Trial Outcomes & Findings for TG4010 and Nivolumab in Patients With Lung Cancer (NCT NCT02823990)

Last Updated: 2025-11-10

Results Overview

Number of patients with a best overall response of CR or PR, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2025-11-10

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment TG4010 + nivolumab Patients enrolled to receive TG4010 SC once per week for courses 1-3 and every 2 weeks for courses thereafter and nivolumab IV over 30 minutes every 2 weeks. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity. TG4010: Given SC Nivolumab: Given IV
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TG4010 and Nivolumab in Patients With Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment TG4010 + Nivolumab n=13 Participants Patients receive TG4010 SC once per week for courses 1-3 and every 2 weeks for courses thereafter and nivolumab IV over 30 minutes every 2 weeks. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity. TG4010: Given SC Nivolumab: Given IV
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants
Age, Customized	69 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome measures
Measure	Treatment TG4010 + nivolumab n=12 Participants Patients receive TG4010 SC once per week for courses 1-3 and every 2 weeks for courses thereafter and nivolumab IV over 30 minutes every 2 weeks. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity. TG4010: Given SC Nivolumab: Given IV
ORR Defined as the Proportion of Patients Whose Best Overall Response (BOR) is Either Complete Response (CR) or Partial Response (PR) According to RECIST 1.1	0.083 Proportion of evaluable participants

SECONDARY outcome

Timeframe: Up to 4 years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI. Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started. Disease control rate (DCR) defined as the proportion of patients whose best overall response (BOR) is either CR, PR or SD,

Outcome measures

Outcome measures
Measure	Treatment TG4010 + nivolumab n=12 Participants Patients receive TG4010 SC once per week for courses 1-3 and every 2 weeks for courses thereafter and nivolumab IV over 30 minutes every 2 weeks. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity. TG4010: Given SC Nivolumab: Given IV
Disease Control Rate (DCR) Defined as the Proportion of Patients Whose Best Overal Response is Either CR, PR or SD, Assessed by RECIST 1.1	0.25 Proportion of evaluable participants

SECONDARY outcome

Timeframe: Time from the first documented response (CR or PR) until the event defined as first documented disease progression, assessed for up to 4 years

Population: Overall number of particpants analyzed = 1 (One participant had a documented response of CR or PR)

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI; Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Duration of response (DOR) defined as patients whose best overall response is CR or PR (confirmed response)

Outcome measures

Outcome measures
Measure	Treatment TG4010 + nivolumab n=1 Participants Patients receive TG4010 SC once per week for courses 1-3 and every 2 weeks for courses thereafter and nivolumab IV over 30 minutes every 2 weeks. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity. TG4010: Given SC Nivolumab: Given IV
Duration of Response (DOR) Defined as Patients Whose Best Overall Response is CR or PR (Confirmed Response)	4 years Interval 4.0 to 4.0

SECONDARY outcome

Timeframe: From the first dose to 100 days after last treatment, approximately up to 2 years.

Outcome measures

Outcome measures
Measure	Treatment TG4010 + nivolumab n=13 Participants Patients receive TG4010 SC once per week for courses 1-3 and every 2 weeks for courses thereafter and nivolumab IV over 30 minutes every 2 weeks. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity. TG4010: Given SC Nivolumab: Given IV
Number of Participants With Adverse Events Reported Per CTCAE v4.0	13 Participants

SECONDARY outcome

Timeframe: Time from enrollment until death from any cause, assessed for up to 4 years

Outcome measures

Outcome measures
Measure	Treatment TG4010 + nivolumab n=13 Participants Patients receive TG4010 SC once per week for courses 1-3 and every 2 weeks for courses thereafter and nivolumab IV over 30 minutes every 2 weeks. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity. TG4010: Given SC Nivolumab: Given IV
Overall Survival (OS)	220 days Interval 171.0 to 341.0

SECONDARY outcome

Timeframe: Time from enrollment to the date of first documented radiographic tumor progression or death due to any cause, whichever occurs first, assessed for up to 4 years

