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An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer (CheckMate040)

Primary Purpose

Hepatocellular Carcinoma

Status

Active

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Nivolumab

Sorafenib

Ipilimumab

Cabozantinib

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Subjects of 18 years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
Dose Escalation Phase: Child-Pugh score of 7 points or less. Cohort 5: Child-Pugh Class B (B7-B8). For all other cohorts Child-Pugh score of 6 points or less

Exclusion Criteria:

History of autoimmune disease
Any prior or current clinically significant ascites
Any history of hepatic encephalopathy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Non-infected: Nivolumab

HCV-infected: Nivolumab

HBV-infected: Nivolumab

Nivolumab

Sorafenib

Nivolumab plus Ipilimumab Combination

Child-Pugh B

Nivolumab plus Cabozantinib Combination

Nivolumab plus Ipilimumab plus Cabozantinib

Arm Description

Nivolumab intravenous solution on specific days

Sorafenib tablets on specific days

Nivolumab intravenous solution + Ipilimumab intravenous solution on specific days

Nivolumab intravenous solution on specific days

Nivolumab intravenous solution + cabozantinib oral tablets on specific days

Nivolumab intravenous solution + Ipilimumab intravenous solution + cabozantinib oral tablets on specific days

Outcomes

Primary Outcome Measures

Safety of nivolumab as evaluated by incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities

Tolerability of nivolumab as evaluated by incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities

Objective response rate (ORR) for Expansion phase of nivolumab

ORR for Nivolumab vs Sorafenib Cohort

Safety of nivolumab plus ipilimumab as evaluated by incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities

Tolerability of nivolumab plus ipilimumab as evaluated by incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities

ORR for Nivolumab plus Ipilimumab Combination Cohort

ORR for Child-Pugh B Cohort

Safety of nivolumab plus ipilimumab plus cabozantinib as evaluated by incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities

Tolerability of nivolumab plus ipilimumab plus cabozantinib as evaluated by incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities

ORR for Nivolumab plus Ipilimumab plus Cabozantinib Combination Cohort

Secondary Outcome Measures

Complete response (CR) Rate

The proportion of subjects whose best overall response (BOR) is CR in the population of interest

Disease control rate (DCR)

The proportion of subjects whose BOR is CR, Partial response (PR) or stable disease (SD) in the population of interest

Duration of response (DOR)

It is defined as time between the date of first radiographic documented objective response and the date of the radiographic disease progression.

Time to response (TTR)

It is defined as the time from randomization to the date of the first confirmed CR or PR for the 1L Nivolumab vs Sorafenib Cohort, and from the first dosing date of any study medication to the date of the first confirmed CR or PR for all other cohorts.

Time to progression (TTP)

It is defined from the date randomization to the date of the first objectively documented disease progression.

TTP Rate

It is defined as the K-M estimated proportion of subjects without progression at select milestones.

Progression free survival (PFS)

PFS is defined as the time from randomization date to the date of the first objectively documented tumor progression or death due to any cause

Overall survival (OS)

It is defined as the time from date of randomization to the date of death

Overall survival rate (OSR)

It is defined as the K-M estimated proportion of subjects surviving at select milestones.

PD-L1 expression

Maximum observed serum concentration (Cmax) of nivolumab

Time of maximum observed serum concentration (Tmax) of nivolumab

Area under the serum concentration time curve in the dosing interval AUC(TAU) of nivolumab

Serum concentration achieved at the end of dosing interval (trough concentration) (Ctrough) of nivolumab

Serum concentration achieved at the end of the infusion (Ceoinf) of nivolumab

Cmax at Cycle 3/ Cmax at Cycle 1 (AI_Cmax) of nivolumab

AUC(TAU) at Cycle 3/ AUC(TAU) at Cycle 1 (AI_AUC) of nivolumab

Effective T-Half of nivolumab

Full Information

NCT ID

NCT01658878

First Posted

August 3, 2012

Last Updated

September 14, 2023

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01658878

Brief Title

An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer

Acronym

CheckMate040

Official Title

A Phase 1/2, Dose-escalation, Open-label, Non-comparative Study of Nivolumab or Nivolumab in Combination With Ipilimumab in Advanced Hepatocellular Carcinoma Subjects With or Without Chronic Viral Hepatitis; and a Randomized, Open-label Study of Nivolumab vs Sorafenib in Advanced Hepatocellular Carcinoma Subjects Who Are Naive to Systemic Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 30, 2012 (Actual)

Primary Completion Date

December 28, 2023 (Anticipated)

Study Completion Date

December 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The first part of the study is the Dose Escalation Phase designed to establish the safety of nivolumab at different dose levels for each of the three cohorts (uninfected hepatocellular carcinoma (HCC) subjects, hepatitis C virus (HCV)-infected HCC subjects, and hepatitis B virus (HBV)-infected subjects). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses for each of the 3 cohorts. A third cohort has been added in this study to compare the efficacy of nivolumab and sorafenib in the treatment of Advanced HCC. A fourth cohort will generate data on the safety and efficacy of the combination nivolumab plus ipilimumab in the treatment of Advanced HCC. In the fifth cohort, additional clinical data will be generated for Child-Pugh B subjects. A Cabozantinib Combination Cohort has been added to evaluate the safety and tolerability of nivolumab in combination with cabozantinib and nivolumab with ipilimumab in combination with cabozantinib.

Detailed Description

Study Classification: Pharmacokinetics/Pharmacodynamics

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

659 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Non-infected: Nivolumab

Arm Type

Experimental

Arm Description

Nivolumab intravenous solution on specific days

Arm Title

HCV-infected: Nivolumab

Arm Type

Experimental

Arm Description

Nivolumab intravenous solution on specific days

Arm Title

HBV-infected: Nivolumab

Arm Type

Experimental

Arm Description

Nivolumab intravenous solution on specific days

Arm Title

Nivolumab

Arm Type

Experimental

Arm Description

Nivolumab intravenous solution on specific days

Arm Title

Sorafenib

Arm Type

Active Comparator

Arm Description

Sorafenib tablets on specific days

Arm Title

Nivolumab plus Ipilimumab Combination

Arm Type

Experimental

Arm Description

Nivolumab intravenous solution + Ipilimumab intravenous solution on specific days

Arm Title

Child-Pugh B

Arm Type

Experimental

Arm Description

Nivolumab intravenous solution on specific days

Arm Title

Nivolumab plus Cabozantinib Combination

Arm Type

Experimental

Arm Description

Nivolumab intravenous solution + cabozantinib oral tablets on specific days

Arm Title

Nivolumab plus Ipilimumab plus Cabozantinib

Arm Type

Experimental

Arm Description

Nivolumab intravenous solution + Ipilimumab intravenous solution + cabozantinib oral tablets on specific days

Intervention Type

Biological

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

BMS-936558

Intervention Type

Drug

Intervention Name(s)

Sorafenib

Intervention Type

Drug

Intervention Name(s)

Ipilimumab

Intervention Type

Drug

Intervention Name(s)

Cabozantinib

Primary Outcome Measure Information:

Title

Safety of nivolumab as evaluated by incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities

Time Frame

100 days after last dose

Title

Time Frame

100 days after last dose

Title

Objective response rate (ORR) for Expansion phase of nivolumab

Time Frame

Approximately 6 months minimum follow-up

Title

ORR for Nivolumab vs Sorafenib Cohort

Time Frame

Approximately 6 months minimum follow-up

Title

Time Frame

100 days after last dose

Title

Time Frame

100 days after last dose

Title

ORR for Nivolumab plus Ipilimumab Combination Cohort

Time Frame

Approximately 6 months minimum follow-up

Title

ORR for Child-Pugh B Cohort

Time Frame

Approximately 6 months minimum follow-up

Title

Time Frame

100 days after last dose

Title

Time Frame

100 days after last dose

Title

ORR for Nivolumab plus Ipilimumab plus Cabozantinib Combination Cohort

Time Frame

Approximately 6 months minimum follow-up

Secondary Outcome Measure Information:

Title

Complete response (CR) Rate

Description

The proportion of subjects whose best overall response (BOR) is CR in the population of interest

Time Frame

Approximately 6 months minimum follow-up

Title

Disease control rate (DCR)

Description

The proportion of subjects whose BOR is CR, Partial response (PR) or stable disease (SD) in the population of interest

Time Frame

Approximately 6 months minimum follow-up

Title

Duration of response (DOR)

Description

It is defined as time between the date of first radiographic documented objective response and the date of the radiographic disease progression.

Time Frame

Approximately 9 years

Title

Time to response (TTR)

Description

Time Frame

Approximately 6 months

Title

Time to progression (TTP)

Description

It is defined from the date randomization to the date of the first objectively documented disease progression.

Time Frame

Approximately 9 years

Title

TTP Rate

Description

It is defined as the K-M estimated proportion of subjects without progression at select milestones.

Time Frame

Approximately 9 years

Title

Progression free survival (PFS)

Description

PFS is defined as the time from randomization date to the date of the first objectively documented tumor progression or death due to any cause

Time Frame

Approximately 9 years

Title

Overall survival (OS)

Description

It is defined as the time from date of randomization to the date of death

Time Frame

100 days after last dose

Title

Overall survival rate (OSR)

Description

It is defined as the K-M estimated proportion of subjects surviving at select milestones.

