A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)

• ClinicalTrials.gov Identifier: NCT02580058
• Recruitment Status: Completed
• First Posted: October 20, 2015
• Results First Posted: November 19, 2019
• Last Update Posted: July 10, 2023
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: October 16, 2015
• First Posted Date: October 20, 2015
• Results First Submitted Date: September 9, 2019
• Results First Posted Date: November 19, 2019
• Last Update Posted Date: July 10, 2023
• Actual Study Start Date: December 21, 2015
• Actual Primary Completion Date: September 19, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 1, 2019)

• Overall Survival (OS) [ Time Frame: From randomization until the date of first documented progression or date of deaths from any cause, whichever came first, assessed up to 30 months (based on cutoff date: 19 September 2018). ]
  OS is defined as the time from the date of randomization to the date of death due to any cause. OS time was summarized by treatment arm using the Kaplan-Meier method.
• Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018. ]
  PFS is defined as the time from date of randomization to the date of the first documentation of progression of disease (PD) or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method. PFS based on BICR assessment was evaluated for this endpoint.

Original Primary Outcome Measures (submitted: October 16, 2015)

Overall Survival (OS) [ Time Frame: randomization up to approximately 20 months ]

Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.

Current Secondary Outcome Measures (submitted: June 20, 2023)

• Objective Response Rate (ORR) Based on BICR Assessment [ Time Frame: Tumor assessments as assessed by BICR were conducted at every 8 weeks from screening until documented disease progression (approximately up to 30 months); based on cutoff date: 19 September 2018. ]
  Percentage of participants achieved objective response (OR) based on BICR assessment is presented for this endpoint. OR is defined as a complete response (CR, disappearance of all target lesions) or partial response (PR, >=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met and before the first documentation of disease progression. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response.
• ORR Based on Investigator Assessment [ Time Frame: Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018. ]
  Percentage of participants achieved OR based on investigator assessment is presented for this endpoint. OR is defined as a CR (disappearance of all target lesions) or PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. The ORR on each randomized treatment arm were estimated by dividing the number of participants with OR (CR or PR) by number of participants randomized to the respective treatment arm.
• PFS Based on Investigator Assessment According to RECIST Version 1.1 [ Time Frame: From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018. ]
  PFS is defined as the time from date of randomization to the date of the first documentation of PD or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method.
• Duration of Response (DR) Based on BICR Assessment [ Time Frame: Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018. ]
  DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR [disappearance of all target lesions] or PR [>=30% decrease under the baseline of the sum of diameters of all target measurable lesions]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.
• DR Based on Investigator Assessment [ Time Frame: Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018. ]
  DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR [disappearance of all target lesions] or PR [>=30% decrease under the baseline of the sum of diameters of all target measurable lesions]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.
• Disease Control (DC) Rate Based on BICR Assessment [ Time Frame: Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018. ]
  Percentage of participants achieving DC based on BICR assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or stable disease (SD) according to the RECIST version 1.1.
• DC Rate Based on Investigator Assessment [ Time Frame: Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018. ]
  Percentage of participants achieving DC based on investigator assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or SD according to the RECIST version 1.1.
• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From the time of the first dose of study treatment through a minimum of 30 days + last dose of study treatment, start day of new anti-cancer therapy -1 day (up to 70 months); based on cutoff date: 13 July 2022. ]
  An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; progression of the malignancy under study. Treatment emergent AEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period.
• Number of Participants With Laboratory Abnormalities [ Time Frame: From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018. ]
  The number of participants with following laboratory abnormalities meeting any of the Grades 1 to 4 classified according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading version 4.03 were summarized: hematology (anemia, lymphocyte count decreased, neutrophil count decreased; and platelet count decreased) and chemistry laboratory tests (creatinine increased; serum amylase increased and lipase increased).
• Change From Baseline in Vital Signs - Blood Pressure [ Time Frame: From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018. ]
  Vital signs included blood pressure and pulse rate. Changes from baseline in sitting diastolic blood pressure (DBP) and systolic blood pressure (SBP) were summarized.
• Change From Baseline in Vital Signs - Pulse Rate [ Time Frame: From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018. ]
  Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized.
• Number of Participants With Electrocardiogram (ECG) Abnormalities [ Time Frame: From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018. ]
  Categorical summarization ECG criteria were as follows: 1) QT interval, QTcB, QTcF and QTcP: increase from baseline >30 ms or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR): change from baseline >=20 bpm and absolute value <=50 bpm or >=120 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS: >= 120 ms.
• Number of Participants With % Left Ventricular Ejection Fraction (LVEF) Decrease From Baseline [ Time Frame: Screening, Cycle 3 Day 1 (repeated every 2 cycles) to the end of treatment/withdrawal visit, based on cutoff date: 19 September 2018. ]
  LVEF decrease was summarized by multiple-gated acquisition (MUGA)/ echocardiogram (ECHO) parameter. Participants with a LVEF% >=10 points and >= 15 points decrease from baseline during the on-treatment period were summarized.
• Number of Participants With PD-L1 Expression for PFS (Based on BICR Assessment) and for OS [ Time Frame: Biomarkers are measured only at screening. ]
  PD-L1 expression was assessed by immunohistochemistry. Participants were considered positive for PD-L1 if their baseline tissue sample demonstrated PD-L1 expression on >=1% of tumor cells or >=5% of immune cells.
• Number of Participants With CD8 Expression for PFS (Based on BICR Assessment) and for OS [ Time Frame: Biomarkers are measured only at screening. ]
  Tumor infiltrating CD8 positive (CD8+) T lymphocytes was assessed by immunohistochemistry. Participants were considered positive for CD8 T cells if their baseline tissue sample demonstrated presence of >=1% CD8+ cells across the area of the tumor.
• Number of Participants With Improved, Stable and Deterioration Based on 10-Point Change for EORTC QLQ-C30 Global QoL [ Time Frame: Day 1 of Cycle 1, Day 1 of each subsequent cycle, end of treatment/withdrawal visit and the 30, 60 and 90 days safety follow up visits, based on cutoff date: 19 September 2018. ]
  The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) is a 30 question survey and includes 5 functional domain subscales, global health status/quality of life, disease/treatment related symptoms, and the perceived financial impact of disease. Higher scores are reflective of a greater presence of symptoms.
• Time to Deterioration in Abdominal/GI Symptom Subscale of EORTC QLQ-OV28 [ Time Frame: From Day 1 of Cycle 1 to prior to end of treatment/withdrawal visit, based on cutoff date: 19 September 2018. ]
  The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer 28 (EORTC QLQ-OV28) is a 28 item instrument with 7 functional domain subscales. Time to deterioration was defined as the time from randomization to the first time the participant's score showed a 15-point or higher increase in the score of the abdominal/GI symptom subscale of the EORTC QLQ-OV28.
• Change From Baseline in EQ-VAS Score at End of Treatment [ Time Frame: Baseline and end of treatment/withdrawal visit ]
  The EuroQol- 5 Dimensions- 5 Levels (EQ-5D-5L) questionnaire consists of the EQ-5D-5L descriptive system and a visual analogue scale (the EuroQol-visual analogue scale [EQ-VAS]). The respondent's self-rated health is assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS.
• Serum Trough Concentration (Ctrough) For Avelumab Following Cycle 2 Day 1 Pegylated Liposomal Doxorubicin (PLD) Dose [ Time Frame: At predose (0 H) on Cycle 2 Day 1 ]
  Ctrough was defined as predose concentration during multiple dosing, and can be observed directly from data.
• Serum Maximum Concentration (Cmax) For Avelumab Following Cycle 2 Day 1 PLD Dose [ Time Frame: At postdose (end of infusion, 1H) on Cycle 2 Day 1 ]
  Cmax was defined as maximum observed serum concentration, and can be observed directly from data.
• Cmax For Doxorubicin Following Cycle 2 Day 1 PLD Dose [ Time Frame: From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose ]
  Cmax was defined as maximum observed serum concentration, and can be observed directly from data.
• Area Under The Concentration Time Profile From Time Zero to 24 Hours (AUC24) For Doxorubicin Following Cycle 2 Day 1 PLD Dose [ Time Frame: From 0 through 24 hours postdose ]
  AUC24 was defined as area under the concentration time profile from time zero to 24 hours.
• Area Under The Concentration Time Profile From Time Zero to 336 Hours (AUC336) For Doxorubicin Following Cycle 2 Day 1 PLD Dose [ Time Frame: From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose ]
  AUC336 was defined as area under the concentration time profile from time zero to 336 hours.
• Area Under The Concentration Time Profile From Time Zero to The Last Quantifiable Concentration (AUClast) For Doxorubicin Following Cycle 2 Day 1 PLD Dose [ Time Frame: From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose ]
  AUClast was defined as area under the concentration time profile from time zero to the time of the last quantifiable concentration (Clast).
• Number of Participants With Treatment-Boosted Anti-Drug Antibody (ADA) [ Time Frame: At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab ]
  Treatment-boosted ADA was defined as a positive ADA result at baseline and the titer ≥ 8×baseline titer at least once after treatment with avelumab.
• Number of Participants With Treatment-Induced ADA [ Time Frame: At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab ]
  Treatment-induced ADA was defined as participant who was ADA-negative at baseline and has at least one positive post-baseline ADA result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result.
• Number of Participants With Treatment-Induced Neutralizing Antibody (nAb) [ Time Frame: At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab ]
  Treatment-induced nAb was defined as participant who was not nAb positive at baseline and had at least one positive post-baseline nAb result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result.

