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Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (HIMALAYA)

Primary Purpose

Hepatocellular Carcinoma

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Durvalumab

Tremelimumab (Regimen 1)

Tremelimumab (Regimen 2)

Sorafenib

Durvalumab (Regimen 1)

Durvalumab (Regimen 2)

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma Non-Resectable

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

HCC based on histopathological confirmation
No prior systemic therapy for HCC
Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C
Child-Pugh Score class A
ECOG performance status of 0 or 1 at enrollment

Exclusion criteria

Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
Clinically meaningful ascites
Main portal vein tumor thrombosis
Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
HBV and HVC co-infection, or HBV and Hep D co-infection

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

Durvalumab

Durvalumab in combination with tremelimumab (Regimen 1)

Durvalumab in combination with tremelimumab (Regimen 2)

Sorafenib

Outcomes

Primary Outcome Measures

Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg

OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This primary outcome measure presents OS analysis of Treme 300mg x1 dose + Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).

Secondary Outcome Measures

Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg

OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This secondary outcome measure presents OS analysis of Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).

Overall Survival (OS) at 18, 24, and 36 Months After Randomization

Percentage of participants who were alive at fixed time points (18, 24, and 36 months) after randomization. The estimated percentage of survival along with the 95% confidence interval were calculated using Kaplan-Meier technique on the full analysis set.

Progression Free Survival (PFS)

PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST 1.1] using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death by any cause in the absence of progression, regardless of whether the patient withdrew from study treatment or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as a at least 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir.

Time To Progression (TTP)

TTP was defined as the time from randomization until objective tumor progression in the absence of death. If participants died without tumor progression, they were censored at the time of death.

Objective Response Rate (ORR)

ORR (per RECIST 1.1 as assessed by the Investigator) was defined as the number (%) of participants with at least 1 confirmed visit response of CR or PR until progression, or the last evaluable assessment in the absence of progression. Participants who go off treatment without progression, receive a subsequent therapy, and then respond will not be included as responders in the ORR. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.

Disease Control Rate (DCR)

Number (%) of participants with a Best Objective Response (BoR) of CR, PR, or SD. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters. Stable disease (ie., SD) was defined as neither sufficient decrease in sum of diameters to qualify for PR nor sufficient increase to qualify for progression.

Duration of Objective Response (DoR)

Time from the date of first documented confirmed response (complete or partial response) until the first date of documented progression or death in the absence of disease progression. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.

Overall Survival (OS) by PD-L1

Overall survival by baseline PD-L1 expression levels (positive vs. negative). PD-L1 expression level is based on the Tumor and Immune Cell Positivity (TIP) score method as: PD-L1 Positive (TIP ≥ 1%) or PD-L1 Negative (TIP < 1%).

EORTC QLQ-C30 Time to Global Health Status/QoL Deterioration

European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-C30), which consists of 30 questions combined to produce a global health status/QoL scale. Higher scores indicate better health. A clinically meaningful deterioration is defined as a decrease in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.

EORTC QLQ-HCC18 Time to Symptom (Abdominal Pain) Deterioration

EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) is an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30, which includes 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. A high score for a symptom scale/item represents a high level of symptomatology/problem. A clinically meaningful deterioration is defined as an increase in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.

EORTC QLQ-HCC18 Time to Symptom (Shoulder Pain) Deterioration

EORTC QLQ-HCC18 Time to Symptom (Abdominal Swelling) Deterioration

Presence of ADA for Durvalumab

Number of participants with Anti-Drug Antibody (ADA) response to Durvalumab. ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA. Results are reported as number of participants with ADA responses to Durvalumab for each indicated category.

Presence of ADA for Tremelimumab

Number of participants with Anti-Drug Antibody (ADA) response to Tremelimumab. ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA. Results are reported as number of participants with ADA responses to Tremelimumab for each indicated category.

Summary of Durvalumab Concentration Over Time

Blood sample were collected at pre-specified timepoints and Durvalumab concentrations in serum (ug/mL) were reported over time.

Summary of Tremelimumab Concentration Over Time

Blood sample were collected at pre-specified timepoints and Tremelimumab concentrations in serum (ug/mL) were reported over time.

