QUILT-3.051: NANT Ovarian Cancer Vaccine: Combination Immunotherapy in Subjects With Epithelial Ovarian Cancer Who Have Progressed on or After Standard-of-care (SoC) Therapy

NCT03197584 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: QUILT-3.051
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with epithelial ovarian cancer who have progressed on or after SoC therapy.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (3)

• Incidence of treatment-emergent adverse events (AEs) and serious AE (SAEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.

  Phase 1b primary endpoint

  1 year

• Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  Phase 2 primary endpoint

  1 year

• ORR by Immune-related response criteria (irRC )

  Phase 2 primary endpoint

  1 year

Secondary Outcomes (9)

• ORR by RECIST Version 1.1

  1 year

• ORR by irRC

  1 year

• Progression-free survival (PFS) by RECIST Version 1.1

  2 years

• PFS by irRC

  2 years

• Overall survival (OS): time from the date of first treatment to the date of death (any cause)

  2 years

Study Arms (1)

NANT Ovarian Cancer Vaccine

EXPERIMENTAL

avelumab, bevacizumab, capecitabine, cyclophosphamide, 5-fluorouracil, fulvestrant, leucovorin, paclitaxel, omega-3-acid ethyl esters, oxaliplatin, stereotactic body radiation therapy, ALT-803, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6301, and hank®.

Biological: Avelumab; Biological: Bevacizumab; Drug: Capecitabine; Drug: Cyclophosphamide; Drug: 5-fluorouracil; Drug: Fulvestrant; Drug: Leucovorin; Drug: Paclitaxel; Drug: omega-3 acid ethyl esters; Drug: Oxaliplatin; Radiation: Stereotactic Body Radiation Therapy; Biological: ALT-803; Biological: ETBX-021; Biological: ETBX-051; Biological: ETBX-061; Biological: GI-4000; Biological: GI-6301; Biological: haNK®

Interventions

Avelumab BIOLOGICAL

Fully human anti-PD-L1 IgG1 lambda monoclonal antibody

NANT Ovarian Cancer Vaccine

Bevacizumab BIOLOGICAL

Recombinant human anti-VEGF IgG1 monoclonal antibody

NANT Ovarian Cancer Vaccine

Capecitabine DRUG

5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine

NANT Ovarian Cancer Vaccine

Cyclophosphamide DRUG

2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate

NANT Ovarian Cancer Vaccine

5-fluorouracil DRUG

5-fluoro-2,4 (1H,3H)-pyrimidinedione

NANT Ovarian Cancer Vaccine

Fulvestrant DRUG

7-alpha-\[9-(4,4,5,5,5-pentafluoropentylsulphinyl) nonyl\]estra-1,3,5-(10)- triene-3,17-beta-diol

NANT Ovarian Cancer Vaccine

Leucovorin DRUG

Calcium N-\[p-\[\[\[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl\]methyl\]amino\]benzoyl\]-L-glutamate (1:1)

NANT Ovarian Cancer Vaccine

Paclitaxel DRUG

5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine

NANT Ovarian Cancer Vaccine

omega-3 acid ethyl esters DRUG

omega-3 acid ethyl esters

NANT Ovarian Cancer Vaccine

Oxaliplatin DRUG

cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum

NANT Ovarian Cancer Vaccine

Stereotactic Body Radiation Therapy RADIATION

Stereotactic Body Radiation Therapy (SBRT)

NANT Ovarian Cancer Vaccine

ALT-803 BIOLOGICAL

Recombinant human super agonist IL-15 complex

NANT Ovarian Cancer Vaccine

ETBX-021 BIOLOGICAL

Ad5 \[E1-, E2b-\]-HER2 vaccine

NANT Ovarian Cancer Vaccine

ETBX-051 BIOLOGICAL

Ad5 \[E1-, E2b-\]-Brachyury vaccine

NANT Ovarian Cancer Vaccine

ETBX-061 BIOLOGICAL

Ad5 \[E1-, E2b-\]-MUC1 vaccine

NANT Ovarian Cancer Vaccine

GI-4000 BIOLOGICAL

Heat-killed S. cerevisiae yeast expressing the mutated RAS oncoproteins

NANT Ovarian Cancer Vaccine

GI-6301 BIOLOGICAL

Heat-killed S. cerevisiae yeast expressing the human Brachyury (hBrachyury) oncoprotein

NANT Ovarian Cancer Vaccine

haNK® BIOLOGICAL

NK-92 \[CD16.158V, ER IL-2\]

NANT Ovarian Cancer Vaccine

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
• Histologically-confirmed epithelial ovarian cancer that has progressed on or after SoC therapy. Germ cell, stromal, and borderline ovarian tumors are not allowed.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Have at least 1 measurable lesion of ≥ 1.5 cm.
• Must have a tumor biopsy specimen following the conclusion of the most recent anticancer treatment. If a historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period.
• Must be willing to provide blood samples and, if considered safe by the Investigator, a tumor biopsy specimen at 8 weeks after the start of treatment.
• Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
• Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception for up to 1 year after completion of therapy, and non-sterile male subjects must agree to use a condom for up to 4 months after treatment.

You may not qualify if:

• History of persistent grade 2 or higher (CTCAE Version 4.03) hematologic toxicity resulting from previous therapy.
• Within 5 years prior to first dose of study treatment, any evidence of other active malignancies or brain metastasis except for controlled basal cell carcinoma; prior history of in situ cancer (eg, breast, melanoma, and cervical); and bulky (≥ 1.5 cm) disease with metastasis in the central hilar area of the chest and involving the pulmonary vasculature.
• Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
• Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma).
• History of organ transplant requiring immunosuppression.
• History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
• Requires whole blood transfusion to meet eligibility criteria.
• Inadequate organ function, evidenced by the following laboratory results:
• White blood cell (WBC) count \< 3,000 cells/mm3
• Absolute neutrophil count \< 1,500 cells/mm3.
• Platelet count \< 100,000 cells/mm3.
• Hemoglobin \< 9 g/dL.
• Total bilirubin greater than the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome).
• Aspartate aminotransferase (AST \[SGOT\]) or alanine aminotransferase (ALT \[SGPT\]) \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases).
• Alkaline phosphatase (ALP) levels \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases, or \>10 × ULN in subjects with bone metastases).

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

avelumab; Bevacizumab; Capecitabine; Cyclophosphamide; Fluorouracil; Fulvestrant; Leucovorin; Paclitaxel; Omacor; Oxaliplatin; Radiosurgery; ALT-803

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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Coordination Complexes; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 23, 2017
• Study Start: December 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: December 28, 2021
• Last Updated: February 21, 2025

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share