Trial · NCT02301039
SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas
NCT02301039, Phase 2, Completed, Sarcoma Alliance for Research through Collaboration; results first posted 2020-09-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas. Trials, record NCT02301039. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02301039
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas
- NCT number
- NCT02301039
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 144 participants, actual
- Lead sponsor
- Sarcoma Alliance for Research through Collaboration
- Conditions
- Soft Tissue Sarcoma, Bone Sarcoma
- Interventions
- Pembrolizumab
- First posted
- 2014-11-25
- Last updated
- 2020-09-29
- Results first posted
- 2020-09-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | Assessments will be conducted at 8 weeks, up to 5 years | The Objective Response Rate (ORR) is the percentage of patient's tumor that shrinks or disappears after treatment. ORR will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, whereby Complete Response is defined as the disappearance of all target lesions and Partial Response is defined as at least a 30% decrease in the sum of the diameters of target lesions in reference to the baseline diameters. Overall Response (OR) = CR + PR. |
| Secondary | Adverse Events Related to Pembrolizumab Treatment in Patients With Advanced Sarcoma, by Patient | Up to 5 years | Related Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a investigational product and related to the investigational product. |
| Secondary | The Progression-free Survival (PFS) | up to 5 yrs | The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. |
| Secondary | Response Rate by Immune-related Response Criteria (Ir-RC) | Assessment at 8 weeks, up to 5 years | Immune related response criteria was developed to adequately assess tumor response to immunotherapy.The irRC are based on bidimensional measurements We aimed to assess response by bidimensional measurements in patients with advanced sarcoma. Immune-related Complete Response (irCR) is the complete disappearance of all index lesions. Immune-related Partial Response (irPR) is the decrease by 50% or greater (from Baseline) in the sum of the products of the two largest perpendicular diameters of all index and new measurable lesions |
| Secondary | Overall Survival (OS) | up to 5 years | The Overall Survival is the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease and are still alive |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate | Assessments will be conducted at 8 weeks, up to 5 years | There were 40 of 42 patients in the soft tissue sarcoma cohort who were evaluable for response. There were 40 of 42 patients in the bone sarcoma cohort who were evaluable for response. There were 53 of 60 patients in the expansion cohort who were evaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Adverse Events Related to Pembrolizumab Treatment in Patients With Advanced Sarcoma, by Patient | Up to 5 years | Grade 3 or higher treatment related AEs | NUMBER | |
| SECONDARY | The Progression-free Survival (PFS) | up to 5 yrs | weeks | MEDIAN | |
| SECONDARY | Response Rate by Immune-related Response Criteria (Ir-RC) | Assessment at 8 weeks, up to 5 years | There were 30 out of 40 total patients evaluable for response in the soft tissue sarcoma cohort. There were 30 out of 40 total patients evaluable for response in the soft tissue sarcoma cohort. There were 52 out of 60 total patients evaluable for response in the soft tissue sarcoma cohort. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | up to 5 years | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate | Soft Tissue Sarcoma | 7 | Participants | ||
| Objective Response Rate | Bone Sarcoma | 2 | Participants | ||
| Objective Response Rate | Expansion Cohort | 7 | Participants | ||
| Adverse Events Related to Pembrolizumab Treatment in Patients With Advanced Sarcoma, by Patient | Soft Tissue Sarcoma | 6 | Grade 3 or higher treatment related AEs | ||
| Adverse Events Related to Pembrolizumab Treatment in Patients With Advanced Sarcoma, by Patient | Bone Sarcoma | 9 | Grade 3 or higher treatment related AEs | ||
| Adverse Events Related to Pembrolizumab Treatment in Patients With Advanced Sarcoma, by Patient | Expansion Cohort | 10 | Grade 3 or higher treatment related AEs | ||
| The Progression-free Survival (PFS) | Soft Tissue Sarcoma | 18 | 95% Confidence Interval 8 to 22 | weeks | |
| The Progression-free Survival (PFS) | Bone Sarcoma | 8 | 95% Confidence Interval 7 to 9 | weeks | |
| The Progression-free Survival (PFS) | Expansion Cohort | 8 | 95% Confidence Interval 7 to 13 | weeks | |
| Response Rate by Immune-related Response Criteria (Ir-RC) | Soft Tissue Sarcoma | irCR | 1 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Soft Tissue Sarcoma | 42 | |
| Overall Study | STARTED | Bone Sarcoma | 42 | |
| Overall Study | STARTED | Expansion Cohort | 60 | |
| Overall Study | COMPLETED | Soft Tissue Sarcoma | 42 | |
| Overall Study | COMPLETED | Bone Sarcoma | 42 | |
| Overall Study | COMPLETED | Expansion Cohort | 60 | |
| Overall Study | NOT COMPLETED | Soft Tissue Sarcoma | 0 | |
| Overall Study | NOT COMPLETED | Bone Sarcoma | 0 | |
| Overall Study | NOT COMPLETED | Expansion Cohort | 0 |
Source ClinicalTrials.gov
Adverse events486
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 | Soft Tissue Sarcoma | 9 | 42 | 9 |
| other | Anemia | Blood and lymphatic system disorders | Bone Sarcoma | 8 | 42 | 8 |
| other | Anemia | Blood and lymphatic system disorders | Expansion | 21 | 60 | 21 |
| other | Blood and Lymphatic Systems Disorder, other | Blood and lymphatic system disorders | Soft Tissue Sarcoma | 0 | 42 | 0 |
| other | Blood and Lymphatic Systems Disorder, other | Blood and lymphatic system disorders | Bone Sarcoma | 0 | 42 | 0 |
| other | Blood and Lymphatic Systems Disorder, other | Blood and lymphatic system disorders | Expansion | 2 | 60 | 2 |
| other | Febrile Neuropenia | Blood and lymphatic system disorders | Soft Tissue Sarcoma | 1 | 42 | 1 |
| other | Febrile Neuropenia | Blood and lymphatic system disorders | Bone Sarcoma | 0 | 42 | 0 |
| other | Febrile Neuropenia | Blood and lymphatic system disorders | Expansion | 1 | 60 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Soft Tissue Sarcoma | 1 | 42 | 1 |
1 to 10 of 486Source ClinicalTrials.gov
See all 486 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Soft Tissue Sarcoma | 4 | 42 |
| Total, all-cause mortality | Bone Sarcoma | 2 | 42 |
| Total, all-cause mortality | Expansion | 2 | 60 |
| Total, other adverse events | Soft Tissue Sarcoma | 40 | 42 |
| Total, other adverse events | Bone Sarcoma | 42 | 42 |
| Total, other adverse events | Expansion | 58 | 60 |
| Total, serious adverse events | Soft Tissue Sarcoma | 19 | 42 |
| Total, serious adverse events | Bone Sarcoma | 15 | 42 |
| Total, serious adverse events | Expansion | 17 | 60 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28988646 | 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/NCT02301039
GET https://conductscience.org/api/trials/v1/NCT02301039/events?page=2