Clinical Trials List
Protocol NumberD7988C00001
NCT Number(ClinicalTrials.gov Identfier)NCT06097728
Active
2023-10-05 - 2029-04-30
Phase III
Not yet recruiting1
Recruiting4
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 (eVOLVE-Meso)
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Trial Applicant
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- KUAN-LI WU 無
- 郭家佑 Division of Thoracic Medicine
- 李玫萱 Division of Thoracic Medicine
- Ying-Ming Tsai Tsai Division of Thoracic Medicine
- Jen-Yu Hung Division of Thoracic Medicine
- Inn-Wen Chong Division of Thoracic Medicine
- 莊政皓 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- YEN-TING LIN Division of General Internal Medicine
- 陳冠宇 Division of General Internal Medicine
- 廖唯昱 Division of General Internal Medicine
- Chong-Jen Yu Division of General Internal Medicine
- Chia-Chi Lin Division of Hematology & Oncology
- 黃俊凱 Division of General Internal Medicine
- 廖斌志 Division of Hematology & Oncology
- 吳尚俊 Division of General Internal Medicine
- 徐偉勛 Division of Hematology & Oncology
- James Chih-Hsin Yang Division of Hematology & Oncology
- 蔡子修 Division of General Internal Medicine
- Jih-Hsiang Lee Division of Hematology & Oncology
- 許嘉林 Division of General Internal Medicine
- 楊景堯 Division of General Internal Medicine
- 錢穎群 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- KUO-HSUAN HSU Division of Thoracic Medicine
- 李柏昕 Division of Thoracic Medicine
- JENG-SEN TSENG Division of Thoracic Medicine
- TSUNG -YING YANG Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chun-Hui Lee
- 蔡政軒 Division of General Internal Medicine
- Chin-Wei Kuo
- Yi-Ting Yen Division of General Internal Medicine
- Chian-Wei Chen Division of General Internal Medicine
- Wu-Chou Su Division of Hematology & Oncology
- Shang-Yin Wu
- Seu-Chun Yang Division of General Internal Medicine
- Yau-Lin Tseng Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Liang Wang Division of Hematology & Oncology
- Shih-Hong Li Division of Hematology & Oncology
- 柯皓文 Division of Hematology & Oncology
- 黃世緯 Division of Thoracic Medicine
- Jia-Shiuan Ju Division of Hematology & Oncology
- 枋岳甫 Division of Hematology & Oncology
- Ping-Chih Hsu Division of Hematology & Oncology
- 黃宗楨 Division of Hematology & Oncology
- 吳浩銘 Division of Thoracic Medicine
- 林定佑 Division of Hematology & Oncology
- Chih-Hsi Kuo Division of Hematology & Oncology
- 吳教恩 Division of Hematology & Oncology
- 邱立忠 Division of Hematology & Oncology
- Chih-Hung Chen Division of Hematology & Oncology
- Chien-Ying Liu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Unresectable Pleural Mesothelioma
Objectives
The objective of this trial is to evaluate volrustomig plus carboplatin plus pemetrexed compared with nivolumab plus ipilimumab or platinum plus pemetrexed, as selected by the trial sponsor, in subjects with pleural mesothelioma of epithelial histology. efficacy and safety.
Test Drug
Volrustomig (MEDI5752)OPDIVO (nivolumab)YERVOY (ipilimumab)Pemetrexed AccordCarboplatin HikmaCisplatinum Accord
Active Ingredient
Volrustomig (MEDI5752)
nivolumab
ipilimumab
pemetrexed
Carboplatin
Cisplatin
nivolumab
ipilimumab
pemetrexed
Carboplatin
Cisplatin
Dosage Form
Lyophilized product for concentrate for solution for infusion
Concentrate for solution for infusion
Concentrate for solution for infusion
Concentrate for solution for infusion
Concentrate for solu
Concentrate for solution for infusion
Concentrate for solution for infusion
Concentrate for solution for infusion
Concentrate for solu
Dosage
250mg/vial
10mg/ml
5mg/mL
25mg/ml
10mg/ml
1mg/ml
10mg/ml
5mg/mL
25mg/ml
10mg/ml
1mg/ml
Endpoints
In PM subjects with epithelial histology, OS (Overall survival) was demonstrated to demonstrate the superiority of volrustomig plus carboplatin plus pemetrexed compared to nivolumab plus ipilimumab or platinum plus pemetrexed, as selected by the trial host. sex
Inclution Criteria
Key Inclusion Criteria:
Participant must be ≥ 18 years 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
Participant must be ≥ 18 years 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
Exclusion Criteria
Key Exclusion 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
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
The Estimated Number of Participants
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Taiwan
13 participants
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Global
825 participants
