Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06535607

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

Led by AstraZeneca · Updated on 2026-03-24

257

Participants Needed

59

Research Sites

223 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at the time of signing consent.
  • Able to provide a tumor sample for PD-L1 testing if applicable.
  • ECOG performance status of 0 or 1.
  • Measurable disease according to RECIST 1.1 or its variations.
  • Life expectancy of at least 12 weeks.
  • Adequate organ and bone marrow function.
  • Body weight greater than 35 kg.
  • Capable of giving informed consent.
Not Eligible

You will not qualify if you...

  • Spinal cord compression.
  • Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days before treatment start (sub-studies 1-4).
  • Untreated or progressive brain metastases (sub-study 5).
  • For sub-studies 1-3, exclusion of primary neuroendocrine, mesenchymal, sarcomatoid, or other non-included histologies.
  • Not recovered to baseline or Grade 1 or less from side effects of prior anti-cancer therapy.
  • Radiotherapy within 2 weeks before enrollment (sub-study 2).
  • Contraindications to 5-FU, paclitaxel, or carboplatin (sub-studies 3 and 4).
  • History of another primary malignancy except specific treated and low-risk cases.
  • History or evidence of organ or stem cell transplant.
  • Active infections including uncontrolled HIV, hepatitis B or C, or active hepatitis A.
  • History of active primary immunodeficiency or autoimmune/inflammatory disorders.
  • Candidates for curative therapy.
  • Prior immune-mediated therapy exposure.
  • Current or recent use of immunosuppressive drugs within 14 days before first study dose, except specific steroid uses.
  • Any anti-cancer therapy within 28 days or 5 half-lives before first dose (sub-studies 1-4).
  • Concurrent chemotherapy except study drugs, radiotherapy, investigational, biologic, or hormonal cancer therapy.
  • Radiotherapy to large bone marrow areas within 4 weeks before first dose.
  • Major surgery within 4 weeks before first dose or still recovering.
  • Live attenuated vaccine within 30 days before first dose.
  • Known allergy or hypersensitivity to study treatments or their ingredients.
  • For sub-study 5, prior systemic therapy, non-palliative radiotherapy, or radical pleuropneumonectomy for mesothelioma.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 59 locations

1

Research Site

Los Angeles, California, United States, 90025

Withdrawn

2

Research Site

Baltimore, Maryland, United States, 21201

Not Yet Recruiting

3

Research Site

Stony Brook, New York, United States, 11794

Not Yet Recruiting

4

Research Site

Columbus, Ohio, United States, 43210

Not Yet Recruiting

5

Research Site

Ijuí, Brazil, 98700-000

Actively Recruiting

6

Research Site

Londrina, Brazil, 86015-520

Actively Recruiting

7

Research Site

São Caetano do Sul, Brazil, 09541-270

Actively Recruiting

8

Research Site

Vitória, Brazil, 29043-260

Actively Recruiting

9

Research Site

Anyang, China, 455000

Not Yet Recruiting

10

Research Site

Beijing, China, 100142

Not Yet Recruiting

11

Research Site

Beijing, China, 100730

Active, Not Recruiting

12

Research Site

Beijing, China, 100730

Actively Recruiting

13

Research Site

Beijing, China, CN-100730

Actively Recruiting

14

Research Site

Bengbu, China, 233004

Withdrawn

15

Research Site

Changchun, China, 130021

Withdrawn

16

Research Site

Changchun, China, 130021

Not Yet Recruiting

17

Research Site

Changsha, China, 410003

Actively Recruiting

18

Research Site

Changsha, China, 410008

Active, Not Recruiting

19

Research Site

Changsha, China, 410008

Actively Recruiting

20

Research Site

Changsha, China, 410013

Completed

21

Research Site

Chengdu, China, 610041

Active, Not Recruiting

22

Research Site

Chengdu, China, 610072

Actively Recruiting

23

Research Site

Chongqing, China, 400030

Actively Recruiting

24

Research Site

Chongqing, China, 400030

Withdrawn

25

Research Site

Dongguan, China, 523009

Active, Not Recruiting

26

Research Site

Dongguan, China, 523009

Actively Recruiting

27

Research Site

Fuzhou, China, 350011

Completed

28

Research Site

Fuzhou, China, 350014

Not Yet Recruiting

29

Research Site

Hangzhou, China, 310022

Active, Not Recruiting

30

Research Site

Hangzhou, China, 310022

Actively Recruiting

31

Research Site

Hefei, China, 230031

Withdrawn

32

Research Site

Jining, China, 272029

Actively Recruiting

33

Research Site

Kunming, China, 650118

Actively Recruiting

34

Research Site

Nanchang, China, 330006

Actively Recruiting

35

Research Site

Nanjing, China, 210009

Not Yet Recruiting

36

Research Site

Nanning, China, 530021

Active, Not Recruiting

37

Research Site

Nanning, China, 530021

Actively Recruiting

38

Research Site

Shandong, China, 250117

Actively Recruiting

39

Research Site

Shandong, China

Actively Recruiting

40

Research Site

Shandong, China

Active, Not Recruiting

41

Research Site

Shandong, China

Not Yet Recruiting

42

Research Site

Shanghai, China, 200120

Active, Not Recruiting

43

Research Site

Shanghai, China, 200120

Actively Recruiting

44

Research Site

Shenyang, China, 110004

Actively Recruiting

45

Research Site

Tianjin, China, 300060

Active, Not Recruiting

46

Research Site

Tianjin, China, 300060

Actively Recruiting

47

Research Site

Wuhan, China, 430022

Actively Recruiting

48

Research Site

Wuhan, China, 430022

Active, Not Recruiting

49

Research Site

Wuhan, China, 430030

Actively Recruiting

50

Research Site

Wuhan, China, 430040

Actively Recruiting

51

Research Site

Wuhan, China, 430079

Actively Recruiting

52

Research Site

Wuhou District, China, 610041

Actively Recruiting

53

Research Site

Zhengzhou, China, 450008

Not Yet Recruiting

54

Research Site

Namdong-gu, South Korea, 21565

Actively Recruiting

55

Research Site

Seoul, South Korea, 03722

Actively Recruiting

56

Research Site

Taichung, Taiwan

Not Yet Recruiting

57

Research Site

Taipei, Taiwan, 112

Actively Recruiting

58

Research Site

Hanoi, Vietnam, 100000

Actively Recruiting

59

Research Site

Ho Chi Minh City, Vietnam, 700000

Actively Recruiting

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

8

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