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)
Overview
- Phase
- Phase 2
- Intervention
- Pembrolizumab (KEYTRUDA® )
- Conditions
- Advanced Melanoma
- Sponsor
- Eikon Therapeutics
- Enrollment
- 740
- Locations
- 77
- Primary Endpoint
- Progression Free Survival (PFS)
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.
Detailed Description
This is 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. The study includes dose optimization and expansion parts.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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 \[WOCBP\]).
Exclusion Criteria
- •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 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.
Arms & Interventions
Arm 1
Participants in this arm will receive Placebo and Standard of Care (Pembrolizumab).
Intervention: Pembrolizumab (KEYTRUDA® )
Arm 2
Participants in this arm will receive EIK1001 (selected dose 1) + Standard of Care (Pembrolizumab).
Intervention: EIK1001
Arm 2
Participants in this arm will receive EIK1001 (selected dose 1) + Standard of Care (Pembrolizumab).
Intervention: Pembrolizumab (KEYTRUDA® )
Arm 3
Participants in this arm will receive EIK1001 (selected dose 2) + Standard of Care (Pembrolizumab).
Intervention: EIK1001
Arm 3
Participants in this arm will receive EIK1001 (selected dose 2) + Standard of Care (Pembrolizumab).
Intervention: Pembrolizumab (KEYTRUDA® )
Outcomes
Primary Outcomes
Progression Free Survival (PFS)
Time Frame: up to 5 years
Progression-free survival (PFS) is defined as the time from the date of randomization to documented progressive disease per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
Overall survival (OS)
Time Frame: up to 5 years
Overall survival (OS) defined as the time from randomization to death due to any cause.
Objective Response (OR) (Dose Optimization Only)
Time Frame: up to 5 years
Objective Response (OR; defined as participants who demonstrate confirmed complete response \[CR\] or partial response \[PR\] by Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1 as assessed by the Investigator) (Dose Optimization Only).
Adverse Events (AEs) (Dose Optimization Only)
Time Frame: up to 2.5 years
Adverse events (AEs), and discontinuation of study treatment due to an AE (Dose Optimization Only). An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Secondary Outcomes
- Adverse Events (AEs) and Discontinuation of study treatment due to any AE.(up to 2.5 years)
- Objective Response (OR)(up to 5 years)
- Duration of Response (DOR).(up to 5 years)
- Progression Free Survival (PFS)(up to 5 years)
- Duration of Response (DOR)(up to 5 years)
- Duration of Response (DOR) (Dose Optimization Only).(up to 5 years)
- Progression-free survival (PFS) per RECIST 1.1 by Investigator (Dose Optimization Only).(up to 5 years)
- Overall survival (OS) (Dose Optimization Only)(up to 5 years)