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Compares treatment options for Advanced Melanoma
Official title Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.
ClinicalTrials.gov ID: NCT06697301
What this study is testing
What is EIK1001?
EIK1001 is an investigational medicine, being studied as a potential treatment for advanced melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- To be eligible for inclusion in this study, participants must:
- Be ≥ 18 years of age on the day of signing of informed consent.
- 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...
- 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...
You likely can't join if
- A participant is excluded from the study if any of the following criteria apply:
- Has melanoma of ocular origin.
- Is currently enrolled 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)...
- 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...
- Experienced a ≥ Grade 3 AE while receiving prior anti PD 1 therapy.
See the full eligibility criteria
Who can join
- To be eligible for inclusion in this study, participants must:
- Be ≥ 18 years of age on the day of signing of informed consent.
- 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 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 dose 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...
- 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.
What rules you out
- A participant is excluded from the study if any of the following criteria apply:
- Has melanoma of ocular origin.
- Is currently enrolled 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 placebo.
- 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 Baseline or stabilized, with a minimum...
- Experienced a ≥ Grade 3 AE while receiving prior anti PD 1 therapy.
- Has had major surgery (\< 3 weeks prior to the first dose).
- 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.
- 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...
- 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...
- 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 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...
- 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...
- 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 pregnant, breastfeeding, or planning to conceive or father children within the projected duration of the study.
- Participant is currently receiving medications known to be strong inhibitors or inducers of CYP3A4 and CYP1A2.
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Hot Springs, Arkansas, United States
- Los Angeles, California, United States
- Santa Rosa, California, United States
- Colorado Springs, Colorado, United States
- Hialeah, Florida, United States
- Bethesda, Maryland, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Canton, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Wollongong, New South Wales, Australia
- Chermside, Queensland, Australia
- Bedford Park, South Australia, Australia
- Box Hill, Victoria, Australia
- Frankston, Victoria, Australia
- Graz, Styria, Austria
- Edegem, Antwerpen, Belgium
- Brussels, Brussels Capital, Belgium
- Yvoir, Namur, Belgium
+ 81 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Hot Springs, Arkansas, United States; Los Angeles, California, United States; Santa Rosa, California, United States; Colorado Springs, Colorado, United States; Hialeah, Florida, United States and 95 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.