Trial · NCT03190174
Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers
NCT03190174, Phase 1, Phase 2, Completed, Sarcoma Oncology Research Center, LLC; results first posted 2025-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers. Trials, record NCT03190174. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03190174
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers
- NCT number
- NCT03190174
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- Sarcoma Oncology Research Center, LLC
- Conditions
Ewing Sarcoma, PEComa, Epithelioid Sarcoma, Desmoid Tumor, Chordoma, Non Small Cell Lung Cancer, Urothelial Carcinoma, Melanoma, Renal Cell Carcinoma, Squamous Cell Carcinoma, Hepatocellular Carcinoma, Classical Hodgkin Lymphoma, Colorectal Cancer, MTOR Activating Mutation
- Interventions
- Nab-Rapamycin, Nivolumab
- First posted
- 2017-06-16
- Last updated
- 2025-02-17
- Results first posted
- 2025-02-17
- Limitations and caveats
- The study was completed with a small number of subjects analyzed.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose of ABI-009 | Week 6 | The maximum tolerated dose is defined as the highest safely tolerated dose, where not more than one patient experienced dose-limiting toxicity (DLT), with the next higher dose level having at least two patients who experienced DLT. |
| Secondary | Disease Control Rate | 12 weeks | The disease control rate is the percent of patients with complete response, partial response and stable disease. |
| Secondary | Progression Free Survival | 24 weeks | Progression free survival is the time from start of treatment to disease progression or death. |
| Secondary | Overall Survival | 30 weeks | The overall survival is the time from treatment initiation to death. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose of ABI-009 | Week 6 | Intention-to-treat population (all participant assigned to the Phase I dose escalation part of the study). | mg/m^2 | NUMBER |
| SECONDARY | Disease Control Rate | 12 weeks | Per pre-specified analysis, only participants in the expansion phase of the study were evaluated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival | 24 weeks | Per pre-specified analysis, only participants in the expansion phase of the study were evaluated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | 30 weeks | Per pre-specified analysis, only participants in the expansion phase of the study were evaluated. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose of ABI-009 | Dose Escalation Phase 1 | 100 | mg/m^2 | ||
| Disease Control Rate | Expansion Phase 1b | 22 | Participants | ||
| Progression Free Survival | Expansion Phase 1b | 22 | Participants | ||
| Overall Survival | Expansion Phase 1b | 22 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Escalation Phase 1 Dose Level I | 3 | |
| Overall Study | STARTED | Dose Escalation Phase 1 Dose Level II | 3 | |
| Overall Study | STARTED | Dose Escalation Phase 1 Dose Level III | 3 | |
| Overall Study | STARTED | Expansion Phase 1b Part | 25 | |
| Overall Study | COMPLETED | Dose Escalation Phase 1 Dose Level I | 3 | |
| Overall Study | COMPLETED | Dose Escalation Phase 1 Dose Level II | 3 | |
| Overall Study | COMPLETED | Dose Escalation Phase 1 Dose Level III | 3 | |
| Overall Study | COMPLETED | Expansion Phase 1b Part | 25 | |
| Overall Study | NOT COMPLETED | Dose Escalation Phase 1 Dose Level I | 0 | |
| Overall Study | NOT COMPLETED | Dose Escalation Phase 1 Dose Level II | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events12
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 | Oral mucositis | Gastrointestinal disorders | Dose Escalation Phase 1 Part I | 0 | 3 | 0 |
| other | Oral mucositis | Gastrointestinal disorders | Dose Escalation Phase 1 Part II | 0 | 3 | 0 |
| other | Oral mucositis | Gastrointestinal disorders | Dose Escalation Phase 1 Part III | 0 | 3 | 0 |
| other | Oral mucositis | Gastrointestinal disorders | Expansion Phase 1b | 2 | 25 | 2 |
| serious | Dehydration | Metabolism and nutrition disorders | Dose Escalation Phase 1 Part I | 0 | 3 | 0 |
| serious | Dehydration | Metabolism and nutrition disorders | Dose Escalation Phase 1 Part II | 0 | 3 | 0 |
| serious | Dehydration | Metabolism and nutrition disorders | Dose Escalation Phase 1 Part III | 0 | 3 | 0 |
| serious | Dehydration | Metabolism and nutrition disorders | Expansion Phase 1b | 1 | 25 | 1 |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Dose Escalation Phase 1 Part I | 0 | 3 | 0 |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Dose Escalation Phase 1 Part II | 0 | 3 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation Phase 1 Part I | 3 | 3 |
| Total, all-cause mortality | Dose Escalation Phase 1 Part II | 3 | 3 |
| Total, all-cause mortality | Dose Escalation Phase 1 Part III | 3 | 3 |
| Total, all-cause mortality | Expansion Phase 1b | 21 | 25 |
| Total, other adverse events | Dose Escalation Phase 1 Part I | 0 | 3 |
| Total, other adverse events | Dose Escalation Phase 1 Part II | 0 | 3 |
| Total, other adverse events | Dose Escalation Phase 1 Part III | 0 | 3 |
| Total, other adverse events | Expansion Phase 1b | 2 | 25 |
| Total, serious adverse events | Dose Escalation Phase 1 Part I | 0 | 3 |
| Total, serious adverse events | Dose Escalation Phase 1 Part II | 0 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT03190174
GET https://conductscience.org/api/trials/v1/NCT03190174/registered