Trial · NCT02718417
Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)
NCT02718417, Phase 3, Terminated, Pfizer; results first posted 2019-12-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100). Trials, record NCT02718417. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02718417
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)
- NCT number
- NCT02718417
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 998 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Ovarian Cancer
- Interventions
- carboplatin, paclitaxel, Avelumab, Avelumab
- First posted
- 2016-03-24
- Last updated
- 2020-07-14
- Other registries' IDs
- eudract:2015-003239-36
- Results first posted
- 2019-12-18
Source ClinicalTrials.gov
Registered outcomes36
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) | Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) | BICR assessed PFS: Duration from randomization until disease progression or death. PFS data was censored on the date of the last adequate tumor assessment for participants who did not have an event (progression of disease or death), who started a new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: as at least a 20 percent (%) increase in the sum of diameters 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 the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method. |
| Secondary | Overall Survival | Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) | Overall survival 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 | Progression-Free Survival (PFS) as Assessed by Investigator | Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) | Investigator assessed PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. Progression as per RECIST 1.1, was defined as at least a 20% increase in the sum of diameters 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 the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test. |
| Secondary | Percentage of Participants With Objective Response as Assessed by Investigator | Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months) | Investigator assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 mm. 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. |
| Secondary | Percentage of Participants With Objective Response as Assessed by Blinded Independent Central Review (BICR) | Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months) | BICR assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of CR or PR. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. 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. |
| Secondary | Duration of Response (DOR) as Assessed by Investigator | First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) | Investigator assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method. |
| Secondary | Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR) | First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) | BICR assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method. |
| Secondary | Maintenance Progression-Free Survival as Assessed by Blinded Independent Central Review (BICR) | From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months) | BICR assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by BICR during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method. |
| Secondary | Maintenance Progression-Free Survival (PFS) as Assessed by Investigator | From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months) | Investigator assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by investigator during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method |
| Secondary | Percentage of Participants With Pathological Complete Response (pCR) | Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) | pCR was defined (for neoadjuvant participants who underwent interval debulking surgery \[IDS\]), as the chemotherapy response score 3 (CSR3), based on a study by Bohm et al, 2015. CSR3 was defined as complete or near-complete response with no residual tumor or minimal irregularly scattered tumor foci seen as individual cells, cell groups, or nodules up to 2 mm. Complete or near-complete response was defined as complete or near-complete microscopic disappearance of invasive tumor/ residual disease. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes36
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) | Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) | The full analysis set included all randomized participants. | months | MEDIAN |
| SECONDARY | Overall Survival | Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) | The full analysis set included all randomized participants. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) as Assessed by Investigator | Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) | The full analysis set included all randomized participants. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response as Assessed by Investigator | Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months) | The full analysis set included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response as Assessed by Blinded Independent Central Review (BICR) | Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months) | The full analysis set included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) as Assessed by Investigator | First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) | Analysis was performed on subset of randomized participants, who had objective response, as assessed by Investigator. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR) | First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) | Analysis was performed on subset of randomized participants, who had objective response, as assessed by BICR. | months | MEDIAN |
