Combination of Talimogene Laherparepvec With Atezolizumab in Early Breast Cancer (PROMETEO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03802604|
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : May 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: Talimogene laherparepvec Drug: Atezolizumab||Early Phase 1|
• To evaluate the efficacy (as measured by residual cancer burden [RCB] class 0/1 rate) of Talimogene Laherparepvec with Atezolizumab given to subjects with operable early breast cancer who present residual disease after neoadjuvant chemotherapy (NAC).
Secondary objectives include:
- To assess the rate of pathological complete response (pCR) in the breast (pCRB) and breast and axilla (pCRBL) at definitive surgery after neoadjuvant treatment with T-VEC and atezolizumab.
- To determine the clinical and radiological ORR of breast tumors to TVEC- atezolizumab given in the neoadjuvant setting.
- To assess RCB index in continuous variable and by the 4 RCB class (RCB0, RCB1, RCB2 and RCB 3) after treatment with T-VEC and atezolizumab.
- Comparing the expression of a gene signature tracking activated CD8 T-cells at surgery after treatment with T-VEC and atezolizumab with residual disease after NAC.
- To evaluate the safety of T-VEC in combination with atezolizumab as assessed by incidence of treatment-emergent and treatment-related adverse events.
- Translational and exploratory objectives are included.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Combination of Talimogene Laherparepvec With Atezolizumab in Patients With Residual Breast Cancer After Standard Neoadjuvant Multi-agent Chemotherapy (PROMETEO TRIAL)|
|Actual Study Start Date :||December 10, 2018|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2023|
Experimental: Talimogene laherparepvec + Atezolizumab
Biological: Talimogene laherparepvec
Talimogene laherparepvec will be given via intra-tumoral injection at an initial dose of 10^6 PFU/mL. On week 3 (i.e. 21 days [± 2] days), a second talimogene laherparepvec injection will be administered at a dose of 10^8 PFU/mL. Third, fourth and fifth injections will be administered every 2 weeks (every 14 [± 2] days). The maximum volume for each injection will be 4.0 mL.
Atezolizumab 840 mg will be administered by IV infusion on Day1 week 3, then every 2 weeks (every 14 [± 2] days), for a total of 4 treatment courses.
Other Name: Tecentric
- Rate of residual cancer burden class 0 and 1 (RCB0/1) [ Time Frame: 24 months since first patient in ]As a dichotomous measure of tumor response, RCB 0/1 yes vs. no., after neoadjuvant treatment, according to the MD Anderson Cancer Center procedures, as per local assessment.
- Rate of pCRB (ypT0/Tis) and pCRBL (ypT0/TisypN0) [ Time Frame: 24 months since first patient in ]Complete absence of invasive carcinoma in the breast or in the breast and axillary lymph nodes on histological examination at the time of definitive surgery, irrespective of in situ carcinoma in the breast and in the breast and axilla by local evaluation will be assessed.
- Tumor ORR [ Time Frame: 24 months since first patient in ]Defined as the sum of PR and CR according to RECIST v1.1, as per Investigator's assessments by breast MRI.
- Rate of residual cancer burden (RCB) [ Time Frame: 24 months since first patient in ]As a continuous variable and by RCB group, after neoadjuvant treatment, according to the MD Anderson Cancer Center procedures, as per local assessment.
- Changes in the expression of a gene signature tracking activated CD8 T-cells. [ Time Frame: 24 months since first patient in ]Differences in in the mean expression of an immune gene signature tracking CD8 T-cells (composed of the following genes: PRF1, CD8A, GZMM, CD8B, FLT3LG) in all patients will be assessed.
- Incidence, duration and severity of AEs assessed by the NCI Common Terminology for Classification of Adverse Events (CTCAE) version 4 [ Time Frame: 24 months since first patient in ]Incidence, duration and severity of AEs assessed by the NCI Common Terminology for Classification of Adverse Events (CTCAE) version 4, including delays and treatment discontinuations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802604
|Contact: Lídice Vidal||+ 34 933 436 firstname.lastname@example.org|
|Contact: Jordi Canes||+ 34 932 702 email@example.com|
|Hospital Universitari Vall d'Hebrón||Recruiting|
|Barcelona, Spain, 08035|
|Contact: Mafalda Oliveira, MD|
|Hospital Clínic de Barcelona||Recruiting|
|Barcelona, Spain, 08036|
|Contact: María Vidal, MD|
|Centro Integral Oncológico Clara Campal||Not yet recruiting|
|Madrid, Spain, 28050|
|Contact: Estela Vega, MD|
|Hospital Clínico universitario de Valencia||Recruiting|
|Valencia, Spain, 46010|
|Contact: Begoña Bermejo, MD|
|Principal Investigator:||Aleix Prat||Hospital Clínic de Barcelona|