A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma

StatusActive, Not Recruiting
PhasePhase 3
SponsorPfizer
Started

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Trial flagged as At Risk
Primary completion moved at least 9 months later Jan 12, 2026 → Oct 30, 2026
See other at-risk trials from Pfizer

Record History

The 50 most recent of 51 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to Oct 30, 2026
    • Trial sites expanded: 143 → 151 locations
    v51
  2. Trial sites expanded: 138 → 143 locationsv50
  3. Study sites: 132 to 138
    • Primary completion date changed from estimate of Dec 14, 2025 to Jan 12, 2026
    • Study completion date: Mar 23, 2026 to Aug 31, 2026
    v49
  4. Enrollment target: 256 to 257
    • Primary completion date: Sep 22, 2025 to Dec 14, 2025
    • Study completion date: Dec 30, 2025 to Mar 23, 2026
    • Study sites revised (132)
    v48
  5. Study sites: 228 to 132v47
Show 45 earlier versionsHide 45 earlier versions
  1. Enrollment target: 258 to 256
    • Primary completion date: May 1, 2025 to Sep 22, 2025
    • Study completion date: Jun 30, 2026 to Dec 30, 2025
    v46
  2. Enrollment target: 257 to 258
    • Study sites revised (228)
    v45
  3. Enrollment target: 189 to 257v44
  4. Enrollment target: 187 to 189v43
  5. Enrollment target: 186 to 187v42
  6. Enrollment target: 176 to 186v41
  7. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 240 to confirmed 176
    • Study sites: 231 to 228
    v40
  8. Enrollment target: 624 to 240
    • Study sites: 230 to 231
    • Primary completion date: Feb 19, 2025 to May 1, 2025
    • Study completion date: Jul 18, 2026 to Jun 30, 2026
    v39
  9. Primary endpoints revised (2)v38 Show 5 more changesShow less
    • Study sites: 229 to 230
    • Primary completion date: Sep 30, 2024 to Feb 19, 2025
    • Study completion date: Feb 9, 2030 to Jul 18, 2026
    • Secondary endpoints: 15 to 14
    • Study description revised
  10. Study sites: 228 to 229v37
  11. Re-verified, no change to tracked fieldsv36
  12. Study sites: 227 to 228v35
  13. Study sites: 226 to 227v34
  14. Study sites: 215 to 226v33
  15. Study sites: 205 to 215v32
  16. Study sites: 188 to 205v31
  17. Study sites: 181 to 188
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 1 of 15 entries
    v30
  18. Site details revised at 17 of 181 sitesv29
  19. Study sites: 172 to 181v28
  20. Study sites: 168 to 172v27
  21. Study sites: 159 to 168v26
  22. Study sites: 147 to 159v25
  23. Study sites: 136 to 147v24
  24. Study sites: 124 to 136v23
  25. Study sites: 113 to 124v22
  26. Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 15 entries
    v21
  27. Study sites revised (113)v20
  28. Study sites: 104 to 113v19
  29. Primary completion date: Jan 10, 2024 to Sep 30, 2024
    • Study sites: 100 to 104
    • Study completion date: May 8, 2030 to Feb 9, 2030
    v18
  30. Study sites: 98 to 100v17
  31. Study sites: 93 to 98v16
  32. Study sites: 80 to 93v15
  33. Study sites: 69 to 80v14
  34. Study sites: 41 to 69
    • Study description expanded, about 15 words
    v13
  35. Study sites: 31 to 41
    • Study description shortened, about 22 words
    • Study title expanded, about 6 words
    v12
  36. Study sites: 24 to 31v11
  37. Study sites: 20 to 24v10
  38. Study sites: 18 to 20v9
  39. Study sites: 17 to 18v8
  40. Re-verified, no change to tracked fieldsv7
  41. Study sites: 8 to 17
    • Primary completion date: Aug 28, 2023 to Jan 10, 2024
    • Study completion date: Dec 24, 2029 to May 8, 2030
    v6
  42. Re-verified, no change to tracked fieldsv5
  43. Study sites: 4 to 8v4
  44. Study sites: 3 to 4
    • Study title expanded, about 1 word
    v3
  45. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Jan 29, 2021 to Jan 15, 2021
    v2
  • 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
441 trials monitored
See 31 trials at risk
Melanoma
1,098 trials monitored
See 64 trials at risk
The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: * is advanced or metastatic (spread to other parts of the body); * has a certain type of abnormal gene called "BRAF"; and * has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic once every 3 weeks as an intravenous (IV) infusion (given directly into a vein). In addition, half of the participants will take encorafenib and binimetinib orally (by mouth) at home every day. Participants may receive pembrolizumab for up to two years. Those participants taking encorafenib and binimetinib can continue until their melanoma is no longer responding. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
Trial Details
NCT Number NCT04657991
Lead Sponsor Pfizer
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Melanoma
Related terms Melanoma, Skin Neoplasms
Enrollment 257 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov