Trial · NCT02636725
Axitinib and Pembrolizumab in Subjects With Advanced Alveolar Soft Part Sarcoma and Other Soft Tissue Sarcomas
NCT02636725, Phase 2, Completed, Jonathan Trent, MD, PhD; results first posted 2021-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Axitinib and Pembrolizumab in Subjects With Advanced Alveolar Soft Part Sarcoma and Other Soft Tissue Sarcomas. Trials, record NCT02636725. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02636725
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Axitinib and Pembrolizumab in Subjects With Advanced Alveolar Soft Part Sarcoma and Other Soft Tissue Sarcomas
- NCT number
- NCT02636725
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- Jonathan Trent, MD, PhD
- Conditions
- Alveolar Soft Part Sarcoma, Soft Tissue Sarcomas
- Interventions
- Axitinib, Pembrolizumab
- First posted
- 2015-12-22
- Last updated
- 2024-07-12
- Results first posted
- 2021-11-26
- Limitations and caveats
- Arm 2, the Axitinib Plus Pembrolizumab Expansion Cohort, did not open.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Evaluable Participants Achieving Progression-Free Survival (PFS) at 3 Months | 3 Months | Percentage of participants who are disease progression free 3 months after initiation of therapy. Disease progression will be evaluated from imaging measures using the Response Evaluation Criteria for Solid Tumors (RECIST) 1.1. |
| Secondary | Percentage of Evaluable Participants Achieving Objective Response Rate (ORR) | Up to 2 Years | Objective Response Rate (ORR) is defined as achieving complete response (CR) or partial response (PR) from imaging measures using (RECIST) 1.1. |
| Secondary | Percentage of Evaluable Participants Achieving Clinical Benefit Response (CBR) | Up to 2 Years | CBR is defined as achieving complete response (CR), partial response (PR) or stable disease (SD) from imaging measures using (RECIST) 1.1. |
| Secondary | Time to Progression (TTP) | Up to 2 years | Time to progression (TTP) is defined as time from treatment initiation until documented disease progression according to Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1) or death (by any cause, in the absence of progression). In progression-free patients, PFS will be censored at the last evaluable tumor assessment. |
| Secondary | Overall Survival (OS) | Up to 5 years | OS is (OS) is defined as the time from treatment initiation to death from any cause, whichever is earlier. Participants alive or those lost to follow-up will be censored at the last date of contact (or last date known to be alive). |
| Secondary | Number of Participants Experiencing Serious Adverse Events (SAEs), Dose-Limiting Toxicities, and Grade 3 or Higher Treatment-Emergent Adverse Events | Up to 25 months | The number of participants experiencing serious adverse events (SAEs), dose-limiting toxicities (DLTs), and grade 3 or higher treatment-emergent adverse events (AEs). AEs, SAEs and DLTs will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Treatment-emergent adverse events are those found to be definitely, probably and possibly related to study therapy. |
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 | Percentage of Evaluable Participants Achieving Progression-Free Survival (PFS) at 3 Months | 3 Months | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Evaluable Participants Achieving Objective Response Rate (ORR) | Up to 2 Years | Evaluable participants received at least 80% of scheduled axitinib doses and two infusions of pembrolizumab, have measurable disease at baseline and at least one post-baseline disease assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Evaluable Participants Achieving Clinical Benefit Response (CBR) | Up to 2 Years | Participants that received at least 80% of scheduled axitinib doses and two infusions of pembrolizumab, have measurable disease at baseline and at least one post-baseline disease assessment. | percentage of participants | NUMBER |
| SECONDARY | Time to Progression (TTP) | Up to 2 years | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Up to 5 years | months | MEDIAN | |
| SECONDARY | Number of Participants Experiencing Serious Adverse Events (SAEs), Dose-Limiting Toxicities, and Grade 3 or Higher Treatment-Emergent Adverse Events | Up to 25 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Evaluable Participants Achieving Progression-Free Survival (PFS) at 3 Months | Axitinib Plus Pembrolizumab Group | 81.8 | 95% Confidence Interval 63.9 to 91.4 | percentage of participants | |
| Percentage of Evaluable Participants Achieving Objective Response Rate (ORR) | Axitinib Plus Pembrolizumab Group | 28.1 | 95% Confidence Interval 13.8 to 46.8 | percentage of participants | |
| Percentage of Evaluable Participants Achieving Clinical Benefit Response (CBR) | Axitinib Plus Pembrolizumab Group | 59.4 | 95% Confidence Interval 40.6 to 76.3 | percentage of participants | |
| Time to Progression (TTP) | Axitinib Plus Pembrolizumab Group | 9.3 | 95% Confidence Interval 3.7 to 12.3 | months | |
| Overall Survival (OS) | Axitinib Plus Pembrolizumab Group | 18.7 | 95% Confidence Interval 12.4 to 58.4 | months | |
| Number of Participants Experiencing Serious Adverse Events (SAEs), Dose-Limiting Toxicities, and Grade 3 or Higher Treatment-Emergent Adverse Events | Axitinib Plus Pembrolizumab Group | Serious Adverse Events (SAEs) | 9 | participants | |
| Number of Participants Experiencing Serious Adverse Events (SAEs), Dose-Limiting Toxicities, and Grade 3 or Higher Treatment-Emergent Adverse Events | Axitinib Plus Pembrolizumab Group | Dose Limiting Toxicities (DLTs) | 7 | participants | |
| Number of Participants Experiencing Serious Adverse Events (SAEs), Dose-Limiting Toxicities, and Grade 3 or Higher Treatment-Emergent Adverse Events | Axitinib Plus Pembrolizumab Group | Grade 3 or higher treatment-emergent AE (excluding SAE and DLT) | 6 | participants |
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 | Axitinib Plus Pembrolizumab Group | 33 | |
| Overall Study | COMPLETED | Axitinib Plus Pembrolizumab Group | 32 | |
| Overall Study | NOT COMPLETED | Axitinib Plus Pembrolizumab Group | 1 |
Source ClinicalTrials.gov
Adverse events206
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 | Abdominal Pain | Gastrointestinal disorders | Axitinib Plus Pembrolizumab Group | 12 | 33 | 20 |
| other | Acidosis | Metabolism and nutrition disorders | Axitinib Plus Pembrolizumab Group | 1 | 33 | 1 |
| other | Alanine aminotransferase increased | Investigations | Axitinib Plus Pembrolizumab Group | 14 | 33 | 26 |
| other | Alkaline phosphatase increased | Investigations | Axitinib Plus Pembrolizumab Group | 10 | 33 | 16 |
| other | Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | Axitinib Plus Pembrolizumab Group | 2 | 33 | 2 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Axitinib Plus Pembrolizumab Group | 1 | 33 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Axitinib Plus Pembrolizumab Group | 6 | 33 | 8 |
| other | Anorexia | Metabolism and nutrition disorders | Axitinib Plus Pembrolizumab Group | 12 | 33 | 27 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Axitinib Plus Pembrolizumab Group | 1 | 33 | 1 |
| other | Aspartate aminotransferase increased | Investigations | Axitinib Plus Pembrolizumab Group | 13 | 33 | 23 |
1 to 10 of 206Source ClinicalTrials.gov
See all 206 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Axitinib Plus Pembrolizumab Group | 22 | 33 |
| Total, other adverse events | Axitinib Plus Pembrolizumab Group | 33 | 33 |
| Total, serious adverse events | Axitinib Plus Pembrolizumab Group | 9 | 33 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31078463 | RESULT |
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/NCT02636725
GET https://conductscience.org/api/trials/v1/NCT02636725/events?page=2