EUCTR2019-001334-34-FR
Active, not recruiting
Phase 1
Randomized, Non-comparative Neoadjuvant Phase II Study in Patients with ER+/HER2- Breast Cancer >= 2 cm with Safety Run-in, Assessing Nivolumab + Abemaciclib or Palbociclib + Anastrozole - CheckMate 7A8: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 7A8
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ER+/HER2- Breast Cancer
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 324
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
- •\- ECOG \<\=1\.
- •Other inclusion criteria apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 161
- •F.1\.3 Elderly (\>\=65 years) yes
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 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 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 costimulation or checkpoint pathways, or history of allergy, or hypersensitivity to study drug components
- •\- Prior Malignancy active within the previous 3 years as well as 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 exclusion criteria apply.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast CancerER+/HER2- Breast CancerMedDRA version: 23.0Level: LLTClassification code 10070577Term: Oestrogen receptor positive breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2019-001334-34-BEBristol-Myers Squibb International Corporation23
Active, not recruiting
Phase 1
A Study of Neoadjuvant Nivolumab + Abemaciclib or Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast CancerER+/HER2- Breast CancerMedDRA version: 21.1Level: PTClassification code 10070577Term: Oestrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2019-001334-34-ESBristol-Myers Squibb International Corporation324
Active, not recruiting
Phase 1
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast CancerEUCTR2019-001334-34-DEBristol-Myers Squibb International Corporation168
Active, not recruiting
Phase 1
Study in kidney cancer patients with at least the kidney tumor present and sometimes enlarged lymph nodes in the vicinity of the affected kidney, in which the subjects first receive an immunotherapy treatment, which may consist of either nivolumab alone, or the combination of nivolumab and ipilimumab, or the combination of nivolumab and relatlimab, after which the kidney tumor (and possibly enlarged lymph nodes) is removed.primary clear cell renal cell cancer at risk for recurrence or distant metastasesMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLGTClassification code 10038364Term: Renal and urinary tract neoplasms malignant and unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2021-002360-51-NLAntoni van Leeuwenhoek ziekenhuis69
Recruiting
Phase 2
Prospective, randomized, neoadjuvant phase II study with combination immuno-oncology in primary clear cell renal cell cancer at risk for recurrence or distant metastases (NESCIO-trial; M21NSC; CA209-6DJ)clear cell renal cell carcinomakidney cancer10038364NL-OMON52016Antoni van Leeuwenhoek Ziekenhuis46