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RecruitingPriority 2 · High priorityNCT04752826

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

ClinicalTrials.gov

Plain-language summary

This Phase 1, Phase 2 trial is comparing BI-1808 and Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection against other options for people whose cutaneous T-cell lymphoma (skin lymphoma) has come back or has not responded to previous treatment. Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 3 US locations.

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)
  • May require specific number of prior treatments

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.

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
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: High

Plain-language summary

This Phase 1, Phase 2 trial is comparing BI-1808 and Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection against other options for people whose cutaneous T-cell lymphoma (skin lymphoma) has come back or has not responded to previous treatment. Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 3 US locations.

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)
  • May require specific number of prior treatments

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

CTCL · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT04752826

Prepared using TrialCompass (trialcompass.com) on July 4, 2026. For informational purposes only. Always discuss with your healthcare team.