18 and older, any sex, with Renal Cell Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Dose Limiting Toxicities (DLTs)Primary· DLT observation period (from the beginning of Cycle 1 up to the end of Cycle 2 [28 days])
DLT: greater than or equal to (\>=) Grade 3 hematologic/non-hematologic toxicity, Grade 3-4 liver-related laboratory test elevation (alanine aminotransferase, aspartate aminotransferase) with Grade 2 elevation of total bilirubin, non-hematologic Grade 3 laboratory abnormality (required medical intervention to treat participant/led to hospitalization), inability to complete \>=75% of first 2 cycles doses of axitinib (from Cycle 1 Day 1 after completion of lead-in period) or 2 infusions of avelumab within DLT observation period due to investigational product related toxicity.
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
1
Number of Participants With All-causality Treatment Emergent Adverse Events (TEAEs)Secondary· Baseline up to 30 days after the last dose of study treatment (maximum of 259.7 weeks)
Adverse event (AE)=any untoward medical occurrence in participant who received study treatment without regard to causality. TEAE=event between first dose of study treatment and up to 30 days after last dose that were absent before treatment or worsened relative to pretreatment state. Serious AE (SAE)=AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. AEs were graded by worst National Cancer Institute (NCI
Participants with TEAEs
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
16
Axitinib + Avelumab
39
Participants with Grade >=3 TEAEs
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
13
Axitinib + Avelumab
30
Participants with SAEs
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
6
Axitinib + Avelumab
18
Number of Participants With Treatment-related TEAEsSecondary· Baseline up to 30 days after the last dose of study treatment (maximum of 259.7 weeks)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAE=event between first dose of study treatment and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. AEs were graded by worst NCI CTCAE v4.03 severity gra
Participants with treatment-related TEAEs
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
15
Axitinib + Avelumab
39
Participants with Grade >=3 treatment-related TEAEs
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
11
Axitinib + Avelumab
23
Participants with treatment-related SAEs
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
3
Axitinib + Avelumab
10
Number of Participants With Laboratory Abnormalities Graded by NCI CTCAE Version 4.03 - HematologySecondary· Baseline up to 30 days after the last dose of study treatment and 1 day before the start day of new anti-cancer drug therapy (maximum of 259.7 weeks)
Laboratory abnormalities (hematology) reported included anemia, platelet count decreased, lymphocyte count decreased, and neutrophil count decreased. Grade 1=mild transient reaction; infusion interruption not indicated; intervention not indicated. Grade 2=therapy or infusion interruption indicated but responds promptly to symptomatic treatment; prophylactic medications indicated for \<=24 hours. Grade 3=prolonged; recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4=life threatening consequences; urgent intervention indicated. Grade 5=d
Participants with Grade >=1 anemia
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
8
Axitinib + Avelumab
24
Participants with Grade >=3 anemia
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
0
Axitinib + Avelumab
2
Participants with Grade >=1 platelet count decreased
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
4
Axitinib + Avelumab
11
Participants with Grade >=3 platelet count decreased
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
0
Axitinib + Avelumab
0
Participants with Grade >=1 lymphocyte count decreased
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
10
Axitinib + Avelumab
16
Participants with Grade >=3 lymphocyte count decreased
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
1
Axitinib + Avelumab
3
Participants with Grade >=1 neutrophil count decreased
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
1
Axitinib + Avelumab
4
Participants with Grade >=3 neutrophil count decreased
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
0
Axitinib + Avelumab
0
Number of Participants With Laboratory Abnormalities Graded by NCI CTCAE Version 4.03 - ChemistrySecondary· Baseline up to 30 days after the last dose of study treatment and 1 day before the start day of new anti-cancer drug therapy (maximum of 259.7 weeks)
Laboratory abnormalities (chemistry) reported included creatinine increased, serum amylase increased, lipase increased, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatine kinase increased, hypoglycemia, and hyperglycemia. Grade 1=mild transient reaction; infusion interruption not indicated; intervention not indicated. Grade 2=therapy or infusion interruption indicated but responds promptly to symptomatic treatment; prophylactic medications indicated for \<=24 hours. Grade 3=prolonged; recurrence of symptoms following initia
Participants with Grade >=1 creatinine increased
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
16
Axitinib + Avelumab
37
Participants with Grade >=3 creatinine increased
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
0
Axitinib + Avelumab
0
Participants with Grade >=1 serum amylase increased
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
11
Axitinib + Avelumab
16
Participants with Grade >=3 serum amylase increased
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
4
Axitinib + Avelumab
3
Participants with Grade >=1 lipase increased
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
9
Axitinib + Avelumab
16
Participants with Grade >=3 lipase increased
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
5
Axitinib + Avelumab
8
Participants with Grade >=1 ALT increased
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
8
Axitinib + Avelumab
20
Participants with Grade >=3 ALT increased
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
2
Axitinib + Avelumab
2
Change From Baseline in Vital Signs - Sitting Diastolic Blood PressureSecondary· Baseline, Day 1 of each cycle, Day 8 of Cycles 1 and 2, end of treatment, Follow-up Days 30, 60, 90 for all participants in the analysis population, and Lead-in Day 7 for participants with lead-in (maximum of 139.6 weeks by PCD)
Blood pressure was taken with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes. Baseline was defined as the last assessment prior to the date/time of the first dose of study treatment, which occurred on Day 1 in Lead-in period for participants with lead-in, and occurred on Cycle 1 Day 1 (C1D1) for participants without lead-in. The results reflect data available on cutoff of primary completion date (PCD) (03 Apr 2018).
