Clinical trial NCT04585750: The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
Official title: A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
Advanced Malignant Neoplasm
Metastatic Cancer
Metastatic Solid Tumor
Lung Cancer
Ovarian Cancer
Endometrial Cancer
Prostate Cancer
Colorectal Cancer
Breast Cancer
Other Cancer
Locally Advanced
Head and Neck Cancer
Gall Bladder Cancer
Small Cell Lung Cancer
Small Cell Lung Cancer ( SCLC )
Small Cell Lung Carcinoma
NSCLC
NSCLC (Non-small Cell Lung Cancer)
SCLC
Non-Small Cell Lung Carcinoma
Triple Negative Breast Cancer
TNBC
HER2+ Breast Cancer
Non-Small Cell Lung Cancer
ER/PR Positive Breast Cancer
HER2- Breast Cancer
HER2-positive Breast Cancer
HER2-negative Breast Cancer
ER/PR(+), Her2(-) Breast Cancer
Keywords: PC14586
p53
Y220C
Phase 1
Phase 1/2
PMV
PMV Pharma
p53 mutation
TP53
TP53 mutation
p53 mutant
p53 reactivator
pembrolizumab
Keytruda
combination
PD-1
PD-L1
anti-PD-1
Merck
MSD
IgG4
mAb
Phase 1b
NGS
Next Generation Sequencing
precision
Phase 2
Rezatapopt
Lead sponsor: PMV Pharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2020-10-14
Enrollment: 230
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: During Phase 2 Monotherapy the Recommended Phase 2 Dose (RP2D) selected at the end of Phase 1 Monotherapy and in Phase 2 (Dose Expansion) the RP2D will be assigned to all participants. Participants will be assigned to one of five cohorts: ovarian cancer, lung cancer, breast cancer, endometrial cancer, or other solid tumors. Enrollment ongoing.

During Phase 1 Monotherapy (Dose Escalation), participants will be assigned a dose level using an accelerated titration design in the initial dose cohorts, followed by a modified toxicity probability interval (mTPI) design in subsequent dose cohorts. Enrollment closed.

During Part 1 of the Ph 1b Combination Therapy, patients will be assigned a dose level using mTPI design. A recommended rezatapopt Phase 2 Dose (RP2D) when administered in combination with pembrolizumab will be selected at the end of Phase 1b Part 1, and the RP2D will be assigned to all participants in Part 2. Enrollment closed.
Primary purpose: TREATMENT

Brief summary: The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.

Detailed description: Rezatapopt is a first-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation.

The primary objective of Phase 2 Monotherapy is to evaluate the efficacy of rezatapopt at the Recommended Phase 2 Dose (RP2D) including the Overall Response Rate (ORR) in the Ovarian Cancer Cohort and the ORR across all cohorts as determined by blinded independent central review. Secondary objectives of Phase 2 are to characterize the safety, pharmacokinetic (PK) properties, quality of life, and other efficacy measures of PC14586 rezatapopt at the RP2D. Enrollment is open for the Phase 2 Monotherapy portion of the study.

The primary objective of Phase 1 Monotherapy is to establish the maximum tolerated dose (MTD) and RP2D of rezatapopt. Secondary objectives are to characterize the PK properties, safety and tolerability, and to assess preliminary efficacy including ORR. Enrollment into Phase 1 Monotherapy is complete.

The primary objective of Phase 1b Combination Therapy is to establish the MTD/RP2D of rezatapopt when administered in combination with pembrolizumab. Secondary objectives of Phase 1b Combination Therapy are to characterize PK, safety and tolerability, and to assess preliminary efficacy of rezatapopt when administered in combination with pembrolizumab, including ORR. Enrollment into Phase 1b Combination Therapy is complete.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.
* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation
* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
* Previously treated with one or more lines of anticancer therapy and progressive disease
* Adequate organ function
* Measurable disease per RECIST v1.1 (Phase 2)

Additional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)

* Anti-PD-1/PD-L1 naive or must have progressed on treatment
* Measurable disease

Exclusion Criteria:

* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug
* Radiotherapy within 28 days of receiving the study drug
* Primary CNS tumor
* History of leptomeningeal disease or spinal cord compression
* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms
* Stroke or transient ischemic attack within 6 months prior to screening
* Heart conditions such as unstable angina, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities
* Strong CYP3A4 inducers
* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication
* History of prior organ transplant
* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer
* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection

Additional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)

* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)

Additional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)

* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)
* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention
* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug
* Hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
* Active autoimmune disease that has required systemic treatment in past 2 years
* History of radiation pneumonitis
* History of (non-infectious) or active pneumonitis / interstitial lung disease that required steroids
* Active infection requiring systemic therapy
* Known history of HIV infection
* Has previously received rezatapopt

Primary outcomes:
measure: Phase 1 Monotherapy (Dose Escalation): Determine the number and type of adverse events to characterize the safety of rezatapopt
timeFrame: 40 months
measure: Phase 1 Monotherapy (Dose Escalation): Establish the Recommended Phase 2 Dose (RP2D)
timeFrame: 30 months
measure: Phase 1 Monotherapy (Dose Escalation): Establish the maximum tolerated dose (MTD) (Phase 1)
timeFrame: The first 28 days of treatment (Cycle 1) per patient
measure: Phase 1b Combination Therapy (Part 1: Dose Escalation): Determine the number and type of adverse events to characterize the safety of rezatapopt when administered in combination with pembrolizumab
timeFrame: 18 months for treatment arm
measure: Phase 1b Combination Therapy (Part 1: Dose Escalation): Establish the maximum tolerated dose (MTD) of rezatapopt when administered in combination with pembrolizumab
timeFrame: The first 28 days of combination treatment arm (starting on Day -7) per patient
measure: Phase 1b Combination Therapy (Part 1: Dose Escalation): Establish the Recommended Phase 2 Dose (RP2D) of rezatapopt when administered in combination with pembrolizumab
timeFrame: 18 months
measure: Phase 1b Combination Therapy (Part 2: Dose Expansion): Determine the number and type of adverse events to characterize the safety of rezatapopt when administered in combination with pembrolizumab
timeFrame: 12 months for treatment arm
measure: Phase 2 Monotherapy (Dose Expansion): Response rate assessment to evaluate the clinical activity / efficacy of rezatapopt
timeFrame: 34 months
Secondary outcomes:
measure: Phase 1 Monotherapy: PK profile of rezatapopt - Peak concentration (Cmax)
timeFrame: Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
measure: Phase 1 Monotherapy: PK profile of rezatapopt - Time of peak concentration (Tmax)
timeFrame: Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
measure: Phase 1 Monotherapy: PK profile of rezatapopt - Area under the plasma concentration-time curve from time zero to time of last sampling timepoint (AUC0-t)
timeFrame: Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
measure: Phase 1 Monotherapy: PK profile of rezatapopt - Area under the plasma concentration-time curve in one dosing interval (AUCtau)
timeFrame: Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
measure: Phase 1 Monotherapy: PK profile of rezatapopt - Trough observed concentrations (Ctrough/Ctau)
timeFrame: Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
measure: Phase 1 Monotherapy: Blood plasma assessment to describe the concentration of PC14586 and metabolite (M1) when rezatapopt is administered orally.
timeFrame: Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
measure: Phase 1 Monotherapy (Dose Escalation): Overall Response Rate per RECIST v1.1 or PCWG3 modified RECIST v1.1
timeFrame: 41 months for study (end of Phase 1)
measure: Phase 1 Monotherapy (Dose Escalation): Time to Response per RECIST v1.1 or PCWG3 modified RECIST v1.1
timeFrame: 41 months for study (end of Phase 1)
measure: Phase 1 Monotherapy (Dose Escalation): Duration of Response per RECIST v1.1 or PCWG3 modified RECIST v1.1
timeFrame: 41 months for study (end of Phase 1)
measure: Phase 1 Monotherapy (Dose Escalation): Disease Control Rate per RECIST v1.1 or PCWG3 modified RECIST v1.1
timeFrame: 41 months for study (end of Phase 1)
measure: Phase 1 Monotherapy (Dose Escalation): Progression Free Survival per RECIST v1.1 or PCWG3 modified RECIST v1.1
timeFrame: 41 months for study (end of Phase 1)
measure: Phase 1 Monotherapy (Dose Escalation): Overall Survival
timeFrame: 41 months for study (end of Phase 1)
measure: Phase 1b Combination Therapy: PK profile of rezatapopt in combination with pembrolizumab - Peak concentration (Cmax)
timeFrame: Approximately 12 months per patient (30 months for treatment arm)
measure: Phase 1b Combination Therapy: PK profile of rezatapopt in combination with pembrolizumab - Time of peak concentration (Tmax)
timeFrame: Approximately 12 months per patient (30 months for treatment arm)
measure: Phase 1b Combination Therapy: PK profile of rezatapopt in combination with pembrolizumab - Area under the plasma concentration-time curve from time zero to time of last sampling timepoint (AUC0-t)
