Sub-study 1 Cervical Cancer (Volrustomig Monotherapy)Phase 2eVOLVE-02NCT06535607

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

A Phase 2 study testing Volrustomig, Cisplatin and Carboplatin in people with Sub-study 1 Cervical Cancer (Volrustomig Monotherapy) and Sub-study 2 Head and Neck Squamous Cell Carcinoma (Volrustomig Monotherapy), run by AstraZeneca at 98 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: 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)
What is being tested?: Volrustomig, Cisplatin and Carboplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 257 participants
Where: 98 sitesin 12 countries
Study dates: 22 Aug 2024to 30 Nov 2028
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 20Show fewer

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.

Trial locations and contacts

98 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

+18772409479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

98 sites in 12 countries

China49 sites, 22 recruiting

Research Site
Anyang, 455000
Not yet recruiting
Research Site
Beijing, 100142
Not yet recruiting
Research Site
Beijing, 100142
Recruiting
Research Site
Beijing, 100730
Active, not recruiting
Research Site
Beijing, 100730
Recruiting
Research Site
Beijing, CN-100730
Active, not recruiting
Research Site
Bengbu, 233004
Withdrawn
Research Site
Changchun, 130021
Withdrawn
Research Site
Changchun, 130021
Recruiting
Research Site
Changsha, 410003
Completed
Research Site
Changsha, 410008
Completed
Research Site
Changsha, 410008
Active, not recruiting
Research Site
Changsha, 410013
Completed
Research Site
Chengdu, 610041
Completed
Research Site
Chengdu, 610041
Active, not recruiting
Research Site
Chengdu, 610072
Recruiting
Research Site
Chongqing, 400030
Active, not recruiting
Research Site
Chongqing, 400030
Withdrawn
Research Site
Dongguan, 523009
Active, not recruiting
Research Site
Dongguan, 523009
Recruiting
Research Site
Fuzhou, 350011
Completed
Research Site
Fuzhou, 350014
Recruiting
Research Site
Fuzhou, 350014
Not yet recruiting
Research Site
Guangzhou, 510000
Not yet recruiting
Research Site
Hangzhou, 310022
Active, not recruiting
Research Site
Harbin, 150081
Not yet recruiting
Research Site
Hefei, 230031
Withdrawn
Research Site
Jining, 272029
Completed
Research Site
Kunming, 650118
Completed
Research Site
Kunming, 650118
Recruiting
Research Site
Nanchang, 330006
Terminated
Research Site
Nanjing, 210009
Not yet recruiting
Research Site
Nanning, 530021
Completed
Research Site
Nanning, 530021
Recruiting
Research Site
Shandong, 250117
Recruiting
Research Site
Shandong
Completed
Research Site
Shandong
Not yet recruiting
Research Site
Shandong
Recruiting
Research Site
Shanghai, 200120
Active, not recruiting
Research Site
Shenyang, 110004
Active, not recruiting
Research Site
Tianjin, 300060
Completed
Research Site
Tianjin, 300060
Recruiting
Research Site
Wuhan, 430022
Completed
Research Site
Wuhan, 430022
Active, not recruiting
Research Site
Wuhan, 430030
Recruiting
Research Site
Wuhan, 430040
Recruiting
Research Site
Wuhan, 430079
Withdrawn
Research Site
Wuhou District, 610041
Recruiting
Research Site
Zhengzhou, 450008
Not yet recruiting

Other trials in China

Germany10 sites, 10 recruiting

Research Site
Cologne, 51109
Recruiting
Research Site
Frankfurt, 60488
Not yet recruiting
Research Site
Gauting, 82131
Recruiting
Research Site
Großhansdorf, 22927
Recruiting
Research Site
Hamburg, 21075
Recruiting
Research Site
Heidelberg, 69120
Recruiting
Research Site
Mainz, 55131
Not yet recruiting
Research Site
Münster, 48153
Recruiting
Research Site
Offenbach, 63069
Not yet recruiting
Research Site
Regensburg, 93049
Recruiting

Other trials in Germany

Brazil8 sites, 8 recruiting

Research Site
Ijuí, 98700-000
Recruiting
Research Site
Londrina, 86015-520
Recruiting
Research Site
Natal, 59075-740
Recruiting
Research Site
Porto Alegre, 91350-200
Not yet recruiting
Research Site
Santo André, 09060-650
Not yet recruiting
Research Site
São Caetano do Sul, 09541-270
Recruiting
Research Site
Vitória, 29043-260
Recruiting
Research Site
Vitória, 29043-260
Not yet recruiting

