Phase
Condition
Neoplasms
Treatment
Pembrolizumab
BAY3375968
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Capable of giving signed informed consent.
Has received, been intolerant to, or been ineligible for all treatment optionsproven to confer clinical benefit.
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1.
Adequate renal and liver function.
Male individuals and female individuals of childbearing potential who engage inheterosexual intercourse must agree to use methods of contraception.
Female participants are eligible if they are not pregnant, not breastfeeding or nota Woman of childbearing potential (WOCBP).
Inclusion criterion for the dose-escalation: Individuals with histologically orcytologically confirmed, advanced or metastatic solid tumors.
Inclusion criteria for disease-specific combination expansion: Individuals withhistologically or cytologically confirmed triple-negative breast cancer (TNBC),non-small cell lung cancer (NSCLC), gastric cancer, melanoma, or head and necksquamous cell carcinoma (HNSCC).
Inclusion criterion for the monotherapy-MoA expansion: Individuals withhistologically or cytologically confirmed NSCLC, TNBC, HNSCC, or melanoma.
Willingness and medical feasibility (as per Investigator assessment) to undergopaired tumor biopsies with a non-significant risk.
Exclusion
Exclusion Criteria:
A known additional malignancy that is progressing or has required active treatmentwithin the past 3 years.
Primary central nervous system malignancy.
Major surgery ≤ 28 days before start of study treatment.
Any unresolved toxicity of Grade ≥ 2, not otherwise specified in other eligibilitycriteria, from previous anticancer treatment, except for alopecia and skinpigmentation.
Uncontrolled intercurrent illness requiring systemic treatment or solid organtransplant.
Known hypersensitivity to study treatment or any drugs similar in structure orclass, including severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any ofits excipients.
Any prior immune-related toxicity (Grade 3 or 4) leading to discontinuation ofimmunotherapy.
History of congestive heart failure New York Heart Association (NYHA) >II.
Medical history of (non-infectious) pneumonitis/interstitial lung disease (ILD),drug-induced ILD, radiation pneumonitis which required steroid treatment, or anyevidence of clinically-active pneumonitis/ILD.
HIV-infection with a history of Kaposi sarcoma and/or Multicentric CastlemanDisease.
Known psychiatric or substance abuse disorder that would interfere with theparticipant's ability to cooperate with the requirements of the study.
History or current evidence of any condition, therapy, laboratory abnormality, orother circumstance that might confound the results of the study or interfere withthe participant's participation for the full duration of the study, such that it isnot in the best interest of the participant to participate, in the opinion of thetreating Investigator.
Any other history, condition, therapy, or uncontrolled intercurrent illness whichcould in the opinion of the Investigator affect compliance with study requirements.
New brain metastases on screening brain MRI/CT; previously treated brain metastasesthat are progressive at screening or leptomeningeal disease.
Prior therapy with a C-C motif chemokine receptor 8 (CCR8) depleting antibody.
Prior allogeneic tissue/solid organ transplant.
Radiation therapy to the lung that is > 30 Gy within 6 months before the start ofstudy treatment.
Diagnosis of immunodeficiency or current chronic systemic steroid therapy (in dosingexceeding 10 mg daily of prednisone equivalent).
Active autoimmune disease that has required systemic treatment in the past 2 years.
Study Design
Connect with a study center
Antwerp University Hospital | Oncology Department
Antwerpen, 2650
BelgiumActive - Recruiting
UZ Antwerpen
Edegem, 2650
BelgiumSite Not Available
Ghent University Hospital | Drug Research Unit Department
Gent, 9000
BelgiumActive - Recruiting
UZ Gent
Gent, 9000
BelgiumSite Not Available
UZ Leuven - Neurology department
Leuven, 3000
BelgiumSite Not Available
UZ Leuven Gasthuisberg
Leuven, 3000
BelgiumSite Not Available
Universitair Ziekenhuis Leuven | Gasthuisberg Campus - General Medical Oncology
Leuven, 3000
BelgiumActive - Recruiting
CHU de Liège
Liege, 4000
BelgiumSite Not Available
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
Cross Cancer Institute, Clinical Trials Unit
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong 510000
ChinaActive - Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510655
ChinaSite Not Available
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou City, Guangdong 510655
ChinaSite Not Available
Jilin Cancer Hospital
Changchun, Jilin 130000
ChinaActive - Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang 310022
ChinaSite Not Available
LinYi Cancer Hospital (Linyi Tumor Hospital)
Linyi, 276001
ChinaActive - Recruiting
Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
Bordeaux, 33000
FranceActive - Recruiting
Institut Bergonié - Unicancer Nouvelle Aquitaine
Bordeaux, 33076
FranceSite Not Available
Centre Oscar Lambret - Service Oncologie
Lille, 59000
FranceActive - Recruiting
Centre Oscar Lambret - Lille
Lille Cedex, 59020
FranceSite Not Available
Institut de Cancerologie Ouest - Saint Herblain - Oncologie medicale
Saint Herblain, 44800
FranceActive - Recruiting
Institut de Cancerologie Ouest - Saint-Herblain
Saint-Herblain, 44800
FranceSite Not Available
Institut de Cancérologie de l'Ouest - Saint Herblain
Saint-Herblain, 44800
FranceSite Not Available
Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)
Villejuif Cedex, 94805
FranceActive - Recruiting
Institut Gustave Roussy - Hematologie
Villejuif cedex, 94805
FranceActive - Recruiting
National Cancer Center Singapore
Singapore, 168583
SingaporeActive - Recruiting
National University Hospital
Singapore, 119074
SingaporeActive - Recruiting
National University Hospital Medical Centre
Singapore, 119074
SingaporeActive - Recruiting
OncoCare Cancer Centre
Singapore, 258499
SingaporeSite Not Available
OncoCare Cancer Centre | Gleneagles Medical Centre
Singapore, 258499
SingaporeSite Not Available
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona
Pamplona, Navarra 31008
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)
Barcelona, 8035
SpainActive - Recruiting
Hospital San Pedro
Logrono, 26006
SpainSite Not Available
Centro Integral Oncológico Clara Campal
Madrid, 28050
SpainActive - Recruiting
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid
Madrid, 28027
SpainActive - Recruiting
Royal Marsden NHS Trust (Surrey)
Sutton, Surrey SM2 5PT
United KingdomActive - Recruiting
The Christie NHS Foundation Trust - Christie Hospital
Manchester, M204BX
United KingdomActive - Recruiting
The University of Chicago
Chicago, Illinois 60637
United StatesActive - Recruiting
The University of Chicago Medical Center (UCMC)
Chicago, Illinois 60637
United StatesActive - Recruiting
The University of Chicago Medical Center - Hyde Park - Hematology & Oncology
Chicago, Illinois 60637
United StatesActive - Recruiting
University of Chicago
Chicago, Illinois 60637
United StatesActive - Recruiting
University of North Carolina
Chapel Hill, North Carolina 27514
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
The Ohio State University - Arthur G James Cancer Hospital and Richard J Solove Research Institute
Columbus, Ohio 43210
United StatesSite Not Available
START | San Antonio
San Antonio, Texas 78229
United StatesActive - Recruiting
South Texas Accelerated Research Therapeutics | START San Antonio
San Antonio, Texas 78229-3307
United StatesActive - Recruiting
South Texas Accelerated Research Therapeutics | START Rocky Mountain Region
West Valley City, Utah 84119
United StatesActive - Recruiting
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