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

January 9, 2024 updated by: AstraZeneca

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

1324

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Barretos, Brazil
        • Research Site
      • Curitiba, Brazil
        • Research Site
      • Florianopolis, Brazil
        • Research Site
      • Porto Alegre, Brazil
        • Research Site
      • Rio de Janeiro, Brazil
        • Research Site
      • Sao Paulo, Brazil
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Research Site
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Research Site
      • Kingston, Ontario, Canada, K7L 2V7
        • Research Site
      • London, Ontario, Canada, N6A 4L6
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Research Site
      • Quebec City, Quebec, Canada, G1R 2J6
        • Research Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Research Site
  • China
      • Beijing, China
        • Research Site
      • Changchun, China
        • Research Site
      • Changsha, China
        • Research Site
      • Chengdu, China
        • Research Site
      • Dalian, China
        • Research Site
      • Fuzhou, China
        • Research Site
      • Guangzhou, China
        • Research Site
      • Hangzhou, China
        • Research Site
      • Harbin, China
        • Research Site
      • Hefei, China
        • Research Site
      • Nanchang, China
        • Research Site
      • Nanjing, China
        • Research Site
      • Nanning, China
        • Research Site
      • Shanghai, China
        • Research Site
      • Suzhou, China
        • Research Site
      • Wuhan, China
        • Research Site
      • Xian, China
        • Research Site
      • Zhengzhou, China
        • Research Site
  • France
      • Clichy, France
        • Research Site
      • Lile, France
        • Research Site
      • Marseille, France
        • Research Site
      • Montpellier, France
        • Research Site
      • Nancy, France
        • Research Site
      • Nantes, France
        • Research Site
      • Nice, France
        • Research Site
      • Pessac, France
        • Research Site
      • Poitiers, France
        • Research Site
      • Reims, France
        • Research Site
      • Rouen, France
        • Research Site
      • Saint-Etienne, France
        • Research Site
      • Toulouse, France
        • Research Site
      • Villejuif, France
        • Research Site
  • Germany
      • Aachen, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Hannover, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Koeln, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Mainz, Germany
        • Research Site
      • Muenchen, Germany
        • Research Site
      • Tuebingen, Germany
        • Research Site
      • Ulm, Germany
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
  • India
      • Bangalore, India
        • Research Site
      • Bhubneshwar, India
        • Research Site
      • Chennai, India
        • Research Site
      • Hubli, India
        • Research Site
      • Hyderabad, India
        • Research Site
      • Karmsad, India
        • Research Site
      • Mumbai, India
        • Research Site
      • Nashik, India
        • Research Site
      • New Delhi, India
        • Research Site
  • Italy
      • Benevento, Italy
        • Research Site
      • Meldola, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Perugia, Italy
        • Research Site
      • Pisa, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • Rozzano, Italy
        • Research Site
  • Japan
      • Bunkyoku, Japan
        • Research Site
      • Chiba, Japan
        • Research Site
      • Fukuoka, Japan
        • Research Site
      • Hiroshima, Japan
        • Research Site
      • Iizuka, Japan
        • Research Site
      • Kanazawa, Japan
        • Research Site
      • Kotoku, Japan
        • Research Site
      • Kumamoto, Japan
        • Research Site
      • Kurume, Japan
        • Research Site
      • Matsuyama, Japan
        • Research Site
      • Mitakashi, Japan
        • Research Site
      • Musashino, Japan
        • Research Site
      • Nagoya, Japan
        • Research Site
      • Ogaki, Japan
        • Research Site
      • Okayama, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Osaka Sayama, Japan
        • Research Site
      • Saga, Japan
        • Research Site
      • Sapporo, Japan
        • Research Site
      • Shiwa, Japan
        • Research Site
      • Suntogun, Japan
        • Research Site
      • Tsu, Japan
        • Research Site
      • Yokohama, Japan
        • Research Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Research Site
      • Daegu, Korea, Republic of, 41944
        • Research Site
      • Seoul, Korea, Republic of, 5505
        • Research Site
      • Seoul, Korea, Republic of, 6351
        • Research Site
      • Seoul, Korea, Republic of, 3080
        • Research Site
      • Seoul, Korea, Republic of, 3722
        • Research Site
    • Gyeonggi-do
      • Ilsan, Gyeonggi-do, Korea, Republic of, 10408
        • Research Site
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • Murmansk, Russian Federation
        • Research Site
      • Nizhniy Novgorod, Russian Federation
        • Research Site
      • Novosibirsk, Russian Federation
        • Research Site
      • Obninsk, Russian Federation
        • Research Site
      • Omsk, Russian Federation
        • Research Site
      • Saint Petersburg, Russian Federation
        • Research Site
      • Ufa, Russian Federation
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Oviedo, Spain
        • Research Site
      • Pamplona Madrid, Spain
        • Research Site
      • Santander, Spain
        • Research Site
  • Taiwan
      • Chiayi, Taiwan
        • Research Site
      • Kaohsiung, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Tainan, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Taoyuan, Taiwan
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Research Site
      • Chang Mai, Thailand
        • Research Site
      • Khon Kaen, Thailand
        • Research Site
      • Phitsanulok, Thailand
        • Research Site
      • Songkhla, Thailand
        • Research Site
  • Ukraine
      • Dnipro, Ukraine
        • Research Site
      • IvanoFrankivsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kropyvnitskyi, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Lviv, Ukraine
        • Research Site
      • Odesa, Ukraine
        • Research Site
      • Uzhgorod, Ukraine
        • Research Site
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Research Site
      • Orange, California, United States, 92868
        • Research Site
      • San Francisco, California, United States, 94158
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Research Site
    • Florida
      • Fort Myers, Florida, United States, 33916
        • Research Site
      • Jacksonville, Florida, United States, 32224
        • Research Site
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Research Site
    • New York
      • New York, New York, United States, 10065
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28262
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15237
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Research Site
      • Dallas, Texas, United States, 75216
        • Research Site
      • Dallas, Texas, United States, 74235
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • Houston, Texas, United States, 77090
        • Research Site
    • Utah
      • Murray, Utah, United States, 84107
        • Research Site
  • Vietnam
      • Hanoi, Vietnam
        • Research Site
      • Hochiminh, Vietnam
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Durvalumab
Drug: Durvalumab
Durvalumab IV (intravenous infusion).
Other Names:
  • MEDI4736
Experimental: Arm 2
Durvalumab in combination with tremelimumab (Regimen 1)
Drug: Tremelimumab (Regimen 1)
Tremelimumab IV (intravenous infusion).
Drug: Durvalumab (Regimen 1)
Durvalumab IV (intravenous infusion).
Experimental: Arm 3
Durvalumab in combination with tremelimumab (Regimen 2)
Drug: Tremelimumab (Regimen 2)
Tremelimumab IV (intravenous infusion).
Drug: Durvalumab (Regimen 2)
Durvalumab IV (intravenous infusion).
Active Comparator: Arm 4
Sorafenib
Drug: Sorafenib
Sorafenib, as per standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg
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).
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).
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 Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg
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).
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).
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).
Overall Survival (OS) at 18, 24, and 36 Months After Randomization
Time Frame: At 18, 24, and 36 months post-randomization. Assessed at the final analysis DCO (27Aug2021).
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.
At 18, 24, and 36 months post-randomization. Assessed at the final analysis DCO (27Aug2021).
Progression Free Survival (PFS)
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)
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.
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)
Time To Progression (TTP)
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).
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.
From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
Objective Response Rate (ORR)
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).
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.
From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
Disease Control Rate (DCR)
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).
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.
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).
Duration of Objective Response (DoR)
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).
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.
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).
Overall Survival (OS) by PD-L1
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).
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%).
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).
EORTC QLQ-C30 Time to Global Health Status/QoL Deterioration
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.
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.
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.
EORTC QLQ-HCC18 Time to Symptom (Abdominal Pain) Deterioration
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.
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.
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.
EORTC QLQ-HCC18 Time to Symptom (Shoulder Pain) Deterioration
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.
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.
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.
EORTC QLQ-HCC18 Time to Symptom (Abdominal Swelling) Deterioration
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.
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.
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.
Presence of ADA for Durvalumab
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).
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.
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).
Presence of ADA for Tremelimumab
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.
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.
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.
Summary of Durvalumab Concentration 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).
Blood sample were collected at pre-specified timepoints and Durvalumab concentrations in serum (ug/mL) were reported over time.
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).
Summary of Tremelimumab Concentration 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).
Blood sample were collected at pre-specified timepoints and Tremelimumab concentrations in serum (ug/mL) were reported over time.
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).

Other Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 4 years
From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2017

Primary Completion (Actual)

August 27, 2021

Study Completion (Estimated)

August 27, 2024

Study Registration Dates

First Submitted

September 19, 2017

First Submitted That Met QC Criteria

September 26, 2017

First Posted (Actual)

October 2, 2017

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D419CC00002
  • 2016-005126-11 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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