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

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.

Study Overview

• Status: Recruiting
• Conditions: Sub-study 1 Cervical Cancer (Volrustomig Monotherapy); Sub-study 2 Head and Neck Squamous Cell Carcinoma (Volrustomig Monotherapy); Sub-study 3 Head and Neck Squamous Cell Carcinoma (Volrustomig in Combination With Chemotherapy); Sub-study 4 Esophageal Squamous Cell Carcinoma (Volrustomig in Combination With Chemotherapy); Sub-study 5 Unresectable Pleural Mesothelioma (Volrustomig Monotherapy)
• Intervention / Treatment: Drug: Carboplatin; Biological: Volrustomig; Drug: Cisplatin; Drug: Paclitaxel; Drug: 5-FU

Detailed Description

eVOLVE-02 study will evaluate volrustomig monotherapy or volrustomig-based combination therapy in various advanced or metastatic solid tumors.

In sub-study 1, volrustomig will be evaluated as monotherapy in approximately 30 evaluable participants with cervical cancer.

In sub-study 2, volrustomig will be evaluated as monotherapy in approximately 20 evaluable participants with head and neck squamous cell carcinoma.

In sub-study 3, Volrustomig in Combination with Chemotherapy will be evaluated in approximately 60 evaluable participants with head and neck squamous cell carcinoma.

In sub-study 4, volrustomig in Combination with Chemotherapy will be evaluated in approximately 60 evaluable participants with esophagus squamous cell carcinoma.

In sub-study 5, volrustomig will be evaluated as monotherapy in approximately 75 evaluable participants with unresectable pleural mesothelioma.

• Study Type: Interventional
• Enrollment (Estimated): 257
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: +18772409479; Email: information.center@astrazeneca.com

