Trial · NCT03583086
Phase I/II Eval Safety & Prelim Activity Nivolumab Comb W/Vorolanib Pts W/Refractory Thoracic Tumors
NCT03583086, Phase 1, Phase 2, Completed, Vanderbilt-Ingram Cancer Center; results first posted 2024-10-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase I/II Eval Safety & Prelim Activity Nivolumab Comb W/Vorolanib Pts W/Refractory Thoracic Tumors. Trials, record NCT03583086. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03583086
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I/II Eval Safety & Prelim Activity Nivolumab Comb W/Vorolanib Pts W/Refractory Thoracic Tumors
- NCT number
- NCT03583086
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 88 participants, actual
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Conditions
- Thymic Carcinoma, Non-small Cell Lung Cancer, Refractory Thoracic Tumors, Small-Cell Lung Cancer
- Interventions
- Vorolanib, Nivolumab
- First posted
- 2018-07-11
- Last updated
- 2024-10-08
- Results first posted
- 2024-10-08
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended Phase II Combination Dose in Phase I (Per Common Terminology Criteria for Adverse Events (CTCAE) Criteria Version 5) | At 28 days | Maximum tolerated dose for vorolanib daily combined with 240mg nivolumab every 2 weeks based on 3+3 dose escalation design. When 2 out of 6 patients at one dose experienced dose limiting toxicity, lower dose will be used. We have specified the phase I and phase II populations as study arms; note outcome measures are then distinct for each arm, with the phase I arm intended to assess safety (MTD), and the phase 2 arm intended to assess efficacy, as typical for phase I-II studies. Thus, for each outcome, only the phase I cohort is included in the analysis population, or only the phase II cohort is including in the analysis population, as relevant to the outcome measure. |
| Primary | Objective Response Rate in Phase II. | Up to 1 year. | Antitumor activity will be assessed by objective response rate. Best response is determined as complete response(CR), partial response(PR), stable disease and progressive disease based on per Response Evaluation Criteria in Solid Tumors (RECIST). Objective response rate is the percentage of patients who had a CR or PR. We have specified the phase I and phase II populations as study arms; note outcome measures are then distinct for each arm, with the phase I arm intended to assess safety (MTD), and the phase 2 arm intended to assess efficacy, as typical for phase I-II studies. Thus, for each outcome, only the phase I cohort is included in the analysis population, or only the phase II cohort is including in the analysis population, as relevant to the outcome measure. |
| Primary | Progression Free Survival in Phase II | Up to 1 year. | Antitumor activity will be assessed by progression free survival. Progression is termined per Response Evaluation Criteria in Solid Tumors (RECIST). Progression free survival (PFS) is defined as time from on treatment to disease progression or death (whicever comes first). Those without progression and alive were censored at last follow up. Kaplan-meier method is used to estimate the median survival time. We have specified the phase I and phase II populations as study arms; note outcome measures are then distinct for each arm, with the phase I arm intended to assess safety (MTD), and the phase 2 arm intended to assess efficacy, as typical for phase I-II studies. Thus, for each outcome, only the phase I cohort is included in the analysis population, or only the phase II cohort is including in the analysis population, as relevant to the outcome measure. |
| Primary | Duration of Response in Phase II. | Up to 1 year | Duration of best response among patients who responsed to the treatment. Best response per Response Evaluation Criteria in Solid Tumors (RECIST). The duration of response was estimated from the first date of best overall response of a complete (CR) or partial response (PR) to the date of disease progression or death, using the Kaplan-Meier method. We have specified the phase I and phase II populations as study arms; note outcome measures are then distinct for each arm, with the phase I arm intended to assess safety (MTD), and the phase 2 arm intended to assess efficacy, as typical for phase I-II studies. Thus, for each outcome, only the phase I cohort is included in the analysis population, or only the phase II cohort is including in the analysis population, as relevant to the outcome measure. |
