Trial · NCT02830594
Pembrolizumab and Palliative Radiation Therapy in Treating Patients With Metastatic Esophagus, Stomach, or Gastroesophageal Junction Cancer
NCT02830594, Phase 2, Completed, City of Hope Medical Center; results first posted 2022-06-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pembrolizumab and Palliative Radiation Therapy in Treating Patients With Metastatic Esophagus, Stomach, or Gastroesophageal Junction Cancer. Trials, record NCT02830594. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02830594
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab and Palliative Radiation Therapy in Treating Patients With Metastatic Esophagus, Stomach, or Gastroesophageal Junction Cancer
- NCT number
- NCT02830594
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
Gastric Adenocarcinoma, Gastric Squamous Cell Carcinoma, Gastroesophageal Junction Adenocarcinoma, Metastatic Malignant Neoplasm in the Stomach, Stage IV Esophageal Adenocarcinoma AJCC v7, Stage IV Esophageal Squamous Cell Carcinoma AJCC v7
- Interventions
- External Beam Radiation Therapy, Laboratory Biomarker Analysis, Pembrolizumab
- First posted
- 2016-07-13
- Last updated
- 2026-11-02
- Results first posted
- 2022-06-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Combined Positive Scoring (CPS) in Non-irradiated Sites Assessed by Flow Cytometry | Baseline to 105 weeks | Multicolor immunofluorescence was performed to quantitate analogous CPS expression in pre- and posttreatment biopsies. Difference in MIDS expression between pre- and posttreatment was tested using a Paired T-test. |
| Primary | Changes in Tumor Proportion Scores (TPS) in Non-irradiated Sites Assessed by Flow Cytometry | Baseline to 105 weeks | Multicolor immunofluorescence was performed to quantitate analogous TPS expression in pre- and posttreatment biopsies. Difference in MIDS expression between pre- and posttreatment was tested using a Paired T-test. |
| Primary | Changes in Myeloid-derived Suppressor Cells (MDSC) in Non-irradiated Sites Assessed by Flow Cytometry | Baseline to 105 weeks | Multicolor immunofluorescence was performed to quantitate analogous MIDS expression in pre- and posttreatment biopsies. Difference in MIDS expression between pre- and posttreatment was tested using a Paired T-test. |
| Secondary | Incidence of Treatment Related Adverse Events of Pembrolizumab | Up to 36 months | Graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Adverse events with incidence greater than 10%. An adverse event is any untoward medical experience or change of an existing condition that occurs during or after treatment, whether or not it is considered to be related to the protocol intervention. Serious Adverse Events as: Death; Is life-threatening experience (places the subject at immediate risk of death from the event as it occurred); Unplanned hospitalization (equal to or greater than 24 hours) or prolongation of existing hospitalization; A persistent or significant disability/incapacity; A congenital anomaly/birth defect; Secondary malignancy; Any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health and may require medical or surgical intervention to prevent one of the outcomes listed above. |
| Secondary | Overall Response Rate (ORR) | Up to 36 months | Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune related (ir)RECIST. Overall Response (OR) = CR + PR. |
| Secondary | Progression-free Survival (PFS) | Up to 36 months | Estimated using the product-limit method of Kaplan and Meier. Event defined as progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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. irPD defined as a minimum 20% increase and minimum 5 mm absolute increase in TMTB compared to nadir, or irPD for non-target or new non-measurable lesions. Confirmation of progression is recommended minimum 4 weeks after the first irPD assessment. |
| Secondary | Overall Survival (OS) | Up to 36 months | Estimated using the product-limit method of Kaplan and Meier. Event defined as death from any cause. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in Combined Positive Scoring (CPS) in Non-irradiated Sites Assessed by Flow Cytometry | Baseline to 105 weeks | One patient did not undergo any biopsies due to site of metastasis not being visualized under image guidance and 2 patients did not undergo the second biopsy for patient safety. Four patients had posttreatment biopsies without any viable cancer cells but only residual stromal tissue. | fold change | MEAN |
