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Regorafenib and Nivolumab Simultaneous Combination Therapy

NCT03406871 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-01-24

Study results available
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Summary

the efficacy and safety ofhe use of regorafenib in combination with nivolumab

Conditions

  • Advanced and Metastatic Solid Tumor

Interventions

DRUG

Regorafenib

One course will last 28 days. Oral administration for 21 consecutive days, with a 1-week washout period. As for the expansion cohort, implemented using the RD estimated in the dose-escalation cohort.

DRUG

Nivolumab

One course will last 28 days. Given once every 2 weeks at a dose of 3.0 mg/kg.

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    collaborator INDUSTRY

  • Bayer Yakuhin, Ltd.

    collaborator INDUSTRY

  • Kohei Shitara

    lead OTHER

Principal Investigators

  • Kohei Shitara, Dr · National Cancer Center Hospital East

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2020-12-15
Completion
2020-12-15

Countries

  • Japan

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 NCT03406871 on ClinicalTrials.gov