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A Multicenter, Randomized, Double-Blind, Active Comparator-Controlled, Adaptive Phase 2/3 Study to Evaluate the Safety and Efficacy of EIK1001 and Pembrolizumab Versus Placebo and Pembrolizumab as First-Line Therapy in Participants with Advanced Melanoma (TeLuRide-006)
EU CTIS ID: 2024-512659-19-00
What this study is testing
1. To evaluate efficacy and safety various doses of EIK1001 in combination with pembrolizumab (Dose Optimization). 2. To compare progression-free survival (PFS) of EIK1001 + pembrolizumab to placebo + pembrolizumab according to RECIST 1.1 by blinded independent central review (BICR) o Hypothesis (H1): EIK1001 + pembrolizumab prolongs PFS compared to placebo + pembrolizumab. 3. To compare overall survival (OS) of EIK1001 + pembrolizumab to placebo + pembrolizumab o Hypothesis (H2): EIK1001 + pembrolizumab prolongs OS compared to placebo + pembrolizumab.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Be ≥ 12 years of age on the day of signing of informed consent/assent.
- 10. 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).
- 11. Be willing and able to provide written, informed consent/assent for the study.
- 2. Have a life expectancy of at least 3 months.
- 3. 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.
- 4. 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.
You likely can't join if
- Has melanoma of ocular origin.
- 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 uncontrolled human immunodeficiency virus (HIV) infection. HIV-infected participants with well-controlled HIV may enroll.
See the full eligibility criteria
Who can join
- 1. Be ≥ 12 years of age on the day of signing of informed consent/assent.
- 10. 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).
- 11. Be willing and able to provide written, informed consent/assent for the study.
- 2. Have a life expectancy of at least 3 months.
- 3. 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.
- 4. 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.
- 5. Have known BRAF V600 mutation status or consent/assent to BRAF V600 mutation testing per local institutional standards during the Screening Period
- 6. Have an ECOG Performance Status of 0 to 1 for participants ≥ 18 years of age, Lansky Performance score (LPS) score ≥ 50 (for participants 12 to 15), or Karnofsky Performance Status (KPS) score ≥ 50 for participants 16 to < 18 years of age.
- 7. 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.
- 8. Have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication (applies to WOCBP).
- 9. 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).
What rules you out
- Has melanoma of ocular origin.
- 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 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; screening should also include an anti-HCV test prior to start of cancer treatment:
- 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 pregnant, breastfeeding, or planning to conceive or father children within the projected duration of the study.
- 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.
- Participant is currently receiving medications known to be strong inhibitors or inducers of CYP3A4 and CYP1A2.
- 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 of 6 months between the last dose of prior therapy and documented disease progression.
- 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 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 a mean resting QTcF > 470 ms on triplicate electrocardiograms
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United Kingdom
- Canada
- Switzerland
- Australia
- United States
- South Africa
- New Zealand
- Serbia
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, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United Kingdom; Canada; Switzerland; Australia; United States and 3 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 EU CTIS; the study team decides eligibility.