Actively Recruiting
BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
Led by BioInvent International AB · Updated on 2026-02-18
176
Participants Needed
25
Research Sites
363 weeks
Total Duration
On this page
Sponsors
B
BioInvent International AB
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 BI-1808 alone or combination with pembrolizumab 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),
CONDITIONS
Official Title
BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Age 18 years or older at consent
- Histologically confirmed advanced malignancy (including advanced solid tumors and T-cell lymphoma)
- Intolerant of, refuses, or not eligible for standard anti-cancer therapy
- At least one measurable disease lesion per RECIST criteria
- Able to safely undergo baseline tumor biopsy on non-irradiated lesions at least 4 weeks after last tumor therapy
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function confirmed by laboratory values
- For ovarian cancer: histologically confirmed recurrent ovarian, fallopian tube, or peritoneal cancer
- For T-cell lymphoma: histologically confirmed diagnosis, stable steroids doses, stage IB-IV disease with at least one systemic therapy failure, no current large cell transformation for cutaneous T-cell lymphoma, prior therapies as specified, and no recent allo hematopoietic stem cell transplant
- For melanoma: histologically confirmed unresectable or metastatic melanoma with required prior therapies depending on study part
- Locally advanced unresectable, recurrent, or metastatic immune checkpoint inhibitor-naive solid tumors likely to benefit from immune checkpoint inhibitor treatment
- Received prior standard therapy appropriate to tumor type and stage or unlikely to tolerate or benefit from standard care
- Known activating mutations must have received prior targeted therapy
You will not qualify if you...
- Requires prednisolone doses higher than 10 mg daily (or equivalent corticosteroids) except as premedication
- Known active central nervous system metastases or carcinomatous meningitis
- Known or suspected hypersensitivity to BI-1808 or pembrolizumab
- Cardiac or renal amyloid light-chain amyloidosis
- Received chemotherapy or small molecule drugs within 4 weeks before first BI-1808 dose
- Radiotherapy within 2 weeks before first BI-1808 dose (1-week washout for palliative radiation allowed)
- Immunotherapy within 4 weeks before first BI-1808 dose
- Not recovered from adverse events to at least Grade 1 by NCI CTCAE
- Grade 3 or higher autoimmune reactions from prior immune checkpoint inhibitors
- History of pneumonitis requiring steroids or current pneumonitis
- Active, known, or suspected autoimmune disease
- Female subjects who are pregnant, lactating, or able to become pregnant without agreeing to contraception requirements
- Male subjects with partners of childbearing potential not agreeing to contraception requirements
- Unrecovered major surgery
- High medical risk from systemic nonmalignant disease or severe infections
- Presence of chronic graft versus host disease
- Prior allogenic tissue or solid organ transplant
- Known HIV or hepatitis B or C infections or positive tests
- History of active tuberculosis
- Live vaccine within 30 days before first dose
- Uncontrolled or significant cardiovascular disease
- Psychiatric or substance abuse disorder interfering with trial participation
- Other conditions or abnormalities that may confound trial results or participation
- Participation in other interventional clinical trials within 4 weeks prior
- Known additional malignancy except certain treated in situ or skin cancers
- Primary or acquired immunodeficiency or recent immunosuppressive therapy
- Symptomatic ascites or pleural effusion requiring intervention
AI-Screening
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Trial Site Locations
Total: 25 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
4
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
5
Herlev Hospital
Herlev, Denmark, 2730
Actively Recruiting
6
PRA Health Sciences - Hungary
Budapest, Hungary, 1077
Active, Not Recruiting
7
Magyar Honvédség-Egészségügyi Központ
Budapest, Hungary, 1134
Actively Recruiting
8
Debreceni Egyetem Klinikai Központ
Debrecen, Hungary, 4032
Withdrawn
9
Byudzhetnoye Uchrezhdeniye Zdravookhraneniya Omskoy Oblasti - Klinicheskiy Onkologicheskiy Dispanser
Omsk, Russia, 644013
Terminated
10
National Medical Research Center VA Almazov
Saint Petersburg, Russia, 197022
Withdrawn
11
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, Russia, 197758
Withdrawn
12
Institut Catala d'oncologia. Hospital Duran I Reynals
Barcelona, Spain, 08907
Not Yet Recruiting
13
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
14
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
15
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Not Yet Recruiting
16
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Actively Recruiting
17
Skanes University Hospital
Lund, Sweden, 223 70
Actively Recruiting
18
Karolinska University Hospital, Solna
Stockholm, Sweden, 17176
Actively Recruiting
19
University Hospital Birmingham
Birmingham, United Kingdom
Actively Recruiting
20
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
21
Guy's and Saint Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Actively Recruiting
22
Sarah Cannon Research Institute UK
London, United Kingdom, W1G 6AD
Actively Recruiting
23
The Royal Marsden Hospital NHS Foundation Trust
London, United Kingdom
Actively Recruiting
24
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
25
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
S
Susanne Gertsson
CONTACT
M
Mona Welschof, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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