Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors
NCT ID: NCT06535607
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
110 participants
INTERVENTIONAL
2024-08-22
2028-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 2)
NCT02108652
My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors
NCT02091141
Study of INCB123667 in Subjects With Advanced Solid Tumors
NCT05238922
Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
NCT05098132
Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies
NCT04644068
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sub-study 1
Volrustomig monotherapy
Volrustomig
IV Infusion
Sub-study 2
Volrustomig monotherapy
Volrustomig
IV Infusion
Sub-study 3
Volrustomig in combination with carboplatin plus paclitaxel or 5-FU plus platinum
Volrustomig
IV Infusion
Cisplatin
IV Infusion
Carboplatin
IV Infusion
Paclitaxel
IV Infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Volrustomig
IV Infusion
Cisplatin
IV Infusion
Carboplatin
IV Infusion
Paclitaxel
IV Infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Age ≥18 at the time of signing the ICF.
2. Provision of tumor sample to assess the PD-L1 expression.
3. Measurable disease according to RECIST 1.1.
4. ECOG performance status of 0 or 1.
5. Life expectancy ≥ 12 weeks.
6. Adequate organ and bone marrow function.
7. Body weight \> 35 kg.
8. Capable of giving signed informed consent.
9. For sub-study 1, participants with R/M cervical cancer with squamous cell, adenocarcinoma or adenosquamous histology, that: have experienced disease progression during or after treatment with standard systematic therapy per local guideline; have received at least 1 line but no more than 2 lines of prior systemic treatment regimens for R/M cervical cancer.
10. For sub-study 2, for participants with OPC must have documented HPV status.
11. For sub-study 2, participants with R/M HNSCC, that: (a) Are histologically or cytologically documented R/M HNSCC of the OP, OC, HP, and LX that is considered incurable by local therapies; (b) Participants that have not been treated in R/M setting must have: (i) a documented PD-L1 positive result, (ii) with no prior systemic anti-cancer therapy for R/M HNSCC; (c) Platinum refractory participants must have relapsed from or are refractory to the first line of prior platinum-containing regimen.
12. For sub-study 3, participants with R/M HNSCC, that: (a) Are histologically or cytologically documented R/M HNSCC of the OP, OC, HP, and LX that is considered incurable by local therapies; (b) Participants that have not been treated in R/M setting
4. Have not recovered (ie, ≤ Grade 1 or at baseline) from an AE due to a previously administered anti-cancer therapy.
5. For sub-study 2, have had radiotherapy within 2 weeks prior to enrollment.
6. For sub-study 3, Participants have contraindications to any of the following drugs: 5-FU, paclitaxel and carboplatin
7. 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.
8. 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.
9. 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.
10. Active or prior documented autoimmune or inflammatory disorders.
11. Participants who are candidates for curative therapy.
12. Prior exposure to any immune-mediated therapy.
13. 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).
14. 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..
15. Any concurrent chemotherapy except study intervention, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
16. 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.
17. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.
18. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.
19. Participants with a known allergy or hypersensitivity to any study intervention, on any excipients of any study intervention.
Exclusion Criteria
2. Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Los Angeles, California, United States
Research Site
Baltimore, Maryland, United States
Research Site
Stony Brook, New York, United States
Research Site
Columbus, Ohio, United States
Research Site
Ijuí, , Brazil
Research Site
Londrina, , Brazil
Research Site
São Caetano do Sul, , Brazil
Research Site
Vitória, , Brazil
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Bengbu, , China
Research Site
Changchun, , China
Research Site
Changsha, , China
Research Site
Changsha, , China
Research Site
Changsha, , China
Research Site
Changsha, , China
Research Site
Chengdu, , China
Research Site
Chengdu, , China
Research Site
Chongqing, , China
Research Site
Dongguan, , China
Research Site
Fuzhou, , China
Research Site
Fuzhou, , China
Research Site
Hangzhou, , China
Research Site
Hangzhou, , China
Research Site
Jining, , China
Research Site
Kunming, , China
Research Site
Nanchang, , China
Research Site
Nanning, , China
Research Site
Nanning, , China
Research Site
Shandong, , China
Research Site
Shandong, , China
Research Site
Shandong, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shenyang, , China
Research Site
Tianjin, , China
Research Site
Tianjin, , China
Research Site
Wuhan, , China
Research Site
Wuhan, , China
Research Site
Wuhan, , China
Research Site
Wuhan, , China
Research Site
Wuhan, , China
Research Site
Wuhou District, , China
Research Site
Namdong-gu, , South Korea
Research Site
Seoul, , South Korea
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Hanoi, , Vietnam
Research Site
Ho Chi Minh City, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D798MC00002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.