Status:
RECRUITING
Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors
Lead Sponsor:
AstraZeneca
Conditions:
Cervical Cancer
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 monothe...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- For inclusion in the study, patients should fulfill the following criteria:
- Age ≥18 at the time of signing the ICF.
- Provision of tumor sample to assess the PD-L1 expression.
- Measurable disease according to RECIST 1.1.
- ECOG performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
- Adequate organ and bone marrow function.
- Body weight \> 35 kg.
- Capable of giving signed informed consent.
- 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.
- For sub-study 2, for participants with OPC must have documented HPV status.
- 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.
- 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
- Exclusion Criteria
- Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- Spinal cord compression.
- Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention.
- 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, 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.
- 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).
- 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.
Exclusion
Key Trial Info
Start Date :
August 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2028
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06535607
Start Date
August 22 2024
End Date
November 30 2028
Last Update
October 29 2025
Active Locations (50)
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1
Research Site
Los Angeles, California, United States, 90025
2
Research Site
Baltimore, Maryland, United States, 21201
3
Research Site
Stony Brook, New York, United States, 11794
4
Research Site
Columbus, Ohio, United States, 43210