NL-OMON45949
Completed
Phase 3
A Randomized, Open-Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Avelumab (MSB0010718C) in Combination with and/or Following Chemotherapy in Patients with Previously Untreated Epithelial Ovarian Cancer - JAVELIN OVARIAN 100
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- ovarian cancer
- Sponsor
- Pfizer
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histologically confirmed Stage III\-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer (according to AJCC/UICC TNM and International Federation of Gynecology and Obstetrics (FIGO) Staging System 2014 edition), including malignant mixed Müllerian tumors with high grade serous component.
- •2\. Patients must be candidates for platinum\-based chemotherapy and previously untreated.
- •3\. Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy.
- •a. For patients enrolling after debulking surgery, the following conditions must be met:
- •\* The minimum surgery required is an abdominal surgery with an attempt at cytoreduction providing tissue for histologic evaluation and establishing and documenting the primary site and stage
- •\* Patient must be randomized at a maximum of 8 weeks after surgery.
- •b. For patients who are candidates for neoadjuvant chemotherapy, the following conditions must be met:
- •\* A core tissue (not fine needle aspiration) biopsy is required. The tissue must be consistent with a tumor of Müllerian origin.
- •\* Stage IIIC\*IV documented via imaging or surgery (without attempt at cytoreduction)
- •\* Serum CA125/ CEA ratio \> 25\. If the serum CA125/CEA ratio is \< 25, workup should be negative for the presence of a primary gastrointestinal or breast malignancy (\< 6 weeks before randomization).
Exclusion Criteria
- •1\. Non\-epithelial tumors, or ovarian tumors with low malignant potential (ie, borderline tumors).
- •2\. Mucinous tumors.
- •3\. 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.
- •4\. Cancer for which intraperitoneal cytotoxic chemotherapy is planned.
- •5\. Prior systemic anti\-cancer treatment for EOC, FTC, or PPC.
- •6\. Prior immunotherapy with IL\-2, IFN\-\*, 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 costimulation or immune checkpoint pathways.
- •7\. Major surgery (other than debulking surgery) for any reason within 4 weeks prior to randomization and/or incomplete recovery from surgery.
- •8\. Known brain, leptomeningeal, or spinal cord metastases.
- •9\. Current or prior use of immunosuppressive medication within 7 days prior to randomization, except the following: intranasal, inhaled, topical steroids, or local steroid injections (eg, intra\-articular injection); systemic corticosteroids at physiologic doses \*10 mg/day of prednisone
- •or equivalent; steroids as premedication for hypersensitivity reactions \[eg, computed tomography (CT) scan premedication].
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 3
A Phase 3 Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physician's Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosisprimary amyloidosisprimary systemic amyloidosis (PSA)10035227NL-OMON50586Millenium Pharmaceuticals7
Completed
Phase 3
A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME-401) in Combination with Rituximab Versus Standard Immunochemotherapy in Patients with Relapsed Indolent Non-Hodgkin*s Lymphoma (iNHL) - The COASTAL Studycancer from white blood cellsLymph node cancer. Recurringslow growing10025322NL-OMON51210MEI Pharma Inc.1
Completed
Phase 3
A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of lenalidomide (Revlimid®) as maintenance therapy for high-risk patients with chronic lymphocytic leukemia following first-line therapyNL-OMON44081HOVO5
Completed
Phase 3
A randomized, multicenter, double-blind phase 3 study of amcenestrant (SAR439859) plus palbociclib versus letrozole plus palbociclib for the treatment of patients with ER (+), HER2 (-) breast cancer who have not received prior systemic anti-cancer treatment for advanced diseaseAdvanced Breast cancer. Metastatic Breastcancer10006291NL-OMON55315Genzyme Europe BV17
Completed
Phase 3
Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302)Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterationsbladder cancerUrothelial Carcinoma10046447NL-OMON55032QED Therapeutics, Inc.5