A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors

PHASE2CompletedINTERVENTIONAL
Enrollment

175

Participants

Timeline

Start Date

February 3, 2021

Primary Completion Date

March 9, 2023

Study Completion Date

March 29, 2024

Conditions
Solid Tumors
Interventions
DRUG

Regorafenib, (Stivarga, BAY73-4506)

"Intake orally, starting with 3x 30 mg tablets every day (once daily.) for 21 days of every 28-day cycle (21 days on, 7 days off).~If the starting dose is well tolerated dose can be escalated to 120 mg (4x30 mg tablets)."

DRUG

Nivolumab (Opdivo)

480 mg administered on Day 1 of each treatment cycle.

Trial Locations (34)

1070

Hôpital Erasme/Erasmus Ziekenhuis, Brussels

2650

UZ Antwerpen, Edegem

3080

Seoul National University Hospital, Seoul

4000

CHU de Liège, Liège

11217

Taipei Veterans General Hospital, Taipei

20089

Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia, Rozzano

20133

IRCCS Foundation Istituto Neurologico Carlo Besta, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda - Oncologia Falck, Milan

31059

Institut Claudius Regaud - iUCT Oncopole, Toulouse

33076

Institut Bergonie - Unicancer Nouvelle Aquitaine, Bordeaux

33612

Moffitt Cancer Center, Tampa

35128

Istituto Oncologico Veneto_Padova - UOC Oncologia 1, Padua

37203

Sarah Cannon Cancer Center, Nashville

40139

AUSL di Bologna_Istituto delle Scienze Neurologiche - UO Oncologia del Sistema Nervoso, Bologna

44800

Institut de Cancerologie Ouest - Saint-Herblain, Saint-Herblain

69008

UNICANCER - Centre Leon Berard (CLB), Lyon

71004

Chi Mei Medical Center, Taikang

75246

Baylor Charles A. Sammons Cancer Center at Dallas, Dallas

75651

APHP-Hopital la Pitie Salpetriere, Paris

77030

University of Texas MD Anderson Cancer Center, Houston

80012

Rocky Mountain Cancer Centers / Aurora, CO, Aurora

91010

City of Hope - Duarte Cancer Center, Duarte

94805

Gustave Roussy - Departement Oncologie-Radiotherapie, Villejuif

404327

China Medical University Hospital, Taichung

464-8681

Aichi Cancer Center Hospital, Nagoya

650-0017

Kobe University Hospital, Kobe

362-0806

Saitama Cancer Center, Kitaadachi-gun

104-0045

National Cancer Center Hospital, Chuo-ku

135-8550

The Cancer Institute Hospital of JFCR, Koto-ku

03722

Severance Hospital, Yonsei University Health System, Seoul

SM2 5PT

Royal Marsden NHS Trust (Surrey), Sutton

CV2 2DX

University Hospitals Coventry and Warwickshire NHS Trust, Coventry

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

Unknown

"The Royal Marsden NHS Foundation Trust , The Royal Marden Hospital - The Royal Marsden Clinical Trials Unit (CTU)"

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Bristol Myers Squibb Co. and Ono Pharmaceutical Co., Ltd

UNKNOWN

lead

Bayer

INDUSTRY