Pembrolizumab and All-Trans Retinoic Acid in Combination Treatment of Advanced Melanoma
This is a Phase I/Ib investigator-initiated open label of the combination of VESANOID and pembrolizumab treatment.
• Diagnosis of advanced melanoma (unresectable Stage III or Stage IV Melanoma).
• Planned standard treatment with pembrolizumab.
• Be willing and able to provide written informed consent for the trial.
• State willingness to comply with all study procedures and be available for the duration of the trial.
• Be ≥ 18 years of age on day of signing informed consent.
• Have a performance status of 0 or 1 on the ECOG Performance Scale.
• Demonstrate adequate organ function as defined in Table 1 of the protocol.
• Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Female subjects of childbearing potential (Section 6.5.2 - Contraception) must be willing to use an adequate method of contraception as outlined in Section 6.5.2 of the protocol - Contraception, for the course of the study through 120 days after the last dose of study medication.
• Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
⁃ Male subjects of childbearing potential (Section 6.5.2- Contraception) must agree to use an adequate method of contraception as outlined in Section 6.5.2 of the protocol - Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
‣ Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.