NCT02684006 · CITED IN SOURCE DOCUMENTS

A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2025-07-30

This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants

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outcome · POSTED

Overall Survival (OS) in PD-L1 Positive Participants

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outcome · POSTED

PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression

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outcome · POSTED

OS in Participants Irrespective of PD-L1 Expression

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outcome · POSTED

Percentage of Participants With Objective Response (OR) as Assessed by BICR Irrespective of PD-L1 Expression

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outcome · POSTED

Percentage of Participants With OR as Assessed by Investigator Irrespective of PD-L1 Expression

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outcome · POSTED

Percentage of Participants With Disease Control (DC) as Assessed by BICR Irrespective of PD-L1 Expression

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outcome · POSTED

Percentage of Participants With DC as Assessed by Investigator Irrespective of PD-L1 Expression

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outcome · POSTED

Time to Tumor Response (TTR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression

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outcome · POSTED

TTR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression

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outcome · POSTED

Duration of Response (DR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression

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outcome · POSTED

DR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression

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outcome · POSTED

PFS as Assessed by Investigator in Participants Irrespective of PD-L1 Expression

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outcome · POSTED

Progression-Free Survival on Next-line Therapy (PFS2) in Participants Irrespective of PD-L1 Expression

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outcome · POSTED

Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (V) 4.03

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outcome · POSTED

Number of Participants According to Grade Shift in Hematology Parameters

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outcome · POSTED

Number of Participants According to Grade Shift in Chemistry Parameters

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outcome · POSTED

Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit

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outcome · POSTED

Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and EOT Visit

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outcome · POSTED

Number of Participants Who Discontinued Treatment Due to Toxicity

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outcome · POSTED

Time to Treatment Discontinuation/Failure Due to Toxicity

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outcome · POSTED

Trough Plasma Concentration (Ctrough) of Avelumab

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outcome · POSTED

Ctrough of Axitinib

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outcome · POSTED

Maximum Plasma Concentration (Cmax) of Axitinib

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outcome · POSTED

Number of Participants With Positive PD-L1 Biomarker Expression in Pre-treatment Tumor Tissue

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outcome · POSTED

PFS in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups

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outcome · POSTED

Percentage of Participants With OR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups

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outcome · POSTED

Percentage of Participants With DC in Biomarker-Positive Subgroup

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outcome · POSTED

TTR in Biomarker-Positive Subgroup

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outcome · POSTED

DR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups

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outcome · POSTED

Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) of Avelumab When Used in Combination With Axitinib

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outcome · POSTED

Time to Symptom Deterioration (TTD) for Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS)

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outcome · POSTED

Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score

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outcome · POSTED

Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Histologically or cytologically confirmed advanced or metastatic RCC with clear cell component * Availability of a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: 1) the biopsy or resection was performed within 1 year of randomization AND 2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and randomization onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then, 15 unstained slides (10 minimum) will be acceptable * Availability of an archival FFPE tumor tissue from primary tumor resection specimen (if not provided per above). If an FFPE tissue block cannot be provided as per documented regulations 15 unstained slides (10 minimum) will be acceptable * At least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate bone marrow function, renal and liver functions Exclusion Criteria: * Prior systemic therapy directed at advanced or metastatic RCC * Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment. * Prior immunotherapy with IL-2, IFN-α, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways * Prior therapy with axitinib and/or sunitinib as well as any prior therapies with other VEGF pathway inhibitors * Newly diagnosed or active brain metastasis * Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011) * Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, LVEF less than LLN, clinically significant pericardial effusion, cerebrovascular accident, transient ischemic attack * Any of the following in the previous 6 months: deep vein thrombosis or symptomatic pulmonary embolism * Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines)
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Avelumab administered at 10 mg/kg IV every two weeks in combination with axitinib, 5 mg PO BID.
intervention Names
Drug: Avelumab (MSB0010718C)
Drug: Axitinib (AG-013736)
label
Avelumab in combination with axitinib
type
EXPERIMENTAL
description
Sunitinib given at 50 mg PO QD on schedule 4/2
intervention Names
Drug: Sunitinib
label
Sunitinib
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Avelumab in combination with axitinib
description
IV treatment Avelumab administered at 10 mg/kg IV every two weeks
name
Avelumab (MSB0010718C)
type
DRUG
arm Group Labels
Avelumab in combination with axitinib
description
Oral treatment Axitinib given 5 mg PO BID
name
Axitinib (AG-013736)
other Names
Inlyta
type
DRUG
arm Group Labels
Sunitinib
description
Oral treatment Sunitinib given at 50 mg PO QD on schedule 4/2
name
Sunitinib
other Names
Sutent
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 886
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
PFS: time from the date of randomization to the date of the first documentation of progressive disease (PD) according to Response Evaluation Criteria in Solid Tumours (RECIST version \[v\] 1.1) or death due to any cause, whichever occurred first as assessed by BICR. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20 percent (%), increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute more than (\>) of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression.
measure
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants
time Frame
From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)
description
OS was defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
measure
Overall Survival (OS) in PD-L1 Positive Participants
time Frame
From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months)

