- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04075604
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer (CheckMate 7A8)
Randomized, Non-comparative Neoadjuvant Phase II Study in Patients With ER+/HER2- Breast Cancer >= 2 cm With Safety Run-in, Assessing Nivolumab + Palbociclib + Anastrozole
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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South Australia
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Elizabeth Vale, South Australia, Australia, 5112
- Local Institution - 0005
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Breast Cancer Research Centre - WA
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Liege, Belgium, 4000
- Local Institution
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Namur, Belgium, 5000
- Local Institution
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Antwerpen
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Wilrijk, Antwerpen, Belgium, 2610
- Local Institution - 0011
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- Local Institution - 0071
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Bordeaux, France, 33077
- Local Institution - 0075
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Creteil Cedex, France, 94010
- Local Institution - 0073
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La Roche-sur-yon Cedex 9, France, 85925
- Local Institution - 0072
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Lyon Cedex 08, France, 69373
- Centre Leon Berard
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Marseille Cedex 9, France, 13273
- Local Institution - 0019
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Montpellier, France, 34070
- Centre de Cancérologie du Grand Montpellier
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TOULOUSE Cedex 9, France, 31059
- Institut Claudius Regaud
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Bonn, Germany, 53111
- Local Institution
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Erlangen, Germany, 91054
- Local Institution
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Essen, Germany, 45136
- Klinik Essen-Mitte
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Moenchengladbach, Germany, 41061
- Local Institution
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Saarbruecken, Germany, 66113
- Local Institution
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Monterrey Ponce, Puerto Rico, 00731
- Local Institution - 0047
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San Juan, Puerto Rico, 00927
- Local Institution - 0002
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San Juan, Puerto Rico, 00936
- Local Institution - 0062
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Barcelona, Spain, 08035
- H. Univ. Vall dHebron
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Barcelona, Spain, 08036
- Local Institution - 0037
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Madrid, Spain, 28041
- Hosp Univer 12 De Octubre
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Malaga, Spain, 29010
- Hospital Universitario Virgen de la Victoria
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Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocío
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Valencia, Spain, 46010
- Hospital Clinico Universitario de Valencia
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California
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Whittier, California, United States, 90603
- Local Institution - 0031
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Georgia
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Athens, Georgia, United States, 30607
- University Cancer Blood Ctr
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Atlanta, Georgia, United States, 30342
- Northside Hospital,Inc.- Central Research Department
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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New Jersey
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Florham Park, New Jersey, United States, 07932
- Local Institution - 0041
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Hackensack, New Jersey, United States, 07601
- The Cancer Center at Hackensack University Medical Center
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Ohio
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Cleveland, Ohio, United States, 44109
- MetroHealth Medical Center
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Virginia
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Fredericksburg, Virginia, United States, 22408
- Hematology-Oncology Associates Of Fredricksburg, Inc
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Newport News, Virginia, United States, 23601
- Peninsula Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
- Participants must have untreated, unilateral, histologically confirmed ER+, HER2- invasive breast cancer with primary tumor ≥2 cm in largest diameter (cT1-3) in one dimension by clinical or radiographic exam, for whom neoadjuvant endocrine monotherapy deemed to be a suitable therapy.
- Participants must be deemed eligible for surgery and must agree to undergo surgery after completion of neoadjuvant therapy and agree to provide tumor tissue at baseline, on-treatment, and at surgery.
- Women must have documented proof that they are not of childbearing potential.
- Participants must have a performance status (PS) ≤ 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Exclusion Criteria:
- Participants who may have had any treatment, including radiotherapy, chemotherapy, and/or targeted therapy administered for the currently diagnosed breast cancer prior to enrollment or for whom upfront chemotherapy is clinically judged appropriate as optimal neoadjuvant treatment.
- Participants who have a history of or active, known or suspected autoimmune disease, or other syndrome that requires systemic steroids above physiological replacement dose or autoimmune agents for the past 2 years.
- Prior treatment with either ET or CDK4/6 inhibitors for Breast Cancer (BC) within 5 years or an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, or history of allergy, or hypersensitivity to study drug components
- Prior malignancy active within the previous 3 years or participants with serious or uncontrolled medical disorders.
- Personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), long or short QT syndrome, Brugada syndrome, or known history of corrected QT prolongation, Torsade de Pointes, or sudden cardiac arrest.
Other protocol-defined inclusion/exclusion criteria apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A: Nivolumab+Palbociclib+Anastrozole (ANZ)
|
Specified Dose on Specified Days
Specified Dose on Specified Days
Specified Dose on Specified Days
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Experimental: Arm B: Palbociclib+ANZ then Nivolumab+Palbociclib+ANZ
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Specified Dose on Specified Days
Specified Dose on Specified Days
Specified Dose on Specified Days
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Active Comparator: Arm C: Palbociclib+ANZ
|
Specified Dose on Specified Days
Specified Dose on Specified Days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number of Participants With Dose Limiting Toxicities (DLT) in the Safety Run-in Phase
Time Frame: From first dose to 4 weeks after first dose
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The number of participants with dose limiting toxicities (DLTs) during the safety run-in phase.
DLTS are defined as treatment emergent adverse events (TEAE) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 that occurs during the first 4 weeks (1 cycle) after treatment.
Participants who withdraw from the study during the DLT evaluation period or have received less than 1 dose of nivolumab and 75% of accumulative doses of palbociclib of the cycle for reasons other than a DLT will not be considered as DLT-evaluable participants.
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From first dose to 4 weeks after first dose
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Residual Cancer Burden (RCB) 0-1 Rate in the Randomized Phase
Time Frame: From randomization phase up to 5 treatment cycles (up to approximately 20 weeks)
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RCB 0-I rate is defined as the percentage of randomized participants who achieve RCB 0: no residual disease or RCB-I: minimal residual disease. RCB is a continuous index combining pathological measurements of primary tumor (size and cellularity) and nodal metastases (number and size) defined by a point system at surgery. No participants continued to the randomized phase; trial was closed after completion of the Safety Run-in. |
From randomization phase up to 5 treatment cycles (up to approximately 20 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: From first dose up to approximately 6 months after first dose
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ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per investigator radiographic assessment.
Complete response is defined as the disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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From first dose up to approximately 6 months after first dose
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Breast Conserving Surgery (BCS) Rate
Time Frame: From first dose up to approximately 6 months after first dose
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The percentage of participants who undergo breast conserving surgery (BCS) after completing the study treatments.
Confidence interval based on the Clopper and Pearson method.
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From first dose up to approximately 6 months after first dose
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Pathological Complete Response (pCR) Rate
Time Frame: From first dose up to approximately 6 months after first dose
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The percentage of participants with an absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.
Confidence interval based on the Clopper and Pearson method.
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From first dose up to approximately 6 months after first dose
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The Number of Participants Experiencing Adverse Events (AEs)
Time Frame: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
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The number of participants experiencing adverse events (AEs).
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
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From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
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The Number of Participants Experiencing Serious Adverse Events (SAEs)
Time Frame: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
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The number of participants experiencing serious adverse events (SAEs).
A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
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From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
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The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
Time Frame: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
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The number of participants experiencing adverse events (AEs) that lead to discontinuation of study treatment.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
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From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
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The Number of Participants Experiencing Immune-Related Adverse Events (AEs)
Time Frame: From first dose to 100 days after last dose of study therapy (up to approximately 8 months)
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The number of participants experiencing adverse events that are immune-related.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
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From first dose to 100 days after last dose of study therapy (up to approximately 8 months)
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The Number of Participants Deaths
Time Frame: From first dose up to approximately 8 months
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The number of participants that have died during the study.
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From first dose up to approximately 8 months
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The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units
Time Frame: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
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The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal |
From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
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The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests
Time Frame: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
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The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal |
From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Immunological
- Protein Kinase Inhibitors
- Hormone Antagonists
- Immune Checkpoint Inhibitors
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Nivolumab
- Palbociclib
- Anastrozole
Other Study ID Numbers
- CA209-7A8
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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