Phase
Condition
Gastric Cancer
Head And Neck Cancer
Esophageal Disorders
Treatment
SGN-PDL1V
pembrolizumab
PF-08046054
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Parts A and B:
Participants must have one of the following histologically- orcytologically-confirmed metastatic or unresectable solid tumor types
Non-small cell lung cancer (NSCLC)
Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngealcancer)
Esophageal squamous cell carcinoma (SCC)
Triple negative breast cancer (TNBC)
Participants must have disease that is relapsed or refractory, that hasprogressed on approved therapies, be intolerant to or refused such therapies,or such and therapies are contraindicated and in the judgement of theinvestigator, should have no appropriate SoC therapeutic option
Participants must have PD-L1 expression based on historical testing
Part C:
Participants must have disease that is relapsed or refractory or be intolerantto SoC therapies and must have one of the following tumor types
HNSCC
Participants with HNSCC must have histologically orcytologically-confirmed HNSCC
NSCLC
Participants must have histologically or cytologically-confirmedNSCLC. Participants with SCC and non--SCC histology are eligible.Note: Participants with a neuroendocrine component or histology arenot eligible.
Esophageal SCC
Ovarian cancer
Melanoma
TNBC
Gastric cancer
Participants must have been previously tested for PD-L1 expression and shouldhave PD-L1 expression ≥1 or <1 by CPS or TPS based on historical testing
Part D and Part E:
Participants must have histologically or cytologically-confirmed disease of theHNSCC or NSCLC
Participants must have PD-L1 expression based on historical testing
Participants with NSCLC; PD-L1 expression ≥ 1% by TPS
Participants with HNSCC; PD--L1 expression ≥1 by CPS
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Measurable disease per RECIST v1.1 at baseline
Exclusion
Exclusion Criteria:
History of another malignancy within 3 years of first dose of study treatment or anyevidence of residual disease from a previously diagnosed malignancy.
Known active central nervous system metastases. Participants with previously-treatedbrain metastases may participate provided they:
Are clinically stable for at least 4 weeks prior to study entry after brainmetastasis treatment
Have no new or enlarging brain metastases
And are off of corticosteroids prescribed for symptoms associate with brainmetastases for at least 7 days prior to first dose of study treatment
Lepto-meningeal disease
Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. Thisduration of time will vary according to the half-life of the specific agent.
Previous receipt of an monomethylauristatin E (MMAE)-containing agent.
Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common TerminologyCriteria for Adverse Events (NCI CTCAE) v5.0.
There are additional inclusion criteria. The study center will determine if criteria for participations are met.
Study Design
Connect with a study center
Institut Jules Bordet
Anderlecht, 1070
BelgiumActive - Recruiting
University Health Network, Princess Margaret Hospital
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
McGill University Department of Oncology / McGill University Health Centre
Montreal, Quebec H3H 2R9
CanadaActive - Recruiting
McGill University Health Centre
Montreal, Quebec H4A 3J1
CanadaActive - Recruiting
Institut Curie
Paris cedex 05, Other 75005
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif, Other 94805
FranceActive - Recruiting
Clinique Ambroise Pare
Neuilly sur seine, 92200
FranceActive - Recruiting
lnstitut Curie Pharmacy
Paris, 75005
FranceActive - Recruiting
Institut Curie
Paris Cedex 05, 75248
FranceActive - Recruiting
Gustave Roussy Institute - Service pharmacie
Villejuif, 94805
FranceActive - Recruiting
Apotheke-Zytostatika Studien Charite- Universitatsmedizin Berlin Campus Virchow Klinkum
Berlin, 13353
GermanyActive - Recruiting
Charite Universitatsmedizin Berlin
Berlin, 12200
GermanyActive - Recruiting
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia
Milano, Milan 20141
ItalyActive - Recruiting
Istituto Europeo di Oncologia
Milano, Other 20141
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Other 37136
ItalyActive - Recruiting
Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B Rossi
Verona, Other 37134
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.B Rossi
Verona, Veneto 37134
ItalyActive - Recruiting
Antoni Van Leeuwenhoekziekenhuis
Amsterdam, Other 1066CX
NetherlandsActive - Recruiting
The Netherlands Cancer Institute
Amsterdam, 1066 CX
NetherlandsActive - Recruiting
CETIR Viladomat
Barcelona, Other 08029
SpainActive - Recruiting
Hospital Duran I Reynals-Institut Català d'Oncologia L'Hospitalet (ICO L'Hospitalet)
Barcelona, Other 08908
SpainActive - Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, Other 08035
SpainActive - Recruiting
Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
Barcelona, Other 08908
SpainActive - Recruiting
START Madrid-CIOCC_Hospital HM Sanchinarro
Madrid, Other 28050
SpainActive - Recruiting
Hospital Quiron Salud Barcelona
Barcelona, 08023
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona
Barcelona, 08023
SpainActive - Recruiting
START Madrid - CIOCC - Hospital Universitario HM Sanchinarro
Madrid, 28050
SpainActive - Recruiting
Sarah Cannon Research Institute UK
London, Other W1G 6AD
United KingdomActive - Recruiting
The Harley Street Clinic (THSC)
London, Other W1G 8BJ
United KingdomActive - Recruiting
The Royal Marsden Hospital
Surrey, Other SM2 5PT
United KingdomSite Not Available
Diagnostic Centre
London, Others WlG 7AF
United KingdomActive - Recruiting
Pharmacy: Royal Marsden Hospital
Sutton, Surrey SM2 5PT
United KingdomActive - Recruiting
Royal Marsden Hospital
Sutton, Surrey SM2 5PT
United KingdomActive - Recruiting
Radiology
London, W1G 8PP
United KingdomActive - Recruiting
Sarah Cannon Research Institute
London, W1G 6AD
United KingdomActive - Recruiting
University of Alabama at Birmingham
Birmingham, Alabama 35249
United StatesActive - Recruiting
University of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama 35249
United StatesActive - Recruiting
Chao Family Comprehensive Cancer Center University of California Irvine
Orange, California 92868
United StatesSite Not Available
University of California Davis
Sacramento, California 95817
United StatesActive - Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United StatesActive - Recruiting
University of California, Davis Medical Center
Sacramento, California 95817
United StatesActive - Recruiting
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United StatesActive - Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan 48201
United StatesActive - Recruiting
Karmanos Cancer Institute
Farmington Hills, Michigan 48334
United StatesActive - Recruiting
Case Western Reserve University / University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services
Houston, Texas 77030
United StatesActive - Recruiting
South Texas Accelerated Research Therapeutics
San Antonio, Texas 78229
United StatesActive - Recruiting
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas 78229
United StatesActive - Recruiting
START Mountain Region
West Valley City, Utah 84119
United StatesActive - Recruiting
South Texas Accelerated Research Therapeutics Mountain Region
West Valley City, Utah 84119
United StatesActive - Recruiting
NEXT Oncology
Fairfax, Virginia 22031
United StatesActive - Recruiting
NEXT Virginia
Fairfax, Virginia 22031
United StatesActive - Recruiting
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