Comparing 3 approaches for advanced melanoma

Exclusion

• −Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate if they are clinically stable for at least 4 weeks with no evidence of new or enlarging brain metastases. There must be no need for immunosuppressive doses of glucocorticoids for at least 2 weeks prior to study treatment administration.
• −There is uncontrolled human immunodeficiency virus (HIV) infection. HIV-infected participants with well-controlled HIV may enroll.
• −There is a positive test result for hepatitis B virus (HBV) or HCV indicating presence of virus (it is expected that all participants will have been serologically tested for hepatitis B in advance of this study, with HBsAG, anti-HBc IgG, and anti-HBs as per ASCO 2020 Provisional Clinical Opinion \[PCO\] on universal Serologic testing for hepatitis B at the onset of anticancer therapy; screeningScreeningThe checks done before joining, to see whether a study fits.Read more → should also include an anti-HCV test prior to start of cancer treatment:
• −A participant is excluded from the study if any of the following criteria apply:
• −Has melanoma of ocular origin.
• −Is currently enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in or has recently participated in a study of an IMP and received an IMP within 4 weeks or 5 half-lives (whichever is shorter) of administration of EIK1001 or placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
• −Prior to the 1St dose of EIK1001 or placebo, the prospective participant has received systemic therapy for advanced melanoma.
• −Note: prior adjuvant or neoadjuvant melanoma therapies (such as anti-PD-1 or anti CTLA 4 therapies or BRAF/MEK inhibitors) are permitted if all related AEs have either returned to BaselineBaselineYour starting measurements, taken before treatment begins.Read more → or stabilized, with a minimum of 6 months between the last dose of prior therapy and documented disease progression.
• −Experienced a ≥ Grade 3 AEAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → while receiving prior anti PD 1 therapy.
• −Has received a live-virus vaccination within 30 days of the first dose of study treatment.
• −Has a known history of prior malignancy, unless the participant has undergone potentially curative therapy with no evidence of disease recurrence for 5 years.
• −There is a mean resting QTcF \> 470 ms on triplicate electrocardiograms.
• −There is active autoimmune disease that has required systemic treatment in the past 2 years. The following autoimmune conditions are permitted: Type 1 diabetes, hypothyroidism (on hormone replacement), or- vitiligo, psoriasis and alopecia as long as no systemic treatment is required.
• −There is either chronic treatment with systemic steroids, other immunosuppressive medication, or either of these has been administered within 14 days of start of study treatment.
• −Note: Participants with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections are eligible. Steroid replacement for adrenal insufficiency is also permitted.
• −There is a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/ interstitial lung disease.
• −There are any active infections requiring therapy.
• −There is a history or clinical evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study or interfere with the participant's participation for the full duration of the study
• −Known psychiatric or substance abuse disorder that would interfere with cooperation with study requirements.
• −There is a known history of regular illicit drug use and/or recent history (within the last year) of substance abuse (including alcohol).
• −Participant is currently receiving medications known to be strong inhibitors or inducers of CYP3A4 and CYP1A2.
• −Participant is pregnant, breastfeeding, or planning to conceive or father children within the projected duration of the study.
• −Has had major surgery (\< 3 weeks prior to the first dose).