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Durvalumab immunotherapy

Phase 2

Hepatocellular Carcinoma | Small molecule | Oncology |Boston Scientific Corporation|Last Updated: Jul 31, 2026

Target and mechanism

Target class-Mab (Antibody)
ModalitySmall molecule

Also known as Durvalumab (Imfinzi) immunotherapy

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Durvalumab immunotherapy · 1 trial · 1 indication

Phase 2 1
NCT05063565TheraSphere With Durvalumab and Tremelimumab for HCCHepatocellular Carcinoma
ACTIVE NOT_RECRUITING100 Analytics
PHASE2ACTIVE NOT_RECRUITING
TheraSphere With Durvalumab and Tremelimumab for HCC
Hepatocellular CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Response Rate (ORR)
Start of Treatment (Day 1) up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated)

Complete response and partial response evaluated by mRECIST.

Secondary Endpoints

Number of immune mediated AEs and SAEs.
Treatment Day 1 up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).
Number of patients whose durvalumab and/or tremelimumab treatment was temporarily halted, postponed or permanently discontinued due to an AE.
Treatment Day 1 up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).
Change from baseline in liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transpeptidase [GGT], alkaline phosphatase [ALK], bilirubin, albumin).
Baseline up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TheraSphere followed by Durvalumab and TremelimumabEXPERIMENTALTheraSphere followed by Tremelimumab plus Durvalumab administered once, then repeated administration of Durvalumab monthly up 18 months.

Interventions

NameTypeDescription
TheraSphere Y-90 glass microsphere therapyDEVICETheraSphere Y-90 glass microsphere therapy administered through the hepatic artery at index procedure.
Durvalumab (Imfinzi) immunotherapyDRUG1500 mg, every 4 weeks that continues for a maximum duration of 18 months or until confirmed progression (by site assessment), unacceptable toxicity, study withdrawal, or study early termination by the sponsor. Treatment beyond confirmed radiographic progression is permitted per patient consent if the following criteria are met: * Absence of clinical symptoms or signs indicating clinically significant disease progression * No decline in performance status * Absence of rapid disease progression or threat to vital organs or critical anatomical sites (i.e. new CNS metastasis, respiratory failure due to tumor compression, spinal cord compression) requiring urgent alternative medical intervention * No other treatment discontinuation criteria are met
Tremelimumab immunotherapyDRUG300 mg, single administration
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: 1. Participants must be aged ≥18 years at the time of screening. 2. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and accountability Act in the US, European Union (EU) data privacy regulations in the EU) obtained from the pat...

Countries:United StatesFranceItalySpainSwitzerland
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Recent Changes (Last 90 Days)

LOWJul 31, 2026NCT05063565lastUpdatePostDate: changed
LOWJul 31, 2026NCT05063565lastUpdatePostDate: changed
LOWJun 23, 2026NCT05063565lastUpdatePostDate: changed
LOWJun 23, 2026NCT05063565lastUpdatePostDate: changed
LOWJun 2, 2026NCT05063565lastUpdatePostDate: changed
LOWJun 2, 2026NCT05063565lastUpdatePostDate: changed
LOWJun 2, 2026NCT05063565lastUpdatePostDate: changed

Frequently asked questions about Durvalumab immunotherapy

What is Durvalumab immunotherapy used for in Hepatocellular Carcinoma?

Durvalumab immunotherapy is being studied for the treatment of Hepatocellular Carcinoma, a type of liver cancer. It is currently in Phase 2 clinical development for this indication. The drug is being evaluated in combination with other therapies to assess its safety and efficacy in patients with this condition.

What does Durvalumab immunotherapy target?

Durvalumab immunotherapy is a monoclonal antibody, classified under the -mab target class. It is designed to target and modulate specific pathways involved in the immune response against cancer cells. In the context of Hepatocellular Carcinoma, it is being investigated for its potential to enhance the body's immune system to fight the tumor.

Who makes Durvalumab immunotherapy?

Durvalumab immunotherapy is being developed by Boston Scientific Corporation, a company traded on the stock exchange under the ticker symbol BSX. The company is conducting clinical trials to evaluate the drug's effectiveness in treating Hepatocellular Carcinoma.

What phase is Durvalumab immunotherapy in?

Durvalumab immunotherapy is currently in Phase 2 clinical trials for Hepatocellular Carcinoma. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 2 study is designed to gather more data on its safety and efficacy in patients.

What clinical trials is Durvalumab immunotherapy in?

Durvalumab immunotherapy is being evaluated in a Phase 2 clinical trial with the identifier NCT05063565. This study, titled 'TheraSphere With Durvalumab and Tremelimumab for HCC,' is actively recruiting participants and aims to enroll 100 patients with Hepatocellular Carcinoma. The trial is being conducted in the United States, France, Italy, Spain, and Switzerland.

Is Durvalumab immunotherapy the same as Durvalumab (Imfinzi) immunotherapy?

Yes, Durvalumab immunotherapy is also known as Durvalumab (Imfinzi) immunotherapy. The drug is referred to by both names in clinical and research settings. This alternative name is used to identify the same investigational therapy being studied for Hepatocellular Carcinoma.