Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)
- Conditions
- Ovarian Cancer
- Interventions
- Registration Number
- NCT02718417
- Lead Sponsor
- Pfizer
- Brief Summary
This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for platinum-based chemotherapy.
The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 998
- Histologically confirmed Stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component
- Patients must be candidates for platinum based chemotherapy and previously untreated
- Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy
- Availability of an archival formalin fixed, paraffin embedded (FFPE) tumor tissue block or a minimum of 15 slides
- ECOG PS 0-1
- Adequate hematological, renal, and liver function
Key
- Non epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors
- Prior systemic anti-cancer treatment for EOC, FTC, or PPC including prior immunotherapy with IL 2, IFN α, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways
- Patients for whom, in the opinion of the Investigator, there is clinical benefit to administer bevacizumab as a first-line treatment and for whom bevacizumab is approved and available in this setting.
- Cancer for which intraperitoneal cytotoxic chemotherapy is planned
- Active autoimmune disease (some exceptions include diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B carboplatin Chemotherapy followed by avelumab in maintenance Arm A paclitaxel Chemotherapy followed by observation Arm A carboplatin Chemotherapy followed by observation Arm B Avelumab Chemotherapy followed by avelumab in maintenance Arm B paclitaxel Chemotherapy followed by avelumab in maintenance Arm C carboplatin Chemotherapy in combination with avelumab followed by avelumab in maintenance Arm C paclitaxel Chemotherapy in combination with avelumab followed by avelumab in maintenance Arm C Avelumab Chemotherapy in combination with avelumab followed by avelumab in maintenance
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) BICR assessed PFS: Duration from randomization until disease progression or death. PFS data was censored on the date of the last adequate tumor assessment for participants who did not have an event (progression of disease or death), who started a new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
- Secondary Outcome Measures
Name Time Method Overall Survival Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
Progression-Free Survival (PFS) as Assessed by Investigator Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) Investigator assessed PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. Progression as per RECIST 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.
Percentage of Participants With Objective Response as Assessed by Investigator Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months) Investigator assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.
Percentage of Participants With Objective Response as Assessed by Blinded Independent Central Review (BICR) Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months) BICR assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of CR or PR. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.
Progression-Free Survival 2 (PFS2) Baseline up to start of second subsequent treatment after first PD or discontinuation from study or death, which ever occured first (maximum duration of 27 months) PFS2 was defined as time (in months) from the date of randomization to the start of second subsequent treatment after first documentation of PD, or death from any cause, whichever occurred first. Progression as per RECIST version 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycles 2, 3, 4 in Chemotherapy Phase; Days 1, 15 and 29 of Cycles 1 and 2 in Maintenance/ Observation Phase and at End of Treatment Baseline, first 3 months of Chemotherapy Phase (CP): Day 1 of Cycles 2, 3 and 4 (each cycle 21 days); Maintenance/Observation Phase (MP/OP): Days 1, 15 and 29 of Cycles 1 and 2 (each cycle 42 days) and at end of treatment (up to 27 months) Vital signs included blood pressure and pulse rate. Blood pressure included sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP). MP is applicable only for two arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab'. OP is applicable only for third arm 'Chemotherapy followed by Observation'. Category titles 'MP/OP' imply which ever phase was applicable for the respective reporting arms.
Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycles 2, 3, 4 in Chemotherapy Phase; Days 1, 15 and 29 of Cycles 1 and 2 in Maintenance/ Observation Phase and at End of Treatment Baseline, first 3 months of Chemotherapy Phase (CP): Day 1 of Cycles 2, 3 and 4 (each cycle 21 days); Maintenance/Observation Phase (MP/OP): Days 1, 15 and 29 of Cycles 1 and 2 (each cycle 42 days) and at end of treatment (up to 27 months) Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized. MP is applicable only for two arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab'. OP is applicable only for third arm 'Chemotherapy followed by Observation'. Category titles 'MP/OP' imply which ever phase was applicable for the respective reporting arms.
Number of Participants With Electrocardiogram (ECG) Abnormalities Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (\>) 30 millisecond (ms) or 60 ms; absolute value \> 450 ms, \>480 ms and \> 500 ms; 2) heart rate (HR) : absolute value \<=50 bpm and decrease from baseline \>=20 bpm; absolute value \>=120 beats per minute (bpm) and increase from baseline \>=20 bpm; 3) PR interval: absolute value \>=220 ms and increase from baseline \>=20 ms; 4) QRS interval: absolute value \>= 120 ms.
Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Paclitaxel (QW Regimen) Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Duration of Response (DOR) as Assessed by Investigator First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) Investigator assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Maintenance Progression-Free Survival (PFS) as Assessed by Investigator From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months) Investigator assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by investigator during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method
Percentage of Participants With Pathological Complete Response (pCR) Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) pCR was defined (for neoadjuvant participants who underwent interval debulking surgery \[IDS\]), as the chemotherapy response score 3 (CSR3), based on a study by Bohm et al, 2015. CSR3 was defined as complete or near-complete response with no residual tumor or minimal irregularly scattered tumor foci seen as individual cells, cell groups, or nodules up to 2 mm. Complete or near-complete response was defined as complete or near-complete microscopic disappearance of invasive tumor/ residual disease.
Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR) First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) BICR assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Maintenance Progression-Free Survival as Assessed by Blinded Independent Central Review (BICR) From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months) BICR assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by BICR during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Progression-Free Survival (PFS) as Assessed by Gynecological Cancer Intergroup (GCIG) Criteria Baseline until disease progression by GCIG criteria or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) PFS by GCIG was assessed by both RECIST 1.1 and cancer antigen 125 (CA-125). It was defined as time from randomization to first documentation of disease progression (PD) or death, whichever occurred first. As per RECIST 1.1, PD: greater than or equal to (\>=) 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study with absolute increase \>= 5 millimeters. PD based on serum CA-125 was defined as (i) participants with elevated CA-125 pretreatment and normalization of CA-125, (ii) participants with CA-125 in the reference range before treatment; (i) and (ii) must have showed CA-125 \>= 2 times the upper limit of the reference range on 2 occasions \>= 1 week apart, or (iii) participants with elevated CA-125 before treatment, which never normalized, showed CA-125 \>= 2 times the nadir value on 2 occasions \>= 1 week apart. Censoring date for PFS by GCIG was the latest of the censoring dates for PFS by RECIST 1.1 and PFS by CA-125.
Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on, National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03 Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 36 months) An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent events are events between first dose of study drug and up to 36 months that were absent before treatment or that worsened relative to pretreatment state.
Number of Participants With Laboratory Abnormalities Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03 Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) As per NCI-CTCAE v 4.03, Grade 3 and above criteria were; Hematology \[Anemia - Grade 3: hemoglobin \<8.0 grams per deciliter (g/dL), \<4.9 millimoles per liter (mmol/L), \<80 grams per liter (g/L), transfusion indicated, Grade 4: life-threatening consequences, urgent intervention indicated, Grade 5: death; platelet count decreased- Grade 3:\<50.0 to 25.0\*10\^9/Liters(L), Grade 4: \<25.0\*10\^9/L; lymphocyte count decreased-Grade 3: \<0.5-0.2\*10\^9/L, Grade 4: \<0.2\*10\^9/L; neutrophil count decreased-Grade 3: \<1.0 to 0.5\*10\^9 /L, Grade 4: \<0.5\*10\^9/L\]. Chemistry \[creatinine increased-Grade 3: \>3.0 to 6.0\*upper limit of normal (ULN), Grade 4: \>6.0\*ULN; serum amylase increased, lipase increased-Grade 3: \>2.0 - 5.0\*ULN, Grade 4: \>5.0\*ULN\]. Liver function \[aspartate aminotransferase (AST) and alanine aminotransferase (ALT)-Grade 3: \>5.0 to 20.0\*ULN, Grade 4: \>20.0\*ULN\].
Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once Every Three Weeks [Q3W] Regimen) Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 Cmax is maximum plasma concentration of paclitaxel. The LLQ of paclitaxel was 10.0 ng/mL.
Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Carboplatin (Total and Free) Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2 Cmax is maximum plasma concentration of carboplatin. The LLQ of carboplatin was 100.0 ng/mL.
Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Carboplatin (Total and Free) Pre-dose (0 hour), 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2 AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose.