secondary Outcomes

description
PFS: time from the date of randomization to the date of the first documentation of PD or death due to any cause, whichever occurred first as assessed by BICR. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute \> of at least 5 mm. The appearance of one or more new lesions was also considered progression.
measure
PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression
time Frame
From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)
description
OS was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
measure
OS in Participants Irrespective of PD-L1 Expression
time Frame
From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months)
description
OR was defined as best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by BICR recorded from date of randomization until disease progression. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. 95% CI was based on Clopper-Pearson method.
measure
Percentage of Participants With Objective Response (OR) as Assessed by BICR Irrespective of PD-L1 Expression
time Frame
From date of randomization until PD (maximum up to approximately 26 months)
description
OR was defined as best overall response of CR or PR according to RECIST v1.1 as assessed by investigator recorded from date of randomization until disease progression. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. 95% CI was based on Clopper-Pearson method.
measure
Percentage of Participants With OR as Assessed by Investigator Irrespective of PD-L1 Expression
time Frame
From date of randomization until PD (maximum up to approximately 89 months)
description
DC was defined as a best overall response of CR, PR, non-CR/non-PD or stable disease (SD) according to RECIST v1.1 as assessed by BICR. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. All lymph nodes must decrease to normal size (short axis\<10mm). PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. Non-CR/Non-PD was defined as persistence of any non-target lesions and/or tumor marker level above the normal limits. SD was defined as not to qualify for CR, PR or PD for target lesions and followed PR only if the sum increased by less than 20% from the nadir (smallest sum of diameters consider baseline and all assessments prior to the time point under evaluation), but enough that a previously documented 30% decrease no longer holds.
measure
Percentage of Participants With Disease Control (DC) as Assessed by BICR Irrespective of PD-L1 Expression
time Frame
From date of randomization until PD (maximum up to approximately 26 months)
description
DC was defined as a best overall response of CR, PR, non-CR/non-PD or SD according to RECIST v1.1 as assessed by investigator. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. All lymph nodes must decrease to normal size (short axis\<10mm). PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. Non-CR/Non-PD was defined as persistence of any non-target lesions and/or tumor marker level above the normal limits. SD was defined as not to qualify for CR, PR or PD for target lesions and followed PR only if the sum increased by less than 20% from the nadir (smallest sum of diameters consider baseline and all assessments prior to the time point under evaluation), but enough that a previously documented 30% decrease no longer holds.
measure
Percentage of Participants With DC as Assessed by Investigator Irrespective of PD-L1 Expression
time Frame
From date of randomization until PD (maximum up to approximately 89 months)
description
TTR was defined as the time from randomization to the first documentation of objective tumor response according to RECIST v1.1 as assessed by BICR (CR or PR) which is subsequently confirmed. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed.
measure
Time to Tumor Response (TTR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression
time Frame
From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months)
description
TTR was defined as the time from randomization to the first documentation of objective tumor response according to RECIST v1.1 as assessed by investigator (CR or PR) which is subsequently confirmed. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed.
measure
TTR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression
time Frame
From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 89 months)
description
BICR assessed DR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of objective tumor progression assessed by BICR or death due to any cause whichever occurred first. As per RECIST v1.1. CR: complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. PD: at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute \> of at least 5 mm. The appearance of one or more new lesions was also considered progression.
measure
Duration of Response (DR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression
time Frame
From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 26 months)
description
Investigator assessed DR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of objective tumor progression (PD) assessed by investigator or death due to any cause whichever occurred first. As per RECIST v1.1. CR: complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. PD: at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute \> of at least 5 mm. The appearance of one or more new lesions was also considered progression.
measure
DR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression
time Frame
From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 89 months)
description
Investigator assessed PFS: time from the date of randomization to the date of the first documentation of PD according to RECIST v1.1 or death due to any cause, whichever occurred first. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute \> of at least 5 mm. The appearance of one or more new lesions was also considered progression.
measure
PFS as Assessed by Investigator in Participants Irrespective of PD-L1 Expression
time Frame
From date of randomization until PD, whichever occurred first (maximum up to approximately 89 months)
description
PFS2 is defined as the time (in months) from randomization to discontinuation of next-line treatment after first objective disease progression by investigator assessment, second objective disease progression by investigator assessment after initiation of next-line treatment, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute \> of at least 5 mm. The appearance of one or more new lesions was also considered progression.
measure
Progression-Free Survival on Next-line Therapy (PFS2) in Participants Irrespective of PD-L1 Expression
time Frame
From date of randomization until PD or death, whichever occurred first (maximum up to approximately 89 months)

Full study description

brief Summary: This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma

Source references

references

citation
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