Trial · NCT02243579
Pembrolizumab in Treating Patients With Relapsed or Refractory Stage IB-IVB Mycosis Fungoides or Sezary Syndrome
NCT02243579, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2019-02-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pembrolizumab in Treating Patients With Relapsed or Refractory Stage IB-IVB Mycosis Fungoides or Sezary Syndrome. Trials, record NCT02243579. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02243579
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab in Treating Patients With Relapsed or Refractory Stage IB-IVB Mycosis Fungoides or Sezary Syndrome
- NCT number
- NCT02243579
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Recurrent Mycosis Fungoides and Sezary Syndrome, Refractory Mycosis Fungoides and Sezary Syndrome, Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IIIA Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IIIB Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IVA Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IVB Mycosis Fungoides and Sezary Syndrome AJCC v7
- Interventions
- Laboratory Biomarker Analysis, Pembrolizumab
- First posted
- 2014-09-18
- Last updated
- 2019-09-20
- Results first posted
- 2019-02-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR), Defined as a Confirmed Partial Response (PR) or Complete Response (CR) Using Global Assessment Standard Response Criteria for Mycosis Fungoides and Sezary Syndrome | Up to 3.2 years | A generalized linear model for the objective response rate used a binominal error distribution. The model included as covariates all available baseline predictors of the missing outcomes. |
| Secondary | Duration of Response | The time interval between the date of first response (CR/PR) and the date of progression as assessed by standard Mycosis Fungoides and Sezary Syndrome response criteria, assessed at 26 and 52 weeks | Was estimated using the Kaplan-Meier method (Duration of Response Probability). |
| Secondary | Progression Free Survival (PFS) | The time from allocation to the first documented disease progression or death due to any cause, whichever occurs first, assessed at 26 and 52 weeks | Was estimated using the Kaplan-Meier method (Progression Free Survival Probability). |
| Secondary | Overall Survival (OS) | The time from randomization to death due to any cause, assessed at 52, 104 and 156 weeks | Was estimated using the Kaplan-Meier method (Overall Survival Probability). |
| Secondary | Time to Onset of First Drug-related Toxicity | Up to 4 years | Summary statistics (mean and SD) for time to onset of first drug-related toxicity was provided. |
| Secondary | Incidence of Adverse Events Graded Using the Common Terminology Criteria for Adverse Events Version 5.0 | Up to 4 years | Adverse events were summarized as counts and frequencies by toxicity grade. |
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 | Objective Response Rate (ORR), Defined as a Confirmed Partial Response (PR) or Complete Response (CR) Using Global Assessment Standard Response Criteria for Mycosis Fungoides and Sezary Syndrome | Up to 3.2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Response | The time interval between the date of first response (CR/PR) and the date of progression as assessed by standard Mycosis Fungoides and Sezary Syndrome response criteria, assessed at 26 and 52 weeks | Duration of Response Probability | NUMBER | |
| SECONDARY | Progression Free Survival (PFS) | The time from allocation to the first documented disease progression or death due to any cause, whichever occurs first, assessed at 26 and 52 weeks | Progression Free Survival Probability | NUMBER | |
| SECONDARY | Overall Survival (OS) | The time from randomization to death due to any cause, assessed at 52, 104 and 156 weeks | Overall Survival Probability | NUMBER | |
| SECONDARY | Time to Onset of First Drug-related Toxicity | Up to 4 years | Patients with drug-related toxicities included in the analysis | Days | MEAN |
| SECONDARY | Incidence of Adverse Events Graded Using the Common Terminology Criteria for Adverse Events Version 5.0 | Up to 4 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR), Defined as a Confirmed Partial Response (PR) or Complete Response (CR) Using Global Assessment Standard Response Criteria for Mycosis Fungoides and Sezary Syndrome | Treatment (Pembrolizumab) | Confirmed Complete Response | 2 | Participants | |
| Objective Response Rate (ORR), Defined as a Confirmed Partial Response (PR) or Complete Response (CR) Using Global Assessment Standard Response Criteria for Mycosis Fungoides and Sezary Syndrome | Treatment (Pembrolizumab) | Confirmed Partial Response | 7 | Participants | |
| Objective Response Rate (ORR), Defined as a Confirmed Partial Response (PR) or Complete Response (CR) Using Global Assessment Standard Response Criteria for Mycosis Fungoides and Sezary Syndrome | Treatment (Pembrolizumab) | Stable Disease | 9 | Participants | |
| Objective Response Rate (ORR), Defined as a Confirmed Partial Response (PR) or Complete Response (CR) Using Global Assessment Standard Response Criteria for Mycosis Fungoides and Sezary Syndrome | Treatment (Pembrolizumab) | Progressive Disease | 6 | Participants | |
| Duration of Response | Treatment (Pembrolizumab) | 26 weeks | 1.0 | Duration of Response Probability | |
| Duration of Response | Treatment (Pembrolizumab) | 52 weeks | 0.8571 | Duration of Response Probability | |
| Progression Free Survival (PFS) | Treatment (Pembrolizumab) | 26 weeks | 0.7380 | Progression Free Survival Probability | |
| Progression Free Survival (PFS) | Treatment (Pembrolizumab) | 52 weeks | 0.6457 | Progression Free Survival Probability | |
| Overall Survival (OS) | Treatment (Pembrolizumab) | 52 weeks | 0.95 | Overall Survival Probability | |
| Overall Survival (OS) | Treatment (Pembrolizumab) | 104 weeks | 0.7917 | Overall Survival Probability |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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) | 24 | |
| Overall Study | COMPLETED | Treatment (Pembrolizumab) | 4 | |
| Overall Study | NOT COMPLETED | Treatment (Pembrolizumab) | 20 |
Source ClinicalTrials.gov
Adverse events128
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) | 7 | 24 | |
| other | Low Hemoglobin | Blood and lymphatic system disorders | Treatment (Pembrolizumab) | 1 | 24 | |
| other | Vertigo | Ear and labyrinth disorders | Treatment (Pembrolizumab) | 2 | 24 | |
| other | Blurred Vision | Eye disorders | Treatment (Pembrolizumab) | 1 | 24 | |
| other | Keratitis | Eye disorders | Treatment (Pembrolizumab) | 1 | 24 | |
| other | Abdominal Pain | Gastrointestinal disorders | Treatment (Pembrolizumab) | 1 | 24 | |
| other | Colonic hemorrhage | Gastrointestinal disorders | Treatment (Pembrolizumab) | 1 | 24 | |
| other | Constipation | Gastrointestinal disorders | Treatment (Pembrolizumab) | 1 | 24 | |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Pembrolizumab) | 3 | 24 | |
| other | Nausia | Gastrointestinal disorders | Treatment (Pembrolizumab) | 2 | 24 |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Pembrolizumab) | 7 | 24 |
| Total, other adverse events | Treatment (Pembrolizumab) | 24 | 24 |
| Total, serious adverse events | Treatment (Pembrolizumab) | 11 | 24 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| U01CA154967 | Cancer Immunotherapy Trials Network Central Operations and Statistical Center | CHEEVER, MARTIN ALEXANDER | FRED HUTCHINSON CANCER RESEARCH CENTER | NATIONAL CANCER INSTITUTE | 2010 to 2017 | NIH RePORTER |
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/NCT02243579
GET https://conductscience.org/api/trials/v1/NCT02243579/events?page=2