Title |
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 |
Protocole ID |
eVOLVE-Meso |
ClinicalTrials.gov ID |
NCT06097728 |
Cancer Type(s) |
Mesothelioma |
Phase |
Phase III |
Stage |
|
Study Type |
Clinical |
Drug |
Volrustomig + carboplatine + pemetrexed versus un platine + pemetrexed ou nivolumab + ipilimumab |
Institution |
INSTITUT UNIVERSITAIRE DE CARDIOLOGIE ET DE PNEUMOLOGIE DE QUEBEC - UL
|
City |
|
Principal Investigator |
Dr. Catherine Labbé
|
Coordinator |
Brigitte Fortin
418-656-8711 poste 2639
|
Status |
Recruiting |
Activation Date |
23-11-2023 |
Eligibility 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
|
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
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