Brief Summary
The study is for patients with advancedat a late stage, far along melanomaa type of cancer that develops from melanocytes, which are the cells that produce pigment generally in the skin (but can develop in other areas of the body) who are eligible for standard therapy with Pembrolizumab.
Intervention / Treatment
- Drug: EIK1001
- Drug: Pembrolizumab (KEYTRUDA® )
Inclusion Criteria:
To be eligible for inclusion in this study, participants must:
- Be ≥ 18 years of age on the day of signing of informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..
- Have a life expectancy of at least 3 months.
- Have histologically or cytologically confirmed Stage 3 (unresectable) or Stage 4 metastatic melanoma per AJCC 8th ed. and be eligible for standard therapy with pembrolizumab.
- Have at least 1 lesion with measurable disease at Baseline by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by assessment of local site Investigator/radiologist.
- Have known BRAF V600 mutation status or consent to BRAF V600 mutation testing per local institutional standards during the screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening period
- Have completed prior radiotherapy at least 2 weeks prior to study treatment administration.
- Have an ECOG Performance Status of 0 to 1.
- Have adequate organ and marrow function as defined by normal CBC, coagulation, serum chemistry and liver function tests on specimens collected within 10 days of treatment start.
- Have a negative serum pregnancy test within 72 hours prior to receiving the first dosethe amount of medication taken of study medication (applies to women of childbearing potential [WOCBP]).
- Be willing to use either 2 adequate methods of contraception, 1 adequate method plus a hormonal method of contraception, or be willing to abstain from heterosexual activity throughout the study (Visit 1 to 120 days after the last dose of study therapy; applies to WOCBP who are not menopausal for > 2 years, post-hysterectomy/oophorectomy, or surgically sterilized).
- Agree to use an approved adequate contraceptive method throughout the study (Visit 1 to 120 days after the last dose of study therapy; applies to sexually active male participants with a partner who is WOCBP).
- Be willing and able to provide written, informed consent for the study.