Trial Outcomes & Findings for Docetaxel Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy in Triple Negative Breast Cancer (NCT NCT04095689)

Last Updated: 2026-01-23

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

18 weeks

Results posted on

2026-01-23

Participant Flow

The first patient was consented on 5/12/2021 and the last patient was consented on 5/16/2023. The final patient was off study on 5/3/2024.

Participant milestones

Participant milestones
Measure	Experimental docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy. Docetaxel: Microtubule-targeting drug (inhibits microtubule depolymerization) Pembrolizumab: Programmed cell death-1 (PD-1) inhibitor IL-12 gene therapy: Adenoviral-mediated IL-12
Overall Study STARTED	8
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy. Docetaxel: Microtubule-targeting drug (inhibits microtubule depolymerization) Pembrolizumab: Programmed cell death-1 (PD-1) inhibitor IL-12 gene therapy: Adenoviral-mediated IL-12
Overall Study Adverse Event	3
Overall Study Lack of Efficacy	1
Overall Study Death	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=8 Participants docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy. Docetaxel: Microtubule-targeting drug (inhibits microtubule depolymerization) Pembrolizumab: Programmed cell death-1 (PD-1) inhibitor IL-12 gene therapy: Adenoviral-mediated IL-12
Age, Categorical <=18 years	0 Participants n=270 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=270 Participants
Age, Categorical >=65 years	1 Participants n=270 Participants
Age, Continuous	56 years n=270 Participants
Sex: Female, Male Female	8 Participants n=270 Participants
Sex: Female, Male Male	0 Participants n=270 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=270 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=270 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=270 Participants
Race (NIH/OMB) Asian	2 Participants n=270 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=270 Participants
Race (NIH/OMB) Black or African American	2 Participants n=270 Participants
Race (NIH/OMB) White	4 Participants n=270 Participants
Race (NIH/OMB) More than one race	0 Participants n=270 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants
Region of Enrollment United States	8 participants n=270 Participants

PRIMARY outcome

Timeframe: 18 weeks

Outcome measures

Outcome measures
Measure	Experimental n=8 Participants docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy. Docetaxel: Microtubule-targeting drug (inhibits microtubule depolymerization) Pembrolizumab: Programmed cell death-1 (PD-1) inhibitor IL-12 gene therapy: Adenoviral-mediated IL-12
Pathological Complete Response (pCR) Rate of Docetaxel Chemotherapy and Pembrolizumab Plus IL-12 Gene Therapy	1 Participants

SECONDARY outcome

Timeframe: 18 weeks

To determine the number of participants with treatment-related adverse events, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0

Outcome measures

Outcome measures
Measure	Experimental n=8 Participants docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy. Docetaxel: Microtubule-targeting drug (inhibits microtubule depolymerization) Pembrolizumab: Programmed cell death-1 (PD-1) inhibitor IL-12 gene therapy: Adenoviral-mediated IL-12
Number of Participants With Treatment-related Adverse Events	8 Participants

Adverse Events

Experimental

Serious events: 6 serious events

Other events: 8 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Experimental n=8 participants at risk docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy. Docetaxel: Microtubule-targeting drug (inhibits microtubule depolymerization) Pembrolizumab: Programmed cell death-1 (PD-1) inhibitor IL-12 gene therapy: Adenoviral-mediated IL-12
Blood and lymphatic system disorders Ferbile Neutropenia	37.5% 3/8 • Number of events 3 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Hepatobiliary disorders Hepatic Biliary disorders, other (Hepatic Toxicity)	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Infections and infestations Sepsis	25.0% 2/8 • Number of events 2 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
General disorders Fatigue	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Investigations Aspartate aminotransferase increased (Transaminitis)	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Respiratory, thoracic and mediastinal disorders Dyspnea	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Vascular disorders Thromboembolism	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Vascular disorders Right Breast Hematoma	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)

Other adverse events

Other adverse events
Measure	Experimental n=8 participants at risk docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy. Docetaxel: Microtubule-targeting drug (inhibits microtubule depolymerization) Pembrolizumab: Programmed cell death-1 (PD-1) inhibitor IL-12 gene therapy: Adenoviral-mediated IL-12
Gastrointestinal disorders Gastroesophageal reflux disease	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Investigations Alanine aminotransferase increased	25.0% 2/8 • Number of events 2 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Investigations Aspartate aminotransferase increased	25.0% 2/8 • Number of events 2 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Nervous system disorders Headache	25.0% 2/8 • Number of events 2 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Musculoskeletal and connective tissue disorders Bone Pain	37.5% 3/8 • Number of events 3 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
General disorders Chills	37.5% 3/8 • Number of events 3 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Gastrointestinal disorders Constipation	37.5% 3/8 • Number of events 3 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Gastrointestinal disorders Diarrhea	37.5% 3/8 • Number of events 3 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 2/8 • Number of events 2 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
General disorders Edema Limbs	25.0% 2/8 • Number of events 3 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
General disorders Fatigue	62.5% 5/8 • Number of events 5 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
General disorders Fever	62.5% 5/8 • Number of events 5 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Skin and subcutaneous tissue disorders Nail Discoloration	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Metabolism and nutrition disorders Hyponatremia	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Vascular disorders Hypotension	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Infections and infestations Breast Infection (Left)	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Nervous system disorders Dysgeusia	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Gastrointestinal disorders Mucositis oral	37.5% 3/8 • Number of events 3 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Gastrointestinal disorders Nausea	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Nervous system disorders Peripheral Sensory Neuropathy	37.5% 3/8 • Number of events 6 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Nervous system disorders Ocular Migraine	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Blood and lymphatic system disorders Pancytopenia	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Musculoskeletal and connective tissue disorders Right Axillary Pain	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Skin and subcutaneous tissue disorders Right Leg Discoloration	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Skin and subcutaneous tissue disorders Dry Skin	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Infections and infestations Skin Infection	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Cardiac disorders Tachycardia	25.0% 2/8 • Number of events 3 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Infections and infestations Upper Respiratory Infection	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Infections and infestations Urinary tract infection	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)
Gastrointestinal disorders Vomiting	12.5% 1/8 • Number of events 1 • At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1)

Additional Information

Polly Niravath, M.D.

Houston Methodist Neal Cancer Center

Phone: (713) 441-9948

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place