NCT04079166

SCIB1 and iSCIB1+ in Melanoma Patients Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab (The SCOPE Study)

Active, enrolled Phase 2 Last updated 19 December 2025

What this trial tests

Phase 2 trial testing SCIB1 or iSCIB1+ DNA vaccine in Malignant Melanoma in 173 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

19 August 2019

Primary endpoint
31 January 2027

31 January 2027

Quick facts

Lead sponsor	Scancell Ltd
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	173
Start date	19 August 2019
Primary completion	31 January 2027
Estimated completion	31 January 2027
Sites	15 locations across United Kingdom

Drugs / interventions tested

• SCIB1 or iSCIB1+ DNA vaccine — full drug profile →

Conditions studied

• Malignant Melanoma — all drugs for Malignant Melanoma →
• Melanoma (Skin) — all drugs for Melanoma (Skin) →
• Melanoma Stage III — all drugs for Melanoma Stage III →
• Melanoma Stage IV — all drugs for Melanoma Stage IV →

Sponsor

Scancell Ltd — full company profile →

Who can join

18 and older, any sex, with Malignant Melanoma or Melanoma (Skin). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to find out if two new treatment cancer vaccines called SCIB1 and iSCIB1+ can be used safely when added to nivolumab (Opdivo) with ipilimumab (Yervoy), or SCIB1 with pembrolizumab (Keytruda). Pembrolizumab or nivolumab with ipilimumab are standard treatments approved for patients with advanced melanoma (skin cancer).

The study will also look to see if SCIB1 or iSCIB1+ can increase the likelihood that melanoma patients will respond to the standard treatments, and also if SCIB1 and iSCIB1+ can help to make those responses last longer. SCIB1 and iSCIB1+ are considered experimental. SCIB1 has been given to melanoma patients in an earlier study. It was generally well-tolerated, and researchers saw some signs that it may help to stimulate the immune system, which is a way in which the body can fight the cancer. iSCIB1+ is similar to SCIB1 but might benefit more patients with melanoma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cancer Vaccines, Adjuvants, and Delivery Systems.
   Paston SJ, Brentville VA, Symonds P, Durrant LG. · · 2021 · cited 139× · PMID 33859638 · DOI 10.3389/fimmu.2021.627932
2. The next-generation DNA vaccine platforms and delivery systems: advances, challenges and prospects.
   Lu B, Lim JM, Yu B, Song S, et al · · 2024 · cited 84× · PMID 38361919 · DOI 10.3389/fimmu.2024.1332939
3. A comprehensive comparison of DNA and RNA vaccines.
   Wang C, Yuan F. · · 2024 · cited 42× · PMID 38810703 · DOI 10.1016/j.addr.2024.115340
4. DNA vaccines as promising immuno-therapeutics against cancer: a new insight.
   Shariati A, Khezrpour A, Shariati F, Afkhami H, et al · · 2024 · cited 13× · PMID 39872522 · DOI 10.3389/fimmu.2024.1498431
5. Overcoming Suppressive Tumor Microenvironment by Vaccines in Solid Tumor.
   Xie YJ, Liu WQ, Li D, Hou JC, et al · · 2023 · cited 13× · PMID 36851271 · DOI 10.3390/vaccines11020394
6. Shaping the Future of Immunotherapy Targets and Biomarkers in Melanoma and Non-Melanoma Cutaneous Cancers.
   Spiliopoulou P, Vornicova O, Genta S, Spreafico A. · · 2023 · cited 10× · PMID 36674809 · DOI 10.3390/ijms24021294
7. Recent Findings on Therapeutic Cancer Vaccines: An Updated Review.
   Sheikhlary S, Lopez DH, Moghimi S, Sun B. · · 2024 · cited 8× · PMID 38672519 · DOI 10.3390/biom14040503
8. DNA-based immunotherapy for cancer: In vivo approaches for recalcitrant targets.
   Bhojnagarwala PS, Jose J, Zhao S, Weiner DB. · · 2025 · cited 7× · PMID 40211538 · DOI 10.1016/j.ymthe.2025.04.008