Time Frame

100 days after last dose

Title

PD-L1 expression

Time Frame

Approximately 6 months

Title

Maximum observed serum concentration (Cmax) of nivolumab

Time Frame

Approximately 6 months

Title

Time of maximum observed serum concentration (Tmax) of nivolumab

Time Frame

Approximately 6 months

Title

Area under the serum concentration time curve in the dosing interval AUC(TAU) of nivolumab

Time Frame

Approximately 6 months

Title

Serum concentration achieved at the end of dosing interval (trough concentration) (Ctrough) of nivolumab

Time Frame

Approximately 6 months

Title

Serum concentration achieved at the end of the infusion (Ceoinf) of nivolumab

Time Frame

Approximately 6 months

Title

Cmax at Cycle 3/ Cmax at Cycle 1 (AI_Cmax) of nivolumab

Time Frame

Approximately 6 months

Title

AUC(TAU) at Cycle 3/ AUC(TAU) at Cycle 1 (AI_AUC) of nivolumab

Time Frame

Approximately 6 months

Title

Effective T-Half of nivolumab

Time Frame

Approximately 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Subjects of 18 years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 Dose Escalation Phase: Child-Pugh score of 7 points or less. Cohort 5: Child-Pugh Class B (B7-B8). For all other cohorts Child-Pugh score of 6 points or less Exclusion Criteria: History of autoimmune disease Any prior or current clinically significant ascites Any history of hepatic encephalopathy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution - 0008

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Local Institution - 0048

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Local Institution - 0053

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32504

Country

United States

Facility Name

Local Institution - 0047

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Local Institution - 0025

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Univ Of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-5331

Country

United States

Facility Name

Local Institution - 0054

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Local Institution - 0067

City

Paterson

State/Province

New Jersey

ZIP/Postal Code

07503

Country

United States

Facility Name

Local Institution - 0001

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

The University Of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Local Institution - 0065

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B4H 2Y9

Country

Canada

Facility Name

Local Institution - 0039

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Local Institution - 0022

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2X 3E4

Country

Canada

Facility Name

Local Institution - 0061

City

Angers

ZIP/Postal Code

49933

Country

France

Facility Name

Local Institution - 0064

City

Creteil Cedex

ZIP/Postal Code

94010

Country

France

Facility Name

Local Institution - 0059

City

Marseille Cedex 5

ZIP/Postal Code

13385

Country

France

Facility Name

Local Institution - 0062

City

Marseille Cedex 9

ZIP/Postal Code

13273

Country

France

Facility Name

Local Institution - 0042

City

Paris Cedex 13

ZIP/Postal Code

75651

Country

France

Facility Name

Local Institution - 0060

City

Reims Cedex

ZIP/Postal Code

51092

Country

France

Facility Name

Local Institution - 0058

City

Vandoeuvre les Nancy

ZIP/Postal Code

54500

Country

France

Facility Name

Local Institution - 0030

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Local Institution - 0028

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Local Institution - 0029

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Local Institution - 0031

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Local Institution - 0005

City

Hong Kong

ZIP/Postal Code

Country

Hong Kong

Facility Name

Local Institution - 0006

City

Hong Kong

Country

Hong Kong

Facility Name

Local Institution - 0032

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Local Institution - 0056

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

Local Institution - 0063

City

Meldola (FC)

ZIP/Postal Code

47014

Country

Italy

Facility Name

Local Institution - 0055

City

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

Local Institution - 0034

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Local Institution - 0035

City

Padova

ZIP/Postal Code

Padova

Country

Italy

Facility Name

Local Institution - 0040

City

Rozzano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Local Institution - 0036

City

Kashiwa-shi

State/Province

Chiba

ZIP/Postal Code

2778577

Country

Japan

Facility Name

Local Institution - 0038

City

Kurume-shi

State/Province

Fukuoka

ZIP/Postal Code

8300011

Country

Japan

Facility Name

Local Institution - 0049

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

2320024

Country

Japan

Facility Name

Local Institution - 0050

City

Kyoto-shi

State/Province

Kyoto

ZIP/Postal Code

6028566

Country

Japan

Facility Name

Local Institution - 0037

City

Osaka-sayama-shi

State/Province

Osaka

ZIP/Postal Code

5898511

Country

Japan

Facility Name

Local Institution - 0051

City

Saga

ZIP/Postal Code

8408571

Country

Japan

Facility Name

Local Institution - 0066

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Facility Name

Local Institution - 0021

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Local Institution - 0026

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Local Institution - 0016

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Local Institution - 0070

City

San Juan

ZIP/Postal Code

00927

Country

Puerto Rico

Facility Name

Local Institution - 0017

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Local Institution - 0009

City

Singapore

ZIP/Postal Code

168583

Country

Singapore

Facility Name

Local Institution - 0007

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Local Institution - 0019

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Local Institution - 0020

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Local Institution - 0018

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Local Institution - 0003

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

Local Institution - 0027

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Local Institution - 0024

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Local Institution - 0023

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Local Institution - 0011

City

London

State/Province

Greater London

ZIP/Postal Code

SE19RT

Country

United Kingdom

Facility Name

Local Institution - 0014

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Local Institution - 0012

City

Glasgow

State/Province

Lanarkshire

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Local Institution - 0015

City

Wirral

State/Province

Merseyside

ZIP/Postal Code

CH63 4JY

Country

United Kingdom

Facility Name

Local Institution - 0013

City

Birmingham

State/Province

West Midlands

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Local Institution - 0010

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

36323435

Citation

Sove RJ, Verma BK, Wang H, Ho WJ, Yarchoan M, Popel AS. Virtual clinical trials of anti-PD-1 and anti-CTLA-4 immunotherapy in advanced hepatocellular carcinoma using a quantitative systems pharmacology model. J Immunother Cancer. 2022 Nov;10(11):e005414. doi: 10.1136/jitc-2022-005414. Erratum In: J Immunother Cancer. 2023 Jan;11(1):

Results Reference

derived

PubMed Identifier

34051329

Citation

Kudo M, Matilla A, Santoro A, Melero I, Gracian AC, Acosta-Rivera M, Choo SP, El-Khoueiry AB, Kuromatsu R, El-Rayes B, Numata K, Itoh Y, Di Costanzo F, Crysler O, Reig M, Shen Y, Neely J, Tschaika M, Wisniewski T, Sangro B. CheckMate 040 cohort 5: A phase I/II study of nivolumab in patients with advanced hepatocellular carcinoma and Child-Pugh B cirrhosis. J Hepatol. 2021 Sep;75(3):600-609. doi: 10.1016/j.jhep.2021.04.047. Epub 2021 May 26.

Results Reference

derived

PubMed Identifier

33001135

Citation

Yau T, Kang YK, Kim TY, El-Khoueiry AB, Santoro A, Sangro B, Melero I, Kudo M, Hou MM, Matilla A, Tovoli F, Knox JJ, Ruth He A, El-Rayes BF, Acosta-Rivera M, Lim HY, Neely J, Shen Y, Wisniewski T, Anderson J, Hsu C. Efficacy and Safety of Nivolumab Plus Ipilimumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib: The CheckMate 040 Randomized Clinical Trial. JAMA Oncol. 2020 Nov 1;6(11):e204564. doi: 10.1001/jamaoncol.2020.4564. Epub 2020 Nov 12. Erratum In: JAMA Oncol. 2021 Jan 1;7(1):140.

Results Reference

derived

PubMed Identifier

32710922

Citation

Sangro B, Melero I, Wadhawan S, Finn RS, Abou-Alfa GK, Cheng AL, Yau T, Furuse J, Park JW, Boyd Z, Tang HT, Shen Y, Tschaika M, Neely J, El-Khoueiry A. Association of inflammatory biomarkers with clinical outcomes in nivolumab-treated patients with advanced hepatocellular carcinoma. J Hepatol. 2020 Dec;73(6):1460-1469. doi: 10.1016/j.jhep.2020.07.026. Epub 2020 Jul 22.

Results Reference

derived

PubMed Identifier

31176752

Citation

Yau T, Hsu C, Kim TY, Choo SP, Kang YK, Hou MM, Numata K, Yeo W, Chopra A, Ikeda M, Kuromatsu R, Moriguchi M, Chao Y, Zhao H, Anderson J, Cruz CD, Kudo M. Nivolumab in advanced hepatocellular carcinoma: Sorafenib-experienced Asian cohort analysis. J Hepatol. 2019 Sep;71(3):543-552. doi: 10.1016/j.jhep.2019.05.014. Epub 2019 Jun 7. Erratum In: J Hepatol. 2019 Dec;71(6):1278.

Results Reference

derived

PubMed Identifier

28434648

Citation

El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, Kim TY, Choo SP, Trojan J, Welling TH Rd, Meyer T, Kang YK, Yeo W, Chopra A, Anderson J, Dela Cruz C, Lang L, Neely J, Tang H, Dastani HB, Melero I. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017 Jun 24;389(10088):2492-2502. doi: 10.1016/S0140-6736(17)31046-2. Epub 2017 Apr 20.

Results Reference

derived

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

Learn more about this trial

An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer

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An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer (CheckMate040)

Hepatocellular Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial