Metastatic Cancer Clinical Trial
Official title:
Randomized Phase II Study of Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation Therapy in Advanced Metastatic Disease
Verified date | June 2023 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether stereotactic body radiation therapy (SBRT) combined with checkpoint blockaded immunotherapy (CBI) will improve the response to the anticancer treatment compared to CBI alone in patients with advanced metastatic cancer.
Status | Active, not recruiting |
Enrollment | 146 |
Est. completion date | June 2023 |
Est. primary completion date | August 16, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient has one lesion that is treatable with SBRT. - Patient has at least 1 site of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria on computed tomography (CT) or Magnetic resonance imaging (MRI) which will not be irradiated. - Histological confirmation of malignancy (primary or metastatic tumor). - Patient may have any prior therapy allowed aside from having had prior radiotherapy to the treatment site. - Eastern Cooperative Oncology Group (ECOG) performance status = 2. - Patient's screening laboratory values must meet protocol limits. - Patient must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Patient has had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. - Patient receiving any investigational or experimental agents other than immunotherapy. - Patient who has had any prior radiotherapy to the treatment site(s). - Patient is a pregnant woman (pregnant women are excluded from this study because radiation treatment has known potential for teratogenic or abortifacient effects). - Patient refuses to sign informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | UCSD Moores Cancer Center | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate | Complete response plus partial response | Responses measured by RECIST at 16 weeks from baseline | |
Secondary | Safety and toxicity of combined CBI plus SBRT | Adverse events assessed from time of first dose to treatment completion (approximately 1 year) | Evaluated at each treatment cycle (each cycle is 2 or 3 weeks), then at 8 weeks, 16 weeks, 6 months, 12 months, 18 months, and 24 months, then every 6 months up to 2 years | |
Secondary | Progression Free Survival | The time from starting treatment to the time of first documented tumor progression or death due to any cause, whichever occurs first | Assessed at 5 years | |
Secondary | Overall Survival | The time from starting treatment until death due to any cause. | Assessed at 5 years | |
Secondary | Rate of Stable Disease | The rates of stable disease great than or equal to 6 months during and after SBRT in combination with CBI compared to CBI alone. | Assessed at 5 years | |
Secondary | Change in anti-tumor immune response | Lesion and blood assays performed in the lab. | At week 3 or 4 after starting treatment (prior to Cycle 2 of CBI) and at 2 months. Each cycle is 2 or 3 weeks. |
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