Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
This study aims to evaluate the safety and activity of the Avelumab in combination with Carboplatin-Paclitaxel in advanced or recurrent endometrial cancer
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Women who are pregnant or lactating
Patients with brain metastases, except those meeting the following criteria:
Prior Anticancer treatment for advanced disease and/or prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. Previous hormonal therapy for advanced disease is allowed, but treatment must be discontinued at least 28 days prior to registration for protocol therapy
History of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3)
Prior organ transplantation, including allogeneic stem cell transplantation
Significant acute or chronic infections including, among others:
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
Persisting toxicity related to prior therapy of Grade >1 NCI-CTCAE v 4.03; however, alopecia and sensory neuropathy Grade ≤ 2 is acceptable
Another primary malignancy within the past five years (except for non-melanoma skin cancer and cervical carcinoma in situ).
Concurrent treatment with immunosuppressive or investigational agents EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
Active cardiac disease, defined as:
Known alcohol or drug abuse
Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines
Any psychiatric condition that would prohibit the understanding or rendering of informed consent
All other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the Investigator, All other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma) including recent or active suicidal ideation or behavior, which, in the opinion of the Investigator, may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Primary purpose
Allocation
Interventional model
Masking
125 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal