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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 | Clinical Trials | Clareo Health

WITHDRAWNPHASE1/PHASE2

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

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

NCT03197584•ImmunityBio, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

Treatment will be administered in two phases, an induction and a maintenance phase. Subjects will continue induction treatment for up to 1 year or until they experience progressive disease (PD) or unacceptable toxicity (not correctable with dose reduction), withdraw consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. Those who have a complete response (CR) in the induction phase will enter the maintenance phase of the study. Subjects may remain in the maintenance phase of the study for up to 1 year. Treatment will continue in the maintenance phase until the subject experiences PD or unacceptable toxicity (not correctable with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. The maximum time on study treatment, including both the induction and maintenance phases, is 2 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years.
•2. Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
•3. Histologically-confirmed epithelial ovarian cancer that has progressed on or after SoC therapy. Germ cell, stromal, and borderline ovarian tumors are not allowed.
•4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
•5. Have at least 1 measurable lesion of ≥ 1.5 cm.
•6. 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.
•7. 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.
•8. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
•9. 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.

Exclusion Criteria

•1. History of persistent grade 2 or higher (CTCAE Version 4.03) hematologic toxicity resulting from previous therapy.
•2. 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.
•3. 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.
•4. Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma).
•5. History of organ transplant requiring immunosuppression.
•6. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
•7. Requires whole blood transfusion to meet eligibility criteria.
•8. Inadequate organ function, evidenced by the following laboratory results:
•1. White blood cell (WBC) count \< 3,000 cells/mm3
•2. Absolute neutrophil count \< 1,500 cells/mm3.
+19 more criteria

Key Dates

Start Date

December 1, 2017

Primary Completion Date

February 1, 2019

Completion Date

December 28, 2021

Last Updated

February 21, 2025

Conditions

Ovarian Cancer

Interventions

Avelumab

BIOLOGICAL

Bevacizumab

BIOLOGICAL

Capecitabine

DRUG

Cyclophosphamide

DRUG

5-fluorouracil

DRUG

Fulvestrant

DRUG

Leucovorin

DRUG

Paclitaxel

DRUG

omega-3 acid ethyl esters

DRUG

Oxaliplatin

DRUG

Stereotactic Body Radiation Therapy

RADIATION

ALT-803

BIOLOGICAL

ETBX-021

BIOLOGICAL

ETBX-051

BIOLOGICAL

ETBX-061

BIOLOGICAL

GI-4000

BIOLOGICAL

GI-6301

BIOLOGICAL

haNK®

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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