Trial · NCT02632344
Pembrolizumab for HPV-associated Recurrent Respiratory Papilloma Patients
NCT02632344, Phase 2, Completed, Massachusetts General Hospital; results first posted 2023-07-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pembrolizumab for HPV-associated Recurrent Respiratory Papilloma Patients. Trials, record NCT02632344. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02632344
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab for HPV-associated Recurrent Respiratory Papilloma Patients
- NCT number
- NCT02632344
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Recurrent Respiratory Papillomatosis
- Interventions
- Pembrolizumab
- First posted
- 2015-12-16
- Last updated
- 2026-04-30
- Results first posted
- 2023-07-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate Via Endoscopic Lesional Burden Score and/or RECIST | Up to 2 years | A Simon two-stage design was used to assess best objective response rate based on endoscopic lesional burden and Response Evaluation Criteria in Solid Tumors (RECIST). For the endoscopic lesions burden score,T=the range of the score is 0 to 83. A lower score means decreased disease burden. |
| Primary | Number of Participants With Adverse Events Through CTCAE | Up to 3 years after enrollment of the last the patient | To determine the safety and tolerability of pembrolizumab in subjects with RRP. |
| Secondary | Assess Duration of Response | Time from observed partial response to the development of progressive disease. | To evaluate the response duration in subjects receiving pembrolizumab. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate Via Endoscopic Lesional Burden Score and/or RECIST | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Adverse Events Through CTCAE | Up to 3 years after enrollment of the last the patient | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Assess Duration of Response | Time from observed partial response to the development of progressive disease. | Duration of Response was assessed among those participants who achieved a partial response (PR). | months | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate Via Endoscopic Lesional Burden Score and/or RECIST | Pembrolizumab | 21 | Participants | ||
| Number of Participants With Adverse Events Through CTCAE | Pembrolizumab | 15 | Participants | ||
| Assess Duration of Response | Pembrolizumab | 13.1 | Standard Deviation 6.2 | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab | 21 | |
| Overall Study | COMPLETED | Pembrolizumab | 13 | |
| Overall Study | NOT COMPLETED | Pembrolizumab | 8 |
Source ClinicalTrials.gov
Adverse events2
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 | Fatigue | General disorders | Pembrolizumab | 15 | 21 | |
| serious | Hypophysitis | Endocrine disorders | Pembrolizumab | 1 | 21 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab | 3 | 21 |
| Total, other adverse events | Pembrolizumab | 15 | 21 |
| Total, serious adverse events | Pembrolizumab | 1 | 21 |
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/NCT02632344
GET https://conductscience.org/api/trials/v1/NCT02632344/registered