iSCIB1+ in Combination With Ipilimumab and Nivolumab as First-Line Treatment for Advanced Unresectable Melanoma
Public ClinicalTrials.gov record NCT07815574. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Adaptive Study of iSCIB1+ in Combination With Ipilimumab and Nivolumab as First-Line Treatment for Advanced Unresectable Melanoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 3 clinical trial is evaluating whether adding iSCIB1+, an investigational DNA-based cancer vaccine, to standard immunotherapy with nivolumab and ipilimumab can improve outcomes for people with advanced unresectable melanoma. Participants will be randomly assigned to receive either iSCIB1+ or a placebo, in addition to standard treatment with nivolumab and ipilimumab. Neither participants nor study doctors will know which treatment has been assigned. The study will compare how long participants live without their cancer worsening, overall survival, tumor response, safety, and quality of life. iSCIB1+ is designed to stimulate the immune system to recognize and attack melanoma cells by targeting proteins commonly found on melanoma tumors. Earlier studies have shown encouraging signs of immune activation and anti-tumor activity when iSCIB1+ was combined with checkpoint inhibitor immunotherapy. This study aims to determine whether adding iSCIB1+ to standard immunotherapy provides additional benefit compared with standard immunotherapy alone
Study identification
- NCT ID
- NCT07815574
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 550 participants
Conditions and interventions
Interventions
- iSCIB1+ Biological
- Nivolumab & Ipilimumab Drug
- Placebo Other
Biological · Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2026
- Primary completion
- Nov 30, 2028
- Completion
- Nov 30, 2032
- Last update posted
- Sep 10, 2026
2026 – 2032
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07815574, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 10, 2026 · Synced Sep 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07815574 live on ClinicalTrials.gov.