Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation in Advanced Metastatic Disease

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego

Criteria

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.