Different Doses of BI-1607 in Combination With Pembrolizumab and Ipilimumab, in Participants With Unresectable or Metastatic Melanoma

StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Record History

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  1. Primary completion date changed from estimate of Dec 30, 2025 to Sep 9, 2026 Show 7 more changesShow less
    • Trial sites reduced: 9 → 4 locations
    • Study completion pushed from Dec 30, 2025 to Jul 30, 2027
    • Interventions: BI-1607 (Biological), Ipilimumab (YervoyTM, 50 mg/10 mL solution) (Biological), pembrolizumab (KEYTRUDA®) (Biological) to BI-1607 (Biological), Ipilimumab (YervoyTM, 50 mg/10 mL solution) (Biological), pembrolizumab (KEYTRUDA®) (Biological)
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study description expanded, about 9 words
    • Collaborators: details revised at 1 of 1 entry
  2. Primary completion date: Sep 30, 2028 to Dec 30, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 30, 2031 to Dec 30, 2025
    • Site details revised at 9 of 9 sites
    v3
  3. Study sites: 3 to 9v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06784648
Lead Sponsor BioInvent International AB
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Melanoma Metastatic, Melanoma of Skin, Melanoma BRAF V600E/K Mutated, Melanoma Recurrent, Melanoma Stage III or IV, Melanoma, Melanoma Negative for bRAF, Melanoma Negative for nRAS +2 more
Related terms Melanoma, Neoplasm Metastasis, Uveal Melanoma
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov