Stereotactic Body Radiation Therapy (SBRT) Combined With Avelumab (Anti-PD-L1) for Management of Early Stage Non-Small Cell Lung Cancer (NSCLC)
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/22/2019 |
Start Date: | October 26, 2017 |
End Date: | October 2021 |
Phase I/II Study of the Safety, Tolerability, and Efficacy of Stereotactic Body Radiation Therapy (SBRT) Combined With Concurrent and Adjuvant Avelumab for Definitive Management of Early Stage Non-Small Cell Lung Cancer (NSCLC)
The purpose of the study is to determine whether avelumab has an effect on cancer and body in
combination with SBRT, a standard treatment for early stage non-small cell lung cancer
(NSCLC).
Avelumab is considered experimental because it is not approved by the United States (U.S.)
Food and Drug Administration (FDA) for the treatment of cancer. It is a type of drug called a
monoclonal antibody (a type of protein). Monoclonal antibodies are made to recognize, target
and bind to specific proteins on the cells that make up your tissues. Avelumab is designed to
block the interaction between PD-1, a known immune checkpoint, and PD-L1. By blocking this
interaction, the immune system may be stimulated, allowing it to more effectively recognize
and attack the cancer.
Stereotactic Body Radiation Therapy (SBRT) is a type of radiation that uses precise targeting
to deliver a high dose of radiation to the tumor over a short period of time. A positioning
cushion such as Vac-lok will be used during radiation treatment that is custom made. This
custom mold forms to the contours of the subjects body to allow for proper positioning
comfort and stability.
combination with SBRT, a standard treatment for early stage non-small cell lung cancer
(NSCLC).
Avelumab is considered experimental because it is not approved by the United States (U.S.)
Food and Drug Administration (FDA) for the treatment of cancer. It is a type of drug called a
monoclonal antibody (a type of protein). Monoclonal antibodies are made to recognize, target
and bind to specific proteins on the cells that make up your tissues. Avelumab is designed to
block the interaction between PD-1, a known immune checkpoint, and PD-L1. By blocking this
interaction, the immune system may be stimulated, allowing it to more effectively recognize
and attack the cancer.
Stereotactic Body Radiation Therapy (SBRT) is a type of radiation that uses precise targeting
to deliver a high dose of radiation to the tumor over a short period of time. A positioning
cushion such as Vac-lok will be used during radiation treatment that is custom made. This
custom mold forms to the contours of the subjects body to allow for proper positioning
comfort and stability.
This is a single arm open label Phase I/II study that will consist of two parts. In Phase I,
investigators will assess the safety and tolerability of SBRT combined with Avelumab. In
Phase II, investigators will determine whether SBRT combined with Avelumab improves relapse
free survival. Subjects with Stage I NSCLC who are not undergoing surgical resection will be
candidates for enrollment. Subjects will receive definitive stereotactic body radiation
(SBRT) in 4-5 fractions combined with concurrent and adjuvant Avelumab at 10mg/kg for a total
of 6 cycles. Subjects will be evaluated for safety as measured by the occurrence of adverse
events, serious adverse events, and laboratory abnormalities. Three blood draws will be
obtained to analyze anti-tumor immune responses and immune correlates.
investigators will assess the safety and tolerability of SBRT combined with Avelumab. In
Phase II, investigators will determine whether SBRT combined with Avelumab improves relapse
free survival. Subjects with Stage I NSCLC who are not undergoing surgical resection will be
candidates for enrollment. Subjects will receive definitive stereotactic body radiation
(SBRT) in 4-5 fractions combined with concurrent and adjuvant Avelumab at 10mg/kg for a total
of 6 cycles. Subjects will be evaluated for safety as measured by the occurrence of adverse
events, serious adverse events, and laboratory abnormalities. Three blood draws will be
obtained to analyze anti-tumor immune responses and immune correlates.
Inclusion Criteria:
- Tumor(s) to be treated is(are) ≤ 5.0 cm or ≤250 cm3
- Stage I NSCLC and is deemed medically inoperable or refuses surgical resection.
- Life expectancy ≥ 9 months.
- Acceptable organ and marrow function
Exclusion Criteria:
- Prior organ transplantation, including allogeneic stem cell transplantation
- Significant acute or chronic infections including:
- Known history of human immunodeficiency virus (HIV) or known acquired
immunodeficiency syndrome (AIDS)
- Known history of HBV or HCV
- Active autoimmune disease
- Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease
not requiring immunosuppressive treatment are eligible.
- Subjects requiring hormone replacement with corticosteroids are eligible if the
steroids are administered only for the purpose of hormonal replacement and at
doses ≤ 10 mg or 10 mg equivalent prednisone per day
- Administration of steroids through a route known to result in a minimal systemic
exposure (topical, intranasal, intro-ocular, or inhalation) are acceptable
- Current use of immunosuppressive medication, EXCEPT for the following:
- intranasal, inhaled, topical steroids, or local steroid injection (eg,
intra-articular injection)
- Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or
equivalent
- Steroids as premedication for hypersensitivity reactions (eg, CT scan
premedication).
- Cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to
enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina,
congestive heart failure, or serious cardiac arrhythmia requiring medication.
- Known severe hypersensitivity reactions to monoclonal antibodies any history of
anaphylaxis, or uncontrolled asthma
- Pregnancy or lactation
- Known alcohol or drug abuse
- Prior radiotherapy to the treatment site(s).
We found this trial at
2
sites
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3855 Health Sciences Dr,
La Jolla, California 92093
La Jolla, California 92093
(858) 822-6100
![UC San Diego Moores Cancer Center](/wp-content/uploads/logos/uc-san-diego-moores-cancer-center.png)
Principal Investigator: Andrew Sharabi, MD
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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