Trial · NCT02684006
A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
NCT02684006, Phase 3, Completed, Pfizer; results first posted 2024-10-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101). Trials, record NCT02684006. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02684006
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
- NCT number
- NCT02684006
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 886 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Renal Cell Cancer
- Interventions
- Avelumab (MSB0010718C), Axitinib (AG-013736), Sunitinib
- First posted
- 2016-02-17
- Last updated
- 2025-07-30
- Other registries' IDs
- eudract:2015-002429-20
- Results first posted
- 2024-10-29
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants | 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) | 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. |
| Primary | Overall Survival (OS) in PD-L1 Positive Participants | 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) | 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. |
| Secondary | PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression | 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) | 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. |
| Secondary | OS in Participants Irrespective of PD-L1 Expression | 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) | 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. |
| Secondary | Percentage of Participants With Objective Response (OR) as Assessed by BICR Irrespective of PD-L1 Expression | From date of randomization until PD (maximum up to approximately 26 months) | 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. |
| Secondary | Percentage of Participants With OR as Assessed by Investigator Irrespective of PD-L1 Expression | From date of randomization until PD (maximum up to approximately 89 months) | 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. |
| Secondary | Percentage of Participants With Disease Control (DC) as Assessed by BICR Irrespective of PD-L1 Expression | From date of randomization until PD (maximum up to approximately 26 months) | 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. |
| Secondary | Percentage of Participants With DC as Assessed by Investigator Irrespective of PD-L1 Expression | From date of randomization until PD (maximum up to approximately 89 months) | 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. |
| Secondary | Time to Tumor Response (TTR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression | From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months) | 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. |
| Secondary | TTR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression | From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 89 months) | 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. |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants | 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) | FAS included all participants who were randomized. Analysis was performed on subset of randomized participants, who were PD-L1 positive. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in PD-L1 Positive Participants | 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) | FAS included all participants who are randomized. Analysis was performed on subset of randomized participants, who were PD-L1 positive. | Months | MEDIAN |
| SECONDARY | PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression | 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) | FAS included all randomized participants. | Months | MEDIAN |
| SECONDARY | OS in Participants Irrespective of PD-L1 Expression | 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) | FAS included all randomized participants. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response (OR) as Assessed by BICR Irrespective of PD-L1 Expression | From date of randomization until PD (maximum up to approximately 26 months) | FAS included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With OR as Assessed by Investigator Irrespective of PD-L1 Expression | From date of randomization until PD (maximum up to approximately 89 months) | FAS included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control (DC) as Assessed by BICR Irrespective of PD-L1 Expression | From date of randomization until PD (maximum up to approximately 26 months) | FAS included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With DC as Assessed by Investigator Irrespective of PD-L1 Expression | From date of randomization until PD (maximum up to approximately 89 months) | FAS included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Time to Tumor Response (TTR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression | From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months) | FAS included all randomized participants. Here Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Months | MEDIAN |
| SECONDARY | TTR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression | From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 89 months) | FAS included all randomized participants. Here Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Months | MEDIAN |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group545
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants | Avelumab + Axitinib | 13.8 | 95% Confidence Interval 11.1 to NA | Months | |
| Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants | Sunitinib | 7.2 | 95% Confidence Interval 5.7 to 9.7 | Months | |
| Overall Survival (OS) in PD-L1 Positive Participants | Avelumab + Axitinib | 43.2 | 95% Confidence Interval 36.5 to 51.7 | Months | |
| Overall Survival (OS) in PD-L1 Positive Participants | Sunitinib | 36.2 | 95% Confidence Interval 29.8 to 44.2 | Months | |
| PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression | Avelumab + Axitinib | 13.8 | 95% Confidence Interval 11.1 to NA | Months | |
| PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression | Sunitinib | 8.4 | 95% Confidence Interval 6.9 to 11.1 | Months | |
| OS in Participants Irrespective of PD-L1 Expression | Avelumab + Axitinib | 44.8 | 95% Confidence Interval 39.7 to 51.1 | Months | |
| OS in Participants Irrespective of PD-L1 Expression | Sunitinib | 38.9 | 95% Confidence Interval 31.4 to 45.2 | Months | |
| Percentage of Participants With Objective Response (OR) as Assessed by BICR Irrespective of PD-L1 Expression | Avelumab + Axitinib | 51.4 | 95% Confidence Interval 46.6 to 56.1 | Percentage of participants | |
| Percentage of Participants With Objective Response (OR) as Assessed by BICR Irrespective of PD-L1 Expression | Sunitinib | 25.7 | 95% Confidence Interval 21.7 to 30.0 | Percentage of participants |
1 to 10 of 545Source ClinicalTrials.gov
See all 545 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Avelumab + Axitinib | 442 | |
| Overall Study | STARTED | Sunitinib | 444 | |
| Overall Study | COMPLETED | Avelumab + Axitinib | 0 | |
| Overall Study | COMPLETED | Sunitinib | 0 | |
| Overall Study | NOT COMPLETED | Avelumab + Axitinib | 442 | |
| Overall Study | NOT COMPLETED | Sunitinib | 444 |
Source ClinicalTrials.gov
Adverse events852
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Avelumab + Axitinib | 41 | 434 | |
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib | 116 | 439 | |
| other | Leukopenia | Blood and lymphatic system disorders | Avelumab + Axitinib | 1 | 434 | |
| other | Leukopenia | Blood and lymphatic system disorders | Sunitinib | 27 | 439 | |
| other | Neutropenia | Blood and lymphatic system disorders | Avelumab + Axitinib | 9 | 434 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sunitinib | 90 | 439 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Avelumab + Axitinib | 17 | 434 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sunitinib | 89 | 439 | |
| other | Hypothyroidism | Endocrine disorders | Avelumab + Axitinib | 135 | 434 | |
| other | Hypothyroidism | Endocrine disorders | Sunitinib | 89 | 439 |
1 to 10 of 852Source ClinicalTrials.gov
See all 852 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Avelumab + Axitinib | 284 | 442 |
| Total, all-cause mortality | Sunitinib | 296 | 444 |
| Total, other adverse events | Avelumab + Axitinib | 429 | 434 |
| Total, other adverse events | Sunitinib | 433 | 439 |
| Total, serious adverse events | Avelumab + Axitinib | 231 | 434 |
| Total, serious adverse events | Sunitinib | 166 | 439 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Avelumab + Axitinib vs Sunitinib: Number of Participants Who Discontinued Treatment Due to Toxicity | Trial comparisons |
| Avelumab + Axitinib vs Sunitinib: Number of Participants With Positive PD-L1 Biomarker Expression in Pre-treatment Tumor Tissue | Trial comparisons |
| Avelumab + Axitinib vs Sunitinib: deaths from any cause | Trial comparisons |
| Avelumab + Axitinib vs Sunitinib: serious adverse events | Trial comparisons |
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.
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.
GET https://conductscience.org/api/trials/v1/NCT02684006
GET https://conductscience.org/api/trials/v1/NCT02684006/registered?page=2