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A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
SponsorGenmab
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 131 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 496 → 264 participants Trial status changed: Recruiting → Active, Not Recruiting · Study sites revised (76)v131 Show 2 more changesShow less
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Study sites revised (76)

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites revised (76)v130 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 75 to 76v129
  4. Study sites revised (75)v128 See this version in full on ClinicalTrials.gov ↗
  5. Study sites revised (75)v127 See this version in full on ClinicalTrials.gov ↗
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 74 to 75v126
  2. Study sites revised (74)v125 See this version in full on ClinicalTrials.gov ↗
  3. Enrollment target: 565 to 496 Interventions: CC-99282 (Drug), Cyclophosphamide (Drug), Doxorubicin Hydrochloride [HCl] (Drug), Epcoritamab (Drug), Ibrutinib (Drug), Lenalidomide… to CC-99282 (Drug), Cyclophosphamide (Drug), Doxorubicin Hydrochloride [HCl] (Drug), Epcoritamab (Drug), Ibrutinib (Drug), Lenalidomide… · Site details revised at 15 of 74 sites · Study arms: 17 to 13 · 1 morev124 Show 4 more changesShow less
    • Interventions: CC-99282 (Drug), Cyclophosphamide (Drug), Doxorubicin Hydrochloride [HCl] (Drug), Epcoritamab (Drug), Ibrutinib (Drug), Lenalidomide… to CC-99282 (Drug), Cyclophosphamide (Drug), Doxorubicin Hydrochloride [HCl] (Drug), Epcoritamab (Drug), Ibrutinib (Drug), Lenalidomide…
    • Site details revised at 15 of 74 sites
    • Study arms: 17 to 13
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites revised (74)v123 See this version in full on ClinicalTrials.gov ↗
  5. Site details revised at 2 of 74 sitesv122
  6. Study sites revised (74)v121 See this version in full on ClinicalTrials.gov ↗
  7. Study sites revised (74)v120 See this version in full on ClinicalTrials.gov ↗
  8. Phase: Phase 1/2 to Phase 2 Site details revised at 1 of 74 sitesv119 Show 1 more changeShow less
    • Site details revised at 1 of 74 sites
  9. Phase: Phase 2 to Phase 1/2 Enrollment target: 622 to 565 · Study sites revised (74) · Eligibility criteria shortened, about 5 wordsv118 Show 3 more changesShow less
    • Enrollment target: 622 to 565
    • Study sites revised (74)
    • Eligibility criteria shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites revised (74)v117 See this version in full on ClinicalTrials.gov ↗
  11. Study sites revised (74)v116 See this version in full on ClinicalTrials.gov ↗
  12. Primary and study completion dates: Jun 2031 to Nov 2032v115
  13. Primary and study completion dates: Nov 26, 2032 to Jun 2031 Study sites revised (74)v114 Show 1 more changeShow less
    • Study sites revised (74)

    See this version in full on ClinicalTrials.gov ↗

  14. Primary and study completion dates: Jun 26, 2031 to Nov 26, 2032 Study sites revised (74)v113 Show 1 more changeShow less
    • Study sites revised (74)

    See this version in full on ClinicalTrials.gov ↗

  15. Study Status, Contacts/Locationsv112
  16. Enrollment target: 394 to 622 Primary and study completion dates: Nov 26, 2032 to Jun 26, 2031 · Interventions: CC-99282 (Drug), Cyclophosphamide (Drug), Doxorubicin Hydrochloride [HCl] (Drug), Epcoritamab (Drug), Ibrutinib (Drug), Lenalidomide… to CC-99282 (Drug), Cyclophosphamide (Drug), Doxorubicin Hydrochloride [HCl] (Drug), Epcoritamab (Drug), Ibrutinib (Drug), Lenalidomide… · Eligibility criteria expanded, about 9 words · 2 morev111 Show 5 more changesShow less
    • Primary and study completion dates: Nov 26, 2032 to Jun 26, 2031
    • Interventions: CC-99282 (Drug), Cyclophosphamide (Drug), Doxorubicin Hydrochloride [HCl] (Drug), Epcoritamab (Drug), Ibrutinib (Drug), Lenalidomide… to CC-99282 (Drug), Cyclophosphamide (Drug), Doxorubicin Hydrochloride [HCl] (Drug), Epcoritamab (Drug), Ibrutinib (Drug), Lenalidomide…
    • Eligibility criteria expanded, about 9 words
    • Study sites revised (74)
    • Study arms: 15 to 17

    See this version in full on ClinicalTrials.gov ↗

  17. Re-verified, no change to tracked fieldsv110
  18. Study sites revised (74)v109 See this version in full on ClinicalTrials.gov ↗
  19. Lead sponsor: AbbVie to Genmab Study sites: 73 to 74 · Collaborator revisedv108 Show 2 more changesShow less
    • Study sites: 73 to 74
    • Collaborator revised

    See this version in full on ClinicalTrials.gov ↗

  20. Study sites revised (73)v107 See this version in full on ClinicalTrials.gov ↗
  21. Study sites: 72 to 73v106
  22. Study sites revised (72)v105 See this version in full on ClinicalTrials.gov ↗
  23. Study sites: 71 to 72v104
  24. Study sites: 69 to 71v103
  25. Study sites: 68 to 69v102
  26. Re-verified, no change to tracked fieldsv101
  27. Study sites revised (68)v100 See this version in full on ClinicalTrials.gov ↗
  28. Study sites: 67 to 68v99
  29. Re-verified, no change to tracked fieldsv98
  30. Primary and study completion dates: May 19, 2029 to Nov 26, 2032v97
  31. Study sites: 66 to 67v96
  32. Re-verified, no change to tracked fieldsv95
  33. Site details revised at 1 of 66 sitesv94
  34. Study sites revised (66)v93 See this version in full on ClinicalTrials.gov ↗
  35. 3 versions Re-verified since Nov 21, 2023, no change to tracked fieldsv90-v92
  36. Study sites: 65 to 66v89
  37. Site details revised at 1 of 65 sitesv88
  38. Site details revised at 1 of 65 sitesv87
  39. Re-verified, no change to tracked fieldsv86
  40. Study sites: 64 to 65v85
  41. 3 versions Re-verified since Oct 16, 2023, no change to tracked fieldsv82-v84
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
Genmab
45 trials monitored
See 3 trials at risk
Non-Hodgkin Lymphoma
1,517 trials monitored
See 84 trials at risk
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 496 adult participants with NHL will be enrolled in 100 sites globally. In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28 day, 21 day, or 56 day cycles dependent on the arm in combination with the anti-neoplastic agents described below: 1: Oral lenalidomide in participants (PPTS) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in PPTS with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in PPTS with newly diagnosed treatment-naïve DLBCL, or completion of treatment in 3B; 4: Oral CC-99282 in PPTS with R/R DLBCL; 5: Oral CC-99282 in PPTS with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in PPTS with R/R mantle cell lymphoma (MCL). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Trial Details
NCT Number NCT05283720
Lead Sponsor Genmab
Collaborators: AbbVie
Conditions Non-Hodgkin Lymphoma
Enrollment 264 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov