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NCT06535607PHASE2Recruiting

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

AstraZeneca

Start Date

8/22/2024

Completion Date

11/30/2028

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

BIOLOGICAL

Volrustomig

DRUG

Cisplatin

DRUG

Carboplatin

DRUG

Paclitaxel

DRUG

5-FU

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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)

Locations

Research Site

Los Angeles, California 90025

United States

Research Site

Baltimore, Maryland 21201

United States

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New York, New York 10065

United States

Research Site

Stony Brook, New York 11794

United States

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Columbus, Ohio 43210

United States

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Philadelphia, Pennsylvania 19104

United States

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Clayton, 3168

Australia

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Nedlands, 6009

Australia

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Ijuí, 98700-000

Brazil

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Londrina, 86015-520

Brazil

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Natal, 59075-740

Brazil

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Porto Alegre, 91350-200

Brazil

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Santo André, 09060-650

Brazil

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São Caetano do Sul, 09541-270

Brazil

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Vitória, 29043-260

Brazil

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Vitória, 29043-260

Brazil

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Edmonton, Alberta T6G 1Z2

Canada

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Montreal, Quebec H2X 0A9

Canada

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Anyang, 455000

China

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Beijing, 100142

China

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Beijing, 100142

China

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Beijing, 100730

China

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Beijing, 100730

China

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Beijing, CN-100730

China

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Bengbu, 233004

China

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Changchun, 130021

China

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Changchun, 130021

China

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Changsha, 410003

China

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Changsha, 410008

China

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Changsha, 410008

China

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Changsha, 410013

China

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Chengdu, 610041

China

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Chengdu, 610041

China

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Chengdu, 610072

China

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Chongqing, 400030

China

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Chongqing, 400030

China

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Dongguan, 523009

China

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Dongguan, 523009

China

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Fuzhou, 350011

China

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Fuzhou, 350014

China

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Fuzhou, 350014

China

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Guangzhou, 510000

China

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Hangzhou, 310022

China

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Hangzhou, 310022

China

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Harbin, 150081

China

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Hefei, 230031

China

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Jining, 272029

China

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Kunming, 650118

China

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Kunming, 650118

China

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Nanchang, 330006

China

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Nanjing, 210009

China

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Nanning, 530021

China

Research Site

Nanning, 530021

China

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Shandong, 250117

China

Research Site

Shandong,

China

Research Site

Shandong,

China

Research Site

Shandong,

China

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Shanghai, 200120

China

Research Site

Shanghai, 200120

China

Research Site

Shenyang, 110004

China

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Tianjin, 300060

China

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Tianjin, 300060

China

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Wuhan, 430022

China

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Wuhan, 430030

China

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Wuhan, 430040

China

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Wuhan, 430079

China

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Wuhou District, 610041

China

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Zhengzhou, 450008

China

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Cologne, 51109

Germany

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Frankfurt, 60488

Germany

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Gauting, 82131

Germany

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Großhansdorf, 22927

Germany

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Hamburg, 21075

Germany

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Heidelberg, 69120

Germany

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Mainz, 55131

Germany

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Münster, 48153

Germany

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Offenbach, 63069

Germany

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Regensburg, 93049

Germany

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Alessandria, 15100

Italy

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Bergamo, 24125

Italy

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Orbassano, 10043

Italy

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Kashiwa, 277-8577

Japan

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Yokohama, 241-8515

Japan

Research Site

Incheon, 21565

South Korea

Research Site

Namdong-gu, 21565

South Korea

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Seoul, 03722

South Korea

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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

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Taipei, 112

Taiwan

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Cambridge, CB2 0QQ

United Kingdom

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Glasgow, G12 0YN

United Kingdom

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Manchester, M23 9LT

United Kingdom

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Hanoi, 100000

Vietnam

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Ho Chi Minh City, 700000

Vietnam