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

NCT06784648 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-11-19

No results posted yet for this study

Summary

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.

Conditions

  • 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
  • Melanomas
  • Uveal Melanoma, Metastatic

Interventions

BIOLOGICAL

pembrolizumab (KEYTRUDA®)

fixed dose 200mg

BIOLOGICAL

BI-1607

Each cohorts will receive either 350mg or 700mg per cycle for 4 cycles

BIOLOGICAL

Ipilimumab (YervoyTM, 50 mg/10 mL solution)

Each cohort will receive either 1mg/kg or 3mg/kg for 4 cycles

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-11
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06784648 on ClinicalTrials.gov