Clinical Trials /

Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

NCT02779855

Description:

The purpose of this study is to determine if an oncolytic virus called Talimogene laherparepvec (a modified herpes simplex 1 virus that can specifically destroy cancer cells while leaving normal cells alone) injected directly into the tumor during chemotherapy prior to surgery can enhance the elimination of triple negative breast cancer tumors. The natural herpes simplex 1 virus typically causes cold sores around the mouth, but the talimogene laherparepvec version of the herpes virus has been changed to prevent it from reproducing in normal tissue. However, it can still attack and break open cancer tissue which is why it is used as a treatment for cancer. It is thought that this virus can also help recruit the participant's immune system to attack the cancer cells during their treatment and possibly destroy the tumor tissue more effectively than chemotherapy alone. This virus is already FDA approved to treat melanoma skin tumors, so investigators want to determine if this virus can achieve a similar benefit in women with triple negative breast tumors.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
  • Official Title: A Phase 1/2 Study of Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: MCC-18621
  • NCT ID: NCT02779855

Conditions

  • Breast Cancer
  • Ductal Carcinoma
  • Invasive Breast Carcinoma
  • Invasive Ductal Breast Carcinoma

Interventions

DrugSynonymsArms
Talimogene laherparepvecIMLYGIC™, modified herpes simplex 1 virusTalimogene laherparepvec + Chemotherapy
PaclitaxelTaxol®Talimogene laherparepvec + Chemotherapy

Purpose

The purpose of this study is to determine if an oncolytic virus called Talimogene laherparepvec (a modified herpes simplex 1 virus that can specifically destroy cancer cells while leaving normal cells alone) injected directly into the tumor during chemotherapy prior to surgery can enhance the elimination of triple negative breast cancer tumors. The natural herpes simplex 1 virus typically causes cold sores around the mouth, but the talimogene laherparepvec version of the herpes virus has been changed to prevent it from reproducing in normal tissue. However, it can still attack and break open cancer tissue which is why it is used as a treatment for cancer. It is thought that this virus can also help recruit the participant's immune system to attack the cancer cells during their treatment and possibly destroy the tumor tissue more effectively than chemotherapy alone. This virus is already FDA approved to treat melanoma skin tumors, so investigators want to determine if this virus can achieve a similar benefit in women with triple negative breast tumors.

Trial Arms

NameTypeDescriptionInterventions
Talimogene laherparepvec + ChemotherapyExperimentalTalimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I: Dose Escalation to Determine Maximum Tolerated Dose (MTD). Phase II: Treatment at MTD.
  • Talimogene laherparepvec
  • Paclitaxel

Eligibility Criteria

        Inclusion Criteria:

          -  Must have histologically or cytologically confirmed clinical stage T2-3 N0-2 triple
             negative (estrogen receptor/progesterone receptor <1% human epidermal growth factor
             receptor 2 (HER2) 0-1 by ImmunoHistoChemistry (IHC) or unamplified by fluorescence in
             situ hybridization (FISH)) invasive ductal carcinoma.

          -  Must have measurable disease, defined as at least one lesion that can be accurately
             measured in at least one dimension (longest diameter to be recorded) as >20 mm with
             conventional techniques or as >10 mm with spiral CT scan. As well, participants must
             have primary tumor able to be visualized on ultrasound and amenable to direct
             injection.

          -  No prior history of an invasive breast cancer

          -  Adults ages 18-70

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Must have normal organ and marrow function as outlined in protocol

          -  Sexually active women of child-bearing potential and men must agree to use adequate
             contraception prior to study entry and for the duration of study participation.

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  T4 tumors, known metastatic disease, recurrent disease, inflammatory breast cancer,
             multicentric disease, and/or synchronous bilateral breast cancer

          -  A second active malignancy, exceptions are localized non-melanoma skin cancers or
             prior in situ carcinoma

          -  Receiving any other investigational agents or are unable to be treated with
             doxorubicin, cyclophosphamide, and paclitaxel.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to talimogene laherparepvec or other agents used in the study

          -  Known active or prior herpes simplex virus infections (HSV), prior complications from
             HSV infections such as encephalitis, or require systemic antiviral therapy at the time
             of study enrollment

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, known active hepatitis B/C infection, symptomatic congestive heart failure,
             unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations
             that would limit compliance with study requirements.

          -  Women who are pregnant or nursing

          -  Immunocompromised patients may be at increased risk of herpetic infections when
             treated with talimogene laherparepvec. Therefore, HIV-positive patients, patients with
             acquired or congenital immunodeficiency conditions, those on chronic systemic
             immunosuppressants (requiring > 10 mg of prednisone or equivalent/day), Those with
             active autoimmune disease are excluded from the study.

          -  Have received any live vaccine therapies used for the prevention of infectious disease
             within 28 days prior to enrollment and during treatment period. Seasonal influenza
             vaccines for injection are generally killed virus vaccines and are allowed. However,
             intranasal influenza vaccines (eg, Flu - Mist®) are live attenuated vaccines, and are
             not allowed.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase I: Maximum Tolerated Dose (MTD) / Recommended Phase II Dose (RP2D)
Time Frame:Up to 6 months
Safety Issue:
Description:MTD/RP2D of talimogene laherparepvec administered with neoadjuvant paclitaxel- doxorubicin/cyclophosphamide chemotherapy.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

Trial Keywords

  • triple negative breast cancer (TNBC)
  • estrogen receptor
  • progesterone receptor
  • invasive ductal carcinoma
  • breast cancer tumors

Last Updated

August 4, 2021