Study of Pembrolizumab (MK-3475) in Combination With Romidepsin

StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary endpoint removed 2 → 1 primary endpoints
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Record History

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  1. Results posted: Sep 30, 2026 Show 4 more changesShow less
    • Primary endpoint(s) modified
    • Primary completion date changed from estimate of Jul 31, 2027 to Mar 31, 2025
    • Eligibility criteria expanded, about 49 words
    • Study description expanded, about 9 words
  2. 5 versions Re-verified since Apr 21, 2026, no change to tracked fieldsv32-v36
  3. Primary endpoints: 2 to 1
    • Primary completion date changed from estimate of Jul 31, 2027 to Mar 31, 2025
    • Secondary endpoints shortened, about 10 words
    v31
  4. Re-verified, no change to tracked fieldsv30
  5. Primary and study completion dates: Jul 31, 2025 to Jul 31, 2027v29
Show 27 earlier versionsHide 27 earlier versions
  1. 2 versions Re-verified since Dec 9, 2024, no change to tracked fieldsv27-v28
  2. Primary and study completion dates: Jul 31, 2024 to Jul 31, 2025v26
  3. 2 versions Re-verified since Nov 28, 2023, no change to tracked fieldsv24-v25
  4. Primary and study completion dates: Jul 31, 2023 to Jul 31, 2024
    • Eligibility criteria expanded, about 77 words
    • Study description expanded, about 10 words
    v23
  5. 2 versions Re-verified since Mar 31, 2023, no change to tracked fieldsv21-v22
  6. Primary and study completion dates: Nov 30, 2021 to Jul 31, 2023
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v20
  7. Primary and study completion dates: Nov 30, 2020 to Nov 30, 2021v19
  8. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 31 to 39
    • Site details revised
    v18
  9. Re-verified, no change to tracked fieldsv17
  10. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 39 to confirmed 31
    • Site details revised
    v16
  11. 2 versions Re-verified since Jul 15, 2019, no change to tracked fieldsv14-v15
  12. Primary endpoints: 1 to 2v13 Show 8 more changesShow less
    • Primary and study completion dates: Nov 2020 to Nov 30, 2020
    • Interventions: Pembrolizumab (Drug), Romidepsin (Drug) to Pembrolizumab (Biological), Romidepsin (Drug)
    • Eligibility criteria expanded, about 48 words
    • Secondary endpoints: 1 to 4
    • Study description shortened, about 490 words
    • Study site revised
    • Collaborator revised
    • Study arms: 2 to 1
  13. Study completion date: Nov 2021 to Nov 2020v12
  14. Re-verified, no change to tracked fieldsv11
  15. Site contact updatedv10
  16. Eligibility criteria revisedv9
  17. Eligibility criteria expanded, about 22 words
    • Study description revised
    v8
  18. Re-verified, no change to tracked fieldsv7
  19. Study completion date: Nov 2020 to Nov 2021
    • Eligibility criteria revised
    v6
  20. Re-verified, no change to tracked fieldsv5
  21. Trial status: Not Yet Recruiting to Recruitingv4 Show 6 more changesShow less
    • Primary completion date: Jun 2020 to Nov 2020
    • Study completion date: Jun 2021 to Nov 2020
    • Start date changed from estimate of Nov 2017 to Nov 14, 2017
    • Eligibility criteria revised
    • Site details revised
    • Study description shortened, about 1 word
  22. Eligibility criteria revisedv3
  23. Eligibility criteria expanded, about 53 words
    • Study description expanded, about 1 word
    v2
  1. 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase I/II trial studies the side effects of pembrolizumab and romidepsin and to see how well they work in treating participants with peripheral T-cell lymphoma that has come back or that does not respond to treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Romidepsin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and romidepsin may work better than pembrolizumab alone in treating participants with recurrent or refractory peripheral T-cell lymphoma.
Trial Details
NCT Number NCT03278782
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Recurrent Anaplastic Large Cell Lymphoma, Recurrent Angioimmunoblastic T-Cell Lymphoma, Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides, Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory Anaplastic Large Cell Lymphoma, Refractory Angioimmunoblastic T-Cell Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma +3 more
Related terms Immunoblastic Lymphadenopathy, Lymphoma, Large-Cell, Anaplastic, Lymphoma, T-Cell, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov