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

University of California San Diego

Status and phase

Active, not recruiting

Phase 2

Conditions

Metastatic Cancer

Treatments

Drug: Checkpoint blockade immunotherapy

Radiation: Checkpoint blockade immunotherapy plus SBRT

Study type

Interventional

Funder types

Other

Identifiers

NCT02843165

151570

Details and patient eligibility

About

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.

Full description

Patients who will receive anti-PD-1/PD-L1 immunotherapy with at least 1 site of measurable metastatic disease which will not be irradiated will be candidates for the study. Patients will be randomized (1:1) to CBI combined with SBRT or CBI alone. SBRT at 9.5Gy x3 fractions will be delivered within 1-21 days of the start of first cycle of CBI. The first six patients will be treated and observed for toxicity in the safety run-in phase for 30 days after radiation before continuing with further accrual. Radiation dose reduction is allowed if necessary to meet tissue constraints (6Gyx3 Minimum Dose). Response rates will be determined from the non-irradiated lesion/lesions. Blood draws will be obtained to analyze anti-tumor immune responses.

Enrollment

146 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.