Status:
RECRUITING
MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma
Lead Sponsor:
AstraZeneca
Conditions:
Unresectable Pleural Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 platinu...
Detailed 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 (MEDI...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
November 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 16 2028
Estimated Enrollment :
825 Patients enrolled
Trial Details
Trial ID
NCT06097728
Start Date
November 9 2023
End Date
November 16 2028
Last Update
December 15 2025
Active Locations (178)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Phoenix, Arizona, United States, 85054
2
Research Site
Duarte, California, United States, 91010
3
Research Site
Santa Rosa, California, United States, 95403
4
Research Site
Aurora, Colorado, United States, 80045