Other trials in Brazil

United States7 sites, 5 recruiting

Research Site
Baltimore, Maryland, 21201
Recruiting
Research Site
Columbus, Ohio, 43210
Not yet recruiting
Research Site
Columbus, Ohio, 43210
Withdrawn
Research Site
Los Angeles, California, 90025
Withdrawn
Research Site
New York, New York, 10065
Recruiting
Research Site
Philadelphia, Pennsylvania, 19104
Not yet recruiting
Research Site
Stony Brook, New York, 11794
Recruiting

Other trials in United States

Taiwan6 sites, 6 recruiting

Research Site
Kaohsiung City, 80756
Recruiting
Research Site
Kaohsiung City, 80756
Not yet recruiting
Research Site
Kaohsiung City, 83301
Not yet recruiting
Research Site
Taichung, 40705
Recruiting
Research Site
Taipei, 112
Recruiting
Research Site
Taipei, 112
Not yet recruiting

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South Korea4 sites, 4 recruiting

Research Site
Incheon, 21565
Not yet recruiting
Research Site
Namdong-gu, 21565
Recruiting
Research Site
Seoul, 03722
Recruiting
Research Site
Seoul, 03722
Not yet recruiting

Other trials in South Korea

Italy3 sites, 3 recruiting

Research Site
Alessandria, 15100
Recruiting
Research Site
Bergamo, 24125
Recruiting
Research Site
Orbassano, 10043
Recruiting

Other trials in Italy

United Kingdom3 sites, 3 recruiting

Research Site
Cambridge, CB2 0QQ
Recruiting
Research Site
Glasgow, G12 0YN
Recruiting
Research Site
Manchester, M23 9LT
Recruiting

Other trials in United Kingdom

Australia2 sites, 2 recruiting

Research Site
Clayton, 3168
Recruiting
Research Site
Nedlands, 6009
Recruiting

Other trials in Australia

Canada2 sites, 2 recruiting

Research Site
Edmonton, Alberta, T6G 1Z2
Recruiting
Research Site
Montreal, Quebec, H2X 0A9
Recruiting

Other trials in Canada

Japan2 sites, 2 recruiting

Research Site
Kashiwa, 277-8577
Not yet recruiting
Research Site
Yokohama, 241-8515
Not yet recruiting

Other trials in Japan

Vietnam2 sites, 2 recruiting

Research Site
Hanoi, 100000
Recruiting
Research Site
Ho Chi Minh City, 700000
Recruiting

Other trials in Vietnam

About this study

Official title: 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.

Read the 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.

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)
Being tested: Volrustomig, Cisplatin, Carboplatin, Paclitaxel, 5-FU
Keywords: Cervical Cancer, Head and Neck Squamous Cell Carcinoma, eVOLVE-02, Volrustomig, Esophageal Squamous Cell Carcinoma, Unresectable Pleural Mesothelioma
Medical subject headings: Uterine Cervical Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VolrustomigBiological
IV Infusion
CisplatinDrug
IV Infusion
CarboplatinDrug
IV Infusion
PaclitaxelDrug
IV Infusion
5-FUDrug
IV Infusion

Study groups in NCT06535607
Study group	Role	What they receive
Sub-study 1	Experimental	Volrustomig monotherapy Receives: Biological: Volrustomig
Sub-study 2	Experimental	Volrustomig monotherapy Receives: Biological: Volrustomig
Sub-study 3 Arm A	Experimental	Volrustomig in combination with carboplatin plus paclitaxel Receives: Biological: Volrustomig; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel
Sub-study 3 Arm B	Experimental	Volrustomig in combination with carboplatin plus paclitaxel Receives: Biological: Volrustomig; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel
Sub-study 3 Arm C	Experimental	Volrustomig in combination with 5-FU plus platinum Receives: Biological: Volrustomig; Drug: Cisplatin; Drug: Carboplatin; Drug: 5-FU
Sub-study 4 Arm A	Experimental	Volrustomig in combination with cisplatin + 5-FU Receives: Biological: Volrustomig; Drug: Cisplatin; Drug: 5-FU
Sub-study 4 Arm B	Experimental	Volrustomig in combination with cisplatin + paclitaxel Receives: Biological: Volrustomig; Drug: Cisplatin; Drug: Paclitaxel
Sub-study 5	Experimental	Volrustomig monotherapy Receives: Biological: Volrustomig

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Through study completion, an average of 4 years

Secondary outcomes (9)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 202430 Nov 2028

First posted2 Aug 2024
Study start22 Aug 2024
Primary completion30 Nov 2028 (estimated)
Study completion30 Nov 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sub-study 1 Cervical Cancer (Volrustomig Monotherapy)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 257 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06535607
Sponsor's protocol ID: D798MC00002
Acronym: eVOLVE-02
Status last verified: Mar 2026
First submitted: 31 Jul 2024
Last updated: 11 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.