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RecruitingPriority 3 · Moderate priorityNCT04752826

BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)

ClinicalTrials.gov

Plain-language summary

This trial is testing BI-1808 for patients with various types of peripheral T-cell lymphoma (PTCL) whose disease has come back or stopped responding to prior treatment. This is a Phase 1/2 trial, which means researchers are determining the best dose and getting early information about effectiveness. Patients are randomly assigned to different treatment groups. This trial is available at 3 locations in the United States. The trial is currently recruiting patients.

Who can join (key eligibility)

  • Age 18 Years or older
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

BI-1808 (DRUG): BI-1808 administered as a flat-dose IV infusion once every 3 weeks | Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection (DRUG): Pembrolizumab administered as a flat-dose IV infusion once every 3 weeks.

  • BI-1808, Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection

Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

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TrialCompass — Clinical Trial Summary

BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)

NCT04752826

Phase: Phase 1, Phase 2 | Status: Recruiting | Priority: Medium

Plain-language summary

This trial is testing BI-1808 for patients with various types of peripheral T-cell lymphoma (PTCL) whose disease has come back or stopped responding to prior treatment. This is a Phase 1/2 trial, which means researchers are determining the best dose and getting early information about effectiveness. Patients are randomly assigned to different treatment groups. This trial is available at 3 locations in the United States. The trial is currently recruiting patients.

Who can join

  • Age 18 Years or older
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)

What's being tested

BI-1808 (DRUG): BI-1808 administered as a flat-dose IV infusion once every 3 weeks | Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection (DRUG): Pembrolizumab administered as a flat-dose IV infusion once every 3 weeks.

Drugs / treatments: BI-1808, Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 176 patients

Primary endpoint: Occurrence of adverse events (AEs); Identify DLTs, determine the maximum tolerated dose and select a recommended Phase 2 dose (RP2D) of BI-1808, given via intravenous (IV) infusion, as a single agent (Phase 1, Part A), and in combination with pembrolizumab (Phase 1, Part B); Occurrence of serious adverse events (SAEs)

Ages: 18 Years to —

Start date: 2021-01-25 | Est. completion: 2028-01-15

Locations

3 US sites · 25 total

California, New York, Pennsylvania

Contact

Susanne Gertsson | susanne.gertsson@bioinvent.com | +46462868550

Sponsor: BioInvent International AB (INDUSTRY)

Tags

All T-cell lymphomas · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT04752826

Prepared using TrialCompass (trialcompass.com) on August 18, 2026. For informational purposes only. Always discuss with your healthcare team.