TeLuRide-006: An adaptive phase 2/3 study of EIK1001, a Toll-like receptor 7/8 (TLR7/8) agonist, in combination with pembrolizumab in patients with advanced melanoma.
Bibliographic record
Abstract
TPS9604 Background: Immune checkpoint inhibitors (ICIs) relieve immunosuppression of tumor-reactive T cells and enhance antitumor response. Significant advances for the treatment of advanced melanoma have been made using ICIs, with overall survival (OS) benefit conferred by ICI monotherapy. While encouraging results have been observed with combinations of ICIs, no α-controlled, statistically significant OS benefit of combinations over monotherapy has been demonstrated in Phase 3 studies. Despite these advances, 5-year survival for advanced disease is only 15 to 20%, motivating development of new therapies. EIK1001 is a TLR7/8 agonist that stimulates myeloid and plasmacytoid dendritic cells, activating immune and inflammatory responses. This dual activity, distinct from effects on checkpoint proteins, enhances antitumor T-cell activity alone or in combination with ICIs. Methods: TeLuRide-006 (NCT#06697301) is a global, multicenter, randomized, double-blind, adaptive Phase 2/3 study of EIK1001 or placebo in combination with pembrolizumab (pembro) as first-line therapy in participants (pts) with advanced melanoma. This study includes dose-optimization (DO), in which pts are randomized 1:1:1 to receive 1 of 2 doses of EIK1001 or placebo in combination with pembro, followed by adaptive Phase 2/3 expansion at the Selected Dose of EIK1001 + pembro or placebo + pembro. Interim analyses will determine whether the study advances from DO to Phase 2 to Phase 3. EIK1001 or placebo is administered intravenously QW until the end of Week 27 then Q3W. Pts are stratified by prior anti-PD-1 adjuvant therapy, LDH level, and BRAF mutational status. Key eligibility criteria: pts ≥ 18 years of age with a life expectancy of ≥ 3 months, Stage 3 (unresectable) or Stage 4 metastatic melanoma, known BRAF V600 mutational status (or consent to BRAF mutation testing), ≥ 1 measurable lesion by RECIST v1.1, and no history of or current pneumonitis/interstitial lung disease. Primary objectives are to evaluate the efficacy and safety of 2 doses of EIK1001 in combination with pembro (DO only) and to compare progression-free survival per RECIST 1.1 by blinded independent central review (BICR) and OS of pts receiving EIK1001 + pembro relative to pts receiving placebo + pembro (at Selected Dose). Secondary objectives include evaluation of the safety and tolerability of the Selected Dose of EIK1001 + pembro relative to placebo + pembro, as well as evaluation of objective response rate and duration of response per RECIST 1.1 by BICR. Exploratory objectives include evaluation of time to objective response, evaluation of potential EIK1001 exposure-response relationships, and evaluation of health-related quality of life, health utilities, and melanoma concerns in pts receiving EIK1001 + pembro relative to placebo + pembro. This study opened on 24 December 2024. Clinical trial information: 06697301 .
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".