Study Locations

• Australia
  • Clayton, Australia, 3168
    • Recruiting
    • Research Site
  • Nedlands, Australia, 6009
    • Not yet recruiting
    • Research Site
• Brazil
  • Ijuí, Brazil, 98700-000
    • Recruiting
    • Research Site
  • Londrina, Brazil, 86015-520
    • Recruiting
    • Research Site
  • Porto Alegre, Brazil, 91350-200
    • Not yet recruiting
    • Research Site
  • Santo André, Brazil, 09060-650
    • Not yet recruiting
    • Research Site
  • São Caetano do Sul, Brazil, 09541-270
    • Recruiting
    • Research Site
  • Vitória, Brazil, 29043-260
    • Not yet recruiting
    • Research Site
  • Vitória, Brazil, 29043-260
    • Recruiting
    • Research Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Not yet recruiting
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
      • Recruiting
      • Research Site
• China
  • Anyang, China, 455000
    • Not yet recruiting
    • Research Site
  • Beijing, China, 100730
    • Recruiting
    • Research Site
  • Beijing, China, 100142
    • Not yet recruiting
    • Research Site
  • Beijing, China, 100142
    • Recruiting
    • Research Site
  • Beijing, China, CN-100730
    • Active, not recruiting
    • Research Site
  • Beijing, China, 100730
    • Active, not recruiting
    • Research Site
  • Bengbu, China, 233004
    • Withdrawn
    • Research Site
  • Changchun, China, 130021
    • Withdrawn
    • Research Site
  • Changchun, China, 130021
    • Recruiting
    • Research Site
  • Changsha, China, 410008
    • Recruiting
    • Research Site
  • Changsha, China, 410003
    • Recruiting
    • Research Site
  • Changsha, China, 410013
    • Completed
    • Research Site
  • Changsha, China, 410008
    • Completed
    • Research Site
  • Chengdu, China, 610072
    • Recruiting
    • Research Site
  • Chengdu, China, 610041
    • Active, not recruiting
    • Research Site
  • Chengdu, China, 610041
    • Completed
    • Research Site
  • Chongqing, China, 400030
    • Withdrawn
    • Research Site
  • Chongqing, China, 400030
    • Active, not recruiting
    • Research Site
  • Dongguan, China, 523009
    • Recruiting
    • Research Site
  • Dongguan, China, 523009
    • Active, not recruiting
    • Research Site
  • Fuzhou, China, 350014
    • Not yet recruiting
    • Research Site
  • Fuzhou, China, 350014
    • Recruiting
    • Research Site
  • Fuzhou, China, 350011
    • Completed
    • Research Site
  • Guangzhou, China, 510000
    • Not yet recruiting
    • Research Site
  • Hangzhou, China, 310022
    • Recruiting
    • Research Site
  • Hangzhou, China, 310022
    • Active, not recruiting
    • Research Site
  • Harbin, China, 150081
    • Not yet recruiting
    • Research Site
  • Hefei, China, 230031
    • Withdrawn
    • Research Site
  • Jining, China, 272029
    • Recruiting
    • Research Site
  • Kunming, China, 650118
    • Not yet recruiting
    • Research Site
  • Kunming, China, 650118
    • Completed
    • Research Site
  • Nanchang, China, 330006
    • Recruiting
    • Research Site
  • Nanjing, China, 210009
    • Not yet recruiting
    • Research Site
  • Nanning, China, 530021
    • Recruiting
    • Research Site
  • Nanning, China, 530021
    • Active, not recruiting
    • Research Site
  • Shandong, China
    • Recruiting
    • Research Site
  • Shandong, China
    • Not yet recruiting
    • Research Site
  • Shandong, China
    • Completed
    • Research Site
  • Shandong, China, 250117
    • Recruiting
    • Research Site
  • Shanghai, China, 200120
    • Recruiting
    • Research Site
  • Shanghai, China, 200120
    • Active, not recruiting
    • Research Site
  • Shenyang, China, 110004
    • Active, not recruiting
    • Research Site
  • Tianjin, China, 300060
    • Recruiting
    • Research Site
  • Tianjin, China, 300060
    • Completed
    • Research Site
  • Wuhan, China, 430030
    • Recruiting
    • Research Site
  • Wuhan, China, 430079
    • Withdrawn
    • Research Site
  • Wuhan, China, 430022
    • Active, not recruiting
    • Research Site
  • Wuhan, China, 430040
    • Recruiting
    • Research Site
  • Wuhou District, China, 610041
    • Recruiting
    • Research Site
  • Zhengzhou, China, 450008
    • Not yet recruiting
    • Research Site
• Germany
  • Cologne, Germany, 51109
    • Not yet recruiting
    • Research Site
  • Frankfurt, Germany, 60488
    • Not yet recruiting
    • Research Site
  • Gauting, Germany, 82131
    • Not yet recruiting
    • Research Site
  • Großhansdorf, Germany, 22927
    • Not yet recruiting
    • Research Site
  • Hamburg, Germany, 21075
    • Not yet recruiting
    • Research Site
  • Heidelberg, Germany, 69120
    • Not yet recruiting
    • Research Site
  • Mainz, Germany, 55131
    • Not yet recruiting
    • Research Site
  • Münster, Germany, 48153
    • Not yet recruiting
    • Research Site
  • Offenbach, Germany, 63069
    • Not yet recruiting
    • Research Site
  • Regensburg, Germany, 93049
    • Not yet recruiting
    • Research Site
• Italy
  • Alessandria, Italy, 15100
    • Not yet recruiting
    • Research Site
  • Bergamo, Italy, 24125
    • Not yet recruiting
    • Research Site
  • Orbassano, Italy, 10043