Lead-in Day 7
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
5.4
± 9.32
C1D1
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
4.1
± 9.36
C1D8
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
3.2
± 12.80
Axitinib + Avelumab
9.8
± 11.81
C2D1
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
3.4
± 13.15
Axitinib + Avelumab
10.1
± 10.03
C2D8
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
1.8
± 10.01
Axitinib + Avelumab
14.7
± 5.03
C3D1
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
6.1
± 12.16
Axitinib + Avelumab
10.2
± 11.80
C4D1
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
3.6
± 10.34
Axitinib + Avelumab
8.8
± 9.60
C5D1
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
4.8
± 10.53
Axitinib + Avelumab
6.9
± 11.64
Change From Baseline in Vital Signs - Sitting Systolic Blood PressureSecondary· Baseline, Day 1 of each cycle, Day 8 of Cycles 1 and 2, end of treatment, Follow-up Days 30, 60, 90 for all participants in the analysis population, and Lead-in Day 7 for participants with lead-in (maximum of 139.6 weeks by PCD)
Blood pressure was taken with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes. Baseline was defined as the last assessment prior to the date/time of the first dose of study treatment, which occurred on Day 1 in Lead-in period for participants with lead-in, and occurred on Cycle 1 Day 1 (C1D1) for participants without lead-in. The results reflect data available on cutoff of PCD (03 Apr 2018).
Lead-in Day 7
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
9.7
± 13.44
C1D1
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
11.0
± 18.20
C1D8
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
8.0
± 18.94
Axitinib + Avelumab
10.3
± 16.12
C2D1
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
4.6
± 18.49
Axitinib + Avelumab
11.2
± 11.47
C2D8
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
0.8
± 15.63
Axitinib + Avelumab
17.7
± 6.66
C3D1
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
9.9
± 18.96
Axitinib + Avelumab
8.7
± 15.05
C4D1
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
6.7
± 15.61
Axitinib + Avelumab
5.8
± 11.73
C5D1
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
6.2
± 19.45
Axitinib + Avelumab
6.7
± 14.90
Change From Baseline in Vital Signs - Pulse RateSecondary· Baseline, Day 1 of each cycle, Day 8 of Cycles 1 and 2, end of treatment, Follow-up Days 30, 60, 90 for all participants in the analysis population, and Lead-in Day 7 for participants with lead-in (maximum of 139.6 weeks by PCD)
Pulse rate was taken with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes. Baseline was defined as the last assessment prior to the date/time of the first dose of study treatment, which occurred on Day 1 in Lead-in period for participants with lead-in, and occurred on Cycle 1 Day 1 (C1D1) for participants without lead-in. The results reflect data available on cutoff of PCD (03 Apr 2018).