Full Information

NCT ID

NCT03298451

First Posted

September 19, 2017

Last Updated

October 2, 2023

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT03298451

Brief Title

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Acronym

HIMALAYA

Official Title

A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 11, 2017 (Actual)

Primary Completion Date

August 27, 2021 (Actual)

Study Completion Date

August 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

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

This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy

Detailed Description

The study population includes patients 18 years of age or older with advanced HCC, Barcelona Clinic Liver Cancer stage B not eligible for locoregional therapy or stage C, and Child-Pugh A classification liver disease. Patients must not have received any prior systemic therapy for unresectable HCC. Patients in all treatment arms may continue receiving their originally assigned treatment, at the Investigator's discretion, until progression Patients in all arms with confirmed PD who, in the Investigator's opinion, continue to receive benefit from their assigned treatment and meet the criteria for treatment in the setting of PD may continue to receive their assigned treatment. If a patient discontinues study drug(s) due to disease progression, the patient will enter survival follow-up. Patients who have discontinued treatment due to toxicity or symptomatic deterioration or who have commenced subsequent anticancer therapy, will have tumor assessments until confirmed PD and will be followed for survival

6. Conditions and Keywords

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

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma Non-Resectable

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1324 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Durvalumab

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

Durvalumab in combination with tremelimumab (Regimen 1)

Arm Title

Arm 3

Arm Type

Experimental

Arm Description

Durvalumab in combination with tremelimumab (Regimen 2)

Arm Title

Arm 4

Arm Type

Active Comparator

Arm Description

Sorafenib

Intervention Type

Drug

Intervention Name(s)

Durvalumab

Other Intervention Name(s)

MEDI4736

Intervention Description

Durvalumab IV (intravenous infusion).

Intervention Type

Drug

Intervention Name(s)

Tremelimumab (Regimen 1)

Intervention Description

Tremelimumab IV (intravenous infusion).

Intervention Type

Drug

Intervention Name(s)

Tremelimumab (Regimen 2)

Intervention Description

Tremelimumab IV (intravenous infusion).

Intervention Type

Drug

Intervention Name(s)

Sorafenib

Intervention Description

Sorafenib, as per standard of care

Intervention Type

Drug

Intervention Name(s)

Durvalumab (Regimen 1)

Intervention Description

Durvalumab IV (intravenous infusion).

Intervention Type

Drug

Intervention Name(s)

Durvalumab (Regimen 2)

Intervention Description

Durvalumab IV (intravenous infusion).

Primary Outcome Measure Information:

Title

Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg

Description

Time Frame

From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).

Secondary Outcome Measure Information:

Title

Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg

Description

OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This secondary outcome measure presents OS analysis of Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).

Time Frame

From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).

Title

Overall Survival (OS) at 18, 24, and 36 Months After Randomization

Description

Time Frame

At 18, 24, and 36 months post-randomization. Assessed at the final analysis DCO (27Aug2021).

Title

Progression Free Survival (PFS)

Description

Time Frame

Tumor scans performed at baseline, every 8 weeks for the first 48 weeks following randomization, and every 12 weeks thereafter until RECIST 1.1-defined progression. Assessed up to DCO (27Aug2021, to a maximum of approximately 46 months)

Title

Time To Progression (TTP)

Description

TTP was defined as the time from randomization until objective tumor progression in the absence of death. If participants died without tumor progression, they were censored at the time of death.

Time Frame

From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).

Title

Objective Response Rate (ORR)

Description

Time Frame

From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).

Title

Disease Control Rate (DCR)

Description

Time Frame

From the date of randomization until objective tumor progression or date of death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).

Title

Duration of Objective Response (DoR)

Description

Time Frame

From the date of first documented response until the first date of documented progression or death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).

Title

Overall Survival (OS) by PD-L1

Description

Time Frame

From the date of randomization until death due to any cause, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).

Title

EORTC QLQ-C30 Time to Global Health Status/QoL Deterioration

Description

Time Frame

At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.

Title

EORTC QLQ-HCC18 Time to Symptom (Abdominal Pain) Deterioration

Description

Time Frame

At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.

Title

EORTC QLQ-HCC18 Time to Symptom (Shoulder Pain) Deterioration

Description

Time Frame

At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.

Title

EORTC QLQ-HCC18 Time to Symptom (Abdominal Swelling) Deterioration

Description

Time Frame

At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.

Title

Presence of ADA for Durvalumab

Description

Time Frame

Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of durvalumab. Assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).

Title

Presence of ADA for Tremelimumab

Description

Time Frame

Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of tremelimumab. Assessed up to approximately 46 months after the first randomization.

Title

Summary of Durvalumab Concentration Over Time

Description

Blood sample were collected at pre-specified timepoints and Durvalumab concentrations in serum (ug/mL) were reported over time.

Time Frame

To evaluate the PK of Durvalumab, samples were collected pre-dose at week 4 and week 12 and post-dose at week 12. Assessed at the final analysis DCO (27Aug2021).

