18 and older, female only, with Ovarian 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.
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)Primary· 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 ba
Group
Value
95% CI
Chemotherapy Followed by Avelumab
16.8
13.5 – NA
Chemotherapy + Avelumab Followed by Avelumab
18.1
14.8 – NA
Chemotherapy Followed by Observation
NA
18.2 – NA
Overall SurvivalSecondary· 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.
Group
Value
95% CI
Chemotherapy Followed by Avelumab
NA
NA – NA
Chemotherapy + Avelumab Followed by Avelumab
NA
NA – NA
Chemotherapy Followed by Observation
NA
NA – NA
Progression-Free Survival (PFS) as Assessed by InvestigatorSecondary· 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 pr
Group
Value
95% CI
Chemotherapy Followed by Avelumab
13.8
12.1 – 15.9
Chemotherapy + Avelumab Followed by Avelumab
16.1
13.9 – 19.4
Chemotherapy Followed by Observation
15.0
13.2 – 18.7
Percentage of Participants With Objective Response as Assessed by InvestigatorSecondary· 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.
Group
Value
95% CI
Chemotherapy Followed by Avelumab
25.9
21.3 – 31.0
Chemotherapy + Avelumab Followed by Avelumab
31.1
26.2 – 36.4
Chemotherapy Followed by Observation
27.8
23.0 – 32.9
Percentage of Participants With Objective Response as Assessed by Blinded Independent Central Review (BICR)Secondary· 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.
Group
Value
95% CI
Chemotherapy Followed by Avelumab
30.4
25.5 – 35.7
Chemotherapy + Avelumab Followed by Avelumab
36.0
30.8 – 41.4
Chemotherapy Followed by Observation
30.4
25.6 – 35.7
Duration of Response (DOR) as Assessed by InvestigatorSecondary· 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 th
Group
Value
95% CI
Chemotherapy Followed by Avelumab
10.6
8.3 – 20.2
Chemotherapy + Avelumab Followed by Avelumab
NA
11.7 – NA
Chemotherapy Followed by Observation
15.4
8.3 – 18.4
Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR)Secondary· 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
Group
Value
95% CI
Chemotherapy Followed by Avelumab
11.9
8.9 – NA
Chemotherapy + Avelumab Followed by Avelumab
14.5
11.7 – NA
Chemotherapy Followed by Observation
NA
16.1 – NA
Maintenance Progression-Free Survival as Assessed by Blinded Independent Central Review (BICR)Secondary· 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 incre
Group
Value
95% CI
Chemotherapy Followed by Avelumab
13.6
9.3 – NA
Chemotherapy + Avelumab Followed by Avelumab
13.8
11.1 – NA
Chemotherapy Followed by Observation
NA
13.8 – NA
Maintenance Progression-Free Survival (PFS) as Assessed by InvestigatorSecondary· 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 th
Group
Value
95% CI
Chemotherapy Followed by Avelumab
10.4
8.2 – 13.6
Chemotherapy + Avelumab Followed by Avelumab
11.6
9.9 – 13.8
Chemotherapy Followed by Observation
12.7
9.5 – NA
Percentage of Participants With Pathological Complete Response (pCR)Secondary· 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.
Group
Value
95% CI
Chemotherapy Followed by Avelumab
15.7
Chemotherapy + Avelumab Followed by Avelumab
17.4
Chemotherapy Followed by Observation
25.9
Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on, National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03Secondary· Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 36 months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care
Grade 1
Group
Value
95% CI
Chemotherapy Followed by Avelumab
11
Chemotherapy + Avelumab Followed by Avelumab
13
Chemotherapy Followed by Observation
15
Grade 2
Group
Value
95% CI
Chemotherapy Followed by Avelumab
89
Chemotherapy + Avelumab Followed by Avelumab
77
Chemotherapy Followed by Observation
96
Grade 3
Group
Value
95% CI
Chemotherapy Followed by Avelumab
151
Chemotherapy + Avelumab Followed by Avelumab
148
Chemotherapy Followed by Observation
131
Grade 4
Group
Value
95% CI
Chemotherapy Followed by Avelumab
67
Chemotherapy + Avelumab Followed by Avelumab
84
Chemotherapy Followed by Observation
76
Grade 5
Group
Value
95% CI
Chemotherapy Followed by Avelumab
5
Chemotherapy + Avelumab Followed by Avelumab
6
Chemotherapy Followed by Observation
3
Number of Participants With Laboratory Abnormalities Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03Secondary· Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
As per NCI-CTCAE v 4.03, Grade 3 and above criteria were; Hematology \[Anemia - Grade 3: hemoglobin \<8.0 grams per deciliter (g/dL), \<4.9 millimoles per liter (mmol/L), \<80 grams per liter (g/L), transfusion indicated, Grade 4: life-threatening consequences, urgent intervention indicated, Grade 5: death; platelet count decreased- Grade 3:\<50.0 to 25.0\*10\^9/Liters(L), Grade 4: \<25.0\*10\^9/L; lymphocyte count decreased-Grade 3: \<0.5-0.2\*10\^9/L, Grade 4: \<0.2\*10\^9/L; neutrophil count decreased-Grade 3: \<1.0 to 0.5\*10\^9 /L, Grade 4: \<0.5\*10\^9/L\]. Chemistry \[creatinine increas
Anemia
Group
Value
95% CI
Chemotherapy Followed by Avelumab
73
Chemotherapy + Avelumab Followed by Avelumab
68
Chemotherapy Followed by Observation
63
Platelet Count Decreased
Group
Value
95% CI
Chemotherapy Followed by Avelumab
20
Chemotherapy + Avelumab Followed by Avelumab
35
Chemotherapy Followed by Observation
38
Lymphocyte Count Decreased
Group
Value
95% CI
Chemotherapy Followed by Avelumab
35
Chemotherapy + Avelumab Followed by Avelumab
63
Chemotherapy Followed by Observation
29
Neutrophil Count Decreased
Group
Value
95% CI
Chemotherapy Followed by Avelumab
144
Chemotherapy + Avelumab Followed by Avelumab
159
Chemotherapy Followed by Observation
156
Creatinine Increased
Group
Value
95% CI
Chemotherapy Followed by Avelumab
2
Chemotherapy + Avelumab Followed by Avelumab
7
Chemotherapy Followed by Observation
0
Serum Amylase Increased
Group
Value
95% CI
Chemotherapy Followed by Avelumab
5
Chemotherapy + Avelumab Followed by Avelumab
9
Chemotherapy Followed by Observation
10
Lipase Increased
Group
Value
95% CI
Chemotherapy Followed by Avelumab
19
Chemotherapy + Avelumab Followed by Avelumab
24
Chemotherapy Followed by Observation
11
ALT or AST
Group
Value
95% CI
Chemotherapy Followed by Avelumab
0
Chemotherapy + Avelumab Followed by Avelumab
1
Chemotherapy Followed by Observation
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to maximum duration of 36 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for platinum-based chemotherapy.
The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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: 14 July 2020
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/NCT02718417.