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| ID | Type | Description | Link |
|---|---|---|---|
| B9991023 | Other Identifier | Pfizer | |
| 2017-001741-27 | EudraCT Number | ||
| JAVELIN CHEMOTHERAPY MEDLEY | Other Identifier | Alias Study Number |
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The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the investigational treatments have been moved to a continuation study (NCT05059522).
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This is a Phase 1b/2, open label, multicenter, safety and clinical activity study of avelumab in combination with chemotherapy as first-line treatment of adult patients with locally advanced or metastatic solid tumors. Initially, avelumab will be evaluated in combination with pemetrexed and carboplatin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) (Cohort A1) and in combination with gemcitabine and cisplatin in patients with cisplatin-eligible urothelial (bladder) cancer (UC) (Cohort A2). As more information is learned about other anti-cancer immunotherapy agents, in future portions of the study, avelumab may be combined with chemotherapy and other anti-cancer immunotherapy agents in patients with these same or different tumor types.
This is a Phase 1b/2, open label, multicenter, safety, clinical activity, pharmacokinetic (PK), and pharmacodynamics (PD) study of avelumab in combination with chemotherapy with or without other anti-cancer immunotherapies, as first-line treatment of adult patients with locally advanced or metastatic solid tumors. Initially, avelumab will be evaluated in combination with pemetrexed and carboplatin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) (Cohort A1) and with gemcitabine and cisplatin in patients with cisplatin-eligible urothelial cancer (UC) (Cohort A2).
Given the growing preclinical and clinical indications that combinations of anti-cancer immunotherapies potentially improve patient outcomes compared to results seen with single agents, in portions of the study to be added in the future, avelumab will be evaluated in combination with both standard-of-care chemotherapy and other anti-cancer immunotherapies in patients with advanced malignancies. Each cohort in the study will consist of a Phase 1b lead-in portion to evaluate safety and a Phase 2 cohort expansion to evaluate safety and efficacy.
In the Phase 1b safety lead-in portion, up to 12 patients will be enrolled into each cohort and evaluated for dose-limiting toxicities (DLT) during the first 2 cycles of treatment. If investigational products administration in a cohort is deemed safe in the Phase 1b lead-in, enrollment may be expanded into the Phase 2 cohort expansion. Up to approximately 40 patients in each cohort (including those enrolled in the Phase 1b lead-in and those enrolled in the Phase 2 cohort expansion) will be enrolled and treated with avelumab plus chemotherapy in the initial portion of the study and, in future portions of the study, with avelumab plus chemotherapy with or without other anti-cancer immunotherapies.
In the Phase 1b lead-in portions of NSCLC Cohort A1 and UC Cohort A2, avelumab is dosed at 800 mg fixed dose every 3 weeks. Under Protocol Amendment 4, avelumab is dosed at 1200 mg fixed dose every 3 weeks in the Phase 1b lead-in portions of NSCLC Cohort A3 and in UC Cohort A4, in combination with the same standard-of-care chemotherapy doublets used in Cohort A1 and Cohort A2, respectively. For each tumor type, the study treatment combination with the highest avelumab dose determined to be safe may be advanced into Phase 2 cohort expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A Cohort A1 | Experimental | Non-squamous non-small cell lung cancer (NSCLC) patients treated with 800 mg avelumab plus pemetrexed/carboplatin |
|
| Group A Cohort A2 | Experimental | Cisplatin-eligible urothelial cancer (UC)patients treated with 800 mg avelumab plus gemcitabine/cisplatin |
|
| Group A Cohort A3 | Experimental | Non-squamous non-small cell lung cancer (NSCLC) patients treated with 1200 mg avelumab plus pemetrexed/carboplatin |
|
| Group A Cohort A4 | Experimental | Cisplatin-eligible urothelial cancer (UC) patients treated with 1200 mg avelumab plus gemcitabine/cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelumab 800 mg in combination with pemetrexed / carboplatin | Drug | Avelumab Pemetrexed Carboplatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b Lead-in: Number of Participants With Dose-Limiting Toxicities (DLT) | DLTs=occurrence of any AEs attributable to study treatment in first 2 treatment cycles:Hematologic: grade(G)4 neutropenia lasting >7days;febrile neutropenia with body temperature >=38 degree Celsius for >1hour; G>=3 neutropenic infection(absolute neutrophil count <1.0*10^9/L),G>=3 thrombocytopenia (platelet count<50.0-25.0*10^9/L)with bleeding;G4 thrombocytopenia(PC<25.0*10^9/L),G4 anemia(life-threatening).Non-hematologic: any G4 toxicities;G3 toxicities persisting for >3days despite medical treatment(nausea,vomiting,diarrhea)except endocrinopathies controlled with hormonal therapy;ALT/AST >3*upper limit of normal(ULN)if normal at baseline or 2*Baseline(>ULN at baseline)with total bilirubin >2*ULN and alkaline phosphatase <2*ULN;G3 QTcF prolongation after correction of any reversible cause(electrolyte abnormalities/hypoxia).Delay of >=3weeks in scheduled administration/failure to deliver 75% of doses due to toxicities attributable to any study treatment. DLT-evaluable analysis set. | Day 1 up to Week 6 (first 2 treatment cycles; 1 cycle = 21 days) |
| Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment | OR: complete response(CR) or partial response(PR)determined by investigator according to RECIST v1.1 from date of first dose of study treatment until date of first documentation of progressive disease(PD),confirmed by repeat assessments performed no less than 4 weeks after first response. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures less than (<)10 millimeter(mm). PR: >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD. | From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 3.5 years approximately) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of Avelumab | The lower limit of quantification (LLOQ) for avelumab was 0.2 micrograms per milliliter. Pharmacokinetic concentration analysis set was subset of safety analysis set and included participants who had at least one concentration measurement for avelumab or other study drugs which they were assigned to receive. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan. |
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Inclusion Criteria:
Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumor that is not amenable for treatment with curative intent as follows:
ECOG performance status 0 or 1
Estimated life expectancy of at least 90 days
Adequate bone marrow, renal, and liver function
Negative serum pregnancy test at screening
Signed and dated informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center - North Campus | Tucson | Arizona | 85719 | United States | ||
| Banner-University Medical Center Tucson |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38669053 | Derived | Wheatley DA, Berardi R, Climent Duran MA, Tomiak A, Greystoke AP, Joshua AM, Arkenau HT, Geczi L, Corbacho JG, Paz-Ares LG, Hussain SA, Petruzelka L, Delmonte A, Chappey C, Masters JC, Michelon E, Murphy DA, Mwewa S, Cesari R, Doger de Speville B. First-line Avelumab plus Chemotherapy in Patients with Advanced Solid Tumors: Results from the Phase Ib/II JAVELIN Chemotherapy Medley Study. Cancer Res Commun. 2024 Jun 28;4(6):1609-1619. doi: 10.1158/2767-9764.CRC-23-0459. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Phase 1b lead-in:49 participants signed inform consent form(ICF).18 participants did not meet eligibility criteria and not enrolled,31 participants enrolled and assigned to treatment. Phase 2:52 participants signed ICF.16 participants did not meet eligibility criteria and not enrolled,36 participants enrolled,1 was not assigned to treatment and 35 assigned to treatment.
