Trial · NCT02777385
Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy (IMRT) in Head and Neck Cancer
NCT02777385, Phase 2, Completed, Dan Zandberg; results first posted 2024-08-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy (IMRT) in Head and Neck Cancer. Trials, record NCT02777385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02777385
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy (IMRT) in Head and Neck Cancer
- NCT number
- NCT02777385
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- Dan Zandberg
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- Pembrolizumab, Cisplatin, IMRT
- First posted
- 2016-05-19
- Last updated
- 2024-08-01
- Results first posted
- 2024-08-01
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival at ≤12 Months | Up to 12 months | Probability of participants (expressed as a percentage) without disease progression at less than or equal to12 after start of treatment: Complete Response (CR) + Partial Response (PR)/total number of patients assessed. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). |
| Primary | Progression-free Survival at ≤ 36 Months | Up to 36 months | Probability of participants (expressed as a percentage) without disease progression at less than or equal to 36 months after start of treatment: Complete Response (CR) + Partial Response (PR)/total number of patients assessed. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). |
| Primary | Progression-free Survival at ≤ 48 Months | Up to 48 months | Probability of participants (expressed as a percentage) without disease progression time from treatment initiation to disease progression or death from any cause or last follow up. Per RECIST v1.1: Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). |
| Primary | Acute Toxicity / DLT Rate | Up to 6 months | The number of patients who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 4.0 |
| Primary | 1-year Locoregional Failure Rate | Up to 1 year | Percent probability of participants for which time to locoregional failure (TTLRF) (calculated from treatment initiation to locoregional failure, or censored at other failure, death, or the last follow up; death is not an event) is less than 1 year. Locoregional failure is disease recurrence in either the location or regional location of the original disease, as opposed to a distant site. |
| Primary | 3-year Locoregional Failure Rate | Up to 3 years | Percent probability of participants for which time to locoregional failure (TTLRF) (calculated from treatment initiation to locoregional failure, or censored at other failure, death, or the last follow up; death is not an event) is less than 3 years. Locoregional failure is disease recurrence in either the location or regional location of the original disease, as opposed to a distant site. |
| Secondary | Progression-free Survival (PFS) | Up to 48 months | Median number of months from treatment initiation to disease progression or death from any cause or last follow up. Per RECIST v1.1 Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). |
| Secondary | Overall Survival (OS) | Up to 48 months | The length of time from start of study treatment that patients are still alive. |
| Secondary | Overall Survival (OS) at ≤ 12 Months | Up to12 months | Probability of patients (expressed as a percentage) still alive at less than or equal to 12 months after start of study. |
| Secondary | Overall Survival (OS) at ≤ 36 Months | Up to 36 months | Probability of patients (expressed as a percentage) still alive at less than or equal to 36 months after start of study. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival at ≤12 Months | Up to 12 months | All patients that received treatment and were radiologically evaluable for response. | percentage of patients | NUMBER |
| PRIMARY | Progression-free Survival at ≤ 36 Months | Up to 36 months | All patients that received treatment and were radiologically evaluable for response. | percentage of patients | NUMBER |
| PRIMARY | Progression-free Survival at ≤ 48 Months | Up to 48 months | All patients that received treatment and were radiologically evaluable for response. | percentage of patients | NUMBER |
| PRIMARY | Acute Toxicity / DLT Rate | Up to 6 months | All treated patients. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 1-year Locoregional Failure Rate | Up to 1 year | All treated patients. | percent probability of participants | NUMBER |
| PRIMARY | 3-year Locoregional Failure Rate | Up to 3 years | All treated patients. | percent probability of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | Up to 48 months | All patients that received treatment and were radiologically evaluable for response. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to 48 months | All patients on study. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) at ≤ 12 Months | Up to12 months | All patients on study. | percentage of patients | NUMBER |
