Trial · NCT03087019
Pembrolizumab With or Without Radiation in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma
NCT03087019, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2021-04-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pembrolizumab With or Without Radiation in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma. Trials, record NCT03087019. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03087019
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab With or Without Radiation in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma
- NCT number
- NCT03087019
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Adenoid Cystic Carcinoma
- Interventions
- Radiation, Pembrolizumab
- First posted
- 2017-03-22
- Last updated
- 2022-10-14
- Results first posted
- 2021-04-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patients Demonstrating Objective Response In Non-Irradiated Lesions (Tumor Size on Scans) | 2 years | 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. |
| Secondary | Progression Free Survival (Time From Randomization to Disease Progression or Death) | 2 years | Progression-free survival is defined as the time from randomization to disease progression or death, whichever occurs first. Patients who are alive without disease progression will be censored at the date of last disease assessment. Progression-free survival will be evaluated using both RECIST 1.1 and immune-related response criteria (irRC), and both sets of results will be reported in each arm. Per RECIST criteria, progression is defined as a \>=20% increase in the sum of the longest diameter of the measured lesions, referencing the smallest longest diameter sum, or the appearance of at least one new lesion. |
| Secondary | Overall Survival (Time From Randomization to Death) | 2 years | Overall survival is defined as the time from randomization to death or date last known alive. Overall survival will be evaluated using both RECIST 1.1 and immune-related response criteria (irRC), and both sets of results will be reported in each arm. will be evaluated using both RECIST 1.1 and immune-related response criteria (irRC), and both sets of results will be reported in each arm. |
| Secondary | Number of Participants With Complete Response (Absence of Non-irradiated Lesions on Scans) | 2 years | Complete disappearance of all measurable non-irradiated lesions. All lymph nodes must be non-pathological in size (\<10 mm short axis). |
| Secondary | Number of Participants With Partial Response (Tumor Size on Scans) | 2 years | At least a 30% decrease in the longest diameter valuated using RECIST 1.1. |
| Secondary | Number of Treatment-Emergent Adverse Events | 2 years | All patients who receive treatment, regardless of eligibility, will be evaluable for toxicity. Toxicity will be graded according to NCI CTCAE, Version 4.0. The proportions of patients with various toxicities will be reported by treatment arm. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patients Demonstrating Objective Response In Non-Irradiated Lesions (Tumor Size on Scans) | 2 years | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (Time From Randomization to Disease Progression or Death) | 2 years | 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. | months | MEAN |
| SECONDARY | Overall Survival (Time From Randomization to Death) | 2 years | 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. | months | MEAN |
| SECONDARY | Number of Participants With Complete Response (Absence of Non-irradiated Lesions on Scans) | 2 years | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Partial Response (Tumor Size on Scans) | 2 years | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Treatment-Emergent Adverse Events | 2 years | 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. | treatment-emergent adverse events | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patients Demonstrating Objective Response In Non-Irradiated Lesions (Tumor Size on Scans) | Pembrolizumab + Radiation | 0 | Participants | ||
| Patients Demonstrating Objective Response In Non-Irradiated Lesions (Tumor Size on Scans) | Pembrolizumab | 0 | Participants | ||
| Progression Free Survival (Time From Randomization to Disease Progression or Death) | Pembrolizumab + Radiation | 4.5 | 95% Confidence Interval 2.4 to 20.6 | months | |
| Progression Free Survival (Time From Randomization to Disease Progression or Death) | Pembrolizumab | 6.6 | 95% Confidence Interval 2.4 to 13.1 | months | |
| Overall Survival (Time From Randomization to Death) | Pembrolizumab + Radiation | NA | 95% Confidence Interval 10.1 to NA | months | |
| Overall Survival (Time From Randomization to Death) | Pembrolizumab | 27.2 | 95% Confidence Interval 22.9 to NA | months | |
| Number of Participants With Complete Response (Absence of Non-irradiated Lesions on Scans) | Pembrolizumab + Radiation | 0 | Participants | ||
| Number of Participants With Complete Response (Absence of Non-irradiated Lesions on Scans) | Pembrolizumab | 0 | Participants | ||
| Number of Participants With Partial Response (Tumor Size on Scans) | Pembrolizumab + Radiation | 0 | Participants | ||
| Number of Participants With Partial Response (Tumor Size on Scans) | Pembrolizumab | 0 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab + Radiation | 11 | |
| Overall Study | STARTED | Pembrolizumab | 10 | |
| Overall Study | COMPLETED | Pembrolizumab + Radiation | 10 | |
| Overall Study | COMPLETED | Pembrolizumab | 10 | |
| Overall Study | NOT COMPLETED | Pembrolizumab + Radiation | 1 | |
| Overall Study | NOT COMPLETED | Pembrolizumab | 0 |
Source ClinicalTrials.gov
Adverse events102
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 | Alanine Aminotransferase Increased | Investigations | Pembrolizumab + Radiation | 2 | 10 | |
| other | Alanine Aminotransferase Increased | Investigations | Pembrolizumab | 1 | 10 | |
| other | Alkaline Phosphatase Increased | Investigations | Pembrolizumab + Radiation | 1 | 10 | |
| other | Alkaline Phosphatase Increased | Investigations | Pembrolizumab | 0 | 10 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Pembrolizumab + Radiation | 1 | 10 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Pembrolizumab | 0 | 10 | |
| other | Anorexia | Metabolism and nutrition disorders | Pembrolizumab + Radiation | 1 | 10 | |
| other | Anorexia | Metabolism and nutrition disorders | Pembrolizumab | 0 | 10 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Pembrolizumab + Radiation | 1 | 10 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Pembrolizumab | 0 | 10 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab + Radiation | 1 | 10 |
| Total, all-cause mortality | Pembrolizumab | 1 | 10 |
| Total, other adverse events | Pembrolizumab + Radiation | 10 | 10 |
| Total, other adverse events | Pembrolizumab | 10 | 10 |
| Total, serious adverse events | Pembrolizumab + Radiation | 3 | 10 |
| Total, serious adverse events | Pembrolizumab | 4 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32781104 | DERIVED |
Source PubMed
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pembrolizumab + Radiation vs Pembrolizumab: Number of Participants With Complete Response (Absence of Non-irradiated Lesions on Scans) | Trial comparisons |
| Pembrolizumab + Radiation vs Pembrolizumab: Patients Demonstrating Objective Response In Non-Irradiated Lesions (Tumor Size on Scans) | Trial comparisons |
| Pembrolizumab + Radiation vs Pembrolizumab: Number of Participants With Partial Response (Tumor Size on Scans) | Trial comparisons |
| Pembrolizumab + Radiation vs Pembrolizumab: deaths from any cause | Trial comparisons |
| Pembrolizumab + Radiation vs Pembrolizumab: serious adverse events | Trial comparisons |
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/NCT03087019
GET https://conductscience.org/api/trials/v1/NCT03087019/events?page=2