this study. An initial cohort of 12 patients per cohort will be recruited, followed by an interim analysis. Recruitment to each cohort will be closed if a qualifying immune-related pathological response is not observed in any patient at an interim analysis. If qualifying immune-related pathological response is observed in at least one patient, additional 9 patients will be recruited in the cohort to 21 patients. Considering potential 10% dropout rate in the trial, an anticipation of 69 patients will be recruited for this study.

Conditions

  • Renal Cell Carcinoma (RCC)

Interventions

DRUG

Toripalimab

Preoperative: Toripalimab 240mg, IV on day 1 in a 3-week cycle. Preoperative Toripalimab contains 4-5 cycles. Postoperative: Toripalimab 240mg, IV on day 1 of a 3-week cycle. Postoperative Toripalimab following surgery within 4 weeks for patients mentioned above in cohort 1, 2 and 3.

DRUG

Lenvatinib

Preoperative: Lenvatinib 20 mg orally, QD in a 3-week cycle. Preoperative Lenvatinib contains 4-5 cycles. Postoperative: Lenvatinib 20 mg orally, QD in a 3-week cycle. Postoperative Lenvatinib following surgery within 4 weeks for patients in cohort 3. Adjustment of dose: For patients with intolerable adverse reactions (CTCAE v5.0 grade 3 or grater), the dose could be reduced to 12mg for those who were suitable to continue taking the drug after systematic evaluation by the investigator. Patients who are assessed as intolerable and not suitable for continued medication will discontinue and undergo nephrectomy within 4 weeks.

Sponsors & Collaborators

  • Jinling Hospital, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-20
Primary Completion
2026-01-10
Completion
2026-01-10
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06114940 on ClinicalTrials.gov