timeFrame: Approximately 12 months per patient (30 months for treatment arm)
measure: Phase 1b Combination Therapy: PK profile of rezatapopt in combination with pembrolizumab - Area under the plasma concentration-time curve in one dosing interval (AUCtau)
timeFrame: Approximately 12 months per patient (30 months for treatment arm)
measure: Phase 1b Combination Therapy: PK profile of rezatapopt in combination with pembrolizumab - Trough observed concentrations (Ctrough/Ctau)
timeFrame: Approximately 12 months per patient (30 months for treatment arm)
measure: Phase 1b Combination Therapy: Blood plasma assessment to describe the concentration of rezatapopt and metabolite (M1) when rezatapopt is administered orally in combination with pembrolizumab.
timeFrame: Approximately 12 months per patient (30 months for treatment arm)
measure: Phase 1b Combination Therapy: Overall Response Rate per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review
timeFrame: 30 months for study (end of Phase 1b)
measure: Phase 1b Combination Therapy: Time to Response per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review
timeFrame: 30 months for study (end of Phase 1b)
measure: Phase 1b Combination Therapy: Duration of Response per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review
timeFrame: 30 months for study (end of Phase 1b)
measure: Phase 1b Combination Therapy: Disease Control Rate per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review
timeFrame: 30 months for study (end of Phase 1b)
measure: Phase 1b Combination Therapy: Overall Survival
timeFrame: 30 months for study (end of Phase 1b)
measure: Phase 1b Combination Therapy: Determine the number and type of adverse events to characterize the safety of rezatapopt
timeFrame: 30 months for study (end of Phase 1b)
measure: Phase 1b Combination Therapy: Progression Free Survival per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review
timeFrame: 30 months for study (end of Phase 1b)
measure: Phase 2 Monotherapy: PK profile of rezatapopt - Time of peak concentration (Tmax)
timeFrame: Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
measure: Phase 2 Monotherapy: PK profile of rezatapopt - Peak concentration (Cmax)
timeFrame: Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
measure: Phase 2 Monotherapy: PK profile of rezatapopt - Area under the plasma concentration-time curve from time zero to time of last sampling timepoint (AUC0-t)
timeFrame: Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
measure: Phase 2 Monotherapy: PK profile of rezatapopt - Area under the plasma concentration-time curve in one dosing interval (AUCtau)
timeFrame: Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
measure: Phase 2 Monotherapy: PK profile of rezatapopt - Trough observed concentrations (Ctrough/Ctau)
timeFrame: Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
measure: Phase 2 Monotherapy: Blood plasma assessment to describe the concentration of rezatapopt and metabolite (M1) when rezatapopt is administered orally.
timeFrame: Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
measure: Phase 2 Monotherapy (Dose Expansion): Determine the number and type of adverse events to characterize the safety of rezatapopt
timeFrame: 34 months for study (end of Phase 2)
measure: Phase 2 Monotherapy (Dose Expansion): Overall Response Rate across all cohorts per RECIST v1.1 as assessed by Investigator
timeFrame: 34 months for study (end of Phase 2)
measure: Phase 2 Monotherapy (Dose Expansion): Overall Response Rate in ovarian cancer cohort per RECIST v1.1 as assessed by Investigator
timeFrame: 34 months for study (end of Phase 2)
measure: Phase 2 Monotherapy (Dose Expansion): Time to Response in ovarian cancer cohort per RECIST v1.1 as assessed by Investigator and as assessed by independent review
timeFrame: 34 months for study (end of Phase 2)
measure: Phase 2 Monotherapy (Dose Expansion): Time to Response across all cohorts per RECIST v1.1 as assessed by Investigator and as assessed by independent review
timeFrame: 34 months for study (end of Phase 2)
measure: Phase 2 Monotherapy (Dose Expansion): Duration of Response in ovarian cancer cohort per RECIST v1.1 as assessed by Investigator and as assessed by independent review
timeFrame: 34 months for study (end of Phase 2)
measure: Phase 2 Monotherapy (Dose Expansion): Duration of Response across all cohorts per RECIST v1.1 as assessed by Investigator and as assessed by independent review
timeFrame: 34 months for study (end of Phase 2)
measure: Phase 2 Monotherapy (Dose Expansion): Disease Control Rate in ovarian cancer cohort per RECIST v1.1 as assessed by Investigator and as assessed by independent review
timeFrame: 34 months for study (end of Phase 2)
measure: Phase 2 Monotherapy (Dose Expansion): Disease Control Rate across all cohorts per RECIST v1.1 as assessed by Investigator and as assessed by independent review