The study was conducted in 2 phases: Phase 1b (lead-in phase) and Phase 2 (cohort expansion phase). Phase 2 was conducted at the highest dose level of avelumab which was determined safe for participants in Phase 1b.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin | Participants with advanced non-squamous non-small cell lung cancer (NSCLC) received avelumab 800 milligrams (mg) as an intravenous (IV) infusion over 1 hour every 3 weeks (Q3W) in combination with IV infusion of pemetrexed 500 milligram per square meter (mg/m^2) and carboplatin dose at area under curve (AUC) 5 (carboplatin dose [mg] = target AUC * glomerular filtration rate[GFR] milliliter per minute [mL/min] + 25, and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1b Lead-in: Treatment |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 2, 2018 | May 26, 2022 |
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| Avelumab 800 mg in combination with gemcitabine / cisplatin. | Drug | Avelumab Gemcitabine Cisplatin |
|
| Avelumab 1200 mg in combination with pemetrexed/carboplatin | Drug | Avelumab Pemetrexed Carboplatin |
|
| Avelumab 1200 mg in combination with gemcitabine/cisplatin | Drug | Avelumab Gemcitabine Cisplatin |
|
| Pre-dose, 1 hour post-dose on Day 1 of Cycle 1, 2, 3, 6, 10, 14; 336 hours post-dose on Day 15 of Cycle 1, 2, 3 (each cycle of 21 days) |
| Absolute Value of Tumor Mutational Burden (TMB) in Tumor Tissue | Mutational load within tumor tissue was defined as number per megabase of the genome, coding, base substitution, and indel mutations present in the sample. Mutational load was determined in whole blood samples using next generation deoxyribonucleic acid (DNA) sequencing followed by computational analysis. | Pre-dose on Day 1 of Cycle 1 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Adverse event (AE) was any untoward medical occurrence in a participants who received any study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. | From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5 years approximately) |
| Number of Participants With Treatment Related TEAEs | A treatment related AE included AEs related to at least one study drug in the combination. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. Relatedness to study drug was assessed by the investigator. | From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5 years approximately) |
| Number of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v 4.03 | AE was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. TEAEs were graded by the investigator using NCI CTCAE v 4.03 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. In this outcome measure, number of participants with grade 3 or higher TEAEs were reported. | From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5 years approximately) |
| Number of Participants With Grade 3 or Higher Laboratory Abnormalities by CTCAE Grade | Participants with laboratory abnormalities of any Grade as per NCI CTCAE toxicity grading v4.03 were summarized:hematology(anemia,hemoglobin increased,lymphocyte count decreased,lymphocyte count increased, neutrophil count decreased,platelet count decreased and white blood cell decreased)and clinical chemistry(alanine aminotransferase increased,alkaline phosphatase,increased,aspartate,aminotransferase increased,blood bilirubin increased,cholesterol high,creatinine phosphokinase[cpk] increased,creatinine increased,gamma-glutamyl transferase[ggt] increased,hypercalcemia,hyperglycemia,hyperkalemia, hypermagnesemia,hypernatremia,hypertriglyceridemia,hypoalbuminemia,hypocalcemia,hypoglycemia,hypokalemia,hypomagnesemia,hyponatremia, hypophosphatemia,serum amylase increased and lipase increased).As per NCI CTCAE toxicity grading v4.03, Grade1=mild;Grade2=moderate;Grade3=severe;Grade4=life-threatening;Grade 5=death.Parameters with at least 1 participant with abnormal value are reported. | From screening up to 90 days after last dose of study drug (maximum up to 5 years approximately) |
| Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies for Avelumab | Blood samples were collected for assessment of avelumab ADAs using a tiered assay and confirmed positive samples were tested for neutralizing antibodies (nAb). | From first dose of study drug up to last dose of study drug (maximum up to 5 years approximately) |
| Progression Free Survival (PFS) as Per RECIST v 1.1 by Investigator Assessment | PFS was defined as the time from the date of first dose of study treatment to the date of the first documentation of PD per RECIST v1.1 or death due to any cause, whichever occurred first. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD. The median duration of PFS was not derived for less than (<) 10 participants. | From start of treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 5 years approximately) |
| Overall Survival (OS) | OS was defined as the time from the first dose of study treatment to the date of death due to any cause. Participants last known to be alive were censored at the date of last contact. The median duration of OS was not derived for less than (<) 10 participants. | From first dose of study treatment until death due to any cause (maximum up to 5 years approximately) |