| PRIMARY | Changes in Tumor Proportion Scores (TPS) in Non-irradiated Sites Assessed by Flow Cytometry | Baseline to 105 weeks | One patient did not undergo any biopsies due to site of metastasis not being visualized under image guidance and 2 patients did not undergo the second biopsy for patient safety. Four patients had posttreatment biopsies without any viable cancer cells but only residual stromal tissue. | fold change | MEAN |
| PRIMARY | Changes in Myeloid-derived Suppressor Cells (MDSC) in Non-irradiated Sites Assessed by Flow Cytometry | Baseline to 105 weeks | One patient did not undergo any biopsies due to site of metastasis not being visualized under image guidance and 2 patients did not undergo the second biopsy for patient safety. Four patients had posttreatment biopsies without any viable cancer cells but only residual stromal tissue. | fold change | MEAN |
| SECONDARY | Incidence of Treatment Related Adverse Events of Pembrolizumab | Up to 36 months | participants | NUMBER | |
| SECONDARY | Overall Response Rate (ORR) | Up to 36 months | percentage of participants | NUMBER | |
| SECONDARY | Progression-free Survival (PFS) | Up to 36 months | Months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Up to 36 months | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Combined Positive Scoring (CPS) in Non-irradiated Sites Assessed by Flow Cytometry | Treatment (Pembrolizumab, RT) | 3.9 | Standard Error 7.0 | fold change | |
| Changes in Tumor Proportion Scores (TPS) in Non-irradiated Sites Assessed by Flow Cytometry | Treatment (Pembrolizumab, RT) | 0.3 | Standard Error 1.7 | fold change | |
| Changes in Myeloid-derived Suppressor Cells (MDSC) in Non-irradiated Sites Assessed by Flow Cytometry | Treatment (Pembrolizumab, RT) | 3.6 | Standard Error 7.2 | fold change | |
| Incidence of Treatment Related Adverse Events of Pembrolizumab | Treatment (Pembrolizumab, RT) | Grade 1-2 Fatigue | 4 | participants | |
| Incidence of Treatment Related Adverse Events of Pembrolizumab | Treatment (Pembrolizumab, RT) | Grade 1-2 Pruritus | 4 | participants | |
| Incidence of Treatment Related Adverse Events of Pembrolizumab | Treatment (Pembrolizumab, RT) | Grade 1-2 Pneumonitis | 2 | participants | |
| Incidence of Treatment Related Adverse Events of Pembrolizumab | Treatment (Pembrolizumab, RT) | Grade 1-2 Skin Rash | 2 | participants | |
| Incidence of Treatment Related Adverse Events of Pembrolizumab | Treatment (Pembrolizumab, RT) | Grade 1-2 Constipation | 2 | participants | |
| Incidence of Treatment Related Adverse Events of Pembrolizumab | Treatment (Pembrolizumab, RT) | Grade 1-2 Xerostomia | 2 | participants | |
| Incidence of Treatment Related Adverse Events of Pembrolizumab | Treatment (Pembrolizumab, RT) | Grade 1-2 Thrombocytopenia | 2 | participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Pembrolizumab, RT) | 14 | |
| Overall Study | COMPLETED | Treatment (Pembrolizumab, RT) | 14 | |
| Overall Study | NOT COMPLETED | Treatment (Pembrolizumab, RT) | 0 |
Source ClinicalTrials.gov
Adverse events73
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Treatment (Pembrolizumab, RT) | 5 | 14 | 34 |
| other | Blood and lymphatic system disorders - O | Blood and lymphatic system disorders | Treatment (Pembrolizumab, RT) | 1 | 14 | 2 |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Treatment (Pembrolizumab, RT) | 1 | 14 | 6 |
| other | Pericardial effusion | Cardiac disorders | Treatment (Pembrolizumab, RT) | 1 | 14 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Pembrolizumab, RT) | 2 | 14 | 3 |
| other | Constipation | Gastrointestinal disorders | Treatment (Pembrolizumab, RT) | 4 | 14 | 7 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Pembrolizumab, RT) | 2 | 14 | 27 |
| other | Dry mouth | Gastrointestinal disorders | Treatment (Pembrolizumab, RT) | 3 | 14 | 4 |
| other | Dysphagia | Gastrointestinal disorders | Treatment (Pembrolizumab, RT) | 2 | 14 | 8 |
| other | Esophagitis | Gastrointestinal disorders | Treatment (Pembrolizumab, RT) | 1 | 14 | 1 |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Pembrolizumab, RT) | 9 | 14 |
| Total, other adverse events | Treatment (Pembrolizumab, RT) | 14 | 14 |
| Total, serious adverse events | Treatment (Pembrolizumab, RT) | 9 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02830594
GET https://conductscience.org/api/trials/v1/NCT02830594/events?page=2