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NCT02843165

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

Completed Phase 2 Results posted Last updated 30 September 2025
What this trial tests

Phase 2 trial testing Checkpoint blockade immunotherapy in Metastatic Cancer in 106 participants. Completed in 15 August 2024.

Timeline
2 September 2016
Primary endpoint
16 August 2021
15 August 2024

Quick facts

Lead sponsorUniversity of California, San Diego
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment106
Start date2 September 2016
Primary completion16 August 2021
Estimated completion15 August 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Diego

Who can join

18 and older, any sex, with Metastatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Objective Response Rate Primary · Responses measured by RECIST at 16 weeks from baseline

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

GroupValue95% CI
Checkpoint Blockade Immunotherapy Plus SBRT11
Checkpoint Blockade Immunotherapy6
Number of Participants With Adverse Events Secondary · up to 5 years

Adverse events assessed from time of first dose to treatment completion (approximately 1 year)

GroupValue95% CI
Checkpoint Blockade Immunotherapy Plus SBRT58
Checkpoint Blockade Immunotherapy48
Progression Free Survival Secondary · Assessed at 5 years

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

GroupValue95% CI
Checkpoint Blockade Immunotherapy Plus SBRT2.381.95 – 3.37
Checkpoint Blockade Immunotherapy1.881.82 – 2.81
Overall Survival Secondary · Assessed at 5 years

The time from starting treatment until death due to any cause.

GroupValue95% CI
Checkpoint Blockade Immunotherapy Plus SBRT14.18.46 – 25.2
Checkpoint Blockade Immunotherapy12.67.14 – 29.2
Rate of Stable Disease Secondary · Assessed at 5 years

The rates of stable disease great than or equal to 6 months during and after SBRT in combination with CBI compared to CBI alone.

GroupValue95% CI
Checkpoint Blockade Immunotherapy Plus SBRT7
Checkpoint Blockade Immunotherapy4

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Checkpoint Blockade Immunotherapy Plus SBRT
Serious: 24/58 (41%)
Deaths: 36/58
Checkpoint Blockade Immunotherapy
Serious: 15/48 (31%)
Deaths: 29/48

Serious adverse events (53 terms)

ReactionSystemCheckpoint Blockade Immuno…Checkpoint Blockade Immuno…
Abdominal painGastrointestinal disorders
VomitingGastrointestinal disorders
Thromboembolic eventVascular disorders
NauseaGastrointestinal disorders
Acute kidney injuryRenal and urinary disorders
CoughRespiratory, thoracic and mediastinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
atrial fibrillationCardiac disorders
Small intestinal obstructionGastrointestinal disorders
FatigueGeneral disorders
PainGeneral disorders
Infections and infestations - OtherInfections and infestations
FallInjury, poisoning and procedural complications
Blood bilirubin increasedInvestigations
Pleural effusionRespiratory, thoracic and mediastinal disorders
anemiaBlood and lymphatic system disorders
Myocardial infarctionCardiac disorders
ventricular fibrillationCardiac disorders
Adrenal insufficiencyEndocrine disorders
HyperthyroidismEndocrine disorders
Abdominal distensionGastrointestinal disorders
AscitesGastrointestinal disorders
ConstipationGastrointestinal disorders
Mucositis oralGastrointestinal disorders
Small intestinal perforationGastrointestinal disorders
Other adverse events (20 terms — click to expand)

ReactionSystemCheckpoint Blockade Immuno…Checkpoint Blockade Immuno…
GASTROINTESTINAL DISORDERSGastrointestinal disorders
GENERAL DISORDERSGeneral disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERSSkin and subcutaneous tissue disorders
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERSMusculoskeletal and connective tissue disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERSRespiratory, thoracic and mediastinal disorders
INVESTIGATIONSInvestigations
METABOLISM AND NUTRITION DISORDERSMetabolism and nutrition disorders
NERVOUS SYSTEM DISORDERSNervous system disorders
INFECTIONS AND INFESTATIONSInfections and infestations
VASCULAR DISORDERSVascular disorders
ENDOCRINE DISORDERSEndocrine disorders
CARDIAC DISORDERSCardiac disorders
PSYCHIATRIC DISORDERSPsychiatric disorders
RENAL AND URINARY DISORDERSRenal and urinary disorders
EAR AND LABYRINTH DISORDERSEar and labyrinth disorders
EYE DISORDERSEye disorders
Blood and lymphatic system disordersBlood and lymphatic system disorders
REPRODUCTIVE SYSTEM AND BREAST DISORDERSReproductive system and breast disorders
IMMUNE SYSTEM DISORDERSImmune system disorders
INJURY, POISONING AND PROCEDURAL COMPLICATIONSInjury, poisoning and procedural complications

Most-reported serious reactions: Abdominal pain, Vomiting, Thromboembolic event, Nausea, Acute kidney injury, Cough, Dyspnea, atrial fibrillation.

Data from ClinicalTrials.gov NCT02843165 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. B Cells Improve Overall Survival in HPV-Associated Squamous Cell Carcinomas and Are Activated by Radiation and PD-1 Blockade.
    Kim SS, Shen S, Miyauchi S, Sanders PD, et al · · 2020 · cited 161× · PMID 32193227 · DOI 10.1158/1078-0432.ccr-19-3211
  2. Exceptional Response to Nivolumab and Stereotactic Body Radiation Therapy (SBRT) in Neuroendocrine Cervical Carcinoma with High Tumor Mutational Burden: Management Considerations from the Center For Personalized Cancer Therapy at UC San Diego Moores Cancer Center.
    Sharabi A, Kim SS, Kato S, Sanders PD, et al · · 2017 · cited 81× · PMID 28550027 · DOI 10.1634/theoncologist.2016-0517
  3. Radiation Treatment in Women with Ovarian Cancer: Past, Present, and Future.
    Fields EC, McGuire WP, Lin L, Temkin SM. · · 2017 · cited 57× · PMID 28871275 · DOI 10.3389/fonc.2017.00177
  4. Cell death pathologies: targeting death pathways and the immune system for cancer therapy.
    Pentimalli F, Grelli S, Di Daniele N, Melino G, et al · · 2019 · cited 48× · PMID 30563970 · DOI 10.1038/s41435-018-0052-x
  5. Current Prospects for Treatment of Solid Tumors via Photodynamic, Photothermal, or Ionizing Radiation Therapies Combined with Immune Checkpoint Inhibition (A Review).
    Anand S, Chan TA, Hasan T, Maytin EV. · · 2021 · cited 44× · PMID 34068491 · DOI 10.3390/ph14050447
  6. Optimizing the Treatment Schedule of Radiotherapy Combined With Anti-PD-1/PD-L1 Immunotherapy in Metastatic Cancers.
    Kong Y, Ma Y, Zhao X, Pan J, et al · · 2021 · cited 34× · PMID 33859942 · DOI 10.3389/fonc.2021.638873
  7. Response to single agent PD-1 inhibitor after progression on previous PD-1/PD-L1 inhibitors: a case series.
    Martini DJ, Lalani AA, Bossé D, Steinharter JA, et al · · 2017 · cited 33× · PMID 28807048 · DOI 10.1186/s40425-017-0273-y
  8. Combination therapy with PD-1/PD-L1 blockade: An overview of ongoing clinical trials.
    Johnson CB, Win SY. · · 2018 · cited 26× · PMID 29632719 · DOI 10.1080/2162402x.2017.1408744

Verify or expand the search:

Other recruiting trials for Metastatic Cancer

Currently open trials in the same condition.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02843165.

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