| Duration of Response (DOR) as Per RECIST v 1.1 by Investigator Assessment | DOR was defined as time from first documentation of objective response (confirmed CR or PR) to the date of first PD documentation or death due to any cause, whichever occurs first. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures less than (<)10 millimeter(mm). PR: >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD. Median DOR was not derived for < 5 participants. | From date of first documented response to date of first documented PD or death due to any cause, whichever occurred first (maximum up to 5 years approximately) |
| Time-to-Tumor Response (TTR) as Per RECIST v 1.1 by Investigator Assessment | TTR was defined as the time from the date of first dose of study treatment to the first documentation of objective response (CR or PR) as assessed by investigator according to RECIST v 1.1. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures less than (<)10 millimeter(mm). PR: >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. | From first dose of study treatment until first documentation of CR or PR (maximum up to 5 years approximately) |
| Number of Participants With Programmed Death-Ligand 1 (PD-L1) Expression | PD-L1 expression was determined using the Ventana PD-L1 SP263 IHC assay. PD-L1-positive status in UC cohorts was defined using an algorithm that combines assessments of PD-L1 staining on tumor and immune cells scored by pathologists and in NSCLC cohorts was defined as PD-L1 expression on >=1% of tumor cells. PD-L1 expression at baseline and on-treatment were reported in this outcome measure. | Baseline and Cycle 2 Day 8 (each cycle of 21 days) |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Stony Brook Cancer Center | Stony Brook | New York | 11794 | United States |
| Stony Brook University | Stony Brook | New York | 11794 | United States |
| Montefiore Medical Center - Einstein Center for Cancer Care | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center - Moses Division | The Bronx | New York | 10467 | United States |
| Duke University Medical Center/Duke Cancer Center | Durham | North Carolina | 27710 | United States |
| Investigational Chemotherapy Service | Durham | North Carolina | 27710 | United States |
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| St Vincent's Public Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| Western Health, Sunshine Hospital | St Albans | Victoria | 3021 | Australia |
| Kingston Health Sciences Centre - | Kingston | Ontario | K7L 2V7 | Canada |
| Fakultni nemocnice Olomouc, Klinika nuklearni mediciny | Olomouc | 779 00 | Czechia |
| Fakultni nemocnice Olomouc, Ustav klinicke a molekularni patologie | Olomouc | 779 00 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 779 00 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 120 00 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 00 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 21 | Czechia |
| Thomayerova nemocnice | Prague | 140 59 | Czechia |
| Thomayerova nemocnice | Prague | 14059 | Czechia |
| Centrum nuklearni mediciny s.r.o. | Prague | 180 81 | Czechia |
| Centrum nuklearni mediciny s.r.o. | Prague | 190 61 | Czechia |
| Orszagos Onkologiai Intezet "C" Belgyogyaszati - Onkologiai es Klinikai Farmakologiai Osztaly | Budapest | 1122 | Hungary |
| AOU Ospedali Riuniti di Ancona Umberto I - GM Lancisi - G Salesi | Torrette Di Ancona | AN | 60126 | Italy |
| IRCCS Istit.Scient.Romagnolo per lo Studio e la Cura dei Tumori | Meldola | FC | 47014 | Italy |
| Centro di Ricerca di Fase 1, ASST Monza-Ospedale San Gerardo | Monza | MB | 20900 | Italy |
| Oncologia, ASST Monza-Ospedale San Gerardo | Monza | MB | 20900 | Italy |
| Istituto Europeo di Oncologia (IEO) | Milan | MI | 20141 | Italy |
| Istituto Nazionale Tumori di Napoli IRCCS Fondazione Pascale | Naples | 80131 | Italy |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic I Provincial | Barcelona | 08036 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Fundacion Instituto Valenciano de Oncologia | Valencia | 46009 | Spain |
| Royal Cornwall Hospital | Truro | Cornwall | TR1 3LJ | United Kingdom |
| The Platinum Medical Centre | London | England | NW8 7JA | United Kingdom |
| The Wellington Hospital - South | London | England | NW8 9LE | United Kingdom |
| Sarah Cannon Research Institute UK | London | England | W1G 6AD | United Kingdom |
| The Harley Street Clinic | London | England | W1G 7LJ | United Kingdom |
| HCA Pharmacy Department | London | England | W1G 8HL | United Kingdom |
| The Harley Street Clinic | London | England | W1G 8PP | United Kingdom |
| The Princess Grace Hospital | London | England | W1U 5LZ | United Kingdom |
| Weston Park Hospital | Sheffield | South Yorkshire | S10 2SJ | United Kingdom |
| Sir Bobby Robson Cancer Trials Research Centre | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| FG001 | Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with urothelial cancer (UC) received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| FG002 | Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| FG003 | Phase 1b Lead-in: Avelumab 1200 mg + Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| FG004 | Phase 2: Avelumab 1200 mg + Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| COMPLETED |
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| NOT COMPLETED |
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| Phase 1b Lead-in: Follow-up |
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| Phase 2: Treatment |