| SECONDARY | Maintenance Progression-Free Survival as Assessed by Blinded Independent Central Review (BICR) | From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months) | The analysis set included randomized participants who proceeded to maintenance phase and who did not have PD by BICR assessment during the chemotherapy phase. | months | MEDIAN |
| SECONDARY | Maintenance Progression-Free Survival (PFS) as Assessed by Investigator | From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months) | The analysis set included randomized participants who proceeded to maintenance phase and who did not have PD by investigator assessment during the chemotherapy phase. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Pathological Complete Response (pCR) | Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) | Analysis was performed on a subset of randomized participants which included neoadjuvant participants who underwent IDS. | percentage of participants | NUMBER |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 outcomesResults by group318
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) | Chemotherapy Followed by Avelumab | 16.8 | 95% Confidence Interval 13.5 to NA | months | |
| Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) | Chemotherapy + Avelumab Followed by Avelumab | 18.1 | 95% Confidence Interval 14.8 to NA | months | |
| Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) | Chemotherapy Followed by Observation | NA | 95% Confidence Interval 18.2 to NA | months | |
| Overall Survival | Chemotherapy Followed by Avelumab | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival | Chemotherapy + Avelumab Followed by Avelumab | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival | Chemotherapy Followed by Observation | NA | 95% Confidence Interval NA to NA | months | |
| Progression-Free Survival (PFS) as Assessed by Investigator | Chemotherapy Followed by Avelumab | 13.8 | 95% Confidence Interval 12.1 to 15.9 | months | |
| Progression-Free Survival (PFS) as Assessed by Investigator | Chemotherapy + Avelumab Followed by Avelumab | 16.1 | 95% Confidence Interval 13.9 to 19.4 | months | |
| Progression-Free Survival (PFS) as Assessed by Investigator | Chemotherapy Followed by Observation | 15.0 | 95% Confidence Interval 13.2 to 18.7 | months | |
| Percentage of Participants With Objective Response as Assessed by Investigator | Chemotherapy Followed by Avelumab | 25.9 | 95% Confidence Interval 21.3 to 31.0 | percentage of participants |
1 to 10 of 318Source ClinicalTrials.gov
See all 318 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Chemotherapy Phase (CP) | STARTED | Chemotherapy Followed by Avelumab | 332 | |
| Chemotherapy Phase (CP) | STARTED | Chemotherapy + Avelumab Followed by Avelumab | 331 | |
| Chemotherapy Phase (CP) | STARTED | Chemotherapy Followed by Observation | 335 | |
| Chemotherapy Phase (CP) | Safety Population | Chemotherapy Followed by Avelumab | 328 | |
| Chemotherapy Phase (CP) | Safety Population | Chemotherapy + Avelumab Followed by Avelumab | 329 | |
| Chemotherapy Phase (CP) | Safety Population | Chemotherapy Followed by Observation | 334 | |
| Chemotherapy Phase (CP) | COMPLETED | Chemotherapy Followed by Avelumab | 280 | |
| Chemotherapy Phase (CP) | COMPLETED | Chemotherapy + Avelumab Followed by Avelumab | 294 | |
| Chemotherapy Phase (CP) | COMPLETED | Chemotherapy Followed by Observation | 289 | |
| Chemotherapy Phase (CP) | NOT COMPLETED | Chemotherapy Followed by Avelumab | 52 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events747
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 | Abdominal distension | Gastrointestinal disorders | Chemotherapy Followed by Avelumab | 22 | 328 | |
| other | Abdominal distension | Gastrointestinal disorders | Chemotherapy + Avelumab Followed by Avelumab | 17 | 329 | |
| other | Abdominal distension | Gastrointestinal disorders | Chemotherapy Followed by Observation | 18 | 334 | |
| other | Abdominal pain | Gastrointestinal disorders | Chemotherapy Followed by Avelumab | 69 | 328 | |
| other | Abdominal pain | Gastrointestinal disorders | Chemotherapy + Avelumab Followed by Avelumab | 68 | 329 | |
| other | Abdominal pain | Gastrointestinal disorders | Chemotherapy Followed by Observation | 58 | 334 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Chemotherapy Followed by Avelumab | 32 | 328 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Chemotherapy + Avelumab Followed by Avelumab | 39 | 329 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Chemotherapy Followed by Observation | 24 | 334 | |
| other | Alanine aminotransferase increased | Investigations | Chemotherapy Followed by Avelumab | 28 | 328 |
1 to 10 of 747Source ClinicalTrials.gov
See all 747 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy Followed by Avelumab | 34 | 328 |
| Total, all-cause mortality | Chemotherapy + Avelumab Followed by Avelumab | 31 | 329 |
| Total, all-cause mortality | Chemotherapy Followed by Observation | 20 | 334 |
| Total, other adverse events | Chemotherapy Followed by Avelumab | 320 | 328 |
| Total, other adverse events | Chemotherapy + Avelumab Followed by Avelumab | 325 | 329 |
| Total, other adverse events | Chemotherapy Followed by Observation | 317 | 334 |
| Total, serious adverse events | Chemotherapy Followed by Avelumab | 92 | 328 |
| Total, serious adverse events | Chemotherapy + Avelumab Followed by Avelumab | 118 | 329 |
| Total, serious adverse events | Chemotherapy Followed by Observation | 64 | 334 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34363762 | DERIVED |
Source PubMed
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.
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/NCT02718417
GET https://conductscience.org/api/trials/v1/NCT02718417/registered?page=2