Docetaxel Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy in Triple Negative Breast Cancer

NCT04095689 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: PRO00028602
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to test the safety and effectiveness of docetaxel chemotherapy and pembrolizumab plus adenoviral-mediated interleukin-12 (ADV/IL-12) gene therapy in patients with anthracycline-refractory, triple negative breast cancer (TNBC).

Conditions

Triple Negative Breast Cancer; Anthracycline-refractory TNBC

Keywords

triple negative breast cancer, neoadjuvant, pembrolizumab; anthracycline-refractory TNBC

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR) Rate of Docetaxel Chemotherapy and Pembrolizumab Plus IL-12 Gene Therapy

  To determine the pCR rate of docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy in patients with TNBC per RECIST v1.1 assessed by CT Scan or MRI. CR: Disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter of target lesions, using the baseline sum longest diameter as a reference. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, using the smallest sum longest diameter as a reference. PD: At least a greater than or equal to 20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Clinical PD: Patients who in the opinion of the treating PI have clinical evidence of PD may be classified as having PD

  18 weeks

Secondary Outcomes (1)

• Number of Participants With Treatment-related Adverse Events

  18 weeks

Study Arms (1)

Experimental

EXPERIMENTAL

docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy.

Drug: Docetaxel; Drug: Pembrolizumab; Drug: IL-12 gene therapy

Interventions

Docetaxel DRUG

Microtubule-targeting drug (inhibits microtubule depolymerization)

Also known as: Taxotere

Experimental

Pembrolizumab DRUG

Programmed cell death-1 (PD-1) inhibitor

Also known as: Keytruda

Experimental

IL-12 gene therapy DRUG

Adenoviral-mediated IL-12

Experimental

Eligibility Criteria

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

You may qualify if:

• Patients are eligible to be included in the trial only if all of the following criteria apply:
• The patient (or legally acceptable representative if applicable) provides written informed consent for the trial.
• Female ≥ 18 years of age on the day of informed consent signing.
• Histologically confirmed triple negative breast cancer is defined as estrogen receptor (ER), progesterone receptor (PR), and HER2 negative. ER/PR negativity is defined as \<10% IHC staining of any intensity.
• HER2 negativity is defined as the following per the 2018 American Society of Clinical Oncology and College of American Pathologists guidelines.
• \. Refractory to standard neoadjuvant anthracycline-containing chemotherapy regimen, demonstrated on MRI.
• \. Bilateral breast cancers that individually meet eligibility criteria are allowed.
• \. Prior immunotherapy treatment allowed. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. Adequate organ function as defined in Table 1. All screening labs should be performed within 28 days of trial treatment initiation.
• \. Cardiac ejection fraction ≥45%. 10. A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) OR
• A WOCBP who agrees to follow the contraceptive guidance in during the treatment period and for at least 120 days after the last dose of trial treatment. WOCBP must have a negative serum pregnancy test (β-human chorionic gonadotropin \[β-HCG\]) within 72 hours prior to trial treatment administration.
• \. Willing to provide biopsy tissue as required by the trial. 12. Willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits and examinations.

You may not qualify if:

• History of poorly controlled hypertension (defined as systolic blood pressure \>150 mmHg). Patients whose hypertension has been well controlled on the same treatment for 1 year prior to Cycle 1, Day 1 are eligible. Only patients on single-agent antihypertensive therapy are allowed.
• History of New York Heart Association class III or greater cardiac disease.
• History of myocardial infarction, stroke, ventricular arrhythmia, or greater than first-degree conduction defect within the past 12 months.
• History of congenital QT prolongation.
• Absolute corrected QT interval of \>480 msec in the presence of potassium \>4.0 mEq/L and magnesium \>1.8 mg/dL.
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to trial treatment administration.
• NOTE: Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
• \. Concurrent use of any complementary or alternative medicines. 9. Concurrent use of inhibitors or inducers of cytochrome P450 (CYP)3A4 and CYP2D6 10. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dose exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to trial treatment administration.
• \. Known history of active tuberculosis (Bacillus Tuberculosis). 12. Known or suspected hypersensitivity to any component or excipient of the proposed regimen (docetaxel chemotherapy, gene vector, pembrolizumab).
• \. Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Patients with ≤ Grade 2 neuropathy may be eligible. If patient received major surgery, she must have recovered adequately from the toxicity and/or complications from the intervention prior to starting the trial treatment.
• \. Known additional malignancy that is progressing or requires active treatment. NOTE: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in situ that have undergone potentially curative therapy are not excluded.
• \. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• \. History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
• \. Active infection requiring systemic therapy. 18. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
• \. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Houston Methodist Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Docetaxel; pembrolizumab

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Polly Niravath, M.D.
• Organization: Houston Methodist Neal Cancer Center

paniravath@houstonmethodist.org

(713) 441-9948

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine in Oncology, Academic Institute

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 19, 2019
• Study Start: May 12, 2021
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: January 23, 2026
• Results First Posted: January 23, 2026

Record last verified: 2026-01

Locations

US (1)