A Clinical Study of MK-4208/TERN-701 in Participants With Chronic Myeloid Leukemia (CML) (MK-4208-003/Tern701-1012/CARDINAL)

Study acronym: CARDINAL
StatusRecruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary endpoint added 6 → 7 primary endpoints
See other at-risk trials from Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Record History

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  1. Primary endpoint(s) modified Show 8 more changesShow less
    • Enrollment increased: 180 → 330 participants
    • Lead sponsor: Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) to Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
    • Interventions modified
    • Trial arms changed: 7 → 10
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints expanded, about 138 words
    • Site details revised at 4 of 54 sites
    • Study title shortened, about 9 words
  2. Changed Sponsor changed: Terns, Inc. to Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
  3. Phase: Phase 1 to Phase 1/2v4 Show 7 more changesShow less
    • Enrollment target: 100 to 180
    • Primary completion date: Nov 30, 2025 to Nov 30, 2029
    • Study sites: 40 to 54
    • Study completion date: May 31, 2026 to May 31, 2030
    • Eligibility criteria revised
    • Study arms: 6 to 7
    • Study title expanded, about 2 words
  4. Re-verified, no change to tracked fieldsv3
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Dec 13, 2023 to Mar 26, 2024
    • Enrollment target: 80 to 100
    • Study sites: 1 to 40
    • Eligibility criteria shortened, about 16 words
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Researchers are looking for a new way to treat a blood cancer called chronic myeloid leukemia (CML). Researchers want to learn if MK-4208 (Tern-701) can treat this type of blood cancer. The goal of this study is to learn about the safety of different doses (amounts) of MK-4208 (Tern-701) and if people tolerate them. Researchers also want to find the highest dose of MK-4208 (Tern-701) that people can tolerate and may work to treat blood cancer.
Trial Details
NCT Number NCT06163430
Lead Sponsor Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions
(from sponsor)		 Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Chronic Myeloid Leukemia, Chronic Phase, Chronic Myeloid Leukemia
Related terms Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase
Enrollment 330 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov