Trial · NCT03316573
Pembrolizumab in Neoplasms or Lymphomas
NCT03316573, Phase 2, Suspended, Dana-Farber Cancer Institute; results first posted 2023-11-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pembrolizumab in Neoplasms or Lymphomas. Trials, record NCT03316573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03316573
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab in Neoplasms or Lymphomas
- NCT number
- NCT03316573
- Status
- Suspended
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Lymphoma, Histiocytic Sarcoma, Follicular Dendritic Cell Sarcoma, Interdigitating Dendritic Cell Sarcoma
- Interventions
- Pembrolizumab
- First posted
- 2017-10-20
- Last updated
- 2026-08-06
- Results first posted
- 2023-11-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | 2 years | The number of subjects with partial response (PR) or complete response (CR) by PET/CT scan Per Lugano criteria, CR is defined as positron emission tomography-computed tomography (PET-CT), score 1, 2, or 3 with or without a residual mass on 5 point scale (5PS) OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in longest diameter (LDi). PR is defined as PET-CT score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. OR on CT ≥50% decrease in the sum of the products of the longest perpendicular diameters (SPD) of up to 6 target measurable nodes and extranodal sites. |
| Secondary | Complete Response Rate | 2 years | The number of patients with complete response (CR) Per Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3 with or without a residual mass on 5PS OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in LDi. |
| Secondary | Number of Patients With Adverse Events of Any Grade | Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment | The number of patients with an adverse event of any grade that has definite, probable, or possible attribution to study treatment. |
| Secondary | Duration of Response | Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment | Length of first complete (CR) or partial response (PR) until progression (PD) Per Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3 with/without a residual mass on 5PS OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in LDi. PR is defined as PET-CT score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. OR on CT ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites. PD is defined as PET-CT score 4 or 5 with an increase in intensity of uptake from baseline and/or new fluoro-2-deoxy-D-glucose (FDG)-avid foci consistent with lymphoma at interim or end-of-treatment assessment. OR on CT, an individual node/lesion must be abnormal. OR new/clear progression of pre-existing nonmeasured lesions. OR regrowth of previously resolved lesions. OR new node \>1.5 cm in any axis or new extranodal site \>1.0 cm in any axis or be unequivocal and attributable to lymphoma. AND/OR new/recurrent involvement of the bone marrow |
| Secondary | Progression-free Survival | Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment | Time from study registration until the earlier of first progression or death from any cause, censored for patients alive without progression or lost to follow-up without documented progression. Per Lugano criteria, progression is defined as PET-CT score 4 or 5 with an increase in intensity of uptake from baseline and/or new FDG-avid foci consistent with lymphoma at interim or end-of-treatment assessment. OR on CT, an individual node/lesion must be abnormal. OR new or clear progression of pre-existing nonmeasured lesions. OR regrowth of previously resolved lesions. OR a new node \>1.5 cm in any axis or a new extranodal site \>1.0 cm in any axis or be unequivocal and must be attributable to lymphoma. AND/OR new or recurrent involvement of the bone marrow |
| Secondary | Duration of Complete Response | Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment | The length of first complete response (CR) until progression (PD) Per Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3 with or without a residual mass on 5PS OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in LDi. PD is defined as PET-CT score 4 or 5 with an increase in intensity of uptake from baseline and/or new FDG-avid foci consistent with lymphoma at interim or end-of-treatment assessment. OR on CT, an individual node/lesion must be abnormal. OR new or clear progression of pre-existing nonmeasured lesions. OR regrowth of previously resolved lesions. OR a new node \>1.5 cm in any axis or a new extranodal site \>1.0 cm in any axis or be unequivocal and must be attributable to lymphoma. AND/OR new or recurrent involvement of the bone marrow |
| Secondary | Overall Survival | Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment | Time from study registration until death from any cause, censored for patients still alive or lost to follow-up |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Complete Response Rate | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients With Adverse Events of Any Grade | Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Response | Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment | months | MEDIAN | |
| SECONDARY | Progression-free Survival | Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment | months | MEDIAN | |
| SECONDARY | Duration of Complete Response | Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment | months | MEDIAN | |
| SECONDARY | Overall Survival | Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment | months | MEDIAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate | Pembrolizumab | 3 | Participants | ||
| Complete Response Rate | Pembrolizumab | 3 | Participants | ||
| Number of Patients With Adverse Events of Any Grade | Pembrolizumab | 18 | Participants | ||
| Duration of Response | Pembrolizumab | 15 | Full Range 4 to 26 | months | |
| Progression-free Survival | Pembrolizumab | 1.5 | Full Range 0.5 to 28 | months | |
| Duration of Complete Response | Pembrolizumab | 12 | Full Range 0 to 24 | months | |
| Overall Survival | Pembrolizumab | 24 | Full Range 1 to 35 | 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 | 18 | |
| Overall Study | COMPLETED | Pembrolizumab | 18 | |
| 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 | Anemia | Blood and lymphatic system disorders | Pembrolizumab | 10 | 18 | 29 |
| other | Fatigue | General disorders | Pembrolizumab | 10 | 18 | 12 |
| other | Alkaline phosphatase increased | Investigations | Pembrolizumab | 9 | 18 | 15 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Pembrolizumab | 7 | 18 | 17 |
| other | Platelet count decreased | Investigations | Pembrolizumab | 7 | 18 | 13 |
| other | Nausea | Gastrointestinal disorders | Pembrolizumab | 7 | 18 | 8 |
| other | White blood cell decreased | Investigations | Pembrolizumab | 6 | 18 | 18 |
| other | Aspartate aminotransferase increased | Investigations | Pembrolizumab | 6 | 18 | 16 |
| other | Alanine aminotransferase increased | Investigations | Pembrolizumab | 6 | 18 | 10 |
| other | Diarrhea | Gastrointestinal disorders | Pembrolizumab | 6 | 18 | 8 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab | 10 | 18 |
| Total, other adverse events | Pembrolizumab | 18 | 18 |
| Total, serious adverse events | Pembrolizumab | 8 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32871584 | 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 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/NCT03316573
GET https://conductscience.org/api/trials/v1/NCT03316573/events?page=2