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Folate Receptor Alpha Peptide Vaccine With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Tapimmune Inc.
Sponsor:
Information provided by (Responsible Party):
Tapimmune Inc.
ClinicalTrials.gov Identifier:
NCT02978222
First received: November 22, 2016
Last updated: May 9, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Platinum Sensitive Ovarian Cancer Ovarian Cancer Biological: FRα peptide plus Adjuvant (GM-CSF) Drug: Adjuvant (GM-CSF) Alone Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Tapimmune Inc.:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 2 years ]
    Time to disease progression or recurrence of ovarian cancer defined as disease progression by RECIST 1.1., disease recurrence, death without progression or CA125 progression


Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 2 years ]
    Death with or without ovarian cancer progression

  • Best overall response rate [ Time Frame: 2 years ]
    Best overall response defined as sum of Complete Responses and Partial Responses in the subset of patients with measurable tumor lesions at baseline

  • Disease control rate [ Time Frame: 2 years ]
    Disease control rate defined as the sum of Complete Responses, Partial Responses and Stable Disease

  • Response Rate by immune-related RECIST (irRECIST) criteria [ Time Frame: 2years ]
  • Cancer Antigen (CA)-125 response [ Time Frame: 2years ]
    2 fold increase from from the baseline CA125 (if above normal at baseline) or 2-fold greater than normal limits (if within normal limits at baseline)


Estimated Enrollment: 120
Actual Study Start Date: January 26, 2017
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FRα peptide plus adjuvant (GM-CSF)
FRα peptide vaccine with GM-CSF adjuvant ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years
Biological: FRα peptide plus Adjuvant (GM-CSF)
Intradermal injection FRα peptides, 500μg each - plus GM-CSF 125 μg
Other Name: TPIV200 with GM-CSF adjuvant
Placebo Comparator: Adjuvant (GM-CSF) Alone
GM-CSF adjuvant alone ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years
Drug: Adjuvant (GM-CSF) Alone
Intradermal injection 125 μg GM-CSF
Other Name: Leukine®

Detailed Description:

This is a multicenter double-blind controlled randomized Phase II study to evaluate the activity of folate receptor alpha (FRα) peptide vaccine as a consolidation treatment following completion of no less than 4 cycles of a platinum containing regimen in patients with platinum-sensitive, non-mucinous ovarian, fallopian tube or primary peritoneal cancer.

The patients will have demonstrated a tumor response or stable disease upon their last regimen (per RECIST v1.1 and/or CA125 GCIG criteria) prior to enrolment in this study.

Following randomization, patients will be administered TPIV200 with GM-CSF adjuvant or GM-CSF control alone. Patients will have booster doses and tumor assessments done every 12 weeks ± 1 week for up to 1.5 years, until objective disease progression or the patient withdraws consent. Tumor responses will be assessed at the study sites by evaluating tumor images/scans according to RECIST v1.1.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Criteria for Inclusion:

  1. Female patient ≥ 18 years
  2. Willing and able to give informed consent
  3. 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.
  4. 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.
  5. 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.
  6. 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
  7. 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.
  8. 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.
  9. 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
  10. Life expectancy > 24 weeks
  11. ECOG performance status of 0 or 1
  12. Formalin fixed, paraffin embedded tumor sample from the primary cancer must be sent for central testing.

Criteria for Exclusion

  1. Histology consistent with non-serous, non-endometrioid (i.e. mucinous or clear cell), or low-grade or borderline serous ovarian carcinoma
  2. Patients with a history of other cancers (other than non-melanoma skin cancers [i.e. basal or squamous cell]) within the past 3 years.
  3. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, biological/cell therapy, tumor embolization, monoclonal antibodies, other investigational agent) < 28 days prior to the first dose of study drug.
  4. Current or prior use of immunosuppressive medication within 28 days prior to the fist dose of study drug with the exception of topical, intranasal or inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
  5. Active autoimmune disease requiring therapy within the past 2 years. Note: patients with vitiligo, Grave's disease or psoriasis not requiring systemic treatment within the past 2 years are not excluded.
  6. History of hypersensitivity to GM-CSF
  7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
  8. Symptomatic thyroid disease, unless negative for thyroid antibodies (TSH receptor, TPO, thyroglobulin).
  9. Subjects who are pregnant or are breast feeding.
  10. Subjects who or of reproductive potential, and are either:

    • Not abstinent;
    • Not in an exclusive relationship with a partner who is surgically sterile;
    • Not employing an effective method of birth control.
  11. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
  12. Symptomatic or uncontrolled brain metastasis requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids
  13. Subject with uncontrolled seizures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02978222

Contacts
Contact: Richard Kenney, MD 206.946.8012 rkenney@tapimmune.com
Contact: Gerald Garrett ggarrett@tapimmune.com

Locations
United States, Tennessee
Tennessee Oncology/Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: askSARAH    877-691-7274    asksarah@scresearch.com   
Principal Investigator: Erika Hamilton, MD         
Sponsors and Collaborators
Tapimmune Inc.
Investigators
Study Director: Richard Kenney, MD Tapimmune Inc.
  More Information

Responsible Party: Tapimmune Inc.
ClinicalTrials.gov Identifier: NCT02978222     History of Changes
Other Study ID Numbers: FRV-004
Study First Received: November 22, 2016
Last Updated: May 9, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ovarian Neoplasms
Hypersensitivity
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 21, 2017