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.

JRCT ID: jRCT2061230075

Registered date:11/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unresectable Pleural Mesothelioma
• Date of first enrollment: 28/11/2023
• Target sample size: 60
• Countries of recruitment: Canada,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 type: Interventional

Intervention(s)

Biologic: Volrustomig
Drug: Pemetrexed
Drug: Carboplatin
Drug: Cisplatin
Biologic: Nivolumab
Biologic: Ipilimumab

Outcome(s)

Primary Outcome

Overall 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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

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

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT06097728