Functional Assessment of Ovarian Symptom Index- 18 (FOSI-18) Score CP: Pre-dose on Day 1 of Cycles 2 to 6 (1 cycle= 21 days); MP/OP: Day 1 of Cycles 1 to 12 (1 cycle= 42 days), End of treatment (any time up to Month 27) National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) Ovarian Symptom Index-18 (FOSI-18) is an 18-itemed participant completed questionnaire, designed to assess impact of cancer therapy on ovarian cancer-related symptoms. Based on numerical point scoring of symptoms. Includes three subscales: disease-related symptoms (10 items), treatment-related side effects (5) and general function/well-being (3). Participants rated their level of symptoms for each items using 5-point scale from 0=not at all to 4=very much. Items that were negatively framed, scores were reversed for analysis so that higher scores= good quality of life. Total symptom index: total of 18 scores, ranging from 0=severely symptomatic to 72=asymptomatic. Higher FOSI-18 scores= better functioning or lower symptom burden. MP applicable only for arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab' and OP for 'Chemotherapy followed by Observation'.
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Score Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 36 months) EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). In VAS, participants rated their overall health status from 0 (worst imaginable) to 100 (best imaginable). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Published weights are available that allow for the creation of a single summary score. 57 overall scores ranged from 0 to 1, with low scores representing a higher level of dysfunction.
Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once a Week [QW] Regimen) Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 Cmax is maximum plasma concentration of paclitaxel. The LLQ of paclitaxel was 10.0 ng/mL.
Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Paclitaxel (Q3W Regimen) Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Carboplatin (Total and Free) Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2 AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (QW Regimen) Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (Q3W Regimen) Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
Maintenance Phase: Predose Plasma Concentration (Ctrough) of Avelumab Pre-dose (0 hour) on Day 1 of Cycle 2 Ctrough is the concentration at the end of the dosing interval when avelumab was given as a Q2W regimen in the absence of carboplatin and paclitaxel following 1 cycle of avelumab dosing, i.e. before administration of drug on Day 1 of cycle 2. Ctrough of Avelumab in the absence of chemotherapy (i.e. in the maintenance phase) has been reported. The LLQ of avelumab was 0.20 micro-gram per milliliter (mcg/mL). Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab" (since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
Maintenance Phase: Maximum Plasma Concentration (Cmax) of Avelumab End of avelumab infusion on Day 1 of Cycle 2 Cmax is the concentration at the end of a 1 hour infusion, corresponding to the maximum plasma concentration of avelumab. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab"(since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Avelumab When Given With Paclitaxel and Carboplatin End of infusion on Day 1 of Cycle 2 Cmax is the concentration at the end of a 1 hour infusion, corresponding to the maximum plasma concentration of avelumab. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy followed by Avelumab" (data not available for this OM as avelumab was not given along with paclitaxel and carboplatin in this arm) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC) Up to 36 months PD-L1 assessment was performed using immunohistochemistry. Participants were considered positive if their pretreatment tumor tissue sample demonstrated cell surface PD-L1 expression greater than or equal to (\>=) 1 percent (%) tumor cells or \>= 5% immune cells and were otherwise considered negative.
Chemotherapy Phase: Predose Plasma Concentration (Ctrough) of Avelumab When Given With Paclitaxel and Carboplatin Pre-dose (0 hour) on Day 1 of Cycle 2 Ctrough is the concentration at the end of the dosing interval when avelumab was given as a Q2W regimen in the absence of carboplatin and paclitaxel following 1 cycle of avelumab dosing, i.e. before administration of drug on Day 1 of cycle 2. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy followed by Avelumab" (data not available for this OM as avelumab was not given along with paclitaxel and carboplatin in this arm) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status Up to 36 months ADA against avelumab in serum samples was determined and reported separately for ADA never-positive and ADA ever-positive participants. Participants were considered ADA ever-positive if they had at least one positive (ADA titer greater than or equal to 60 with assay cut point of 1.12) ADA result at any time point during 36 months and were otherwise considered negative. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Chemotherapy followed by Observation", since, avelumab was not administered in this arm.
Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status Up to 36 months nAb against avelumab in serum samples was determined and reported separately for nAb never-positive and nAb ever-positive participants. Participants were considered nAb ever-positive if they had at least one positive nAb results (less than or equal to cut point of 0.710 in qualitative competitive ligand binding assay) at any time point during 36 months. nAb never-positive participants were those who had at least one negative nAb results (greater than cut point of 0.710 in qualitative competitive ligand binding assay) at any time point. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Chemotherapy followed by Observation", since, avelumab was not administered in this arm.
Number of Participants With Positive Tumor-Infiltrating Cluster of Differentiation 8 (CD8+) T Lymphocytes Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC) Up to 36 months CD8 assessment was performed using immunohistochemistry. Participants were considered positive if their pre-treatment tumor tissue sample demonstrated \>= 1% CD8 positive cells and were otherwise considered negative.
Trial Locations
- Locations (276)
Investigational Drug Service, Emory University Clinic
🇺🇸Atlanta, Georgia, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
University Hospital, The Cancer Center
🇺🇸Newark, New Jersey, United States
Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center
🇺🇸Springfield, Missouri, United States
University Hospital, Ambulatory Care Center
🇺🇸Newark, New Jersey, United States
University Hospital, Investigational Drug Pharmacy
🇺🇸Newark, New Jersey, United States
University Hospital
🇺🇸Newark, New Jersey, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Asante Rogue Regional Medical Center
🇺🇸Medford, Oregon, United States
OSU Wexner Medical Center, Arthur G. James Cancer Hospital & Solove Research Institute
🇺🇸Columbus, Ohio, United States
OSU Wexner Medical Center, Investigational Drug Services
🇺🇸Columbus, Ohio, United States
OSU Wexner Medical Center, Stefanie Spielman Comprehensive Breast Center
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center Attn: Nisha Sharma
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Institute Attn: Vasilika Koci, PharmD
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Miami Hospital and Clinics
🇺🇸Miami, Florida, United States
California Pacific Medical Center - Medical Office Building
🇺🇸San Francisco, California, United States
California Pacific Medical Center - Davies Campus
🇺🇸San Francisco, California, United States
Bryan Hemming Cancer Care Center - California Pacific Medical Center
🇺🇸San Francisco, California, United States
California Pacific Medical Center-Pacific Campus
🇺🇸San Francisco, California, United States
California Pacific Medical Center-Research Institute
🇺🇸San Francisco, California, United States
East Kent Hospitals University NHS Foundation Trust
🇬🇧Margate, Kent, United Kingdom
St James's Hospital
🇮🇪Dublin 8, Ireland
Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Onkologiai Kozpont
🇭🇺Szolnok, Hungary
Bon Secours Hospital
🇮🇪Cork, Ireland
Arizona Oncology Associates, PC - HAL
🇺🇸Tempe, Arizona, United States
Tartu University Hospital, Hematology and Oncology Clinic
🇪🇪Tartu, Estonia
Rocky Mountain Cancer Centers
🇺🇸Lakewood, Colorado, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Gynecologic Oncology Associates
🇺🇸Newport Beach, California, United States
Johns Hopkins Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hyogo Cancer Center
🇯🇵Akashi, Hyogo, Japan
University of Tsukuba Hospital
🇯🇵Tsukuba, Ibaraki, Japan
Tohoku University Hospital
🇯🇵Sendai, Miyagi, Japan
Wojewodzki Szpital Specjalistyczny w Olsztynie
🇵🇱Olsztyn, Poland