| Primary | Disease Control Rate in Phase II. Best Response Per Response Evaluation Criteria in Solid Tumors (RECIST) | Up to 1 year | Antitumor activity will be assessed by disease control rate. Best response (complete response,CR; partial response, PR;stable disease , SD; or progression,PD) per Response Evaluation Criteria in Solid Tumors (RECIST). Disease control rate is the percentage of patients who had a CR,PR or SD. We have specified the phase I and phase II populations as study arms; note outcome measures are then distinct for each arm, with the phase I arm intended to assess safety (MTD), and the phase 2 arm intended to assess efficacy, as typical for phase I-II studies. Thus, for each outcome, only the phase I cohort is included in the analysis population, or only the phase II cohort is including in the analysis population, as relevant to the outcome measure. |
| Primary | Overall Survival in Phase II. | Up to 2 years. | Antitumor activity will be assessed by overall survival. Overall survial is defined as the time from on treatment to death. Those alive were censored at last follow up. Kaplan-meier method is used to estimate the median overall survival time. We have specified the phase I and phase II populations as study arms; note outcome measures are then distinct for each arm, with the phase I arm intended to assess safety (MTD), and the phase 2 arm intended to assess efficacy, as typical for phase I-II studies. Thus, for each outcome, only the phase I cohort is included in the analysis population, or only the phase II cohort is including in the analysis population, as relevant to the outcome measure. |
| Other | Correlation Between Biomarkers and Response for Phase II Patients | Up to 1 year | Antitumor activity will be assessed by correlation between the biomarkers and clinical outcomes. This is a exploratory end point. To assess the effects of combinatorial treatment on specific pharmacodynamic and pharmacogenetic biomarkers, including but not limited to circulating levels of serum CSF1 and VEGF, protein expression using CyTOF, and multiplex immunofluorescence. |
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 | Recommended Phase II Combination Dose in Phase I (Per Common Terminology Criteria for Adverse Events (CTCAE) Criteria Version 5) | At 28 days | 8 patients with NSCLC and 2 patients with TC who received vorolanib orally daily and 240mg nivolumab every 2 weeks, and had assessable results. | mg | NUMBER |
| PRIMARY | Objective Response Rate in Phase II. | Up to 1 year. | Patients who received 200mg vorolanib daily with 240mg nivolumab every two weeks and were available for measurement of tumor response. | percentage of participants | NUMBER |
| PRIMARY | Progression Free Survival in Phase II | Up to 1 year. | Patients who received 200mg vorolanib daily with 240mg nivolumab every two weeks and were available for measurement of tumor response(progression). | months | MEDIAN |
| PRIMARY | Duration of Response in Phase II. | Up to 1 year | Patients who received 200mg vorolanib daily with 240mg nivolumab every two weeks, were available for measurement of tumor response, and had partial or complete response. No patients in the Dose Expansion - Small Cell Lung Cancer - Progressed on Platinum-based Chemotherapy group had a partial or complete response. | months | MEDIAN |
| PRIMARY | Disease Control Rate in Phase II. Best Response Per Response Evaluation Criteria in Solid Tumors (RECIST) | Up to 1 year | Patients who received 200mg vorolanib daily with 240mg nivolumab every two weeks and were available for measurement of tumor response. | percentage of participants | NUMBER |
| PRIMARY | Overall Survival in Phase II. | Up to 2 years. | Patients who received 200mg vorolanib daily with 240mg nivolumab every two weeks and were available for measurement of survival. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Correlation Between Biomarkers and Response for Phase II Patients | Up to 1 year |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recommended Phase II Combination Dose in Phase I (Per Common Terminology Criteria for Adverse Events (CTCAE) Criteria Version 5) | Escalation | 200 | mg | ||
| Objective Response Rate in Phase II. | Dose Expansion - Non Small-Cell-Lung Cancer Acquired Resistance | 11.1 | 95% Confidence Interval 0 to 27.8 | percentage of participants | |
| Objective Response Rate in Phase II. | Dose Expansion - Non Small-Cell-Lung Cancer Naive | 33 | 95% Confidence Interval 13 to 60 | percentage of participants | |
| Objective Response Rate in Phase II. | Dose Expansion - Non Small-Cell-Lung Cancer Primary Refractory | 5.9 | 95% Confidence Interval 0 to 17.6 | percentage of participants | |
