Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients (NCT04291105) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients
United States, Brazil87 participantsStarted 2020-04-24
Plain-language summary
This is a Phase 2 study designed to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with cemiplimab. The study will enroll patients with three distinct separate tumor cohorts. The cancers types are colorectal, head and neck carcinoma, and melanoma that are progressing on CPI treatment. (CRC and melenoma cohorts are now closed to new patients)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years on day of signing informed consent.
. Specific by tumor cohorts:
. At least one tumor lesion amenable to IT injection and biopsy that has not been previously irradiated.
. Measurable disease based on RECIST 1.1., including ≥ 1 measurable lesion(s) to be injected
. Performance status of 0 or 1 on the ECOG Performance Scale
. Life expectancy of \>3 months.
. Willingness to provide biological samples required for the duration of the study, including a fresh tumor biopsy sample whilst on study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate (ORR) per imaging assessment
. Adequate organ function assessed by laboratory values obtained ≤14 days prior to enrollment
Exclusion criteria
. Availability of and patient acceptance of an alternative curative therapeutic option.
. Patients with tumor lesion(s) \> 5cm in diameter.
. Recent or ongoing serious infection, including any active Grade 3 or higher per the NCI CTCAE, v5.0 viral, bacterial, or fungal infection within 2 weeks of registration.
. Patients who have a diagnosis of ocular, mucosal or acral melanoma.
. Known seropositivity for and with active infection with HIV.
. Seropositive for and with evidence of active viral infection with HBV.
. Seropositive for and with active viral infection with HCV.