Comparison · NCT03087019-857548a1
Pembrolizumab + Radiation vs Pembrolizumab: Patients Demonstrating Objective Response In Non-Irradiated Lesions (Tumor Size on Scans)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Pembrolizumab + Radiation vs Pembrolizumab: Patients Demonstrating Objective Response In Non-Irradiated Lesions (Tumor Size on Scans). Trial comparisons, record NCT03087019-857548a1. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03087019-857548a1
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.278 | wilson | |
| Risk in group 2 | 0 | 0 | 0.299 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.299 | 0.278 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Pembrolizumab + Radiation | * Up to 5 metastatic lesions targeted with radiation~* Over 5 fractions starting within 7 calendar days following the first dose of pembrolizumab~* Pembrolizumab will be administered on day 1 of each 21day cycle~* Pembrolizumab is delivered intravenously~Radiation: Standard use of radiation is administered~Pembrolizumab: Pembrolizumab is designed to restore the natural ability of the immune system to recognize and target cancer cells. | 0 | 10 | OG000 |
| Group 2 | Pembrolizumab | * Pembrolizumab will be administered on day 1 of each 21day cycle~* Pembrolizumab is delivered intravenously~Pembrolizumab: Pembrolizumab is designed to restore the natural ability of the immune system to recognize and target cancer cells. | 0 | 9 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Patients Demonstrating Objective Response In Non-Irradiated Lesions (Tumor Size on Scans)
- Description
Objective response will be assessed in non-irradiated lesions among all eligible and treated patients pursuing RECIST 1.1. Per RECIST guidelines for target lesions, Complete Response (CR): disappearance of all target lesions; Partial Response (PR): \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): \>20% increase in sum of the longest diameter (LD) of measured lesions, referencing the smallest sum LD, or new lesions; Stable Disease (SD): neither PR nor PD. Objective response refers to tumor shrinkage at least qualifying as PR.
- Time frame
- 2 years
- Population
21 subjects were enrolled. One subject withdrew consent before starting treatment and was replaced. A total of 20 patients (10 per each arm) received protocol treatment. Among 20 patients treated, 1 patient withdrew consent in order to pursue hospice care after receiving a single dose of pembrolizumab and was not evaluable for response.
Source ClinicalTrials.gov
Trial
- Title
- Pembrolizumab With or Without Radiation in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma
- NCT number
- NCT03087019
- Phases
- PHASE2
- Conditions
- Adenoid Cystic Carcinoma
- Interventions
- Radiation, Pembrolizumab
- Lead sponsor
- Dana-Farber Cancer Institute
- Results first posted
- 2021-04-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03087019?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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