Clinical Trials

Title   Gradalis CL-PTL-126
Principal Investigator/ Physician   Rodney Rocconi, MD
Protocol┬áNo.   CL-PTL-126
Open Date   03/17/2017
Gender   Female
Cancer Site   Ovarian
Status   Open
Sponsor   Gradalis
Contact Email   MCI Clinical Trials

Protocol: A Randomized, Intra-patient Crossover, Safety,Biomarker and Anti-Tumor Activity Assessment of the Combination of Atezolizumab and Vigil in Patients with Advanced Gynecological Cancers

Inclusion Criteria: Successful manufacturing of at least 4 vials of Vigil; Failure to meet the eligibililty criteria for Protocol CL-PTL-119 due to i) histology of ovarian cancer and failure to achieve a complete clinical response following primary debulking surgery and standard paclitaxel/carboplatin therapy OR, ii) a histologic diagnosis of another gynecologic malignancy which is not ovarian cancer; ECOG performance status (PS) ≤ 1; Estimated survival ≥ 6 months; Measureable or evaluable disease; Adequate organ and bone marrow function.

Exclusion Criteria: Rceived more than two additional chemotherapy regimens for platinum resistant/refractory ovarian cancer, after their initial treatment with paclitaxel/carboplatin, OR have received more than two additional chemotherapy regimens for the treatment of another gynecologic malignancy; Participation in another clinical study with an investigational product within the last 3 weeks prior to study start; Patients with autoimmune diseases are excluded from enrollment with the exception of patients with hypothyroidism on stable thyroxine replacement, and patients with T1DM on stable insulin replacement; Receipt of steroid therapy within the 2 weeks of the first dose of study therapy; Post-surgery complication; Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.


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