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

NCT02978222 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: FRV-004
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Platinum Sensitive Ovarian Cancer; Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  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

  2 years

Secondary Outcomes (3)

• Overall Survival (OS)

  2 years

• Best Overall Response Rate

  2 years

• Disease Control Rate

  2 years

Study Arms (2)

FRα peptide plus adjuvant (GM-CSF)

EXPERIMENTAL

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)

Adjuvant (GM-CSF) Alone

PLACEBO COMPARATOR

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

Interventions

FRα peptide plus Adjuvant (GM-CSF) BIOLOGICAL

Intradermal injection FRα peptides, 500μg each - plus GM-CSF 125 μg

Also known as: TPIV200 with GM-CSF adjuvant

FRα peptide plus adjuvant (GM-CSF)

Adjuvant (GM-CSF) Alone DRUG

Intradermal injection 125 μg GM-CSF

Also known as: Leukine®

Adjuvant (GM-CSF) Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Marker Therapeutics, Inc.: lead

Study Sites (18)

UAB Gynecology Oncology

Birmingham, Alabama, 35233, United States

Location

Mayo Clinic Cancer Center

Phoenix, Arizona, 85054, United States

Location

Women's Cancer Research Foundation

Newport Beach, California, 92663, United States

Location

The Stamford Hospital/Bennett Cancer Center

Stamford, Connecticut, 06904, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Mt. Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Florida Cancer Specialist

West Palm Beach, Florida, 33401, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Research Partners

Jackson, Mississippi, 39202, United States

Location

MidAmerica Division, Inc. c/o Research Medical Center

Kansas City, Missouri, 64132, United States

Location

University Of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87102, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Hematology/Oncology Lenox Hill Hospital

New York, New York, 10075, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

OHSU

Portland, Oregon, 97239, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Tennessee Oncology/Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• Gupta A, O'Cearbhaill RE, Block MS, Hamilton E, Konner JA, Knutson KL, Potts J, Garrett G, Kenney RT, Wenham RM; TPIV200 Ovarian Cancer Study Investigators (listed at the end). Vaccination with folate receptor-alpha peptides in patients with ovarian cancer following response to platinum-based therapy: A randomized, multicenter clinical trial. Gynecol Oncol. 2024 Oct;189:90-97. doi: 10.1016/j.ygyno.2024.07.675. Epub 2024 Jul 27.

  PMID: 39068739 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Adjuvants, Pharmaceutic; Granulocyte-Macrophage Colony-Stimulating Factor; Single Person; sargramostim

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Limitations and Caveats

The trial was stopped due futility. Therefore, results are not for the complete study as designed.

Results Point of Contact

• Title: Gerald Garrett
• Organization: Marker Therapeutics

ggarrett@markertherapeutics.com

713.400.6400

Study Officials

• Richard Kenney, MD

  Marker Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 30, 2016
• Study Start: July 20, 2017
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: December 15, 2022
• Results First Posted: December 15, 2022

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)