Study of Volrustomig as Monotherapy or in Combination with Anti- cancer Agents in Participants with Advanced/Metastatic Solid Tumors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-05-06

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

AstraZeneca AB

External identifiers

EU CT number

2025-523947-36-00

ClinicalTrials.gov

NCT06535607

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacodynamic, Therapy, Pharmacokinetic

To estimate the effectiveness of volrustomig monotherapy or in combination with other anti cancer agents by assessment of confirmed ORR.

Secondary objectives 6

1. To estimate the effectiveness of volrustomig monotherapy or in combination with other anti cancer agents by assessment of DoR.
2. To estimate the effectiveness of volrustomig monotherapy or in combination with other anti cancer agents by assessment of PFS.
3. To estimate the effectiveness of volrustomig monotherapy or in combination with other anti cancer agents by assessment of TTR.
4. To estimate the effectiveness of volrustomig monotherapy or in combination with other anti cancer agents by assessment of OS.
5. To assess the PK of volrustomig.
6. To investigate the immunogenicity of volrustomig.

Conditions and MedDRA coding

Sub-study 5: Unresectable Pleural Mesothelioma (Volrustomig Monotherapy)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Age ≥18 at the time of signing the ICF.
2. Provision of tumor sample to assess the PD-L1 expression.
3. ECOG performance status of 0 or 1.
4. Measurable disease according to RECIST 1.1.
5. Life expectancy ≥ 12 weeks.
6. Adequate organ and bone marrow function.
7. Body weight > 35 kg.
8. Capable of giving signed informed consent.

Exclusion criteria 17

1. Spinal cord compression.
2. 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.
3. Have not recovered (ie, ≤ Grade 1 or at baseline) from an AE due to a previously administered anti-cancer therapy.
4. For sub-study 4, participants have contraindications to any of the following drugs: 5- FU, paclitaxel and carboplatin
5. 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.
6. 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.
7. 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.
8. History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.
9. Participants who are candidates for curative therapy.
10. Prior exposure to any immune-mediated therapy.
11. 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).
12. 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.
13. Any concurrent chemotherapy except study intervention, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
14. 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.
15. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.
16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.
17. Participants with a known allergy or hypersensitivity to any study intervention, on any excipients of any study intervention.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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
2. 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

Secondary endpoints 9

1. 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
2. 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
3. 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
4. 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
5. PK of volrustomig. Concentration of Volrustomig in serum. Through study completion, an average of 4 years
6. The immunogenicity of volrustomig. Incidence of ADAs against volrustomig in serum. Through study completion, an average of 4 years
7. 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
8. PFS landmark. The landmark of PFS rates at 6, 9, and 12 months. Through study completion, an average of 4 years
9. OS landmark. The median OS and the landmark of OS rate at 12 months. Through study completion, an average of 4 years

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Locations

2 EU/EEA countries · 14 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 25 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications