M7824 in Treating Patients With Stage II-III HER2 Positive Breast Cancer
|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: NCT03620201|
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : October 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8||Drug: Bintrafusp Alfa||Phase 1|
I. To evaluate the change in tumor-infiltrating lymphocytes (TIL) percentage pre and post M7824 therapy.
I. To evaluate the safety and tolerability of M7824 in early stage breast cancer (stage II/III).
II. To evaluate pathological response at the time of surgery after 2 doses of M7824 followed by neoadjuvant (human epidermal growth factor receptor 2) HER2 targeted therapy in combination with chemotherapy of physician's choice.
I. To evaluate imaging based response to M7824. II. To evaluate potential systemic and tumor based predictive biomarker candidates of response.
III. To evaluate immune responses induced by exposure to M7824 systemically and in tumor microenvironment (TME).
Patients receive anti-PD-L1/TGFbetaRII fusion protein M7824 intravenously (IV) over 1 hour on days 1 and 15. During days 28-56 patients receive planned neoadjuvant chemotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Single Arm Open Label Trial Evaluating M7824 (Anti-PD-L1/TGF-Beta TRAP) in a Window Setting in Patients With Stage II-III HER2/Neu Positive (HER2+) Breast Cancer (BC)|
|Actual Study Start Date :||August 3, 2018|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2024|
Experimental: Treatment (M7824)
Participants receive anti-PD-L1/TGFbetaRII fusion protein M7824 IV over 1 hour on days 1 and 15. During days 28-56 participants receive planned neoadjuvant chemotherapy.
Drug: Bintrafusp Alfa
- Change in tumor-infiltrating lymphocytes (TIL) percentage [ Time Frame: Baseline up to post M7824 therapy ]
- Laboratory parameters [ Time Frame: Up to 1 year ]
- Eye symptoms (and signs if symptoms warranted additional evaluation) [ Time Frame: Up to 1 year ]
- Vital signs [ Time Frame: Up to 1 year ]
- Electrocardiogram parameters [ Time Frame: Up to 1 year ]
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): NCT03620201
|Contact: Rashmi K Murthy, MD||(713) 563-0779||RMurthy1@mdanderson.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Rashmi K. Murthy 713-792-2817|
|Principal Investigator: Rashmi K. Murthy|
|Principal Investigator:||Rashmi K Murthy, MD||M.D. Anderson Cancer Center|