RecruitingPhase 2NCT06535607

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

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

Sponsor

AstraZeneca

Enrollment

257 participants

Start Date

Aug 22, 2024

Study Type

INTERVENTIONAL

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)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new immunotherapy drug called volrustomig, alone or combined with other cancer treatments, in people with advanced or metastatic solid tumors. It focuses on cancers like cervical cancer and head and neck cancers that have stopped responding to standard treatment. **You may be eligible if...** - You are 18 or older with advanced or metastatic cancer - Your cancer is measurable and has been confirmed by tissue testing - You are in good physical condition (ECOG performance score of 0 or 1) - Your cancer has progressed after at least one prior treatment **You may NOT be eligible if...** - You have active brain metastases that are causing symptoms or require steroids - You have an active autoimmune disease or have had an organ transplant - You have active HIV, hepatitis B, or hepatitis C - You received other cancer therapy or a live vaccine recently - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALVolrustomig

IV Infusion

DRUGCisplatin

IV Infusion

DRUGCarboplatin

IV Infusion

DRUGPaclitaxel

IV Infusion

DRUG5-FU

IV Infusion

Locations(95)

Research Site

Los Angeles, California, United States

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Baltimore, Maryland, United States

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New York, New York, United States

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Stony Brook, New York, United States

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Columbus, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Clayton, Australia

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Nedlands, Australia

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Ijuí, Brazil

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Londrina, Brazil

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Porto Alegre, Brazil

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Santo André, Brazil

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São Caetano do Sul, Brazil

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Vitória, Brazil

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Vitória, Brazil

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Edmonton, Alberta, Canada

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Montreal, Quebec, Canada

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Anyang, China

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Beijing, China

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Beijing, China

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Beijing, China

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Beijing, China

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Beijing, China

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Bengbu, China

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Changchun, China

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Changchun, China

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Changsha, China

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Changsha, China

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Changsha, China

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Changsha, China

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Chengdu, China

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Chengdu, China

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Chengdu, China

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Chongqing, China

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Chongqing, China

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Dongguan, China

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Dongguan, China

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Fuzhou, China

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Fuzhou, China

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Fuzhou, China

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Guangzhou, China

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Hangzhou, China

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Hangzhou, China

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Harbin, China

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Hefei, China

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Jining, China

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Kunming, China

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Kunming, China

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Nanchang, China

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Nanjing, China

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Nanning, China

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Nanning, China

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Shandong, China

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Shandong, China

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Shandong, China

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Shandong, China

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Shanghai, China

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Shanghai, China

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Shenyang, China

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Tianjin, China

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Tianjin, China

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Wuhan, China

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Wuhan, China

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Wuhan, China

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Wuhan, China

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Wuhou District, China

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Zhengzhou, China

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Cologne, Germany

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Frankfurt, Germany

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Gauting, Germany

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Großhansdorf, Germany

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Hamburg, Germany

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Heidelberg, Germany

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Mainz, Germany

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Münster, Germany

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Offenbach, Germany

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Regensburg, Germany

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Alessandria, Italy

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Bergamo, Italy

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Orbassano, Italy

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Kashiwa, Japan

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Yokohama, Japan

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Incheon, South Korea

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Namdong-gu, South Korea

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Seoul, South Korea

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Kaohsiung City, Taiwan

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Cambridge, United Kingdom

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Glasgow, United Kingdom

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Manchester, United Kingdom

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Hanoi, Vietnam

Research Site

Ho Chi Minh City, Vietnam

View Full Details on ClinicalTrials.gov

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NCT06535607