TG4010 and Nivolumab in Patients With Lung Cancer

NCT02823990 | Completed Phase 2 Results DMC

• 4 other identifiers: 885316UCDCC#263P30CA093373NCI-2016-00960
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 4

Brief Summary

This phase II trial studies how well TG4010 and nivolumab work in previously treated patients with non-small cell lung cancer. Vaccines that are made from a gene-modified virus, such as TG4010, may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as nivolumab, interfere with the ability of tumor cells to grow and spread. Giving TG4010 and nivolumab together may work better in previously treated patients with non-small cell lung cancer.

Conditions

Recurrent Non-Small Cell Lung Carcinoma; Stage I Non-Small Cell Lung Cancer; Stage II Non-Small Cell Lung Cancer; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Non-Small Cell Lung Cancer; Stage IV Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Up to 2 years

Secondary Outcomes (6)

• 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

  Up to 4 years

• Duration of Response (DOR) Defined as Patients Whose Best Overall Response is CR or PR (Confirmed Response)

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

• Number of Participants With Adverse Events Reported Per CTCAE v4.0

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

• Overall Survival (OS)

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

• Progression Free Survival (PFS) Defined by RECIST 1.1

  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

Study Arms (1)

Treatment TG4010 + nivolumab

EXPERIMENTAL

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.

Biological: TG4010; Biological: Nivolumab

Interventions

TG4010 BIOLOGICAL

Given SC

Also known as: Modified Vaccinia Ankara Encoding Human MUC-1 Antigen and Interleukin-2 Suspension, MVA-MUC1-IL2, MVA-MUC1-IL2 Vaccine

Treatment TG4010 + nivolumab

Nivolumab BIOLOGICAL

Given IV

Also known as: BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo

Treatment TG4010 + nivolumab

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed non-squamous NSCLC; patients with adenocarcinoma must have had epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutational testing; those with an actionable mutations/rearrangements are excluded
• Stage IIIB or IV patients must have progressed after a platinum based chemotherapy; a maximum of 3 previous systemic regimens are allowed (one regimen can be a tyrosine kinase inhibitor); patients with stage I-IIIB NSCLC who have progressed within 6 months of a full dose platinum based regimen as adjuvant therapy or with radiotherapy are eligible; patients who received weekly low dose chemotherapy with radiation only are not eligible
• At least one measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) based on RECIST version 1.1
• Performance status (PS) 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
• Minimum life expectancy of 3 months
• Hemoglobin \>= 10.0 g/dL
• White blood cells (WBC) \>= 3.0 x 10\^9/L
• Neutrophils \>= 1.5 x 10\^9/L
• Total lymphocyte count \>= 0.5 x 10\^9/L
• Platelet counts \>= 100 x 10\^9/L
• Serum alkaline phosphatase =\< 3 x upper limit of normal (ULN) in absence of liver or bone metastases and =\< 5 x ULN in patients with documented bone or liver metastases
• Total bilirubin =\< 1.5 x ULN
• Serum transaminases (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) =\< 2.5 x ULN in the absence of liver metastases and =\< 5 x ULN in case of liver metastases
• Glomerular Filtration Rate \>= 60 mL/min (according to Modification of Diet in Renal Disease \[MDRD\] formula or Cockcroft \& Gault formula)
• Serum albumin \>= 30 g/L

You may not qualify if:

• Patients having active central nervous system (CNS) metastases; patients adequately treated and neurologically returned to baseline (except for residual signs of symptoms related to the CNS treated) for at least 2 weeks prior to enrolment are allowed; in addition, patients must be either off corticosteroids or on a stable or decreasing dose of \< 10 mg daily prednisone or equivalent
• Prior exposure to cancer immunotherapy including any immune checkpoint inhibitor and/or cancer vaccines
• Prior history of other malignancy except:
• Basal cell carcinoma of skin
• Cervical intra-epithelial neoplasia
• Other cancer curatively treated with no evidence of disease for at least 2 years
• Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs (e.g. cyclosporine) for a period of at least 4 weeks and whose treatment was not stopped 1 week prior to start of the study treatment (day 1 \[D1\] of cycle 1)
• Positive serology for human immunodeficiency virus (HIV) or hepatitis C virus (HCV); presence in the serum of the antigen hemoglobin (HBs)
• Patient with any underlying medical condition that the treating physician considers might be aggravated by treatment or which is not controlled (e.g. elevated troponin or creatinine, uncontrolled diabetes)
• Patients with major surgery or radiotherapy within 4 weeks prior to the start of the study treatment (i.e. D1 of cycle 1); however, prior surgery or radiation therapy aimed at local palliation or attempted local disease control (except in case of thoracic radiotherapy) is permitted but has to be completed one week before treatment start
• Pregnant or nursing (lactating) women, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (\> 10 mIU/mL); pregnancy is ruled out by a beta hCG test completed if necessary with an ultrasound
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are:
• Women whose sexual orientation precludes intercourse with a male partner
• Women whose partners have been sterilized by vasectomy or other means
• Using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices \[IUDs\]; periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable)

Sponsors & Collaborators

• Megan Daly, MD: lead
• National Cancer Institute (NCI): collaborator
• Transgene: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (4)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

UCSF Medical Center-Mount Zion

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

TG4010; Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Analyst
• Organization: University of California, Davis

nlogihara@ucdavis.edu

916-734-8053

Study Officials

• Karen Kelly

  University of California, Davis

  PRINCIPAL INVESTIGATOR

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: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 6, 2016
• Study Start: December 14, 2016
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-10

Locations

US (4)