timeFrame: 34 months for study (end of Phase 2)
measure: Phase 2 Monotherapy (Dose Expansion): Progression Free Survival in ovarian cancer cohort per RECIST v1.1 as assessed by Investigator and as assessed by independent review
timeFrame: 34 months for study (end of Phase 2)
measure: Phase 2 Monotherapy (Dose Expansion): Progression Free Survival across all cohorts per RECIST v1.1 as assessed by Investigator and as assessed by independent review
timeFrame: 34 months for study (end of Phase 2)
measure: Phase 2 Monotherapy (Dose Expansion): Overall Survival in ovarian cancer cohort
timeFrame: 34 months for study (end of Phase 2)
measure: Phase 2 Monotherapy (Dose Expansion): Overall Survival across all cohorts
timeFrame: 34 months for study (end of Phase 2)
measure: Phase 2 Monotherapy (Dose Expansion): Quality of life assessment
timeFrame: Evaluated at every visit. 34 months for treatment arm (end of Phase 2)
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Hoag Cancer Center
state: California
city: Irvine
country: United States
facility: University of California Irvine Chao Family Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA Jonsson Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: University of San Francisco
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants
state: Delaware
city: Miami
country: United States
facility: University of Miami - Sylvester Comprehensive Cancer Center
state: Florida
city: Orlando
country: United States
facility: Advent Health
state: Florida
city: Port Charlotte
country: United States
facility: Florida Cancer Specialists South
state: Florida
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU)
state: Oregon
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: York
country: United States
facility: WellSpan York Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - Ingram Cancer Center
state: Tennessee
city: Austin
country: United States
facility: New Experimental Therapeutics - NEXT Oncology
state: Texas
city: Dallas
country: United States
facility: UTSW - Moody Outpatient Center - Parkland Health
state: Texas
city: Dallas
country: United States
facility: UT Southwest Simmons Cancer Center
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: New Experimental Therapeutics of San Antonio - NEXT Oncology
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Seattle
country: United States
facility: University of Washington, Fred Hutchinson Cancer Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Cancer Care Centre
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Center
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Strasbourg
country: France
facility: ICANS - Institut de cancérologie Strasbourg Europe
state: Bas-Rhin
city: Bordeaux
country: France
facility: Institut Bergonie
state: Gironde
city: Toulouse
country: France
facility: Institut Claudius Regaud
state: Haute-Garonne
city: Saint-Herblain
country: France
facility: EDOG Institut de Cancerologie de l'Ouest
state: Loire-Atlantique
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
state: Puy-de-Dôme
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Val-de-Marne
city: Lyon
country: France
facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer
city: Nîmes
country: France
facility: CHU de Nîmes
city: Vandœuvre-lès-Nancy
country: France
facility: Institute Cancer De Lorraine
city: Heidelberg
country: Germany
facility: Nationale Centrum für Tumorerkrankungen (NCT) Heidelberg
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
state: Bayern
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
state: Hessen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: Nordrhein-Westfalen
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: Lazio
city: Rome
country: Italy
facility: Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena
state: Lazio
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Dei Tumori
state: Lombardia
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia (IRCCS)
state: Torino
city: Napoli
country: Italy
facility: IRCCS - lstituto Nazionale Tumori - Fondazione G. Pascale
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University
city: Kent Ridge
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Center of Singapore
city: Barcelona
country: Spain
facility: Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON
city: Barcelona
country: Spain
facility: NEXT Oncology-Hospital Quironsalud Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: START MADRID_Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: START MADRID_Hospital Universitario HM Sanchinarro - CIOCC
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
state: Middlesex
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
state: Tyne And Wear
Study officials:
affiliation: Sr. Vice President of Medical Affairs
name: Marc Fellous, MD
role: STUDY_DIRECTOR
References: