VOLRUSTOMIG for Malignant pleural mesothelioma | Esophageal squamous cell carcinoma

Inclusion criteria

• {"criterion_text":"- Age ≥18 at the time of signing the ICF.\n- Provision of tumor sample to assess the PD-L1 expression.\n- ECOG performance status of 0 or 1.\n- Measurable disease according to RECIST 1.1.\n- Life expectancy ≥ 12 weeks.\n- Adequate organ and bone marrow function.\n- Body weight > 35 kg.\n- Capable of giving signed informed consent."}

Exclusion criteria

• {"criterion_text":"- Spinal cord compression.\n- Prior exposure to any immune-mediated therapy.\n- Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control).\n- For sub-study 4, participants are ineligible if they have received any anti-cancer therapy within 28 days prior to the first dose of study intervention or within 5 half-lives of the respective agent, whichever is longer.\n- Any concurrent chemotherapy except study intervention, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.\n- Radiotherapy treatment with a wide field of radiation or to more than 30% of the bone marrow within 4 weeks, prior to the first dose of study intervention.\n- Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.\n- Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.\n- Participants with a known allergy or hypersensitivity to any study intervention, on any excipients of any study intervention.\n- For sub-study 4, brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. For sub-study 5, participants with untreated or progressive brain metastases.\n- Have not recovered (ie, ≤ Grade 1 or at baseline) from an AE due to a previously administered anti-cancer therapy.\n- For sub-study 4, participants have contraindications to any of the following drugs: 5- FU, paclitaxel and carboplatin\n- History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention and of low potential risk for recurrence; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease.\n- Any evidence of diseases, and/or history of organ transplant or allogenic stem cell transplant, which makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.\n- Evidence of the following infections: active infection including tuberculosis; known HIV infection. that is not well controlled; active or uncontrolled HBV or HCV; or active hepatitis A.\n- History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.\n- Participants who are candidates for curative therapy."}

Primary endpoints

• {"endpoint_text":"- Objective response rate (ORR). Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by Investigator per RECIST 1.1. Through study completion, an average of 4 years","definition_or_measurement_approach":"Confirmed ORR defined as proportion with confirmed CR or confirmed PR as determined by Investigator per RECIST 1.1; assessed through study completion (average 4 years)."}
• {"endpoint_text":"- The number of participants with adverse events/serious adverse events. Number of participants with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline. Through study completion, an average of 4 years","definition_or_measurement_approach":"Count of participants experiencing adverse events and serious adverse events, including abnormal clinical observations, ECG parameters, laboratory assessments and vital signs changes from baseline; monitored through study completion (average 4 years)."}

Secondary endpoints

• {"endpoint_text":"- Duration Of Response (DOR). DoR is defined as the time from the date of first documented confirmed response (which is subsequently confirmed) until date of documented progression per RECIST 1.1 as assessed by Investigator or ICR, or death due to any cause. Through study completion, an average of 4 years","definition_or_measurement_approach":"Time from first documented confirmed response until documented progression per RECIST 1.1 (Investigator or ICR) or death; assessed through study completion (~4 years)."}
• {"endpoint_text":"- Progression free survival (PFS). PFS is defined as the time from date of first dose of study intervention until progression per RECIST 1.1 as assessed by Investigator or ICR, or death due to any cause. Through study completion, an average of 4 years","definition_or_measurement_approach":"Time from first dose to progression per RECIST 1.1 (Investigator or ICR) or death; assessed through study completion (~4 years)."}
• {"endpoint_text":"- Time to response (TTR). TTR is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1, as assessed by Investigator or ICR. Through study completion, an average of 4 years","definition_or_measurement_approach":"Time from first dose to first documented objective response (confirmed per RECIST 1.1) as assessed by Investigator or ICR; through study completion (~4 years)."}
• {"endpoint_text":"- Overall Survival (OS). OS is defined as the time from the date of first dose of study intervention until the date of death due to any cause. Through study completion, an average of 4 years","definition_or_measurement_approach":"Time from first dose to death from any cause; through study completion (~4 years)."}
• {"endpoint_text":"- PK of volrustomig. Concentration of Volrustomig in serum. Through study completion, an average of 4 years","definition_or_measurement_approach":"Measurement of serum concentration of volrustomig (pharmacokinetics); assessed through study completion (~4 years)."}
• {"endpoint_text":"- The immunogenicity of volrustomig. Incidence of ADAs against volrustomig in serum. Through study completion, an average of 4 years","definition_or_measurement_approach":"Incidence of anti-drug antibodies (ADAs) against volrustomig in serum; assessed through study completion (~4 years)."}
• {"endpoint_text":"- Disease control rate (DCR). Disease control rate is defined as the proportion of participants with a BOR of confirmed CR, confirmed PR, or SD, as determined by Investigator per RECIST 1.1. Through study completion, an average of 4 years","definition_or_measurement_approach":"Proportion of participants with best overall response (confirmed CR, PR, or SD) per RECIST 1.1 assessed by Investigator; through study completion (~4 years)."}
• {"endpoint_text":"- PFS landmark. The landmark of PFS rates at 6, 9, and 12 months. Through study completion, an average of 4 years","definition_or_measurement_approach":"Landmark PFS rates at 6, 9, and 12 months; assessed through study completion (~4 years)."}
• {"endpoint_text":"- OS landmark. The median OS and the landmark of OS rate at 12 months. Through study completion, an average of 4 years","definition_or_measurement_approach":"Median overall survival and OS rate at 12 months; assessed through study completion (~4 years)."}

Germany

Earliest CTIS Part Ii Submission Date

16-04-2026

Latest Decision Or Authorization Date

06-05-2026

Processing Time Days

20

Number Of Sites

11

Number Of Participants

24

Italy

Earliest CTIS Part Ii Submission Date

26-03-2026

Latest Decision Or Authorization Date

05-05-2026

Processing Time Days

40

Number Of Sites

3

Number Of Participants

18

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden