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NCT06784648
Different Doses of BI-1607 in Combination With Pembrolizumab and Ipilimumab, in Participants With Unresectable or Metastatic Melanoma
Phase 1, PHASE2 trial testing pembrolizumab (KEYTRUDA®) in Melanoma Metastatic in 35 participants. Participants enrolled and being followed up; not accepting new ones.
30 December 2025
Quick facts
| Lead sponsor | BioInvent International AB |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 11 December 2024 |
| Primary completion | 30 December 2025 |
| Estimated completion | 30 December 2025 |
| Sites | 9 locations across United Kingdom, Germany, Spain |
Drugs / interventions tested
- pembrolizumab (KEYTRUDA®) — full drug profile →
- BI-1607 — full drug profile →
- Ipilimumab (YervoyTM, 50 mg/10 mL solution) — full drug profile →
Conditions studied
- Melanoma Metastatic — all drugs for Melanoma Metastatic →
- Melanoma of Skin — all drugs for Melanoma of Skin →
- Melanoma BRAF V600E/K Mutated — all drugs for Melanoma BRAF V600E/K Mutated →
- Melanoma Recurrent — all drugs for Melanoma Recurrent →
Sponsor
BioInvent International AB — full company profile →
Who can join
18 and older, any sex, with Melanoma Metastatic or Melanoma of Skin. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Why the research is needed: Researchers are looking for a better way to treat melanoma that has spread or cannot be removed surgically. Melanoma is a type of skin cancer that starts in melanocytes, the cells that make the pigment that gives skin its color. In people with cancer, the body cannot control the growth of cells, which can come together to form tumors. This trial's new treatment is called BI-1607. BI-1607 is designed to work by improving the effectiveness of other targeted therapies already used for melanoma treatment; ipilimumab and pembrolizumab. BI-1607 will improve the ability of these two treatments to help the body's defense system to destroy cancer cells.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Current Treatment Standards for Metastatic Uveal Melanoma.
Rogala P, Czarnecka AM, Dudzisz-Śledź M, Dawidowska A, et al · · 2026 · PMID 41681947 · DOI 10.3390/cancers18030475
Verify or expand the search:
- PubMed search for NCT06784648
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of pembrolizumab (KEYTRUDA®)
Trials testing the same drug.
- NCT04993677 — A Study of SEA-CD40 Given With Other Drugs in Cancers · Phase 2 · completed
- NCT04811027 — Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent o · Phase 2 · completed
- NCT04332653 — NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors · Phase 1, PHASE2 · completed
- NCT03625323 — Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previo · Phase 2 · completed
- NCT03674567 — Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination with Pembrolizumab · Phase 1, PHASE2 · completed
Other recruiting trials for Melanoma Metastatic
Currently open trials in the same condition.
- NCT06889610 — A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors. · Phase 2 · recruiting
- NCT06767306 — Stereotactic Ablative Radiotherapy (XRT) and Immunotherapy for Oligometastatic Extracranial Melanoma · Phase 2 · recruiting
- NCT07050940 — Anti PD-1 Plus Postbiotic Versus Anti PD-1 Alone in Locally Advanced or Metastatic, Treatment naïve, Cutaneous Melanoma · NA · recruiting
- NCT06783270 — T-cell Therapy with CRISPR PD1-edited Tumor Infiltrating Lymphocytes for Patients with Metastatic Melanoma · Phase 1 · recruiting
- NCT07376317 — Optimization of Immunotherapy Treatment for Advanced Melanoma in the Context of the Public Brazilian Health System (OTIM · Phase 2 · active not recruiting
Other BioInvent International AB trials
Trials by the same sponsor.
- NCT06205706 — BI-1910 as a Single Agent and in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors · Phase 1, PHASE2 · active not recruiting
- NCT05555251 — BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors · Phase 1, PHASE2 · terminated
- NCT04752826 — BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20) · Phase 1, PHASE2 · recruiting
- NCT03571568 — A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06784648 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by BioInvent International AB
- Last refreshed: 19 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06784648.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing