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Trial ยท NCT01772004

Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)

NCT01772004, Phase 1, Completed, EMD Serono Research & Development Institute, Inc.; results first posted 2021-12-20

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ConductScience Library. Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor). Trials, record NCT01772004. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01772004

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)
NCT number
NCT01772004
Status
Completed
Phases
Phase 1
Enrollment
1,756 participants, actual
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Conditions
Solid Tumors
Interventions
Avelumab
First posted
2013-01-21
Last updated
2021-12-20
Other registries' IDs
eudract:2013-002834-19
Results first posted
2021-12-20

Source ClinicalTrials.gov

Registered outcomes31

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryDose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs)Dose Escalation: Baseline up to Week 3
DLT: defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0, as any one of following: any Grade (Gr) \>=3toxicity that is possibly/probably/ definitely related to avelumab, except for any of following: Gr 3 infusion-related reaction resolving within 6 hours and controlled with medical management, Transient Gr 3 flu-like symptoms/fever, which is controlled with medical management, Transient Gr 3 fatigue, local reactions, headache, nausea, emesis that resolves to \<= Gr 1, Gr3 diarrhea, Gr 3 skin toxicity, Gr 3 liver function test increase that resolves to \<= Gr1 in \< 7 days after medical management has been initiated, Single laboratory values out of normal range that were unlikely related to study treatment according to investigator, did not have any clinical correlate, and resolved to \<= Gr1 within 7 days with adequate medical management and tumor flare phenomenon defined as local pain, irritation/rash localized at sites of known/suspected tumor.
Primary
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Ovarian Cancer Efficacy Expansion: Baseline up to Day 620
Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30%reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions.
Primary
Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Urothelial Carcinoma Efficacy Expansion: Baseline up to Day 931
Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1 or more new lesions and unequivocal progression of non-target lesions.
Primary
Efficacy Expansion Cohort (GC/GEJC, Third Line): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
GC/GEJC, Third Line Efficacy Expansion: Baseline up to Day 871
Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1 or more new lesions and unequivocal progression of non-target lesions.
Primary
Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
HNSCC Efficacy Expansion: Baseline up to Day 1072
Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30%reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions.
SecondaryDose Escalation and Expansion Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs as Per SeverityUp to Day 2511
Adverse event(AE): any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of study drug, whether or not related to study drug. A serious adverse event(SAE) was an AE that resulted in any of following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration.TEAEs included both Serious TEAEs and non-serious TEAEs. Severity of TEAEs were graded using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 toxicity grades, as follows: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death.
SecondaryDose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per SeverityBaseline up to Day 2511
AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. Treatment-emergent events were the events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs. Treatment related AE was defined as having a "Possible" or "Related" relationship to study treatment, as assessed by the Investigator. Severity of Treatment-Related TEAEs were graded using NCI-CTCAE version 4.0 toxicity grades, as follows: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death.
SecondaryDose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under Serum Concentration-Time Curve From the Time of Dosing to the Time of the Last Observation (AUC0-t) of AvelumabPre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion
Area under the serum concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the lower limit of quantification (LLLQ). AUC(0-t) was calculated according to the mixed log-linear trapezoidal rule.
SecondaryDose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of AvelumabPre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusionThe AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
SecondaryDose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Maximum Observed Serum Concentration (Cmax) of AvelumabPre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusionCmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.

Outcomes31

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYDose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs)Dose Escalation: Baseline up to Week 3
DLT analysis set included all participants with data used for implementing the dose-escalation schedule. These participants should have received all study drug administrations in the DLT evaluation period, or should have stopped treatment because of DLTs in the DLT evaluation period.
ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARY
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Ovarian Cancer Efficacy Expansion: Baseline up to Day 620Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARY
Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Urothelial Carcinoma Efficacy Expansion: Baseline up to Day 931
Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.
ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARY
Efficacy Expansion Cohort (GC/GEJC, Third Line): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
GC/GEJC, Third Line Efficacy Expansion: Baseline up to Day 871Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARY
Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
HNSCC Efficacy Expansion: Baseline up to Day 1072Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYDose Escalation and Expansion Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs as Per SeverityUp to Day 2511Safety analysis set (SAF) included all participants who have received at least 1 dose of study treatment.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYDose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per SeverityBaseline up to Day 2511SAF included all participants who have received at least 1 dose of study treatment.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYDose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under Serum Concentration-Time Curve From the Time of Dosing to the Time of the Last Observation (AUC0-t) of AvelumabPre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusionPharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements.Hours*micrograms per milliliterMEAN
SECONDARYDose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of AvelumabPre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion
Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements. Here Overall number of participants analyzed signifies those who were evaluable for this outcome measure.
Hours*micrograms per milliliterMEAN
SECONDARYDose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Maximum Observed Serum Concentration (Cmax) of AvelumabPre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusionPharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements.Micrograms per milliliter (mcg/mL)MEAN