Lean-in Day 7
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
-0.5
-16.0 – 28.0
C1D1
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
-1.0
-21.0 – 19.0
C1D8
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
-2.0
-20.0 – 24.0
Axitinib + Avelumab
-2.0
-27.0 – 41.0
C2D1
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
3.0
-20.0 – 24.0
Axitinib + Avelumab
4.0
-30.0 – 29.0
C2D8
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
8.0
-6.0 – 25.0
Axitinib + Avelumab
2.0
-14.0 – 10.0
C3D1
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
4.0
-25.0 – 29.0
Axitinib + Avelumab
2.0
-34.0 – 35.0
C4D1
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
1.5
-20.0 – 24.0
Axitinib + Avelumab
4.0
-28.0 – 48.0
C5D1
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
0.0
-27.0 – 16.0
Axitinib + Avelumab
2.5
-40.0 – 26.0
Number of Participants Achieving Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1Secondary· Cycle 1 Day 1 up to 30 months after the first dose
Confirmed OR was defined as complete response (CR) or partial response (PR) according to RECIST v1.1 from the start date until disease progression or death due to any cause. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 mm). PR was defined as \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesio
CR
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
2
Axitinib + Avelumab
2
PR
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
8
Axitinib + Avelumab
21
Number of Participants Achieving Disease Control (DC) Based on RECIST Version 1.1Secondary· Cycle 1 Day 1 up to 30 months after the first dose
DC was defined as OR (CR or PR) or stable disease (SD) per RECIST v1.1 from the start date until the first documentation of objective disease progression or death due to any cause. SD was defined as not qualifying for CR, PR, or progression (PD). PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must de
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
15
Axitinib + Avelumab
28
Duration of Response (DR) Based on RECIST Version 1.1Secondary· Cycle 1 Day 1 up to 30 months after the first dose
DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 mm). PR was defined as \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
NA
4.2 – NA
Axitinib + Avelumab
NA
9.6 – NA
Progression-free Survival (PFS)Secondary· Cycle 1 Day 1 up to 30 months after the first dose
PFS was defined as defined as the time from the start date to the date of the first documentation of objective progression of disease (PD) or death due to any cause, whichever occurred first. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. All target lesions must have been assessed. The results reflect data available on cutoff of PCD (03 Apr 2018).
Group
Value
95% CI
Axitinib + Avelumab With Lead-in
19.2
4.4 – NA
Axitinib + Avelumab
7.6
4.1 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to 30 days after last dose of study treatment (maximum duration of 259.7 weeks for participants with Lead-in, and maximum duration of 244.4 weeks for participants without lead-in).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Axitinib + Avelumab With Lead-in
Serious: 6/16 (38%)
Deaths: 6/16
Axitinib + Avelumab
Serious: 18/39 (46%)
Deaths: 14/39
Serious adverse events (38 terms)
Reaction
System
Axitinib + Avelumab With L…
Axitinib + Avelumab
Disease progression
General disorders
—
—
Infusion related reaction
Injury, poisoning and procedural complications
—
—
Presyncope
Nervous system disorders
—
—
Spinal cord compression
Nervous system disorders
—
—
Haematoma
Vascular disorders
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Neutropenia
Blood and lymphatic system disorders
—
—
Myocarditis
Cardiac disorders
—
—
Palpitations
Cardiac disorders
—
—
Tachycardia
Cardiac disorders
—
—
Adrenal insufficiency
Endocrine disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Adverse drug reaction
General disorders
—
—
Pyrexia
General disorders
—
—
Sepsis
Infections and infestations
—
—
Tooth abscess
Infections and infestations
—
—
Lower limb fracture
Injury, poisoning and procedural complications
—
—
Rib fracture
Injury, poisoning and procedural complications
—
—
Spinal fracture
Injury, poisoning and procedural complications
—
—
Alanine aminotransferase increased
Investigations
—
—
Amylase increased
Investigations
—
—
Aspartate aminotransferase increased
Investigations
—
—
Lipase increased
Investigations
—
—
Other adverse events (202 terms — click to expand)
This is a Phase 1b, open-label, multi-center, multiple-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D) of avelumab (MSB0010718C) in combination with axitinib (AG-013736). Once the MTD of avelumab administered in combination with axitinib is estimated (dose finding portion), the dose expansion phase will be opened to further characterize the combination in term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and biomarker modulation.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03472560 — A Study of Avelumab in Combination With Axitinib In Non-Small Cell Lung Cancer (NSCLC) or Urothelial Cancer (Javelin Med
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· terminated
NCT03289533 — A Study Of Avelumab In Combination With Axitinib In Advanced HCC (VEGF Liver 100)
· Phase 1
· completed
NCT02684006 — A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 18 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02493751.