Trial · NCT02888665
Pembrolizumab and Doxorubicin Hydrochloride in Treating Patients With Sarcoma That is Metastatic or Cannot Be Removed by Surgery
NCT02888665, Phase 1, Phase 2, Completed, Fred Hutchinson Cancer Center; results first posted 2021-05-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pembrolizumab and Doxorubicin Hydrochloride in Treating Patients With Sarcoma That is Metastatic or Cannot Be Removed by Surgery. Trials, record NCT02888665. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02888665
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab and Doxorubicin Hydrochloride in Treating Patients With Sarcoma That is Metastatic or Cannot Be Removed by Surgery
- NCT number
- NCT02888665
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- Fred Hutchinson Cancer Center
- Conditions
- Sarcoma
- Interventions
- Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Pembrolizumab
- First posted
- 2016-09-05
- Last updated
- 2021-05-26
- Results first posted
- 2021-05-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Doxorubicin Hydrochloride Plus Pembrolizumab According to the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) Version 4.0 (Phase I) | Up to 42 days (6 weeks) | Defined as a dose limiting toxicity (DLT) in less than 2 of 6 subjects. Only Phase 1 subjects will be evaluated for MTD. |
| Primary | Objective Response Rate (ORR) (Phase II) | Up to 2 years | Evaluated per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT. Complete Response (CR) is a complete elimination of the tumor; Partial Response (PR) is 30% reduction. If a subject experienced a PR, this was required to be confirmed with a second scan at the next appropriate cycle. |
| Secondary | Duration of Response | Up to 2 years | Duration of response is the mean time to progression for all subjects who responded. |
| Secondary | Median Progression-free Survival (PFS) | Up to 2 years | The Kaplan-Meier method will be used to estimate median PFS. |
| Secondary | Overall Survival (OS) | Up to 2 years | The Kaplan-Meier method will be used to estimate median OS. |
| Secondary | Time to Response | Up to 2 years | Average time to response |
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 | Maximum Tolerated Dose (MTD) of Doxorubicin Hydrochloride Plus Pembrolizumab According to the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) Version 4.0 (Phase I) | Up to 42 days (6 weeks) | Only Phase 1 subjects were evaluated for a Maximum Tolerated Dose (MTD) based off of Dose-Limiting Toxicities experienced per subject as defined in the protocol. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Objective Response Rate (ORR) (Phase II) | Up to 2 years | Only Phase 2 subjects were evaluated for this outcome as Phase 1 subjects were only included in the protocol for safety evaluation. | percent of participants | NUMBER |
| SECONDARY | Duration of Response | Up to 2 years | Only 5 appropriate subjects had partial responses for evaluation. | Days | MEAN |
| SECONDARY | Median Progression-free Survival (PFS) | Up to 2 years | This combined the phase I and phase II populations as we had intended for this analysis. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to 2 years | This combined the phase I and phase II populations as we had intended for this analysis. | months | MEDIAN |
| SECONDARY | Time to Response | Up to 2 years | Only 5 appropriate subjects had partial responses for evaluation. | Days | MEAN |
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 |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Doxorubicin Hydrochloride Plus Pembrolizumab According to the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) Version 4.0 (Phase I) | Phase 1 Cohort 1 | 0 | Participants | ||
| Maximum Tolerated Dose (MTD) of Doxorubicin Hydrochloride Plus Pembrolizumab According to the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) Version 4.0 (Phase I) | Phase 1 Cohort 2 | 0 | Participants | ||
| Objective Response Rate (ORR) (Phase II) | Phase 2: Treatment (Pembrolizumab, Doxorubicin Hydrochloride) | 13 | percent of participants | ||
| Duration of Response | Treatment (Pembrolizumab, Doxorubicin Hydrochloride) | 247 | Standard Deviation 180 | Days | |
| Median Progression-free Survival (PFS) | Treatment (Pembrolizumab, Doxorubicin Hydrochloride) | 8.1 | 95% Confidence Interval 7.6 to 10.8 | months | |
| Overall Survival (OS) | Treatment (Pembrolizumab, Doxorubicin Hydrochloride) | 27.6 | 95% Confidence Interval 18.7 to NA | months | |
| Time to Response | Treatment (Pembrolizumab, Doxorubicin Hydrochloride) | 152.2 | Standard Deviation 65 | Days |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1, Part 1 | 3 | |
| Overall Study | STARTED | Phase 1, Part 2 | 3 | |
| Overall Study | STARTED | Phase 2 | 31 | |
| Overall Study | COMPLETED | Phase 1, Part 1 | 3 | |
| Overall Study | COMPLETED | Phase 1, Part 2 | 3 | |
| Overall Study | COMPLETED | Phase 2 | 31 | |
| Overall Study | NOT COMPLETED | Phase 1, Part 1 | 0 | |
| Overall Study | NOT COMPLETED | Phase 1, Part 2 | 0 | |
| Overall Study | NOT COMPLETED | Phase 2 | 0 |
Source ClinicalTrials.gov
Adverse events510
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 | Nausea | Gastrointestinal disorders | Phase 1 Cohort 1 | 3 | 3 | 3 |
| other | Nausea | Gastrointestinal disorders | Phase 1 Cohort 2 | 3 | 3 | 3 |
| other | Nausea | Gastrointestinal disorders | Phase 2 | 27 | 31 | 37 |
| other | Fatigue | General disorders | Phase 1 Cohort 1 | 1 | 3 | 1 |
| other | Fatigue | General disorders | Phase 1 Cohort 2 | 3 | 3 | 3 |
| other | Fatigue | General disorders | Phase 2 | 21 | 31 | 26 |
| other | Anorexia | Metabolism and nutrition disorders | Phase 1 Cohort 1 | 2 | 3 | 3 |
| other | Anorexia | Metabolism and nutrition disorders | Phase 1 Cohort 2 | 2 | 3 | 3 |
| other | Anorexia | Metabolism and nutrition disorders | Phase 2 | 14 | 31 | 19 |
| other | Constipation | Gastrointestinal disorders | Phase 1 Cohort 1 | 1 | 3 | 1 |
1 to 10 of 510Source ClinicalTrials.gov
See all 510 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1 Cohort 1 | 2 | 3 |
| Total, all-cause mortality | Phase 1 Cohort 2 | 0 | 3 |
| Total, all-cause mortality | Phase 2 | 15 | 31 |
| Total, other adverse events | Phase 1 Cohort 1 | 3 | 3 |
| Total, other adverse events | Phase 1 Cohort 2 | 3 | 3 |
| Total, other adverse events | Phase 2 | 31 | 31 |
| Total, serious adverse events | Phase 1 Cohort 1 | 1 | 3 |
| Total, serious adverse events | Phase 1 Cohort 2 | 2 | 3 |
| Total, serious adverse events | Phase 2 | 13 | 31 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32910151 | DERIVED |
Source PubMed
Grants1
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 |
|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Phase 1 Cohort 1 vs Phase 1 Cohort 2: Maximum Tolerated Dose (MTD) of Doxorubicin Hydrochloride Plus Pembrolizumab According to the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) Version 4.0 (Phase I) |
Source 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/NCT02888665
GET https://conductscience.org/api/trials/v1/NCT02888665/events?page=2