SBHI Saint-Petersburg Clinical Scientific - Practice Center of Specialized Types of Medical Care
🇷🇺Saint Petersburg, Russian Federation
Summit Medical Group PA
🇺🇸Florham Park, New Jersey, United States
Pharmacy Department, St James's Hospital
🇮🇪Dublin 8, Ireland
Shizuoka Cancer Center
🇯🇵Sunto-gun, Shizuoka, Japan
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
Instituto Nacional de Cancerologia
🇲🇽Mexico, Distrito Federal, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
🇲🇽Monterrey, Nuevo LEON, Mexico
Limited liability company (LLC) EVIMED
🇷🇺Chelyabinsk, Chelyabinsk Region, Russian Federation
Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie, Apteka Szpitalna
🇵🇱Krakow, Poland
State Budgetary Healthcare Institution
🇷🇺Chelyabinsk, Chelyabinsk Region, Russian Federation
Limited liability company VitaMed-LLC VitaMed
🇷🇺Moscow, Russian Federation
Oncology Institute of Southern Switzerland (IOSI)
🇨🇭Bellinzona, Ticino, Switzerland
Ospedale San Giovanni
🇨🇭Bellinzona, Ticino, Switzerland
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Clinical Trial Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center
🇨🇳Taipei City, Taiwan
Chang Gung Memorial Hospital - Linkou Branch
🇨🇳Taoyuan City, Taiwan
Municipal Institution Kryviy Rih Oncology Center of Dnipropetrovsk regional Council
🇺🇦Kryviy Rig, Ukraine
Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
🇵🇱Opole, Poland
National University Hospital, Pharmacy @ NCIS
🇸🇬Singapore, Singapore
Kantonsspital Winterthur
🇨🇭Winterthur, Zurich, Switzerland
Mackay Memorial Hospital
🇨🇳Taipei City, Taiwan
The Royal Marsden NHS Foundation Trust
🇬🇧Sutton, Surrey, United Kingdom
SAHI "Republican Clinical Oncology Dispensary of the MoH of TR"
🇷🇺Kazan, Tatarstan Republic, Russian Federation
Raffles Hospital
🇸🇬Singapore, Singapore
Cl Dnipropetrovsk City Multifield Clinical Hospital
🇺🇦Dnipropetrovsk, Ukraine
Oso HomeCare
🇺🇸Irvine, California, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
🇺🇸Los Angeles, California, United States
Arizona Oncology Associates, PC-HOPE
🇺🇸Tucson, Arizona, United States
Highlands Oncology Group
🇺🇸Rogers, Arkansas, United States
California Pacific Medical Center - Pacific Heights Outpatient Pharmacy
🇺🇸San Francisco, California, United States
Hematology-Oncology Medical Group of Orange County
🇺🇸Orange, California, United States
St. Joseph Hospital of Orange
🇺🇸Orange, California, United States
California Pacific Medical Center - Van Ness Campus
🇺🇸San Francisco, California, United States
UC Irvine Health
🇺🇸Orange, California, United States
Maryland Oncology Hematology
🇺🇸Wheaton, Maryland, United States
Holy Cross Hospital, Pharmacy
🇺🇸Silver Spring, Maryland, United States
Medical Oncology Care Associates
🇺🇸Orange, California, United States
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
🇺🇸Orange, California, United States
SKCCC at Johns Hopkins, Green Spring Station
🇺🇸Lutherville, Maryland, United States
UHEALTH Deerfield Beach
🇺🇸Deerfield Beach, Florida, United States
Holy Cross Resource Center
🇺🇸Silver Spring, Maryland, United States
NYU Winthrop Hospital, Infusion Center
🇺🇸Mineola, New York, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Mercy Ministry Office
🇺🇸Chesterfield, Missouri, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Holy Cross Hospital
🇺🇸Silver Spring, Maryland, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
NYU Winthrop Hospital, Clinical Trials Center
🇺🇸Mineola, New York, United States
Mercy - Women's Oncology
🇺🇸Springfield, Missouri, United States
ProHealth Radiology
🇺🇸Huntington, New York, United States
Summit Medical Group
🇺🇸Berkeley Heights, New Jersey, United States
Medical Arts Radiology
🇺🇸Huntington, New York, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Oncology Hematology Care, Inc.