| Objective Response Rate in Phase II. | Dose Expansion - Small Cell Lung Cancer - Progressed on Platinum-based Chemotherapy | 0 | 95% Confidence Interval 0 to 0 | percentage of participants | |
| Objective Response Rate in Phase II. | Dose Expansion - Thymic Carcinoma | 11 | 95% Confidence Interval 0 to 33 | percentage of participants | |
| Progression Free Survival in Phase II | Dose Expansion - Non Small-Cell-Lung Cancer Acquired Resistance | 1.97 | 95% Confidence Interval 1.54 to 4.60 | months | |
| Progression Free Survival in Phase II | Dose Expansion - Non Small-Cell-Lung Cancer Naive | 7.16 | 95% Confidence Interval 1.38 to NA | months | |
| Progression Free Survival in Phase II | Dose Expansion - Non Small-Cell-Lung Cancer Primary Refractory | 3.22 | 95% Confidence Interval 1.84 to 4.60 | months | |
| Progression Free Survival in Phase II | Dose Expansion - Small Cell Lung Cancer - Progressed on Platinum-based Chemotherapy | 1.36 | 95% Confidence Interval 0.92 to 1.81 | months |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Escalation Level 1 (Vorolanib 200 mg +Nivolumab 240mg) | 3 | |
| Overall Study | STARTED | Escalation Level 2 (Vorolanib 300mg + Nivolumab 240mg) | 7 | |
| Overall Study | STARTED | Dose Expansion - Non Small-Cell-Lung Cancer Acquired Resistance | 19 | |
| Overall Study | STARTED | Dose Expansion - Non Small-Cell-Lung Cancer Naive | 15 | |
| Overall Study | STARTED | Dose Expansion - Non Small-Cell-Lung Cancer Primary Refractory | 17 | |
| Overall Study | STARTED | Dose Expansion - Small Cell Lung Cancer - Progressed on Platinum-based Chemotherapy | 18 | |
| Overall Study | STARTED | Dose Expansion - Thymic Carcinoma | 9 | |
| Overall Study | COMPLETED | Escalation Level 1 (Vorolanib 200 mg +Nivolumab 240mg) | 1 | |
| Overall Study | COMPLETED | Escalation Level 2 (Vorolanib 300mg + Nivolumab 240mg) | 1 | |
| Overall Study | COMPLETED | Dose Expansion - Non Small-Cell-Lung Cancer Acquired Resistance | 4 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events2,184
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 | Hyperkalemia | Metabolism and nutrition disorders | Escalation Level 1 (Vorolanib 200+Nivolumab 240mg) | 1 | 3 | 1 |
| other | Hyperkalemia | Metabolism and nutrition disorders | Escalation Level 2 (Vorolanib 300+Nivolumab 240mg) | 0 | 7 | 0 |
| other | Hyperkalemia | Metabolism and nutrition disorders | Dose Expansion - Non Small-Cell-Lung Cancer Acquired Resistance | 0 | 19 | 0 |
| other | Hyperkalemia | Metabolism and nutrition disorders | Dose Expansion - Non Small-Cell-Lung Cancer Naive | 0 | 15 | 0 |
| other | Hyperkalemia | Metabolism and nutrition disorders | Dose Expansion - Non Small-Cell-Lung Cancer Primary Refractory | 0 | 17 | 0 |
| other | Hyperkalemia | Metabolism and nutrition disorders | Dose Expansion - Small Cell Lung Cancer - Progressed on Platinum-based Chemotherapy | 0 | 18 | 0 |
| other | Hyperkalemia | Metabolism and nutrition disorders | Dose Expansion - Thymic Carcinoma | 1 | 9 | 1 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Escalation Level 1 (Vorolanib 200+Nivolumab 240mg) | 3 | 3 | 5 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Escalation Level 2 (Vorolanib 300+Nivolumab 240mg) | 1 | 7 | 2 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Dose Expansion - Non Small-Cell-Lung Cancer Acquired Resistance | 0 | 19 | 0 |
1 to 10 of 2,184Source ClinicalTrials.gov
See all 2,184 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Escalation Level 1 (Vorolanib 200+Nivolumab 240mg) | 2 | 3 |
| Total, all-cause mortality | Escalation Level 2 (Vorolanib 300+Nivolumab 240mg) | 6 | 7 |
| Total, all-cause mortality | Dose Expansion - Non Small-Cell-Lung Cancer Acquired Resistance | 13 | 19 |
| Total, all-cause mortality | Dose Expansion - Non Small-Cell-Lung Cancer Naive | 12 | 15 |
| Total, all-cause mortality | Dose Expansion - Non Small-Cell-Lung Cancer Primary Refractory | 14 | 17 |
| Total, all-cause mortality | Dose Expansion - Small Cell Lung Cancer - Progressed on Platinum-based Chemotherapy | 14 | 18 |
| Total, all-cause mortality | Dose Expansion - Thymic Carcinoma | 4 | 9 |
| Total, other adverse events | Escalation Level 1 (Vorolanib 200+Nivolumab 240mg) | 3 | 3 |
| Total, other adverse events | Escalation Level 2 (Vorolanib 300+Nivolumab 240mg) | 7 | 7 |
| Total, other adverse events | Dose Expansion - Non Small-Cell-Lung Cancer Acquired Resistance | 19 | 19 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03583086
GET https://conductscience.org/api/trials/v1/NCT03583086/results?page=2