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