Original Secondary Outcome Measures (submitted: October 16, 2015)

• OR (Objective Response) [ Time Frame: Baseline up to approximately 20 months ]
  Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥ 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥ 30% decrease in sum of the longest diameters dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.
• PFS (Progression Free Survival) [ Time Frame: randomization up to approximately 20 months ]
  The period from study entry until disease progression, death or date of last contact.
• DR (Duration of Response) [ Time Frame: first documentation of objective tumor response up to approximately 20 months ]
  Duration of response (DR) is defined, for patients with an objective response per RECIST v1.1, as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.
• DC (Disease Control) [ Time Frame: Randomization up to approximately 20 months ]
  Defined as complete response (CR), partial response (PR), or stable disease (SD) 24 weeks according to the RECIST version 1.1 recorded from randomization until disease progression or death due to any cause. The DC rate (DCR) on each randomized treatment arm will be estimated by dividing the number of patients with CR, PR, or SD 24 weeks by the number of patients randomized to the treatment arm. The corresponding exact 2 sided 95% CI for the DC rates will be provided by treatment arm
• Ctrough for avelumab [ Time Frame: pre dose and at the end of infusion (immediately before the end of avelumab infusion) on Days 1 and 15. ]
  Ctrough is defined as the trough plasma concentrate at the end of an avelumab interval
• Cmax for avelumab [ Time Frame: pre dose and at the end of infusion (immediately before the end of avelumab infusion) on Days 1 and 15. ]
  Cmax defined as the maximum plasma concentration of avelumab
• Cmax for PLD [ Time Frame: in the first 12 patients pre dose, immediately prior to end of infusion, and at 2, 6, 24, and 336 hours (Day 15) post start infusion of PLD on Day 1 of next dose. ]
  Cmax defined as the maximum plasma concentration of PLD
• Vd (volume of distribution) for PLD [ Time Frame: in the first 12 patients pre dose, immediately prior to end of infusion, and at 2, 6, 24, and 336 hours (Day 15) post start infusion of PLD on Day 1 of next dose. ]
  Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug
• CL (clearance) for PLD [ Time Frame: in the first 12 patients pre dose, immediately prior to end of infusion, and at 2, 6, 24, and 336 hours (Day 15) post start infusion of PLD on Day 1 of next dose. ]
  CL is a quantitative measure of the rate at which PLD is removed from the body
• AUC (area under the concentration time curve) for PLD [ Time Frame: in the first 12 patients pre dose, immediately prior to end of infusion, and at 2, 6, 24, and 336 hours (Day 15) post start infusion of PLD on Day 1 of next dose. ]
  AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption
• Incidence of Anti-Drug Antibody (ADA) [ Time Frame: prior to start of avelumab infusion on Day 1 and at end of treatment for up to 24 months. ]
  immunogenicity assessment for avelumab
• EORTC QLQ C30 [ Time Frame: once a month before dosing, up to 24 months ]
  30 question survey and includes 5 functional domain subscales, including a physical functioning sub scale, a role functioning subscale, an emotional functioning sub scale, a cognitive functioning sub scale and a social functioning subscale. Higher scores on the functioning domains are indicative of higher levels of functioning
• 7.2.2. EORTC QLQ OV28 [ Time Frame: once a month before dosing, up to 24 months ]
  28 item instrument with seven (7) functional domain subscales. The 7 subscales include: (i) an abdominal/gastrointestinal symptom subscale (7 items); (ii) a peripheral neuropathy subscale (3 items); (iii) an other chemotherapy side effects subscale (7 items); (iv) a hormonal/menopausal symptoms subscale (2 items); (v) a body image subscale (2 items); (vi) an attitude to disease and treatment subscale (3 items) and (vii) a sexual function subscale (4 items)
• FOSI [ Time Frame: once a month before dosing, up to 24 months ]
  a very brief ovarian cancer symptom index derived from the FACT O (ie, Functional Assessment of Cancer Therapy Ovarian) to measure symptom response to treatment for ovarian cancer. The 8 item FOSI includes items assessing worry about future deterioration, contentment with QoL, and lack of energy in addition to 5 questions to assess GI related symptoms
• EuroQoL EQ 5D [ Time Frame: once a month before dosing, up to 24 months ]
  6 item patient completed questionnaire designed to assess health status in terms of a single index value or utility score. There are 2 components to the EuroQol EQ 5D: a Health State Profile which has individuals rate their level of problems (no, some or moderate, extreme) in 5 areas (mobility, self care, usual activities, pain/discomfort, and anxiety/depression) and a Visual Analogue Scale (VAS) in which patients rate their overall health status from 0 (worst imaginable) to 100 (best imaginable). Published weights are available that allow for the creation of a single summary score. Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction
• Tumor Tissue Biomarkers [ Time Frame: Baseline, optional sample at disease progression ]
  May include but not limited to PD L1 expression and tumor infiltrating CD8+ T lymphocytes by IHC, and/or tissue expression of FoxP3, PD 1, PD L2
• Nab (neutralizing antibodies) against avelumab [ Time Frame: performed if ADA is positive: prior to start of avelumab infusion on Day 1 and at end of treatment for up to 24 months. ]
  immunogenicity assessment for avelumab

