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Nivolumab Plus Metformin in Metastatic Renal Cell Carcinoma

NCT06884683 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-03-19

No results posted yet for this study

Summary

Phase 2 single arm study that evaluated the addition of metformin to nivolumab in pre-treated metastatic renal cell carcinoma (mRCC) patients.

Primary aim: to investigate the efficacy of the combination of nivolumab+metformin in mRCC patients previously treated with VEGFR-TKI

Secondary aims:

* to assess the activity, safety and efficacy of the experimental combination
* to assess the quality of life of enrolled patients

Enrolled patients will received:

* nivolumab 240 mg e.v. every 14 day
* metformin 500 mg orally twice a day continuously Patients will be trated untill disease progression, or unexpected toxicity, whichever comes first

Conditions

  • Metastatic Renal Cell Carcinoma

Interventions

DRUG

Metformin

Drug: metformin tablet 500 mg, 1 tablet twice a day (total dose 1000 mg daily), administered orally continuously \+ Biological: Nivolumab 240 mg via IV infusion every 14 days Other Names: Opdivo®

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Giampaolo Tortora · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-17
Primary Completion
2023-09-13
Completion
2023-09-13

Countries

  • Italy

Study Locations

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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 NCT06884683 on ClinicalTrials.gov