    • Not yet recruiting
    • Research Site
• Japan
  • Kashiwa, Japan, 277-8577
    • Not yet recruiting
    • Research Site
  • Yokohama, Japan, 241-8515
    • Not yet recruiting
    • Research Site
• South Korea
  • Incheon, South Korea, 21565
    • Not yet recruiting
    • Research Site
  • Namdong-gu, South Korea, 21565
    • Recruiting
    • Research Site
  • Seoul, South Korea, 03722
    • Recruiting
    • Research Site
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Not yet recruiting
    • Research Site
  • Kaohsiung City, Taiwan, 80756
    • Not yet recruiting
    • Research Site
  • Taichung, Taiwan, 40705
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 112
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 112
    • Not yet recruiting
    • Research Site
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Research Site
  • Glasgow, United Kingdom, G12 0YN
    • Not yet recruiting
    • Research Site
  • Manchester, United Kingdom, M23 9LT
    • Recruiting
    • Research Site
• United States
  • California
    • Los Angeles, California, United States, 90025
      • Withdrawn
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Not yet recruiting
      • Research Site
  • New York
    • New York, New York, United States, 10065
      • Not yet recruiting
      • Research Site
    • Stony Brook, New York, United States, 11794
      • Not yet recruiting
      • Research Site
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Not yet recruiting
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Not yet recruiting
      • Research Site
• Vietnam
  • Hanoi, Vietnam, 100000
    • Recruiting
    • Research Site
  • Ho Chi Minh City, Vietnam, 700000
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• For sub-study 1,2,3, participants with primary neuroendocrine, mesenchymal, sarcomatoid histologies, or other histologies not mentioned as part of the inclusion criteria.
• 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.
• Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.
• Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.
• Participants with a known allergy or hypersensitivity to any study intervention, on any excipients of any study intervention.
• For substudy 5: Participants with any prior systemic therapy, non-palliative radiotherapy, radical pleuropneumonectomy for pleural mesothelioma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sub-study 1; Volrustomig monotherapy	Biological: Volrustomig; IV Infusion
Experimental: Sub-study 2; Volrustomig monotherapy	Biological: Volrustomig; IV Infusion
Experimental: Sub-study 3 Arm A; Volrustomig in combination with carboplatin plus paclitaxel	Drug: Carboplatin; IV Infusion; Biological: Volrustomig; IV Infusion; Drug: Cisplatin; IV Infusion; Drug: Paclitaxel; IV Infusion
Experimental: Sub-study 3 Arm B; Volrustomig in combination with carboplatin plus paclitaxel	Drug: Carboplatin; IV Infusion; Biological: Volrustomig; IV Infusion; Drug: Cisplatin; IV Infusion; Drug: Paclitaxel; IV Infusion
Experimental: Sub-study 3 Arm C; Volrustomig in combination with 5-FU plus platinum	Drug: Carboplatin; IV Infusion; Biological: Volrustomig; IV Infusion; Drug: Cisplatin; IV Infusion; Drug: 5-FU; IV Infusion
Experimental: Sub-study 4 Arm A; Volrustomig in combination with cisplatin + 5-FU	Biological: Volrustomig; IV Infusion; Drug: Cisplatin; IV Infusion; Drug: 5-FU; IV Infusion
Experimental: Sub-study 4 Arm B; Volrustomig in combination with cisplatin + paclitaxel	Biological: Volrustomig; IV Infusion; Drug: Cisplatin; IV Infusion; Drug: Paclitaxel; IV Infusion
Experimental: Sub-study 5; Volrustomig monotherapy	Biological: Volrustomig; IV Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
PK of volrustomig	Concentration of Volrustomig in serum.	Through study completion, an average of 4 years
The immunogenicity of volrustomig	Incidence of ADAs against volrustomig in serum.	Through study completion, an average of 4 years
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
PFS landmark	The landmark of PFS rates at 6, 9, and 12 months.	Through study completion, an average of 4 years
OS landmark	The median OS and the landmark of OS rate at 12 months.	Through study completion, an average of 4 years

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cervical Cancer; Head and Neck Squamous Cell Carcinoma; Esophageal Squamous Cell Carcinoma; Volrustomig; Unresectable Pleural Mesothelioma; eVOLVE-02
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Uterine Diseases; Genital Diseases, Female; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Esophageal Diseases; Genital Neoplasms, Female; Carcinoma; Neoplasms, Squamous Cell; Uterine Cervical Diseases; Uterine Neoplasms; Carcinoma, Squamous Cell; Esophageal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Esophageal Squamous Cell Carcinoma; Uterine Cervical Neoplasms; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Taxoids; Cyclodecanes; Diterpenes; Pyrimidines; Uracil; Pyrimidinones; Platinum Compounds; Fluorouracil; Carboplatin; Paclitaxel; Cisplatin
• Other Study ID Numbers: D798MC00002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No