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| Phase 2: Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin | Participants with advanced non-squamous non-small cell lung cancer (NSCLC) received avelumab 800 milligrams (mg) as an intravenous (IV) infusion over 1 hour every 3 weeks (Q3W) in combination with IV infusion of pemetrexed 500 milligram per square meter (mg/m^2) and carboplatin dose at area under curve (AUC) 5 (carboplatin dose [mg] = target AUC * glomerular filtration rate[GFR] milliliter per minute [mL/min] + 25, and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| BG001 | Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with urothelial cancer (UC) received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| BG002 | Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| BG003 | Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. Participants from both Phase 1b and Phase 2 Avelumab 1200 mg + Gemcitabine/Cisplatin were included in this arm. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
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| Secondary | Serum Concentration of Avelumab | The lower limit of quantification (LLOQ) for avelumab was 0.2 micrograms per milliliter. Pharmacokinetic concentration analysis set was subset of safety analysis set and included participants who had at least one concentration measurement for avelumab or other study drugs which they were assigned to receive. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan. | The PK concentration analysis sets are subsets of the safety analysis set including participants who have at least one concentration measurement for avelumab which they were assigned to receive,based on the treatment group.Overall number of participants analyzed=participants evaluable for this outcome measure and only those contributing to data for this outcome measure.Number analyzed=participants evaluable and contributing at specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Pre-dose, 1 hour post-dose on Day 1 of Cycle 1, 2, 3, 6, 10, 14; 336 hours post-dose on Day 15 of Cycle 1, 2, 3 (each cycle of 21 days) |
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| Secondary | Absolute Value of Tumor Mutational Burden (TMB) in Tumor Tissue | Mutational load within tumor tissue was defined as number per megabase of the genome, coding, base substitution, and indel mutations present in the sample. Mutational load was determined in whole blood samples using next generation deoxyribonucleic acid (DNA) sequencing followed by computational analysis. | The tumor tissue-based biomarker analysis set was subset of the safety analysis set and included participants who had at least one baseline and one on-treatment biomarker assessment for the same biomarker. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan. | Posted | Mean | Standard Deviation | Mutations per megabase | Pre-dose on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||||||
| Primary | Phase 1b Lead-in: Number of Participants With Dose-Limiting Toxicities (DLT) | DLTs=occurrence of any AEs attributable to study treatment in first 2 treatment cycles:Hematologic: grade(G)4 neutropenia lasting >7days;febrile neutropenia with body temperature >=38 degree Celsius for >1hour; G>=3 neutropenic infection(absolute neutrophil count <1.0*10^9/L),G>=3 thrombocytopenia (platelet count<50.0-25.0*10^9/L)with bleeding;G4 thrombocytopenia(PC<25.0*10^9/L),G4 anemia(life-threatening).Non-hematologic: any G4 toxicities;G3 toxicities persisting for >3days despite medical treatment(nausea,vomiting,diarrhea)except endocrinopathies controlled with hormonal therapy;ALT/AST >3*upper limit of normal(ULN)if normal at baseline or 2*Baseline(>ULN at baseline)with total bilirubin >2*ULN and alkaline phosphatase <2*ULN;G3 QTcF prolongation after correction of any reversible cause(electrolyte abnormalities/hypoxia).Delay of >=3weeks in scheduled administration/failure to deliver 75% of doses due to toxicities attributable to any study treatment. DLT-evaluable analysis set. | The DLT analysis set is a subset of the safety analysis set and includes all enrolled participants in the Phase 1b lead-in who are eligible for the study, receive at least one dose of the combination treatment, and either experience DLT during the first 2 cycles (6 weeks) of treatment, or complete the DLT observation period for the first 2 cycles of treatment. | Posted | Count of Participants | Participants | Day 1 up to Week 6 (first 2 treatment cycles; 1 cycle = 21 days) |
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| Primary | Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment | OR: complete response(CR) or partial response(PR)determined by investigator according to RECIST v1.1 from date of first dose of study treatment until date of first documentation of progressive disease(PD),confirmed by repeat assessments performed no less than 4 weeks after first response. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures less than (<)10 millimeter(mm). PR: >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD. | The full analysis set (FAS) will include all participants who receive at least one dose of study drug. Participants will be classified according to the study treatment actually received. If a participant receives more than one treatment the participant will be classified according to the first study treatment received. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 3.5 years approximately) |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Adverse event (AE) was any untoward medical occurrence in a participants who received any study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. | Safety analysis set included all participants who received at least 1 dose of any study drug. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan. | Posted | Count of Participants | Participants | From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5 years approximately) |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Related TEAEs | A treatment related AE included AEs related to at least one study drug in the combination. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. Relatedness to study drug was assessed by the investigator. | Safety analysis set included all participants who received at least 1 dose of any study drug. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan. | Posted | Count of Participants | Participants | From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5 years approximately) |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v 4.03 | AE was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. TEAEs were graded by the investigator using NCI CTCAE v 4.03 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. In this outcome measure, number of participants with grade 3 or higher TEAEs were reported. | Safety analysis set included all participants who received at least 1 dose of any study drug. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan. | Posted | Count of Participants | Participants | From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5 years approximately) |
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| Secondary | Number of Participants With Grade 3 or Higher Laboratory Abnormalities by CTCAE Grade | Participants with laboratory abnormalities of any Grade as per NCI CTCAE toxicity grading v4.03 were summarized:hematology(anemia,hemoglobin increased,lymphocyte count decreased,lymphocyte count increased, neutrophil count decreased,platelet count decreased and white blood cell decreased)and clinical chemistry(alanine aminotransferase increased,alkaline phosphatase,increased,aspartate,aminotransferase increased,blood bilirubin increased,cholesterol high,creatinine phosphokinase[cpk] increased,creatinine increased,gamma-glutamyl transferase[ggt] increased,hypercalcemia,hyperglycemia,hyperkalemia, hypermagnesemia,hypernatremia,hypertriglyceridemia,hypoalbuminemia,hypocalcemia,hypoglycemia,hypokalemia,hypomagnesemia,hyponatremia, hypophosphatemia,serum amylase increased and lipase increased).As per NCI CTCAE toxicity grading v4.03, Grade1=mild;Grade2=moderate;Grade3=severe;Grade4=life-threatening;Grade 5=death.Parameters with at least 1 participant with abnormal value are reported. | Safety analysis set included all participants who received at least 1 dose of any study drug. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan. | Posted | Count of Participants | Participants | From screening up to 90 days after last dose of study drug (maximum up to 5 years approximately) |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies for Avelumab | Blood samples were collected for assessment of avelumab ADAs using a tiered assay and confirmed positive samples were tested for neutralizing antibodies (nAb). | The immunogenicity analysis set is a subset of the safety analysis set and will include participants who have at least one ADA/nAb sample collected for avelumab. | Posted | Count of Participants | Participants | From first dose of study drug up to last dose of study drug (maximum up to 5 years approximately) |
| ||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) as Per RECIST v 1.1 by Investigator Assessment | PFS was defined as the time from the date of first dose of study treatment to the date of the first documentation of PD per RECIST v1.1 or death due to any cause, whichever occurred first. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD. The median duration of PFS was not derived for less than (<) 10 participants. | The full analysis set (FAS) included all participants who received at least 1 dose of study drug. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan. | Posted | Median | 95% Confidence Interval | Months | From start of treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 5 years approximately) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the first dose of study treatment to the date of death due to any cause. Participants last known to be alive were censored at the date of last contact. The median duration of OS was not derived for less than (<) 10 participants. | The full analysis set (FAS) included all participants who received at least 1 dose of study drug. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan. | Posted | Median | 95% Confidence Interval | Months | From first dose of study treatment until death due to any cause (maximum up to 5 years approximately) |
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| Secondary | Duration of Response (DOR) as Per RECIST v 1.1 by Investigator Assessment | DOR was defined as time from first documentation of objective response (confirmed CR or PR) to the date of first PD documentation or death due to any cause, whichever occurs first. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures less than (<)10 millimeter(mm). PR: >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD. Median DOR was not derived for < 5 participants. | The full analysis set (FAS) included all participants who received at least 1 dose of study drug. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan. | Posted | Median | 95% Confidence Interval | Months | From date of first documented response to date of first documented PD or death due to any cause, whichever occurred first (maximum up to 5 years approximately) |
