A Randomized Multicenter Phase II Trial to Evaluate the Safety, Efficacy and Immunogenicity of Vaccination With Folate Receptor Alpha Peptides With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer and a Response or Stable Disease to Platinum Therapy
This is a double-blind, randomized, parallel groups Phase II trial. Patients with platinum-sensitive advanced ovarian cancer, defined as a lack of progression by RECIST v1.1 criteria following completion of standard-of-care chemotherapy, including a minimum of 4 cycles of a platinum-containing regimen. Patients will be randomized to either the vaccine regimen with GM-CSF adjuvant or GM-CSF adjuvant alone as a control group. Treatment will be administered as a consolidation therapy within one year of the last administration of platinum, targeting the first remission.
• Female patient ≥ 18 years
• Willing and able to give informed consent
• Stage III-IV platinum-sensitive (defined as a lack of progression by RECIST v1.1 criteria following completion of standard-of-care chemotherapy, including a minimum of 4 cycles of a platinum-containing regimen) epithelial ovarian, fallopian tube or primary peritoneal carcinoma in first remission.
• Histologic documentation of diagnosis of carcinoma is required and the following histologic subtypes are eligible: high grade (grade ≥3+) serous or endometrioid carcinoma, carcinosarcoma, or poorly-differentiated adenocarcinoma, or mixed (including above subtypes only). Note that synchronous serous or endometrioid uterine or fallopian cancers are allowed.
• The patient must have demonstrated an objective response (PR or CR) or stable disease (SD) with the last chemotherapy prior to enrollment and this response must be stable (without progressive disease) before randomization.
• Patients must receive their first dose of vaccine within 1 year of completion of their final dose of a chemotherapeutic agent of the platinum-containing regimen
• Adequate normal organ and marrow function within 14 days prior to first vaccine administration:
‣ Absolute neutrophil count \> 1.5 x 109/L
⁃ Platelet \> 100 x 109/L
⁃ Hemoglobin \> 9.0 g/dL
⁃ Serum bilirubin \< 1.5 times ULN (unless Gilbert's syndrome without concurrent clinically significant liver disease
⁃ AST/ALT \< 2.5 ULN unless liver metastasis in which case it must be \< 5 x ULN
⁃ Serum creatinine CL \> 40 mL/min by Cockcroft-Gault formula.
• Anti-nuclear antibody (ANA) negative or low-positive institutional range, as determined within 28 days from registration. Intermediate values (usually defined by a titer of ≤1:80, or as indicated by institutional range) are acceptable if there are, in the opinion of the Investigator, no early signs of an autoimmune disease.
• Female subjects must either be of non-reproductive potential (i.e. post-menopause by history: \> 60 years old and no menses for \> 12 months naturally or secondary to radiation/chemotherapy; OR serum FSH, LH and estradiol levels in the post-menopausal range; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy), or must have a negative serum pregnancy test upon study entry
⁃ Life expectancy \> 24 weeks
⁃ ECOG performance status of 0 or 1
⁃ Formalin fixed, paraffin embedded tumor sample from the primary cancer must be sent for central testing.