RACHEL1: Radiation and CHEckpoint bLockade Trial in Patients With Metastatic Hormone Receptor Positive, HER2 Negative 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: NCT03524170|
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : June 21, 2018
The goal of this clinical research study is to find the highest tolerable dose of M7824 (MSB0011359C) that can be given with radiation therapy to patients with estrogen and/or progesterone receptor (HR) positive, HER2-negative breast cancer that is metastatic (has spread). The safety and tolerability of MSB0011359C will also be studied.
Researchers also want to learn more about how certain immune cells may change when MSB0011359C in given in combination with radiation therapy. The effect of the study treatment combination will also be studied.
This is an investigational study. MSB0011359C is not FDA approved or commercially available. It is currently being used for research purposes only.
Radiation therapy is part of standard of care for many breast cancer patients.
The study doctor can describe how the study drug and radiation therapy are designed to work.
Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm of Breast||Drug: M7824 Radiation: Radiation Therapy||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||RACHEL1: A Phase I Radiation and CHEckpoint bLockade Trial in Patients With Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer|
|Actual Study Start Date :||April 30, 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2020|
|Experimental: M7824 + Radiation Therapy||
M7824 given at 1200 mg per infusion once every 14 days in a 28 day cycle.
Once a patient finishes the first 6 weeks of DLT evaluation and biopsy at 56 days, the monotherapy of M7824 administered at 1200 mg per infusion once every 14 days (maintenance period), if dose 0 is the maximum tolerated dose. If the MTD is 600 mg, then the maintenance dose will be 600 mg.
Other Name: MSB0011359C
Radiation: Radiation Therapy
Radiation therapy starts within 3 days after the 2nd infusion of M7824 to one of the sites of metastatic disease and delivered in 5 fractions x 4 Gy or 10 fractions x 3 Gy.
- Recommended phase II dose (RP2D) of M7824 and radiation therapy in patients with metastatic HR+/HER2- breast cancer determined by dose limiting toxicity (DLT) [ Time Frame: 6 weeks after first administration of M7824. ]RP2D defined as the highest dose level with no more than 1 patient with DLT out of 6 patients that are treated.
- Safety and tolerability of M7824 and radiation therapy in patients with metastatic HR+/HER2- breast cancer. [ Time Frame: Start of study drug up to 30 days after study drug stopped ]Safety determined by National Cancer Institute - Common Terminology Criteria for AEs (CTCAE), version 4.03.
- Progression-free survival (PFS) [ Time Frame: Start of study drug up to 90 days after study drug stopped ]Progression-free survival (PFS) defined as the time from treatment until objective tumor progression or death, whichever occurs first.
- Overall survival (OS) [ Time Frame: Start of study drug up to 90 days after study drug stopped ]Overall survival (OS) defined as the time from treatment until death from any cause.
- Immunologic/molecular response [ Time Frame: 56 days ]Immunologic/molecular response defined as % change in tumor infiltrating lymphocytes (TIL) pre and post therapy to M7824 and radiation therapy in patients with HR+/HER2- metastatic breast cancer.
- Evaluation of the size of metastasis after treatment with anti-PD-L1/TGF-β Trap (M7824) with radiation (in-field) and non-irradiated (abscopal) sites determined by RECIST [ Time Frame: 56 days ]
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): NCT03524170
|Contact: Jennifer Litton, MD||713-792-2817||CR_Study_Registration@mdanderson.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Clinical Research Operations CR_Study_Registration@mdanderson.org|
|Principal Investigator:||Jennifer Litton, MD||M.D. Anderson Cancer Center|