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NCT03038672

Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas

StatusActive, Not Recruiting
PhasePhase 2
Primary completion
Track this trial

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Record History

The 50 most recent of 99 versions: 27 with changes below, 23 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from Oct 24, 2026 to Oct 23, 2027
  2. Study completion date: Oct 24, 2026 to Oct 23, 2027
  3. Secondary endpoints: details revised at 4 of 4 entries
    • Site details revised at 3 of 33 sites
  4. Study completion date: Oct 25, 2025 to Oct 24, 2026v96
  5. Study sites revised (33)v94
Show 23 earlier versionsHide 23 earlier versions
  1. Study sites revised (33)v93
  2. Study completion date: Oct 25, 2024 to Oct 25, 2025
    • Study sites revised (33)
    v92
  3. Results first posted: Oct 16, 2024v91
  4. Enrollment target: 52 to 54v89
  5. Enrollment target: estimated 106 to confirmed 52
    • Primary completion date changed from estimate of Dec 31, 2023 to May 26, 2023
    • Study completion date: Dec 31, 2023 to Oct 25, 2024
    v85
  6. Start date: Nov 30, 2017 to Dec 21, 2018v84
  7. Primary and study completion dates: Dec 31, 2022 to Dec 31, 2023v80
  8. Study sites revised (33)v79
  9. Trial status: Suspended to Active, Not Recruitingv78
  10. Primary and study completion dates: Dec 31, 2021 to Dec 31, 2022v72
  11. Trial status: Recruiting to Suspended Sponsor's reason: Scheduled Interim Monitoring
    • Site details revised at 33 of 33 sites
    v69
  12. Site details revised at 1 of 33 sitesv67
  13. Site details revised at 1 of 33 sitesv66
  14. Site details revised at 2 of 33 sitesv65
  15. Site details revised at 1 of 33 sitesv64
  16. Site contacts updated at 1 of 33 sitesv62
  17. Study sites: 19 to 33v61
  18. Primary and study completion dates: Dec 31, 2020 to Dec 31, 2021v58
  19. Site contacts updated at 3 of 19 sitesv57
  20. Study sites: 18 to 19v55
  21. Site details revised at 4 of 18 sitesv54
  22. Study sites: 17 to 18v52
  23. Site details revised at 1 of 17 sitesv51
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Overall Response Rate
Timeframe: 2 years

Secondary (4)

Duration of Response
Overall Survival
Progression Free Survival (PFS)
Proportion of Patients With Grade 3 or Higher Adverse Events

Arms and interventions

Group I (nivolumab)Active comparator

Patients receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression.

Group II (varlilumab, nivolumab)Experimental

Patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity.

Biologicals: Nivolumab

Drugs: Varlilumab

Sites

33 sites in 1 country