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)
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: avelumab; PLD
Intervention description: 10 mg/kg will be given as a 1 hour intravenous infusion (IV) every 2 weeks (Q2W) in 4 week cycles; 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
Intervention MeSH terms: Doxorubicin; Avelumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 566.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: platinum resistant; platinum refractory

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.
    

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.