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| Secondary | Time-to-Tumor Response (TTR) as Per RECIST v 1.1 by Investigator Assessment | TTR was defined as the time from the date of first dose of study treatment to the first documentation of objective response (CR or PR) as assessed by investigator according to RECIST v 1.1. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures less than (<)10 millimeter(mm). PR: >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. | The full analysis set (FAS) included all participants who received at least 1 dose of study drug. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan. | Posted | Median | Full Range | Months | From first dose of study treatment until first documentation of CR or PR (maximum up to 5 years approximately) |
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| Secondary | Number of Participants With Programmed Death-Ligand 1 (PD-L1) Expression | PD-L1 expression was determined using the Ventana PD-L1 SP263 IHC assay. PD-L1-positive status in UC cohorts was defined using an algorithm that combines assessments of PD-L1 staining on tumor and immune cells scored by pathologists and in NSCLC cohorts was defined as PD-L1 expression on >=1% of tumor cells. PD-L1 expression at baseline and on-treatment were reported in this outcome measure. | FAS included all participants who received at least one dose of study drug. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan. | Posted | Count of Participants | Participants | Baseline and Cycle 2 Day 8 (each cycle of 21 days) |
|
All-cause mortality: From start of the treatment up to 90 days post last dose of study treatment (maximum of 5 years approximately), TEAEs and Serious TEAEs: From start of the treatment up to 30 days post last dose of study treatment
Same event may appear as both an AE and SAE. Safety set was evaluated. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin | Participants with advanced non-squamous non-small cell lung cancer (NSCLC) received avelumab 800 milligrams (mg) as an intravenous (IV) infusion over 1 hour every 3 weeks (Q3W) in combination with IV infusion of pemetrexed 500 milligram per square meter (mg/m^2) and carboplatin dose at area under curve (AUC) 5 (carboplatin dose [mg] = target AUC * glomerular filtration rate[GFR] milliliter per minute [mL/min] + 25, and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. | 3 | 6 | 3 | 6 | 6 | 6 |
| EG001 | Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with urothelial cancer (UC) received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. | 8 | 13 | 9 | 13 | 13 | 13 |
| EG002 | Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. | 5 | 6 | 5 | 6 | 6 | 6 |
| EG003 | Phase 1b and 2: Avelumab 1200 mg + Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. Participants from both Phase 1b and Phase 2 Avelumab 1200 mg + Gemcitabine/Cisplatin were included in this arm. | 29 | 41 | 20 | 41 | 40 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Renal haemorrhage | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Near drowning | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abdominal rigidity | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pancreatic failure | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Procedural pneumothorax | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Urinary tract stoma complication | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Clubbing | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Genitourinary symptom | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Urine odour abnormal | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Superficial vein thrombosis | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Extravasation | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Thirst | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
|
The study was terminated since there was no need for further safety or efficacy data to be collected. The subjects having benefit from the investigational treatments have been moved to a continuation study NCT05059522
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 8007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2021 | May 26, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000609138 | avelumab |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Other |
|
| Study terminated by sponsor |
|
| Progressive disease |
|
| Other |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| Death |
|
| Lost to Follow-up |
|
| Other |
|
| Study terminated by sponsor |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Cycle 1/Day 15- 336 hours |
|
|
| Cycle 2/Day 1- pre-dose |
|
|
| Cycle 2/Day 1- 1 hour |
|
|
| Cycle 2/Day 15- 336 hours |
|
|
| Cycle 3/Day 1- pre-dose |
|
|
| Cycle 3/Day 1- 1 hour |
|
|
| Cycle 3/Day 15- 336 hours |
|
|
| Cycle 6/Day 1- pre-dose |
|
|
| Cycle 6/Day 1- 1 hour |
|
|
| Cycle 10/Day 1- pre-dose |
|
|
| Cycle 10/Day 1- 1 hour |
|
|
| Cycle 14/Day 1- pre-dose |
|
|
| Cycle 14/Day 1- 1 hour |
|
|
| OG001 |
| Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin |
Participants (cisplatin-eligible) with urothelial cancer (UC) received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG002 | Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG003 | Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. Participants from both Phase 1b and Phase 2 Avelumab 1200 mg + Gemcitabine/Cisplatin were included in this arm. |
