Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors
eVOLVE-02
A Phase II, Multi-Center Study to Evaluate the Efficacy and Safety of Volrustomig as Monotherapy or in Combination With Anti-cancer Agents in Participants With Advanced/Metastatic Solid Tumors
1 other identifier
interventional
257
12 countries
97
Brief Summary
eVOLVE-02 study will evaluate the efficacy and safety of volrustomig as monotherapy or in combination with anti-cancer agents in participants with advanced/metastatic solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2024
Typical duration for phase_2
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2024
CompletedFirst Posted
Study publicly available on registry
August 2, 2024
CompletedStudy Start
First participant enrolled
August 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2028
July 6, 2026
July 1, 2026
4.3 years
July 31, 2024
July 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (9)
Duration Of Response (DOR)
Through study completion, an average of 4 years
Progression free survival (PFS)
Through study completion, an average of 4 years
Time to response (TTR)
Through study completion, an average of 4 years
Overall Survival (OS)
Through study completion, an average of 4 years
PK of volrustomig
Through study completion, an average of 4 years
- +4 more secondary outcomes
Study Arms (8)
Sub-study 1
EXPERIMENTALVolrustomig monotherapy
Sub-study 2
EXPERIMENTALVolrustomig monotherapy
Sub-study 3 Arm A
EXPERIMENTALVolrustomig in combination with carboplatin plus paclitaxel
Sub-study 3 Arm B
EXPERIMENTALVolrustomig in combination with carboplatin plus paclitaxel
Sub-study 3 Arm C
EXPERIMENTALVolrustomig in combination with 5-FU plus platinum
Sub-study 4 Arm A
EXPERIMENTALVolrustomig in combination with cisplatin + 5-FU
Sub-study 4 Arm B
EXPERIMENTALVolrustomig in combination with cisplatin + paclitaxel
Sub-study 5
EXPERIMENTALVolrustomig monotherapy
Interventions
IV Infusion
IV Infusion
Eligibility Criteria
You may qualify if:
- Age ≥18 at the time of signing the ICF.
- Provision of tumor sample to assess the PD-L1 expression (if applicable).
- ECOG performance status of 0 or 1.
- Measurable disease according to RECIST 1.1 (variations of RECIST 1.1 if applicable).
- Life expectancy ≥ 12 weeks.
- Adequate organ and bone marrow function.
- Body weight \> 35 kg
- Capable of giving signed informed consent.
You may not qualify if:
- Spinal cord compression.
- For sub-study 1,2,3,4, 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.
- Have not recovered (ie, ≤ Grade 1 or at baseline) from an AE due to a previously administered anti-cancer therapy.
- For sub-study 2, have had radiotherapy within 2 weeks prior to enrollment.
- For sub-study 3,4, participants have contraindications to any of the following drugs: 5-FU, paclitaxel and carboplatin
- 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.
- 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.
- 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.
- History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.
- Participants who are candidates for curative therapy.
- Prior exposure to any immune-mediated therapy.
- 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).
- For sub-study 1,2,3,4, 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.
- Any concurrent chemotherapy except study intervention, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (97)
Research Site
Los Angeles, California, 90025, United States
Research Site
Baltimore, Maryland, 21201, United States
Research Site
New York, New York, 10065, United States
Research Site
Stony Brook, New York, 11794, United States
Research Site
Columbus, Ohio, 43210, United States
Research Site
Philadelphia, Pennsylvania, 19104, United States
Research Site
Clayton, 3168, Australia
Research Site
Nedlands, 6009, Australia
Research Site
Ijuí, 98700-000, Brazil
Research Site
Londrina, 86015-520, Brazil
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Natal, 59075-740, Brazil
Research Site
Porto Alegre, 91350-200, Brazil
Research Site
Santo André, 09060-650, Brazil
Research Site
São Caetano do Sul, 09541-270, Brazil
Research Site
Vitória, 29043-260, Brazil
Research Site
Vitória, 29043-260, Brazil
Research Site
Edmonton, Alberta, T6G 1Z2, Canada
Research Site
Montreal, Quebec, H2X 0A9, Canada
Research Site
Anyang, 455000, China
Research Site
Beijing, 100142, China
Research Site
Beijing, 100142, China
Research Site
Beijing, 100730, China
Research Site
Beijing, 100730, China
Research Site
Beijing, CN-100730, China
Research Site
Bengbu, 233004, China
Research Site
Changchun, 130021, China
Research Site
Changchun, 130021, China
Research Site
Changsha, 410003, China
Research Site
Changsha, 410008, China
Research Site
Changsha, 410008, China
Research Site
Changsha, 410013, China
Research Site
Chengdu, 610041, China
Research Site
Chengdu, 610041, China
Research Site
Chengdu, 610072, China
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Chongqing, 400030, China
Research Site
Chongqing, 400030, China
Research Site
Dongguan, 523009, China
Research Site
Dongguan, 523009, China
Research Site
Fuzhou, 350011, China
Research Site
Fuzhou, 350014, China
Research Site
Fuzhou, 350014, China
Research Site
Guangzhou, 510000, China
Research Site
Hangzhou, 310022, China
Research Site
Hangzhou, 310022, China
Research Site
Harbin, 150081, China
Research Site
Hefei, 230031, China
Research Site
Jining, 272029, China
Research Site
Kunming, 650118, China
Research Site
Kunming, 650118, China
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Nanchang, 330006, China
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Nanjing, 210009, China
Research Site
Nanning, 530021, China
Research Site
Nanning, 530021, China
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Shandong, 250117, China
Research Site
Shandong, China
Research Site
Shandong, China
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Shandong, China
Research Site
Shanghai, 200120, China
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Shanghai, 200120, China
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Shenyang, 110004, China
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Tianjin, 300060, China
Research Site
Tianjin, 300060, China
Research Site
Wuhan, 430022, China
Research Site
Wuhan, 430030, China
Research Site
Wuhan, 430040, China
Research Site
Wuhan, 430079, China
Research Site
Wuhou District, 610041, China
Research Site
Zhengzhou, 450008, China
Research Site
Cologne, 51109, Germany
Research Site
Frankfurt, 60488, Germany
Research Site
Gauting, 82131, Germany
Research Site
Großhansdorf, 22927, Germany
Research Site
Hamburg, 21075, Germany
Research Site
Heidelberg, 69120, Germany
Research Site
Mainz, 55131, Germany
Research Site
Münster, 48153, Germany
Research Site
Offenbach, 63069, Germany
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Regensburg, 93049, Germany
Research Site
Alessandria, 15100, Italy
Research Site
Bergamo, 24125, Italy
Research Site
Orbassano, 10043, Italy
Research Site
Kashiwa, 277-8577, Japan
Research Site
Yokohama, 241-8515, Japan
Research Site
Incheon, 21565, South Korea
Research Site
Namdong-gu, 21565, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Kaohsiung City, 80756, Taiwan
Research Site
Kaohsiung City, 83301, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Taipei, 112, Taiwan
Research Site
Taipei, 112, Taiwan
Research Site
Cambridge, CB2 0QQ, United Kingdom
Research Site
Glasgow, G12 0YN, United Kingdom
Research Site
Manchester, M23 9LT, United Kingdom
Research Site
Hanoi, 100000, Vietnam
Research Site
Ho Chi Minh City, 700000, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2024
First Posted
August 2, 2024
Study Start
August 22, 2024
Primary Completion (Estimated)
November 30, 2028
Study Completion (Estimated)
November 30, 2028
Last Updated
July 6, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.