Regorafenib will be initiated at full dose (160 mg/day; 3 weeks on and 1 week off) in monotherapy for the first 8 weeks. After week 8, regorafenib will be continued in combination with nivolumab, until symptomatic tumor progression, unacceptable adverse events, patient decision or death

Hepatocellular Carcinoma

Regorafenib 160 mg/day 3 weeks on and 1 week off

Regorafenib

Nivolumab at the dose of 1.5 mg/kg, 3 mg/kg or 240 mg/infusion every 2 weeks. Dose will be adjusted depending on the incidence of adverse events

Nivolumab

Hospital Clinic

Hospital Vall d'Hebron

Hospital Gregorio Marañon

Hospital Puerta de Hierro

Hospital Ramon y Cajal

Hospital Central de Asturias

Clinica Universidad de Navarra

Regorafenib Followed by Nivolumab in Patients With Hepatocellular Carcinoma (GOING)

The GOING Study: Regorafenib Followed by Nivolumab in Patients With Hepatocellular Carcinoma Progressing Under Sorafenib

Time from the date of start of treatment until the date of objective disease progression or death

Time from the date of start of treatment until the date of objective response

Time from the date of start of treatment until the date of death

Time from the date of disease progression until the date of death

Time from the date of start of treatment until the date of objective new extra-hepatic progression

Maria Reig

Principal Investigator

Fundacion Clinic per a la Recerca Biomédica

Apices Soluciones S.L.

Gastrointestinal Stromal Tumors

imatinib mesylate

J Clin Oncol 30, 2012 (suppl; abstr e20514) (From 2012 ASCO Annual Meeting )

See results for CSTI571BIC08 at Novartis Clinical Trials Database

Novartis Investigative Site

Safety and Efficacy Evaluation of Two Year Imatinib Treatment in Adjuvant Gastrointestinal Stromal Tumor (GIST)

A Multi-center, Single Arm, Phase II Study of Adjuvant Imatinib (Glivec®) in Patients Following the Resection of Primary Gastrointestinal Stromal Tumor ( GIST)

Novartis Pharmaceuticals

Metastatic Prostate Cancer Treated With Sunitinib

Sex: Female, Male

Region of Enrollment

Prostate specific antigen (PSA) responses, defined as the number of men who exhibit PSA decline of at least 50% that is confirmed by a second PSA value 4 or more weeks later (PSA Working Group I Criteria)

The Number of Men With Advanced Prostate Cancer Treated With Sunitinib Who Have a Prostate Specific Antigen (PSA) Response

The response rate is defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions as assessed by radiographic evaluation. Complete response(CR): disappearance of all target lesions; Partial response(PR): >=30% decrease in the sum of the longest diameter of target lesions; Overall response = CR + PR.

gastrointestinal stromal tumors/diarrea

Regorafenib Followed by Nivolumab in Patients With Hepatocellular Carcinoma (GOING)

Safety and Efficacy Evaluation of Two Year Imatinib Treatment in Adjuvant Gastrointestinal Stromal Tumor (GIST)

Study of SU11248 in Men With Advanced Prostate Cancer

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