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Trial Title:
"neoBREASTIM": Atezolizumab Plus RP1 Oncolytic Immunotherapy in the NeoAdjuvant Setting of Triple-Negative Breast Cancer
NCT ID:
NCT06067061
Condition:
Triple Negative Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Atezolizumab
Conditions: Keywords:
Triple Negative Breast Cancer
Early-stage
Immunotherapy
Oncolytic virus
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
An open-label, monocentric, single arm, phase II study with a safety run-in.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Atezolizumab + RP1
Description:
Patients will be treated in a window period (ie 3 treatment cycles). After evaluation,
patients that had no increase in ctDNA after 3 cycles (see Definition of ctDNA status)
will continue on the same treatment (intratumoral injections of RP1 in combination with
Atezolizumab) for a total of 10 treatment cycles prior to surgery.
Arm group label:
Atezolizumab plus RP1 (Immulytic™) oncolytic immunotherapy
Other name:
Tecentriq®
Other name:
Vusolimogene Oderparepvec
Summary:
Neoadjuvant treatment is an important part of the treatment strategy for locally advanced
TNBC having established a positive and significant correlation of pathologic Complete
Response (pCR) with long-term clinical benefit such as Event-Free Survival (EFS) and
Overall Survival (OS) as shown via large meta-analysis. Much effort has been made to
identify novel agents and new drug combinations that can improve pCR rates in this
specific clinical setting, which is the leading rationale to evaluate RP1 oncolytic
immunotherapy in combination with Atezolizumab.
Detailed description:
The combination of RP1 plus Atezolizumab, while being expected to result in increased
efficacy, is not expected to result in significant additional toxicity, as compared to
either agent alone. Capitalizing on the strong prognostic and predictive value of the TIL
infiltrate in early-stage TNBC and the capacity of circulating tumor DeoxyriboNucleic
Acid (ctDNA) detection to predict response to immunotherapy and NeoAdjuvant Chemotherapy
(NAC), neoBREASTIM - a single-arm phase 2 study - will evaluate a novel, biomarker-driven
combination of Atezolizumab plus RP1 oncolytic immunotherapy in the neo-adjuvant setting
of patients diagnosed with early-stage, TIL-high TNBC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Female subject
2. Age ≥ 18 years old.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1.
4. Newly diagnosed Triple-Negative Breast Cancer (TNBC), defined as the absence of
estrogen expression and progesterone expression, and of Human Epidermal growth
factor Receptor 2 (HER2) overexpression, must be determined by local testing of a
screening tumor sample as defined by American Society of Clinical Oncology/College
of American Pathologists guidelines.
5. TNBC defined as the following combined primary tumor (T), regional lymph node (N),
and metastatic (M) American Joint Committee on Cancer staging criteria: cT ≥15 - ≤30
mm, N0, M0 according to Mammogram, breast Ultrasound and MRI, and PET-CT. In case of
a difference in the measurement of the primary tumor among different imaging
methods, the breast MRI measurement is the reference.
6. Unicentric, unifocal and unilateral disease.
7. Tumor-infiltrating lymphocytes (TILs) ≥ 30%, as defined by the International TILs
Working Group 2014.
8. ctDNA dosing at baseline.
9. Agreement to provide tissue samples (tumor biopsy at screening and on-treatment),
and at surgery for immune monitoring and translational research activities.
10. Agreement to perform blood samples at screening, on-treatment, and at surgery for
immune monitoring and translational research activities.
Exclusion Criteria:
1. Inflammatory breast cancer.
2. Prior treatment with an oncolytic virus-based therapy.
3. Patients with active significant herpetic infections or prior complications of
Herpes Simplex Virus-1 (HSV-1) infection.
4. Patients who require intermittent or chronic use of systemic (oral or IV) antivirals
with known antiherpetic activity (e.g., acyclovir).
5. Diagnosis of immunodeficiency.
6. Has active autoimmune disease (e.g. inflammatory bowel disease, systemic lupus
erythematosus, ankylosing spondylitis, scleroderma, and multiple sclerosis, celiac
disease, Wegener's granulomatosis) that has required systemic treatment in the past
3 years (i.e. with use of disease modifying agents, corticosteroids or
immunosuppressive drugs).
7. Prior systemic immunosuppressive medication (except physiologic corticosteroid
replacement therapy) within 30 days of planned start of study therapy.
8. Any live (attenuated) vaccine within 14 days of planned start of study therapy.
9. Prior immunotherapy, including tumor vaccine, cytokine, anti-CTLA4, PD-1/PD-L1
blockade or similar agents, T cell receptor-based (TCR-based) or Chimeric Antigen
Receptor-T (CAR-T) cell based adoptive cell therapy.
10. Known history of, or any evidence of active, non-infectious pneumonitis.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75005
Country:
France
Status:
Recruiting
Contact:
Last name:
Emanuela Curie, MD
Phone:
+33172389335
Email:
emanuela.romano@curie.fr
Start date:
April 5, 2024
Completion date:
April 5, 2031
Lead sponsor:
Agency:
Institut Curie
Agency class:
Other
Collaborator:
Agency:
Replimune Inc.
Agency class:
Industry
Collaborator:
Agency:
Roche Pharma AG
Agency class:
Industry
Source:
Institut Curie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06067061
