Clinical trial · Interventional
Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation in Advanced Metastatic Disease
Randomized Phase II Study of Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation Therapy in Advanced Metastatic Disease
NCT02843165CI-TRIAL-00096007completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Checkpoint blockade immunotherapy | Drug | — | UNRESOLVED |
| Checkpoint blockade immunotherapy plus SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Checkpoint blockade immunotherapy plus SBRT
- description
- Checkpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT)
- interventionNames
- Radiation: Checkpoint blockade immunotherapy plus SBRT
- type
- ACTIVE_COMPARATOR
- label
- Checkpoint blockade immunotherapy
- description
- Checkpoint blockade immunotherapy (CBI) alone
- interventionNames
- Drug: Checkpoint blockade immunotherapy
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- Responses measured by RECIST at 16 weeks from baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.