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)

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 daysfollowing the last administered dose of platinum therapy (resistant), or lack ofresponse 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 platinumresistant disease
• Measurable disease by investigator assessment with at least 1 unidimensionalmeasurable lesion by RECIST v.1.1 that has not previously been irradiated
• Active autoimmune disease that might deteriorate when receiving an immunostimulatoryagents. Patients with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroiddisease not requiring immunosuppressive treatment are eligible. Mandatory tumor biopsy must be performed prior to enrollment for all patients (unless thereis a documented clinical contraindication). In addition, availability of archived FFPEtumor tissue should be confirmed. If a patient underwent tumor tissue collection within 3months prior to enrollment with no intervening treatment, and the sample is provided, thena new de novo tumor biopsy is not required.

Exclusion Criteria:

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