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

Sponsor
BioInvent International AB
Study ID
NCT06784648
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Melanoma
  • Melanoma BRAF V600E/K Mutated
  • Melanoma Metastatic
  • Melanoma Negative for bRAF
  • Melanoma Negative for nRAS
  • Melanoma Recurrent
  • Melanoma Stage III or IV
  • Melanoma of Skin
  • Melanomas
  • Uveal Melanoma, Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • pembrolizumab (KEYTRUDA®) — BIOLOGICAL
    fixed dose 200mg
  • BI-1607 — BIOLOGICAL
    Each cohorts will receive either 350mg or 700mg per cycle for 4 cycles
  • Ipilimumab (YervoyTM, 50 mg/10 mL solution) — BIOLOGICAL
    Each cohort will receive either 1mg/kg or 3mg/kg for 4 cycles

Study Details

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.

Key Dates

Start date
Dec 11, 2024
Status verified
Nov 2025
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination of BI-1607, Ipilimumab and pembrolizumab
    In each cohort in phase Ib BI-1607 will be given with ipilimumab in 3-week cycles for 4 cycles in combination with pembrolizumab (KEYTRUDA) from cycle 3 for up to 2 years from start of treatment. In the phase 2 pembrolizumab (KEYTRUDA) will be given in combination with BI-1607 and ipilimumab in 3-week cycles for 4 cycles then a pembrolizumab (KEYTRUDA) monotherapy will be provided from cycle 5 for up to 2 years from start of treatment.

Primary Outcome Measure

Safety and tolerability [ Time Frame: end of Cycle 4 (each cycle is 21 days) ]

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