Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: Avelumab; Drug: carboplatin; Drug: paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02718417

JAVELIN OVARIAN 100 (Other Identifier)

B9991010

2015-003239-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 998 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Histologically confirmed Stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component
• Patients must be candidates for platinum based chemotherapy and previously untreated
• Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy
• Availability of an archival formalin fixed, paraffin embedded (FFPE) tumor tissue block or a minimum of 15 slides
• ECOG PS 0-1
• Adequate hematological, renal, and liver function

Key Exclusion Criteria:

• Non epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors
• Prior systemic anti-cancer treatment for EOC, FTC, or PPC including prior immunotherapy with IL 2, IFN α, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways
• Patients for whom, in the opinion of the Investigator, there is clinical benefit to administer bevacizumab as a first-line treatment and for whom bevacizumab is approved and available in this setting.
• Cancer for which intraperitoneal cytotoxic chemotherapy is planned
• Active autoimmune disease (some exceptions include diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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998 participants in 3 patient groups

Arm A

Active Comparator group

Description:

Chemotherapy followed by observation

Treatment:

Drug: carboplatin

Drug: paclitaxel

Arm B

Experimental group

Description:

Chemotherapy followed by avelumab in maintenance

Treatment:

Drug: Avelumab

Drug: carboplatin

Drug: paclitaxel

Drug: Avelumab

Arm C

Experimental group

Description:

Chemotherapy in combination with avelumab followed by avelumab in maintenance

Treatment:

Drug: Avelumab

Drug: carboplatin

Drug: paclitaxel

Drug: Avelumab