|
|
| OG001 | Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with urothelial cancer (UC) received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG002 | Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG003 | Phase 1b Lead-in: Avelumab 1200mg+Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
|
|
Participants with advanced non-squamous non-small cell lung cancer (NSCLC) received avelumab 800 milligrams (mg) as an intravenous (IV) infusion over 1 hour every 3 weeks (Q3W) in combination with IV infusion of pemetrexed 500 milligram per square meter (mg/m^2) and carboplatin dose at area under curve (AUC) 5 (carboplatin dose [mg] = target AUC * glomerular filtration rate[GFR] milliliter per minute [mL/min] + 25, and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG001 | Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with urothelial cancer (UC) received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG002 | Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG003 | Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. Participants from both Phase 1b and Phase 2 Avelumab 1200 mg + Gemcitabine/Cisplatin were included in this arm. |
|
|
| OG001 | Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with urothelial cancer (UC) received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG002 | Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG003 | Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. Participants from both Phase 1b and Phase 2 Avelumab 1200 mg + Gemcitabine/Cisplatin were included in this arm. |
|
|
| OG001 | Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with urothelial cancer (UC) received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG002 | Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG003 | Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. Participants from both Phase 1b and Phase 2 Avelumab 1200 mg + Gemcitabine/Cisplatin were included in this arm. |
|
|
| OG001 | Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with urothelial cancer (UC) received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG002 | Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG003 | Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. Participants from both Phase 1b and Phase 2 Avelumab 1200 mg + Gemcitabine/Cisplatin were included in this arm. |
|
|
| OG001 | Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with urothelial cancer (UC) received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG002 | Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG003 | Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. Participants from both Phase 1b and Phase 2 Avelumab 1200 mg + Gemcitabine/Cisplatin were included in this arm. |
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Participants (cisplatin-eligible) with urothelial cancer (UC) received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
| OG002 | Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG003 | Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. Participants from both Phase 1b and Phase 2 Avelumab 1200 mg + Gemcitabine/Cisplatin were included in this arm. |
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| OG001 | Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with urothelial cancer (UC) received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG002 | Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG003 | Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. Participants from both Phase 1b and Phase 2 Avelumab 1200 mg + Gemcitabine/Cisplatin were included in this arm. |
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Participants (cisplatin-eligible) with urothelial cancer (UC) received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG002 | Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG003 | Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. Participants from both Phase 1b and Phase 2 Avelumab 1200 mg + Gemcitabine/Cisplatin were included in this arm. |
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| OG001 | Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with urothelial cancer (UC) received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG002 | Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG003 | Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. Participants from both Phase 1b and Phase 2 Avelumab 1200 mg + Gemcitabine/Cisplatin were included in this arm. |
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| OG001 | Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with urothelial cancer (UC) received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG002 | Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG003 | Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. Participants from both Phase 1b and Phase 2 Avelumab 1200 mg + Gemcitabine/Cisplatin were included in this arm. |
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| Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin |
Participants (cisplatin-eligible) with urothelial cancer (UC) received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG002 | Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. |
| OG003 | Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. Participants from both Phase 1b and Phase 2 Avelumab 1200 mg + Gemcitabine/Cisplatin were included in this arm. |
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