Results by group993

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs)Dose Escalation Cohort: Avelumab 1.0 mg/kg0Participants
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs)Dose Escalation Cohort: Avelumab 3.0 mg/kg0Participants
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs)Dose Escalation Cohort: Avelumab 10.0 mg/kg0Participants
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs)Dose Escalation Cohort: Avelumab 20.0 mg/kg1Participants
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Efficacy Expansion Cohort: Ovarian CancerComplete response (CR)3Participants
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Efficacy Expansion Cohort: Ovarian CancerPartial response (PR)1Participants
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Efficacy Expansion Cohort: Ovarian CancerStable disease (SD)41Participants
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Efficacy Expansion Cohort: Ovarian CancerProgressive disease (PD)39Participants
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Efficacy Expansion Cohort: Ovarian CancerNon-CR/Non-PD3Participants
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Efficacy Expansion Cohort: Ovarian CancerNon-evaluable16Participants

Participant flow138

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Dose Escalation PhaseSTARTEDDose Escalation Cohort: Avelumab 1.0 mg/kg4
Dose Escalation PhaseSTARTEDDose Escalation Cohort: Avelumab 3.0 mg/kg13
Dose Escalation PhaseSTARTEDDose Escalation Cohort: Avelumab 10.0 mg/kg15
Dose Escalation PhaseSTARTEDDose Escalation Cohort: Avelumab 20.0 mg/kg21
Dose Escalation PhaseSTARTEDDose Escalation Cohort: Avelumab 10.0 mg/kg Weekly8
Dose Escalation PhaseSTARTEDPrimary Expansion Cohort: NSCLC, Post-platinum Doublet0
Dose Escalation PhaseSTARTEDPrimary Expansion Cohort: NSCLC, First Line0
Dose Escalation PhaseSTARTEDPrimary Expansion Cohort: Metastatic Breast Cancer0
Dose Escalation PhaseSTARTEDPrimary Expansion Cohort: GC/GEJC Progressed0
Dose Escalation PhaseSTARTEDPrimary Expansion Cohort: GC/GEJC Non Progressed0

Adverse events40,618

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherFatigueGeneral disordersDose Escalation Cohort: Avelumab 1.0 mg/kg24
otherFatigueGeneral disordersDose Escalation Cohort: Avelumab 3.0 mg/kg713
otherFatigueGeneral disordersDose Escalation Cohort: Avelumab 10.0 mg/kg1315
otherFatigueGeneral disordersDose Escalation Cohort: Avelumab 20.0 mg/kg621
otherFatigueGeneral disordersDose Escalation Cohort: Avelumab 10.0 mg/kg Weekly38
otherFatigueGeneral disordersPrimary Expansion Cohort: NSCLC, Post-platinum Doublet74184
otherFatigueGeneral disordersPrimary Expansion Cohort: NSCLC, First Line71156
otherFatigueGeneral disordersPrimary Expansion Cohort: Metastatic Breast Cancer66168
otherFatigueGeneral disordersPrimary Expansion Cohort: GC/GEJC Progressed1360
otherFatigueGeneral disordersPrimary Expansion Cohort: GC/GEJC Non Progressed2090

Adverse event totals69

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityDose Escalation Cohort: Avelumab 1.0 mg/kg44
Total, all-cause mortalityDose Escalation Cohort: Avelumab 3.0 mg/kg1113
Total, all-cause mortalityDose Escalation Cohort: Avelumab 10.0 mg/kg1115
Total, all-cause mortalityDose Escalation Cohort: Avelumab 20.0 mg/kg1621
Total, all-cause mortalityDose Escalation Cohort: Avelumab 10.0 mg/kg Weekly28
Total, all-cause mortalityPrimary Expansion Cohort: NSCLC, Post-platinum Doublet161184
Total, all-cause mortalityPrimary Expansion Cohort: NSCLC, First Line124156
Total, all-cause mortalityPrimary Expansion Cohort: Metastatic Breast Cancer141168
Total, all-cause mortalityPrimary Expansion Cohort: GC/GEJC Progressed5060
Total, all-cause mortalityPrimary Expansion Cohort: GC/GEJC Non Progressed7590

Papers19

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
28239472DERIVEDPubMed
28373005BACKGROUNDPubMed
28373007BACKGROUNDPubMed
28375787BACKGROUNDPubMed
29217288DERIVEDPubMed
30348224DERIVEDPubMed
30605211DERIVEDPubMed
30651126DERIVEDPubMed
30676622DERIVEDPubMed
30717797DERIVEDPubMed

1 to 10 of 19

See all 19 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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