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MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

PHASE3RECRUITING

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.

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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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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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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

Image related to Unresectable Pleural Mesothelioma

Condition: Unresectable Pleural Mesothelioma
DRUG: Volrustomig and other drugs
Chermside, Not Specified, Australia and more
Sponsor: AstraZeneca

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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 Volrustomig in combination with carboplatin plus pemetrexed	DRUG: Volrustomig MEDI5752: Administered as IV infusion
ACTIVE_COMPARATOR: Investigator's choice of standard care The investigator's choice of nivolumab plus ipilimumab or platinum plus pemetrexed chemotherapy for participants with epithelioid histology, and nivolumab plus ipilumab for participants with non-epithelioid histology.	DRUG: Pemetrexed Alimta: Administered as IV infusion

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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References

Clinical Trials Gov: MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma