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MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-11-09
Primary completion: 2027-03-15
Study completion finish: 2028-03-13
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06097728
Intervention or treatment
DRUG: Volrustomig
DRUG: Pemetrexed
DRUG: Carboplatin
DRUG: Cisplatin
DRUG: Nivolumab
DRUG: Ipilimumab
Conditions
- • Unresectable Pleural Mesothelioma
Find a site
Closest Location:
Research Site
Research sites nearby
Select from list below to view details:
Research Site
Chermside, Not Specified, Australia
Research Site
Clayton, Not Specified, Australia
Research Site
Melbourne, Not Specified, Australia
Research Site
Nedlands, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Volrustomig + Carboplatin + pemetrexed
| DRUG: Volrustomig
|
ACTIVE_COMPARATOR: Investigator's choice of standard care
| DRUG: Pemetrexed
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Overall Survival (OS) in experimental arm relative to comparator arm | OS is defined as the time from randomization until the date of death due to any cause. | up to approximately 52 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Overall Survival (OS) | OS is defined as the time from randomization until the date of death due to any cause. | up to approximately 52 months |
Progression Free Survival (PFS) | PFS is defined as the time from randomization until progression per mRECIST 1.1 and/or RECIST 1.1 as assessed by the investigator at local site, or death due to any cause. | up to approximately 52 months |
Landmark OS | Landmarks of OS12, OS18, OS24, and OS36. | 12, 18, 24, 36 months |
Landmark PFS | Landmarks of PFS6, PFS12, PFS18, and PFS24 | 6, 12, 18, 24 months |
Overall Response Rate (ORR) | Proportion of participants who have a confirmed Complete Response or confirmed Partial Response, as determined by the investigator at local site per mRECIST 1.1 and/or RECIST 1.1. | up to approximately 52 months |
Duration of Response (DoR) | DoR defined as the time from the date of first documented response until date of documented progression per mRECIST 1.1 and/or RECIST 1.1 as assessed by the investigator at local site or death due to any cause. | up to approximately 52 months |
PFS2 | PFS2 defined as the time from randomization to the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death. | up to approximately 52 months |
Patient-reported physical functioning | TTD in physical functioning as measured by PROMIS (Patient Reported Outcomes Measurement Information System) Physical Function Short Form 8c. There are 8 questions each from a scale of 1 (unable to do) to a scale of 5 (With a little difficulty). The higher the scores the better the patient-reported physical functioning is. | up to approximately 52 months. |
Disease-related symptoms using EORTC IL305 (Q1) | Change from baseline in disease-related symptoms as measured by individual symptom items from the EORTC (European Organisation For Research And Treatment Of Cancer) IL305 (Item Library 305) (Q1). It is scored from a 1 (not at all) to a 4 (very much). The higher the score the higher the disease-related symptoms. | Up to approximately 52 months. |
Disease-related symptoms using PRO-CTCAE (Q1, 5, 6, 9) | Change from baseline in disease-related symptoms as measured by individual symptom items from the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) (Q1, 5, 6, 9). PRO-CTCAE responses are scored from 0 to 4 (or 0/1 for absent/present). The higher the score the higher the disease-related symptoms. | Up to approximately 52 months |
Patient-reported role functioning using EORTC QLQ-C30 RF subscale (IL305 Q2 3) | Change from baseline in functioning will be assessed by the following measure: Role functioning: EORTC (European Organisation For Research And Treatment Of Cancer) QLQ (Quality of Life Questionnaire) -C30 RF (Role Functioning) subscale (IL305 Q2 3) (Item Library 305). The questions are from a scale of 1 (not at all) to 4 (very much). The lower the score the higher the patient-reported role functioning is. | up to approximately 52 months |
Patient-reported HRQoL (Health-related Quality of Life) using EORTC QLQ-C30 HRQoL subscale (IL305 Q7-8) | Change from baseline in functioning will be assessed by the following measure: HRQoL: EORTC (European Organisation For Research And Treatment Of Cancer) QLQ (Quality of Life Questionnaire) -C30 HRQoL subscale (IL305 Q7-8) (Item Library 305). The questions are from a scale of 1 (very poor) to 7 (excellent). The higher the score the higher the HRQoL. | Up to approximately 52 months |
Immunogenicity of volrustomig | Incidence of Anti-Drug Antibodies against volrustomig. | up to approximately 52 months |
Incidence of Adverse Events (AEs) AEs graded by CTCAE version 5.0 | Incidence of Adverse Events (AEs) AEs graded by CTCAE (Common Terminology Criteria for Adverse Events) version 5.0. Grade refers to the severity of the AE. The CTCAE displays grade 1 (mild) through 5 (death related to AE). Grade 2 (moderate), Grade 3 (Severe) and Grade 4 (Life-threatening consequences). | Up to approximately 52 months |
Area under the curve (AUC) | The concentration of MEDI5752 in serum will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered. | Up to approximately 52 months |
Maximum plasma concentration of the drug (Cmax) | The concentration of MEDI5752 in serum will be determined (Cmax will be derived). | Up to approximately 52 months |
The time taken to reach the maximum concentration (Tmax) | The concentration of MEDI5752 in serum will be determined (Tmax will be derived). | Up to approximately 52 months |
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