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)
• Official Title: A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB (MSB0010718C) ALONE OR IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS PEGYLATED LIPOSOMAL DOXORUBICIN ALONE IN PATIENTS WITH PLATINUM-RESISTANT/REFRACTORY OVARIAN CANCER
• Brief Summary: A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ovarian Cancer

Intervention

• Biological: avelumab
  10 mg/kg will be given as a 1 hour intravenous infusion (IV) every 2 weeks (Q2W) in 4 week cycles
• Drug: PLD
  PLD (Arm B, Arm C) 40 mg/m2 will be given as a 1 hour IV infusion every 4 weeks (Q4W) in 4 week cycles
  Other Name: doxorubicin, caelyx

Study Arms

• Experimental: avelumab
  Arm A: avelumab alone
  Intervention: Biological: avelumab
• Experimental: avelumab plus pegylated liposomal doxorubicin (PLD)
  Arm B: avelumab plus PLD
  Interventions:

  • Biological: avelumab
  • Drug: PLD
• Active Comparator: PLD
  Arm C: PLD alone
  Intervention: Drug: PLD

• Publications *: Pujade-Lauraine E, Fujiwara K, Ledermann JA, Oza AM, Kristeleit R, Ray-Coquard IL, Richardson GE, Sessa C, Yonemori K, Banerjee S, Leary A, Tinker AV, Jung KH, Madry R, Park SY, Anderson CK, Zohren F, Stewart RA, Wei C, Dychter SS, Monk BJ. Avelumab alone or in combination with chemotherapy versus chemotherapy alone in platinum-resistant or platinum-refractory ovarian cancer (JAVELIN Ovarian 200): an open-label, three-arm, randomised, phase 3 study. Lancet Oncol. 2021 Jul;22(7):1034-1046. doi: 10.1016/S1470-2045(21)00216-3. Epub 2021 Jun 15.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 3, 2018): 566
• Original Estimated Enrollment (submitted: October 16, 2015): 550
• Actual Study Completion Date: July 12, 2022
• Actual Primary Completion Date: September 19, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component.
• Platinum resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively.
• Received up to 3 lines of systemic anticancer therapy for platinum sensitive disease, most recently platinum containing, and no prior systemic therapy for platinum resistant disease
• Measurable disease by investigator assessment with at least 1 unidimensional measurable lesion by RECIST v.1.1 that has not previously been irradiated
• Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible.

Mandatory tumor biopsy must be performed prior to enrollment for all patients (unless there is a documented clinical contraindication). In addition, availability of archived FFPE tumor tissue should be confirmed. If a patient underwent tumor tissue collection within 3 months prior to enrollment with no intervening treatment, and the sample is provided, then a new de novo tumor biopsy is not required.

Exclusion Criteria:

• Non epithelial tumor or ovarian tumors with low malignant potential (ie, borderline tumors).
• Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab, tremelimumab or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways).
• Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks prior to study entry and are neurologically stable.
• Diagnosis of any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.
• Severe gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4 weeks prior to enrollment, or history of inflammatory bowel disease.

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, Norway, Poland, Russian Federation, Singapore, Spain, Switzerland, Taiwan, United Kingdom, United States
• Removed Location Countries: Czech Republic

Administrative Information

• NCT Number: NCT02580058
• Other Study ID Numbers: B9991009; 2015-003091-77 ( EudraCT Number ); JAVELIN OVARIAN 200 ( Other Identifier: Alias Study Number )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Current Responsible Party: Pfizer
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: June 2023