| SECONDARY | Overall Survival (OS) at ≤ 36 Months | Up to 36 months | All patients on study. | percentage of patients | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival at ≤12 Months | Cisplatin + Radiation + Pembrolizumab - Concurrent | 71 | percentage of patients | ||
| Progression-free Survival at ≤12 Months | Cisplatin + Radiation + Pembrolizumab - Sequential | 83 | percentage of patients | ||
| Progression-free Survival at ≤ 36 Months | Cisplatin + Radiation + Pembrolizumab - Concurrent | 57 | percentage of patients | ||
| Progression-free Survival at ≤ 36 Months | Cisplatin + Radiation + Pembrolizumab - Sequential | 75 | percentage of patients | ||
| Progression-free Survival at ≤ 48 Months | Cisplatin + Radiation + Pembrolizumab - Concurrent | 49 | percentage of patients | ||
| Progression-free Survival at ≤ 48 Months | Cisplatin + Radiation + Pembrolizumab - Sequential | 67 | percentage of patients | ||
| Acute Toxicity / DLT Rate | Cisplatin + Radiation + Pembrolizumab - Concurrent | 3 | Participants | ||
| Acute Toxicity / DLT Rate | Cisplatin + Radiation + Pembrolizumab - Sequential | 0 | Participants | ||
| 1-year Locoregional Failure Rate | Cisplatin + Radiation + Pembrolizumab - Concurrent | 15 | percent probability of participants | ||
| 1-year Locoregional Failure Rate | Cisplatin + Radiation + Pembrolizumab - Sequential | 4 | percent probability of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cisplatin + Radiation + Pembrolizumab - Concurrent | 41 | |
| Overall Study | STARTED | Cisplatin + Radiation + Pembrolizumab - Sequential | 39 | |
| Overall Study | COMPLETED | Cisplatin + Radiation + Pembrolizumab - Concurrent | 41 | |
| Overall Study | COMPLETED | Cisplatin + Radiation + Pembrolizumab - Sequential | 39 | |
| Overall Study | NOT COMPLETED | Cisplatin + Radiation + Pembrolizumab - Concurrent | 0 | |
| Overall Study | NOT COMPLETED | Cisplatin + Radiation + Pembrolizumab - Sequential | 0 |
Source ClinicalTrials.gov
Adverse events722
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 | Cisplatin + Radiation + Pembrolizumab - Concurrent | 32 | 41 | |
| other | Anemia | Blood and lymphatic system disorders | Cisplatin + Radiation + Pembrolizumab - Sequential | 34 | 39 | |
| other | Blood and lymphatic system disorders - Other, specifygranulomatous lymphadenitis | Blood and lymphatic system disorders | Cisplatin + Radiation + Pembrolizumab - Concurrent | 0 | 41 | |
| other | Blood and lymphatic system disorders - Other, specifygranulomatous lymphadenitis | Blood and lymphatic system disorders | Cisplatin + Radiation + Pembrolizumab - Sequential | 1 | 39 | |
| other | Blood and lymphatic system disorders - Other, specifyvenous thrombosis | Blood and lymphatic system disorders | Cisplatin + Radiation + Pembrolizumab - Concurrent | 1 | 41 | |
| other | Blood and lymphatic system disorders - Other, specifyvenous thrombosis | Blood and lymphatic system disorders | Cisplatin + Radiation + Pembrolizumab - Sequential | 0 | 39 | |
| other | Acute coronary syndrome | Cardiac disorders | Cisplatin + Radiation + Pembrolizumab - Concurrent | 0 | 41 | |
| other | Acute coronary syndrome | Cardiac disorders | Cisplatin + Radiation + Pembrolizumab - Sequential | 1 | 39 | |
| other | Aortic valve disease | Cardiac disorders | Cisplatin + Radiation + Pembrolizumab - Concurrent | 0 | 41 | |
| other | Aortic valve disease | Cardiac disorders | Cisplatin + Radiation + Pembrolizumab - Sequential | 1 | 39 |
1 to 10 of 722Source ClinicalTrials.gov
See all 722 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cisplatin + Radiation + Pembrolizumab - Concurrent | 11 | 41 |
| Total, all-cause mortality | Cisplatin + Radiation + Pembrolizumab - Sequential | 6 | 39 |
| Total, other adverse events | Cisplatin + Radiation + Pembrolizumab - Concurrent | 38 | 41 |
| Total, other adverse events | Cisplatin + Radiation + Pembrolizumab - Sequential | 38 | 39 |
| Total, serious adverse events | Cisplatin + Radiation + Pembrolizumab - Concurrent | 21 | 41 |
| Total, serious adverse events | Cisplatin + Radiation + Pembrolizumab - Sequential | 10 | 39 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cisplatin + Radiation + Pembrolizumab - Concurrent vs Cisplatin + Radiation + Pembrolizumab - Sequential: Acute Toxicity / DLT Rate | Trial comparisons |
| Cisplatin + Radiation + Pembrolizumab - Concurrent vs Cisplatin + Radiation + Pembrolizumab - Sequential: deaths from any cause | Trial comparisons |
| Cisplatin + Radiation + Pembrolizumab - Concurrent vs Cisplatin + Radiation + Pembrolizumab - Sequential: 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/NCT02777385
GET https://conductscience.org/api/trials/v1/NCT02777385/results?page=2