🇺🇸Fairfield, Ohio, United States
OSU Wexner Medical Center, Gynecologic Oncology at Mill Run
🇺🇸Hilliard, Ohio, United States
Hematology Oncology Associates
🇺🇸Medford, Oregon, United States
Magee-Women's Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Tennessee Oncology, PLLC
🇺🇸Smyrna, Tennessee, United States
Parkland Health and Hospital System
🇺🇸Dallas, Texas, United States
The Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
US Oncology Investigational Products Center (IPC)
🇺🇸Irving, Texas, United States
Emily Couric Cancer Center
🇺🇸Charlottesville, Virginia, United States
Utah Cancer Specialists
🇺🇸West Jordan, Utah, United States
Texas Oncology - San Antonio Medical Center
🇺🇸San Antonio, Texas, United States
East Tallinn Central Hospital
🇪🇪Tallinn, Estonia
US Oncology Investigational Products Center
🇺🇸Irving, Texas, United States
MHAT for Female Health-Nadezhda OOD
🇧🇬Sofia, Bulgaria
Oncology Pharmacy McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Klinicki bolnicki centar Split
🇭🇷Split, Croatia
North Estonia Medical Centre Foundation, Pharmacy
🇪🇪Tallinn, Estonia
North Estonia Medical Centre Foundation
🇪🇪Tallinn, Estonia
Zentralapotheke Zytostatika
🇩🇪Chemnitz, Germany
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Shato Ead
🇧🇬Sofia, Bulgaria
East-Tallinn Central Hospital, Center of Oncology
🇪🇪Tallinn, Estonia
Radiologie Muenchen
🇩🇪Muenchen, Germany
Johannes Apotheke Klinikversorgung
🇩🇪Groebenzell, Germany
Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Germany
McGill University Health Centre-Glen Site
🇨🇦Montreal, Quebec, Canada
Klinicki bolnicki centar Sestre milosrdnice
🇭🇷Zagreb, Croatia
CHU de Quebec-Universite Laval
🇨🇦Quebec, Canada
Radiologie Uniklinik Koeln
🇩🇪Koeln, Germany
Klinikum Ernst von Bergmann gGmbH
🇩🇪Potsdam, Germany
Queen Elizabeth Hospital
🇭🇰Hong Kong, Hong Kong
The University of Hong Kong
🇭🇰Hong Kong, Hong Kong
Uniklinik Koeln Apotheke
🇩🇪Koeln, Germany
Uniklinik Koeln Klinik fuer Frauenheilkunde und Geburtshilfe
🇩🇪Koeln, Germany
Universitaetsklinikum Wuerzburg Frauenklinik und Poliklinik
🇩🇪Wuerzburg, Germany
Diagnostische und Interventionelle Radiologie
🇩🇪Potsdam, Germany
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland
Semmelweis Egyetem Onkologiai Kozpont
🇭🇺Budapest, Hungary
Bon Secours Hospital Ireland
🇮🇪Cork, Ireland
The Jikei University Kashiwa Hospital
🇯🇵Kashiwa-shi, Chiba, Japan
Shikoku Cancer Center
🇯🇵Matsuyama, Ehime, Japan
Ehime University Hospital
🇯🇵Toon, Ehime, Japan
Tokai University Hospital
🇯🇵Isehara, Kanagawa, Japan
National Defense Medical College Hospital
🇯🇵Tokorozawa, Saitama, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata, Japan
CHA Bundang Medical Center, CHA University, Clinical Trial Pharmacy
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of
Kyoto University Hospital
🇯🇵Sakyo-ku, Kyoto, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka, Saitama, Japan
The Jikei University Hospital
🇯🇵Minato-ku, Tokyo, Japan
Center for Uterine Cancer, National Cancer Center
🇰🇷Goyang-Si, Gyeonggi-do, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
CTC Cancer Pharmacy, Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital, Clinical Trial Pharmacy
🇰🇷Seoul, Korea, Republic of
Daugavpils Regional Hospital, Oncology Department (11 floor)
🇱🇻Daugavpils, Latvia
Natalja Goncarova -Radiology Services
🇱🇻Daugavpils, Latvia
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Clinical Trial Pharmacy, Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Daugavpils Regional Hospital
🇱🇻Daugavpils, Latvia
Medical Society "ARS" Ltd
🇱🇻Riga, Latvia
Maastricht Universitair Medisch Centrum
🇳🇱Maastricht, Netherlands
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Inga Vigule-Radiology services
🇱🇻Liepaja, Latvia
Pharmacy Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
LUMC
🇳🇱Leiden, Netherlands
Liepaja Regional hospital
🇱🇻Liepaja, Latvia
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Pharmacy Zuyderland Medisch Centrum
🇳🇱Sittard-Geleen, Netherlands
Zuyderland Medisch Centrum
🇳🇱Sittard-Geleen, Netherlands
Szpitale Pomorskie Sp. z.o.o., Apteka Szpitalna
🇵🇱Gdynia, Poland
Centrum Onkologii, Instytut im.M.Sklodowskiej-Curie, Oddzial w Krakowie
🇵🇱Krakow, Poland
Wojewodzki Szpital Specjalistyczny w Olsztynie. Apteka Szpitalna
🇵🇱Olsztyn, Poland
SC Oncolab SRL
🇷🇴Craiova, Dolj, Romania
SC Centrul de Oncologie Euroclinic SRL
🇷🇴Iasi, Romania
Szpitale Pomorskie, Sp. z o. o., Oddzial Onkologii i Radioterapii
🇵🇱Gdynia, Poland
Ginekologiczno - Polozniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego w
🇵🇱Poznan, Poland
SBHI Orenburg Regional Clinical Oncology Dispensary (SBHI ORCOD)
🇷🇺Orenburg, Orenburg Region, Russian Federation
SBHI Moscow Clinical Scientific and Practical Centre of Moscow City Healthcare Department
🇷🇺Moscow, Russian Federation
Regional Budgetary Healthcare Institution (RBHI) Ivanovo Regional Oncology Dispensary
🇷🇺Ivanovo, Ivanovo Region, Russian Federation
Radiologia ORBV
🇨🇭Bellinzona, Ticino, Switzerland
National University Hospital
🇸🇬Singapore, Singapore
Onkologicky ustav sv. Alzbety a.s.
