PLUTO: a Pilot Phase II Study of Perioperative TORIPALIMAB Plus LENVATINIB in Patients with Renal Cell Carcinoma Undergoing Nephrectomy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 five 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, an additional patients will be recruited in the cohort to 18 patients. A maximum of 54 patients will be recruited for this study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• Have fully understood and voluntarily signed the informed consent Form (ICF);

• Age: 18-80 years old (at the time of signing the informed consent); Both male and female; ECOG PS score: 0-1;

• RCC with clear cell component confirmed by histology or cytopathology, including locally advanced RCC with clear cell component;

• ECOG 0-1 points

• T1b-T2bN0M0, T3a-4N0M0, TanyN1M0 or M1RCC diagnosed by imaging at initial diagnosis:

‣ Cohort 1: T1b-T2bN0M0 RCC;

⁃ Cohort 2: T3a-4N0M0 or TanyN1M0 RCC;

⁃ Cohort 3: M1 RCC undergoing cytoreductive nephrectomy.

• Radical nephrectomy or partial nephrectomy or renal tumor enucleation was decided after the clinician made the treatment plan and communicated with the patient;

• Willingness and ability to comply with planned visits, therapeutic laboratory testing, and other procedures.

Locations
Other Locations
China
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
RECRUITING
Nanjing
Contact Information
Primary
Le Qu, M.D.
septsoul@hotmail.com
15720625951
Time Frame
Start Date: 2022-12-20
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 54
Treatments
Experimental: Toripalimab + Lenvatinib followed by nephrectomy
After 4-5 cycles of preoperative therapy, patients will undergo nephrectomy within 4 weeks. Patients with WHO/ISUP grading 4 RCC in cohort 1, and all patients of cohort 2 and 3 will receive postoperative dosing within 4 weeks for at most 17 doses. Subsequent follow-up will then be completed to assess adverse events and long-term outcomes.~Cohort 1: Localized RCC (cT1b-T2bN0M0). Nephrectomy following preoperative therapy. For patients with WHO/ISUP grading 4 RCC in the resected tumor, postoperative dosing of Toripalimab beginning within 4 weeks after surgery for at most 17 doses.~Cohort 2: Locally advanced RCC (cT3N0M0 or cTanyN1M0). Nephrectomy following preoperative therapy. Postoperative dosing of Toripalimab beginning within 4 weeks after surgery for at most 17 doses.~Cohort 3: Metastatic RCC (cT4N0M0 or M1). Cytoreductive nephrectomy following preoperative therapy. Postoperative dosing of Toripalimab plus Lenvatinib beginning within 4 weeks after surgery for at most 17 doses.
Related Therapeutic Areas
Sponsors
Leads: Jinling Hospital, China

This content was sourced from clinicaltrials.gov