Progression free survival (PFS) defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Treatment TG4010 + nivolumab n=12 Participants Patients receive TG4010 SC once per week for courses 1-3 and every 2 weeks for courses thereafter and nivolumab IV over 30 minutes every 2 weeks. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity. TG4010: Given SC Nivolumab: Given IV
Progression Free Survival (PFS) Defined by RECIST 1.1	41 days Interval 39.0 to 124.0

SECONDARY outcome

Timeframe: Up to 4 years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI; Stable disease (SD) rate defined as the proportion of patients whose best overall response (BOR) is stable disease (SD),

Outcome measures

Outcome measures
Measure	Treatment TG4010 + nivolumab n=12 Participants Patients receive TG4010 SC once per week for courses 1-3 and every 2 weeks for courses thereafter and nivolumab IV over 30 minutes every 2 weeks. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity. TG4010: Given SC Nivolumab: Given IV
Stable Disease (SD) Rate Defined as the Proportion of Patients Whose Best Overall Response (BOR) is SD, Assessed by RECIST 1.1	0.17 Proportion of evaluable participants

Adverse Events

Treatment TG4010 + nivolumab

Serious events: 1 serious events

Other events: 13 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Treatment TG4010 + nivolumab n=13 participants at risk Patients receive TG4010 SC once per week for courses 1-3 and every 2 weeks for courses thereafter and nivolumab IV over 30 minutes every 2 weeks. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity. TG4010: Given SC Nivolumab: Given IV
Cardiac disorders Myocarditis	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years

Other adverse events

Other adverse events
Measure	Treatment TG4010 + nivolumab n=13 participants at risk Patients receive TG4010 SC once per week for courses 1-3 and every 2 weeks for courses thereafter and nivolumab IV over 30 minutes every 2 weeks. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity. TG4010: Given SC Nivolumab: Given IV
Gastrointestinal disorders Abdominal pain	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Investigations Alanine aminotransferase increased	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Investigations Alkaline phosphatase increased	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Metabolism and nutrition disorders Anorexia	30.8% 4/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Investigations Aspartate aminotransferase increased	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Eye disorders Blurred vision	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
General disorders Chills	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Respiratory, thoracic and mediastinal disorders Cough	15.4% 2/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Nervous system disorders Dizziness	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Gastrointestinal disorders Dry mouth	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Nervous system disorders Dysgeusia	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
General disorders Edema limbs	15.4% 2/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Eye disorders Eye disorders - Other, Macular Edema	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
General disorders Fatigue	61.5% 8/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
General disorders Fever	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Musculoskeletal and connective tissue disorders Flank pain	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
General disorders Flu like symptoms	15.4% 2/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Nervous system disorders Headache	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Skin and subcutaneous tissue disorders Hyperhidrosis	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Endocrine disorders Hyperthyroidism	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Metabolism and nutrition disorders Hyponatremia	15.4% 2/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Vascular disorders Hypotension	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Endocrine disorders Hypothyroidism	15.4% 2/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Respiratory, thoracic and mediastinal disorders Hypoxia	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
General disorders Injection site reaction	61.5% 8/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Investigations INR increased	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Investigations Lymphocyte count decreased	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Musculoskeletal and connective tissue disorders Myalgia	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Cardiac disorders Myocarditis	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Gastrointestinal disorders Nausea	23.1% 3/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Investigations Neutrophil count decreased	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Gastrointestinal disorders Non-cardiac chest pain	15.4% 2/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
General disorders Pain	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Skin and subcutaneous tissue disorders Photosensitivity	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Investigations Platelet count decreased	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Skin and subcutaneous tissue disorders Pruritus	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Skin and subcutaneous tissue disorders Rash maculo-papular	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Respiratory, thoracic and mediastinal disorders Parainfluenza	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Skin and subcutaneous tissue disorders Other, Brown Lesions on chest & back	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Skin and subcutaneous tissue disorders Other, Lesions on chest	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Infections and infestations Skin infection	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Investigations Weight loss	15.4% 2/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years
Investigations White blood cell decreased	7.7% 1/13 • From the first dose to 100 days after last treatment. Approximately up to 2 years. All-Cause Mortality was from enrollment until death from any cause, assessed for up to 4 years

Additional Information

Analyst

University of California, Davis

Phone: 916-734-8053

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place