Different Doses of BI-1607 in Combination With Pembrolizumab and Ipilimumab, in Participants With… (NCT06784648) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Different Doses of BI-1607 in Combination With Pembrolizumab and Ipilimumab, in Participants With Unresectable or Metastatic Melanoma
Germany, Spain35 participantsStarted 2024-12-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Is willing and able to provide written informed consent for the trial.
✓. Is ≥ 18 years of age on the day of signing informed consent.
✓. Has histologically confirmed advanced melanoma (unresectable or metastatic melanoma) with established disease progression.
✓. Participants must have progressed on treatment with an anti-PD-1/L1 mAb. Subjects with uveal melanoma are not required to have received any prior anti-PD-1/L1 treatment. PD-1 treatment progression is defined by meeting all of the following criteria:
✓. Has received at least 2 doses of an approved anti-PD-1/L1 mAb.
✓. Has demonstrated disease progression after anti PD-1/L1 as defined by RECIST v1.1.
✓. Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1/L1 mAb.
✓. Participants may have received previous treatment with BRAF inhibitors alone or in combination with mitogen extracellular kinase (MEK) inhibitors.
. Has previously been treated with an anti-CTLA-4 mAb or anti-LAG3 mAb (anti-Lymphocyte Activation Gene 3).
✕. Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.
✕. Has received the following:
✕. Chemotherapy or small molecule products within 4 weeks of first dose of BI-1607.
✕. Radiotherapy within 2 weeks of first dose of BI-1607, or has radiation-related toxicities, requiring corticosteroids. Participants who have previously had radiation pneumonitis are not allowed.
✕. Immunotherapy or biological anti-cancer therapy or an investigational agent or an investigational device within 4 weeks prior to the first dose of BI-1607.
✕. Has not recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline.
✕. Has had major surgery from which the participant has not yet recovered or is scheduled to have major surgery \< 28 days prior to the first dose of trial intervention.
Recommended doses for the expansion cohort
Timeframe: End of Cycle 3 (each cycle is 21 days)
10
Efficacy
Timeframe: Through study completion, a maximum of 2 years
11
Efficacy
Timeframe: Through study completion, a maximum of 2 years
12
Efficacy
Timeframe: Through study completion, a maximum of 2 years
13
Efficacy
Timeframe: Through study completion, a maximum of 2 years
14
Efficacy
Timeframe: Through study completion, a maximum of 2 years
15
Efficacy
Timeframe: Through study completion, a maximum of 2 years