Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants Wi… (NCT06535607) | Clinical Trial Compass
RecruitingPhase 2
Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors
United States, Brazil257 participantsStarted 2024-08-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Objective response rate (ORR)
Timeframe: Through study completion, an average of 4 years
2
The number of participants with adverse events/serious adverse events
Timeframe: Through study completion, an average of 4 years