🇸🇰Bratislava, Slovakia
FSBI National Research Medical Center of Oncology N.A.
🇷🇺Moscow, Russian Federation
FSBI - NMRRC Minzdrav Russia at the branch A.F.Tsyb Medical Radiological Research Centre
🇷🇺Obninsk, Kaluga Region, Russian Federation
NsP sv. Jakuba, n.o. , Bardejov
🇸🇰Bardejov, Slovakia
Vychodoslovensky onkologicky ustav, a.s.
🇸🇰Kosice, Slovakia
POKO Poprad s.r.o.
🇸🇰Poprad, Slovakia
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
Cathay General Hospital
🇨🇳Taipei City, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Clinical Trial Pharmacy, MacKay Memorial Hospital
🇨🇳Taipei city, Taiwan
Chemotherapy Pharmacy, Chang Gung Memorial Hospital - Linkou Branch
🇨🇳Taoyuan City, Taiwan
Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty
🇹🇷Istanbul, Turkey
Clinic of National Cancer Institute
🇺🇦Kyiv, Ukraine
Guy's & St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom
Central Municipal Clinical Hospital, Municipal oncology center, therapeutics department
🇺🇦Uzhhorod, Ukraine
Royal Surrey County Hospital NHS Foundation Trust
🇬🇧Guildford, Surrey, United Kingdom
Istituto Nazionale Tumori Napoli IRCCS Fondazione Pascale
🇮🇹Napoli, Italy
Dip.to per la Tutela della Salute della Donna, della Vita Nascente, del Bambino e dell'Adolescente
🇮🇹Roma, Italy
The Clatterbridge Cancer Centre NHS Foundation Trust
🇬🇧Wirral, Merseyside, United Kingdom
University College London Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Clinical Trial Pharmacy, National Cancer Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center, Clinical Research Pharmacy
🇰🇷Seoul, Korea, Republic of
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Medical Center, Cedars-Sinai
🇺🇸Los Angeles, California, United States
University of California, Irvine/UC Irvine Health
🇺🇸Orange, California, United States
Palo Alto Medical Foundation Group
🇺🇸San Francisco, California, United States
Sansum Clinic
🇺🇸Solvang, California, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
Asante Pharmacy
🇺🇸Medford, Oregon, United States
University of Pittsburgh Cancer Institute Investigational Drug Service
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
UT Southwestern Medical Center-Clements University Hospital
🇺🇸Dallas, Texas, United States
Texas Oncology Bedford
🇺🇸Bedford, Texas, United States
UT Southwestern Medical Center-Zale Lipshy University Hospital
🇺🇸Dallas, Texas, United States
Texas Oncology - Fort Worth Cancer Center
🇺🇸Fort Worth, Texas, United States
NYU Winthrop Hospital, Gynecologic Oncology
🇺🇸Mineola, New York, United States
NYU Winthrop Radiology
🇺🇸Mineola, New York, United States
Clinic
🇷🇺Moscow, Russian Federation
Clinical Trial Pharmacy, Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Massachusetts General Hospital Attn: Svetlana Rashkova, RPh
🇺🇸Boston, Massachusetts, United States
NYU Winthrop Hospital, Research Pharmacy
🇺🇸Mineola, New York, United States
Frauenklinik am Rotkreuzklinikum Muenchen
🇩🇪Muenchen, Germany
Debreceni Egyetem Klinikai Kozpont, Szuleszeti es Nogyogyaszati Klinika
🇭🇺Debrecen, Hungary
Debreceni Egyetem Klinikai Gyogyszertar
🇭🇺Debrecen, Hungary
Mater Private Hospital
🇮🇪Dublin, Ireland
