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JRCT ID: jRCT2061230075

Registered date:11/11/2023

A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination With Carboplatin Plus Pemetrexed Versus Platinum Plus Pemetrexed or Nivolumab Plus Ipilimumab in Participants With Unresectable Pleural Mesothelioma.

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedUnresectable Pleural Mesothelioma
Date of first enrollment28/11/2023
Target sample size60
Countries of recruitmentCanada,Japan,USA,Japan,Brazil,Japan,South Afric,Japan,South Korea,Japan,China,Japan,Taiwan,Japan,Australia,Japan,Belgium,Japan,Denmark,Japan,France,Japan,Germany,Japan,Italy,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,Spain,Japan,Switzerland,Japan,Turkey,Japan,UK,Japan
Study typeInterventional
Intervention(s)Biologic: Volrustomig Drug: Pemetrexed Drug: Carboplatin Drug: Cisplatin Biologic: Nivolumab Biologic: Ipilimumab


Primary OutcomeOverall Survival (OS) in experimental arm relative to comparator arm [ Time Frame: up to approximately 52 months ] OS is defined as the time from randomization until the date of death due to any cause.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
Include criteria- Participant must be 18 years or more at the time of screening - Histologically proven diagnosis of pleural mesothelioma with known histology (epithelioid vs. non-epithelioid) - Advanced unresectable disease that cannot be treated with curative surgery (with or without chemotherapy) - WHO/ECOG performance status of 0 or 1 with no deterioration (that is, ECOG PS>1) over the previous 2 weeks prior to day of first dosing - Has measurable disease per modified RECIST1.1 - Has adequate bone marrow reserve and organ function at baseline
Exclude criteria- As judged by the investigator, any condition that would interfere with evaluation of the investigational product or interpretation of participant safety or study results. - Active or prior documented autoimmune or inflammatory disorders - History of another primary malignancy with exceptions. - Uncontrolled intercurrent illness - Tuberculosis, hepatitis B (HBV) or hepatitis C (HCV), human immunodeficiency virus (HIV) infection that is not well controlled - Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment - Untreated or progressive CNS metastatic disease

Related Information


Public contact
Name Kazushige Hibi
Address 3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osak Osaka Japan 530-0011
Telephone +81-6-4802-3533
Affiliation Astrazeneka K.K
Scientific contact
Name Kazushige Hibi
Address 3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka Osaka Japan 530-0011
Telephone +81-6-4802-3533
Affiliation Astrazeneka K.K