Tests BI-1808 alone and with pembrolizumab in advanced cancers
Tests BI-1808, an antibody, alone and with pembrolizumab in advanced cancers.
Plain-language title generated from the registry record
Registry title: BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
Key facts
- Where
- Copenhagen and Herlev, DenmarkSee the 2 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic cancer (solid tumors or T-cell lymphoma) whose disease got worse after standard treatment. It tests BI-1808 alone and with pembrolizumab.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Advanced or metastatic cancer confirmed by tissue examination. Disease got worse after standard treatment, or standard treatment was not tolerated, not possible, or refused. For Part C: platinum-resistant high-grade serous or clear-cell ovarian cancer.
- Earlier treatment
- Standard treatment must have been tried, or not tolerated, not possible, or refused. Part C needs earlier platinum-based treatment as set out in the protocol. Recent cancer treatment, vaccines or trial drugs within the protocol's waiting period are not allowed.
Main reasons for not taking part
- Active cancer spread to the brain or its covering
- Active autoimmune disease, weak immune system, or immune-suppressing treatment
- Earlier serious immune side effects from checkpoint inhibitor treatment, including lung inflammation
- Earlier organ or tissue transplant, or active graft-versus-host disease
- Pregnancy or breastfeeding
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Have you ever been told you have ovarian, fallopian tube or peritoneal cancer?
- Have your doctors told you that your cancer is advanced (stage 3 or 4)? This means it has spread beyond the ovaries to other parts of the belly or the body, even if it was later removed by surgery.
- Has your cancer spread to the brain or the spinal cord?
Source: NCT04752826, who can take part
Where in Denmark
- RigshospitaletCopenhagen, DenmarkContact: Kristoffer Staal Rohrberg (principal investigator)Taking people
- Herlev HospitalHerlev, DenmarkContact: Rikke Løvendahl Eefsen (principal investigator)Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- BioInvent International AB
- Trial code
- NCT04752826EU 2023-509847-29-00
- Record updated
- 18 September 2026
- Original description
The goal of this first in human clinical trial is to test BI-1808 administered as single agent and in combination with pembrolizumab in subjects with advanced malignancies whose disease has progressed after standard therapy.Read full original descriptionShow less
Phase 1/2a Open-Label, Dose-Escalation, Multicenter, FIH, Consecutive-Cohort, Clinical Trial of BI-1808, a Monoclonal Antibody to TNFR 2 as a Single Agent and in Combination With Pembrolizumab (MK-3475-D20) in Subjects With Advanced Malignancies
The goal of this first in human clinical trial is to test BI-1808 administered as single agent and in combination with pembrolizumab in subjects with advanced malignancies whose disease has progressed after standard therapy.
The main questions it aims to answer are:
* how safe and tolerable is BI-1808 * what is maximum tolerated or administrated dose * to determine recommended dose for further clinical trials. Participants will receive infusions of with BI-1808 as a single agent, BI-1808 in combination with pembrolizumab and BI-1808 in combination with pembrolizumab and paclitaxel every 3 weeks.
For the purpose of this study, subjects with advanced malignancies includes subjects with advanced solid tumors and subjects with T-cell lymphoma (TCL),
Inclusion: Able and willing to provide written informed consent; Aged 18 years or older; Histologically confirmed advanced or metastatic malignancy eligible for an enrolling study cohort; Disease progression following, intolerance of, ineligibility for, or refusal of applicable standard therapy; At least one measurable lesion according to the response criteria specified in the protocol; Eastern Cooperative Oncology Group performance status of 0 or 1; Life expectancy of at least 12 weeks; Adequate organ function; Willing and medically suitable to provide required tumor or skin biopsies; Meets the disease-specific and treatment-history requirements of the applicable Phase 2a cohort; For Phase 2a Part C: Histologically confirmed platinum-resistant high-grade serous or clear-cell ovarian carcinoma, prior platinum-based treatment as specified in the protocol, and suitability for paclitaxel treatment.
Exclusion: Prior treatment-related toxicity not recovered to the level specified in the protocol; Prior anticancer therapy, radiotherapy, immunotherapy, investigational treatment, or live vaccine within the protocol-defined washout period; History of clinically significant immune-mediated toxicity, including pneumonitis, associated with previous immune-checkpoint inhibitor treatment; Major surgery without adequate recovery; Prior allogeneic tissue or solid-organ transplantation or active graft-versus-host disease; Active or clinically significant autoimmune disease, immunodeficiency, or use of prohibited immunosuppressive treatment; Uncontrolled or clinically significant cardiovascular disease, serious infection, or another condition that could compromise safety or study participation; Known hypersensitivity to a study treatment or its components; Another active malignancy, except for protocol-defined permitted malignancies; Active central nervous system metastases or carcinomatous meningitis; Pregnancy or breastfeeding, or unwillingness to comply with protocol-defined contraceptive requirements; Participation in another interventional clinical trial that conflicts with this study; Unable or unlikely to comply with study procedures and requirements; For Phase 2a Part C: Receipt of prohibited colony-stimulating factors within the protocol-defined period before treatment.