Title

Summary of Tremelimumab Concentration Over Time

Description

Blood sample were collected at pre-specified timepoints and Tremelimumab concentrations in serum (ug/mL) were reported over time.

Time Frame

To evaluate the PK of Tremelimumab, samples were collected at week 0 (post-dose), week 4, and week 12. Assessed at the final analysis DCO (27Aug2021).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria HCC based on histopathological confirmation No prior systemic therapy for HCC Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C Child-Pugh Score class A ECOG performance status of 0 or 1 at enrollment Exclusion criteria Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy Clinically meaningful ascites Main portal vein tumor thrombosis Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months HBV and HVC co-infection, or HBV and Hep D co-infection

Facility Information:

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Research Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Research Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94158

Country

United States

Facility Name

Research Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Research Site

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Research Site

City

Westwood

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

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Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

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Research Site

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Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

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United States

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Research Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

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Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10065

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United States

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City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28262

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United States

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Portland

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Oregon

ZIP/Postal Code

97213

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United States

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Pittsburgh

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Pennsylvania

ZIP/Postal Code

15237

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United States

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Dallas

State/Province

Texas

ZIP/Postal Code

74235

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United States

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Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

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United States

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Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

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Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

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Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

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Research Site

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

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United States

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City

Barretos

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Brazil

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Curitiba

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Brazil

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Florianopolis

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Brazil

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Porto Alegre

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Brazil

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Rio de Janeiro

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Brazil

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Sao Paulo

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Brazil

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Calgary

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Alberta

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T2N 4N2

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Canada

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Edmonton

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Alberta

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T6G 1Z2

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Canada

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Hamilton

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Ontario

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L8V 5C2

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Canada

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Kingston

State/Province

Ontario

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K7L 2V7

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Canada

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London

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Ontario

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N6A 4L6

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Canada

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Toronto

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Ontario

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M4N 3M5

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Canada

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Montreal

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Quebec

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H2X 0A9

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Canada

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Quebec City

State/Province

Quebec

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G1R 2J6

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Canada

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City

Sherbrooke

State/Province

Quebec

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J1H 5N4

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Canada

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City

Beijing

Country

China

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Changchun

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China

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Changsha

Country

China

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Chengdu

Country

China

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Dalian

Country

China

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Fuzhou

Country

China

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Guangzhou

Country

China

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Hangzhou

Country

China

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Harbin

Country

China

Facility Name

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Hefei

Country

China

Facility Name

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City

Nanchang

Country

China

Facility Name

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Nanjing

Country

China

Facility Name

Research Site

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Nanning

Country

China

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Shanghai

Country

China

Facility Name

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City

Suzhou

Country

China

Facility Name

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Wuhan

Country

China

Facility Name

Research Site

City

Xian

Country

China

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City

Zhengzhou

Country

China

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City

Clichy

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France

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City

Lile

Country

France

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City

Marseille

Country

France

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City

Montpellier

Country

France

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City

Nancy

Country

France

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City

Nantes

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France

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Nice

Country

France

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Pessac

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France

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Poitiers

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France

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Reims

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France

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Rouen

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France

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Saint-Etienne

Country

France

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Toulouse

Country

France

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Villejuif

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France

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Aachen

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Germany

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Essen

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Germany

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Hannover

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Germany

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Heidelberg

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Germany

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Koeln

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Germany

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Leipzig

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Germany

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Mainz

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Germany

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Muenchen

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Germany

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Tuebingen

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Germany

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Ulm

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Germany

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Hong Kong

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Hong Kong

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Bangalore

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India

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City

Bhubneshwar

Country

India

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City

Chennai

Country

India

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City

Hubli

Country

India

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Research Site

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Hyderabad

Country

India

Facility Name

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City

Karmsad

Country

India

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City

Mumbai

Country

India

Facility Name

Research Site

City

Nashik

Country

India

Facility Name

Research Site

City

New Delhi

Country

India

Facility Name

Research Site

City

Benevento

Country

Italy

Facility Name

Research Site

City

Meldola

Country

Italy

Facility Name

Research Site

City

Milano

Country

Italy

Facility Name

Research Site

City

Napoli

Country

Italy

Facility Name

Research Site

City

Perugia

Country

Italy

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City

Pisa

Country

Italy

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Research Site

City

Roma

Country

Italy

Facility Name

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City

Rozzano

Country

Italy

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City

Bunkyoku

Country

Japan

Facility Name

Research Site

City

Chiba

Country

Japan

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Research Site

City

Fukuoka

Country

Japan

Facility Name

Research Site

City

Hiroshima

Country

Japan

Facility Name

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City

Iizuka

Country

Japan

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City

Kanazawa

Country

Japan

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Research Site

City

Kotoku

Country

Japan

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Kumamoto

Country

Japan

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Kurume

Country

Japan

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Matsuyama

Country

Japan

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Mitakashi

Country

Japan

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Musashino

Country

Japan

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City

Nagoya

Country

Japan

Facility Name

Research Site

City

Ogaki

Country

Japan

Facility Name

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City

Okayama

Country

Japan

Facility Name

Research Site

City

Osaka Sayama

Country

Japan

Facility Name

Research Site

City

Osaka

Country

Japan

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Research Site

City

Saga

Country

Japan

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Research Site

City

Sapporo

Country

Japan

Facility Name

Research Site

City

Shiwa

Country

Japan

Facility Name

Research Site

City

Suntogun

Country

Japan

Facility Name

Research Site

City

Tsu

Country

Japan

Facility Name

Research Site

City

Yokohama

Country

Japan

Facility Name

Research Site

City

Ilsan

State/Province

Gyeonggi-do

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Research Site

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Research Site

City

Busan

ZIP/Postal Code

49241

Country

Korea, Republic of

Facility Name

Research Site

City

Daegu

ZIP/Postal Code

41944

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

3080

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

3722

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

5505

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

6351

Country

Korea, Republic of

Facility Name

Research Site

City

Moscow

Country

Russian Federation

Facility Name

Research Site

City

Murmansk

Country

Russian Federation

Facility Name

Research Site

City

Nizhniy Novgorod

Country

Russian Federation

Facility Name

Research Site

City

Novosibirsk

Country

Russian Federation

Facility Name

Research Site

City

Obninsk

Country

Russian Federation

Facility Name

Research Site

City

Omsk

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

Country

Russian Federation

Facility Name

Research Site

City

Ufa

Country

Russian Federation

Facility Name

Research Site

City

Barcelona

Country

Spain

Facility Name

Research Site

City

Madrid

Country

Spain

Facility Name

Research Site

City

Oviedo

Country

Spain

Facility Name

Research Site

City

Pamplona Madrid

Country

Spain

Facility Name

Research Site

City

Santander

Country

Spain

Facility Name

Research Site

City

Chiayi

Country

Taiwan

Facility Name

Research Site

City

Kaohsiung

Country

Taiwan

Facility Name

Research Site

City

Taichung

Country

Taiwan

Facility Name

Research Site

City

Tainan

Country

Taiwan

Facility Name

Research Site

City

Taipei

Country

Taiwan

Facility Name

Research Site

City

Taoyuan

Country

Taiwan

Facility Name

Research Site

City

Bangkok

Country

Thailand

Facility Name

Research Site

City

Chang Mai

Country

Thailand

Facility Name

Research Site

City

Khon Kaen

Country

Thailand

Facility Name

Research Site

City

Phitsanulok

Country

Thailand

Facility Name

Research Site

City

Songkhla

Country

Thailand

Facility Name

Research Site

City

Dnipro

Country

Ukraine

Facility Name

Research Site

City

IvanoFrankivsk

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

Country

Ukraine

Facility Name

Research Site

City

Kropyvnitskyi

Country

Ukraine

Facility Name

Research Site

City

Kyiv

Country

Ukraine

Facility Name

Research Site

City

Lviv

Country

Ukraine

Facility Name

Research Site

City

Odesa

Country

Ukraine

Facility Name

Research Site

City

Uzhgorod

Country

Ukraine

Facility Name

Research Site

City

Hanoi

Country

Vietnam

Facility Name

Research Site

City

Hochiminh

Country

Vietnam

12. IPD Sharing Statement

Links:

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D419CC00002&attachmentIdentifier=5492a658-0cae-4a53-9c5f-2c7d7dd2f180&fileName=419CC00002CSP_redacted.pdf&versionIdentifier=

Description

CSP_redacted

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D419CC00002&attachmentIdentifier=dfa10daf-41b0-454d-ab99-f62959a00fdc&fileName=D419CC00002_SAP_redacted.pdf&versionIdentifier=

Description

SAP_redacted

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D419CC00002&attachmentIdentifier=7f90991f-10dd-4176-8b36-c5535f3ba6d6&fileName=D419CC00002_CSR__synopsis_redacted.pdf&versionIdentifier=

Description

CSR_synopsis

Learn more about this trial

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

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Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (HIMALAYA)

Hepatocellular Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

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