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Recruiting Phase 3 NCT06097728

MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

Phase 3 – large-scale trial before approval
Conditions: Unresectable Pleural Mesothelioma

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of Volrustomig (MEDI5752) + Carboplatin + Pemetrexed vs the investigator's choice of platinum + Pemetrexed or Nivolumab + Ipilimumab in participants with unresectable pleural mesothelioma.
Description
Adult patients with histologically proven diagnosis of pleural mesothelioma with advanced unresectable disease are eligible to be enrolled. Patients will be randomized 1:1 to receive Volrustomig (MEDI5752) + Carboplatin + Pemetrexed or the investigator's choice of platinum+Pemetrexed or Nivolumab+Ipilimumab, based on their histology.
Who can participate
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 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
Locations 20
Australia (1)
Research Site
Chermside
ACTIVE_NOT_RECRUITING
Belgium (1)
Research Site
Anderlecht
ACTIVE_NOT_RECRUITING
Brazil (1)
Research Site
Barretos
ACTIVE_NOT_RECRUITING
Canada (1)
Research Site
Edmonton , Alberta
ACTIVE_NOT_RECRUITING
China (1)
Research Site
Beijing
ACTIVE_NOT_RECRUITING
Denmark (1)
Research Site
Aarhus N
ACTIVE_NOT_RECRUITING
France (1)
Research Site
Brest
COMPLETED
Italy (1)
Research Site
Alessandria
ACTIVE_NOT_RECRUITING
Japan (1)
Research Site
Amagasaki-shi
ACTIVE_NOT_RECRUITING
Netherlands (1)
Research Site
Amsterdam
ACTIVE_NOT_RECRUITING
Norway (1)
Research Site
Lørenskog
COMPLETED
Poland (1)
Research Site
Bydgoszcz
WITHDRAWN
South Africa (1)
Research Site
Cape Town
ACTIVE_NOT_RECRUITING
South Korea (1)
Research Site
Cheongju-si
WITHDRAWN
Spain (1)
Research Site
Barakaldo
Switzerland (1)
Research Site
Baden
ACTIVE_NOT_RECRUITING
Taiwan (1)
Research Site
Kaohsiung City
ACTIVE_NOT_RECRUITING
Turkey (1)
Research Site
Adana
WITHDRAWN
United Kingdom (1)
Research Site
Cambridge
ACTIVE_NOT_RECRUITING
United States (1)
Research Site
Phoenix , Arizona
WITHDRAWN
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
09.11.2023
Completion date
16.11.2028
Registry ID
NCT06097728
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.