Azienda Ospedaliero -Universitaria di Bologna Policlinico S. Orsola - Malpighi
🇮🇹Bologna, BO, Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola - Malpighi
🇮🇹Bologna, BO, Italy
E.O. Ospedali Galliera
🇮🇹Genova, GE, Italy
Farmacia Galliera
🇮🇹Genova, GE, Italy
Istituto Europeo di Oncologia
🇮🇹Milano, MI, Italy
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, MI, Italy
Azienda Socio Sanitaria Territoriale ASST della Valtellina e dell Alto Lario
🇮🇹Sondrio, SO, Italy
Istanbul University Oncology Institute
🇹🇷Istanbul, Turkey
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
SC Medisprof SRL
🇷🇴Cluj Napoca, Cluj, Romania
Narodny onkologicky ustav
🇸🇰Bratislava, Slovakia
Koo Foundation Sun Yat-Sen Cancer Center
🇨🇳Taipei City, Taiwan
Clinical Trial Pharmacy, Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Bezmialem Vakif University Medical Faculty Hospital
🇹🇷Istanbul, Turkey
Baskent University Ankara Hospital, Department of Oncology
🇹🇷Ankara, Turkey
Baskent University Adana Training and Research Hospital
🇹🇷Adana, Turkey
Communal Institution Chernivtsi Regional Clinical Oncology Dispensary
🇺🇦Chernivtsi, Ukraine
Ege University Faculty of Medicine Hospital
🇹🇷Izmir, Turkey
CNE of Lviv Regional Council "Lviv Oncological Regional Therapeutical and Diagnostic Centre"
🇺🇦Lviv, Ukraine
Torbay and South Devon NHS Foundation Trust
🇬🇧Torquay, Devon, United Kingdom
East and North Hertfordshire NHS Trust
🇬🇧Northwood, Middlesex, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Headington, Oxford, United Kingdom
Royal Marsden NHS Foundation Trust
🇬🇧London, United Kingdom
University Hospitals Bristol NHS Foundation trust
🇬🇧Bristol, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Baxter Healthcare
🇬🇧Stockport, United Kingdom
The Christie Hospital NHS Foundation Trust
🇬🇧Manchester, United Kingdom
University College London Hospital
🇬🇧London, United Kingdom
Alabama Oncology
🇺🇸Birmingham, Alabama, United States
Alabama Oncology, Bruno Cancer Center
🇺🇸Birmingham, Alabama, United States
Rcca Md Llc
🇺🇸Germantown, Maryland, United States
Women's Health Specialists of Montgomery County
🇺🇸Rockville, Maryland, United States
C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven
🇺🇸New Haven, Connecticut, United States
Smilow Cancer Hospital at Yale-New Haven
🇺🇸New Haven, Connecticut, United States
Orlando Health Gynecological Cancer Center
🇺🇸Orlando, Florida, United States
Orlando Health UF Health Cancer Center
🇺🇸Orlando, Florida, United States
Orlando Health, Inc.
🇺🇸Orlando, Florida, United States
Orlando Health, Inc
🇺🇸Orlando, Florida, United States
Texas Oncology-Austin Central
🇺🇸Austin, Texas, United States
Texas Oncology - South Austin
🇺🇸Austin, Texas, United States
Montefiore - Einstein Center for Cancer Care
🇺🇸Bronx, New York, United States
Montefiore Medical Center, Centennial Women's Center
🇺🇸Bronx, New York, United States
Willamette Valley Cancer Institute and Research Center
🇺🇸Eugene, Oregon, United States
Asante Three Rivers Medical Center
🇺🇸Grants Pass, Oregon, United States
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Montefiore Medical Center
🇺🇸Bronx, New York, United States