NeoVax With Nivolumab in Patients With Ovarian Cancer

NCT04024878 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 18-318
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is evaluating a new type of vaccine called "Personalized NeoAntigen Cancer Vaccine" in combination with Nivolumab (Opdivo®) for ovarian cancer.

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer

Outcome Measures

Primary Outcomes (3)

• Percentage of patients pre-srceened who have enough neoantigens for generation of the vaccine, are not platinum refractory, and who initiate vaccination

  To demonstrate that regimen of NeoVax with Nivolumab is feasible and safe for the treatment of patients with ovarian cancer.

  2 years

• Overall incidence of treatment-emergent AEs, SAEs, AEs of at least Grade 3 severity, related AEs, and AEs leading to withdrawal of treatment will be described

  Safety analysis will be performed on all patients who receive at least one dose of the NeoVax.

  2 years

• The rates of autoimmune effects

  2 years

Secondary Outcomes (4)

• Objective Response Rate

  2 years

• Duration of Response

  2 years

• Progression Free Survival

  2 Years

• Overall Survival

  2 years

Study Arms (2)

Stanfard Platinum

EXPERIMENTAL

* A total of 5 NeoVax immunizations will be administered over a 3-week period * Two booster vaccinations will be given at Week 12 * Nivolumab administered by intravenous (IV) infusion over 30 minutes every 2 weeks.

Drug: Nivolumab; Biological: NeoVax

Stanfard Platinum with Surgical or Core Needle Biopsy

EXPERIMENTAL

* A total of 5 NeoVax immunizations will be administered over a 3-week period * Two booster vaccinations will be given at Week 12 * Nivolumab administered by intravenous (IV) infusion over 30 minutes every 2 weeks. * Will undergo required surgical or core needle biopsy at first recurrence with progression free interval

Drug: Nivolumab; Biological: NeoVax; Procedure: Core Needle Biopsy

Interventions

Nivolumab DRUG

Nivolumab (Opdivo®) is an antibody. An antibody is a common type of protein produced by the body that the immune system uses to find and destroy foreign molecules.

Also known as: Opdivo

Stanfard Platinum; Stanfard Platinum with Surgical or Core Needle Biopsy

NeoVax BIOLOGICAL

The vaccine will consist of up to 20 peptides as well as a drug that activates the immune system called Poly-ICLC. Poly-ICLC (also called Hiltonol) is an experimental "viral mimic" and an activator of immunity

Stanfard Platinum; Stanfard Platinum with Surgical or Core Needle Biopsy

Core Needle Biopsy PROCEDURE

Surgical procedure

Stanfard Platinum with Surgical or Core Needle Biopsy

Eligibility Criteria

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

You may qualify if:

• Diagnosis of epithelial ovarian cancer, primary peritoneal or fallopian tube cancer. High grade serous, high grade endometrioid, clear cell and carcinosarcoma (carcinosarcomas only with high grade serous epithelial component) histologies are allowed. Low grade histologies and mucinous histology are not allowed.
• Participants must be classified into one of two cohorts:
• Cohort A: Patients with newly diagnosed stage IIIC or stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer who are planned to undergo neoadjuvant chemotherapy. Patients must be candidates for platinum-based chemotherapy and previously untreated. At the time of pre-screening consent, patients must have disease that is amenable to biopsy and are agreeable and can safely undergo biopsy.
• Cohort B: Patients with recurrent (first recurrence only) epithelial ovarian, primary peritoneal or fallopian tube cancer with platinum sensitive disease defined as disease progression greater or equal than 6 months but not more than 18 months after completion of their last dose of first line platinum chemotherapy. Prior hormonal therapy is allowed but no other therapy for recurrence is allowed, including no chemotherapy, no targeted therapy, and no antiangiogenic therapy. Maintenance therapy after first line chemotherapy is allowed. At the time of pre-screening consent, patients must have measurable disease by RECIST 1.1 and disease that is amenable to biopsy and are agreeable and can safely undergo biopsy.
• Eastern Cooperative Group (ECOG) performance status ≤2 (please see Appendix A)
• Age ≥18 years
• Patients must have adequate organ and bone marrow function:
• Haemoglobin ≥ 8.0 g/dL
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• White blood cells (WBC) \> 2x109/L
• Platelet count ≥ 100 x 109/L
• Total bilirubin ≤ 1.5 x institutional upper limit of normal
• AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN
• Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)
• Negative serum β-HCG or urine pregnancy test

You may not qualify if:

• Non-epithelial tumors or ovarian tumors with low malignant potential (i.e. borderline tumors)
• Mucinous or low grade histologies (i.e. low grade serous or low grade endometrioid)
• Cohort A and B patients who have signed prescreening consent form and then, in the opinion of the investigator, have progressed after 3 or 4 cycles of platinum-based chemotherapy, are ineligible for the treatment part of the study and no vaccine will be manufactured
• Prior immunotherapy with IL-2, IFN-α, or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated antigen 4 (anti-CTLA-4) antibody (including Ipilimumab), or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways
• Major surgery (other than debulking surgery for ovarian, primary peritoneal or fallopian tube cancer) for any reason within 4 weeks prior to initiation of vaccination and/or incomplete recovery from surgery
• Known brain metastases or leptomeningeal metastases because of their poor prognosis and because patients often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. A scan to confirm the absence of brain metastases is not required.
• Active or history of autoimmune disease (known or suspected). Exceptions are permitted for vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition requiring only hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
• Have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to the first dose of study drug (Nivolumab). Inhaled or topical steroids and adrenal replacement doses (≤ 10 mg daily prednisone equivalents) are permitted in the absence of active autoimmune disease.
• Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illnesses unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, interfere with participation in this study.
• Known allergy to tetanus toxoid
• Have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
• Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the investigator, would compromise study administration as per protocol or compromise the assessment of AEs.
• Pregnant women are excluded from this study because Nivolumab, personalized neoantigen peptides, and Poly-ICLC are agents with unknown risks to the developing fetus.
• Nursing women are excluded from this study because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with Nivolumab, personalized neoantigen peptides, and Poly-ICLC.
• Have a history of an invasive malignancy, except for the following circumstance: individuals with a history of invasive malignancy are eligible if they have been disease-free for at least 2 years or are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated carcinoma in situ of the breast, oral cavity or cervix, localized prostate cancer, basal cell or squamous cell carcinoma of the skin.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• United States Department of Defense: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Nivolumab; Biopsy, Large-Core Needle

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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Panagiotis Konstantinopoulos, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: July 18, 2019
• Study Start: November 20, 2020
• Primary Completion: April 30, 2025
• Study Completion (Estimated): April 30, 2029
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)