Trial · NCT02954991
Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer
NCT02954991, Phase 2, Terminated, Mirati Therapeutics Inc.; results first posted 2024-04-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer. Trials, record NCT02954991. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02954991
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer
- NCT number
- NCT02954991
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 161 participants, actual
- Lead sponsor
- Mirati Therapeutics Inc.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Glesatinib, Sitravatinib, Mocetinostat, Nivolumab
- First posted
- 2016-11-04
- Last updated
- 2024-04-22
- Results first posted
- 2024-04-22
- Limitations and caveats
Enrollment into glesatinib cohorts was discontinued in November 2017 as a result of Sponsor portfolio reprioritization. The analysis and reporting of this treatment arm is limited and will be summarized for selected tables only.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | Up to 40.6 months | ORR is defined as the percentage of participants that were documented to have a confirmed complete response (CR) or partial response (PR) as defined by RECIST v1.1. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to 28 days after the last dose (median time on treatment was: CIT experienced 3.7 months; CIT naïve 4.8 months) | TEAEs were defined as any event that first occur or increase in severity on or after the first dose of study treatment and not more than 28 days after the last dose of study treatment and prior to the initiation of subsequent systemic anti- cancer therapy. Any clinically significant changes in laboratory tests were recorded as TEAEs. |
| Secondary | Duration of Response (DOR) | Up to 38.8 months | DOR was defined as the time in months from date of the first documentation of objective response (CR or PR) to the first documentation of objective progressive disease (PD) or to death due to any cause in the absence of documented PD. (Be aware, the population analyzed here is the Clinical Activity Evaluable Population and not the Full Analysis Set as used in outcome measure 1). |
| Secondary | Progression Free Survival (PFS) | Up to 40.6 months | PFS was defined as the time from the first dose of study drug to the date of PD or death due to any cause in the absence of documented PD, whichever occurs first. |
| Secondary | Overall Survival (OS) | Up to 43.8 months | OS was defined as the time from first dose of study drug to the date of death due to any cause. |
| Secondary | Blood Plasma Concentrations | Cycle 1 Day 1 through Cycle 5 Day 1 | Predose (trough) concentrations for sitravatinib |
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 | Objective Response Rate (ORR) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | Up to 40.6 months | The Full Analysis Set (FAS) was defined as all participants who received at least 1 dose of both study treatments (sitravatinib or glesatinib) and nivolumab. Data was only planned to be reported for participants in the Phase 2 study, so no data is present for the 5 participants who received glesatinib in the lead- in phase only. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to 28 days after the last dose (median time on treatment was: CIT experienced 3.7 months; CIT naïve 4.8 months) | The Safety Population was defined as all participants who received at least 1 dose of any study treatment (sitravatinib, glesatinib, or nivolumab). Per statistical analysis plan, only AEs for sitravatinib + nivolumab will be summarized. TEAE tables for glesatinib + nivolumab were not produced and therefore will not be reported here. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | Up to 38.8 months | Clinical Activity Evaluable Population was defined as all participants who received at least 1 dose of both study treatments (sitravatinib or glesatinib) and nivolumab, had an evaluable baseline tumor assessment, and ≥ 1 postbaseline tumor assessment. DOR was only calculated for the participants that achieved a confirmed CR or PR. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | Up to 40.6 months | The FAS was defined as all participants who received at least 1 dose of both study treatment (sitravatinib or glesatinib) and nivolumab. Data was only planned to be collected for participants in the Phase 2 study, so no data is present for the 5 participants who received glesatinib in the lead-in phase only. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to 43.8 months | FAS was defined as all participants who received at least 1 dose of both study treatments (sitravatinib or glesatinib) and nivolumab. Data was only planned to be collected for participants in the Phase 2 study, so no data is present for the 5 participants who received glesatinib in the lead-in phase only. | months | MEDIAN |
| SECONDARY | Blood Plasma Concentrations | Cycle 1 Day 1 through Cycle 5 Day 1 | ng/ml | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | CIT Experienced: Sitravatinib and Nivolumab | 15.3 | 95% Confidence Interval 9.5 to 22.9 | percentage of participants | |
| Objective Response Rate (ORR) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | CIT Naïve: Sitravatinib and Nivolumab | 25 | 95% Confidence Interval 11.5 to 43.4 | percentage of participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | CIT Experienced: Sitravatinib and Nivolumab | 123 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | CIT Naïve: Sitravatinib and Nivolumab | 32 | Participants | ||
| Duration of Response (DOR) | CIT Experienced: Sitravatinib and Nivolumab | 11.0 | 95% Confidence Interval 3.7 to 13.1 | months | |
| Duration of Response (DOR) | CIT Naïve: Sitravatinib and Nivolumab | 11.1 | 95% Confidence Interval 3.7 to NA | months | |
| Progression Free Survival (PFS) | CIT Experienced: Sitravatinib and Nivolumab | 5.4 | 95% Confidence Interval 4.2 to 5.7 | months | |
| Progression Free Survival (PFS) | CIT Naïve: Sitravatinib and Nivolumab | 7.1 | 95% Confidence Interval 4.0 to 13.1 | months | |
| Overall Survival (OS) | CIT Experienced: Sitravatinib and Nivolumab | 11.5 | 95% Confidence Interval 8.7 to 15.0 | months | |
| Overall Survival (OS) | CIT Naïve: Sitravatinib and Nivolumab | NA | 95% Confidence Interval 9.8 to NA | months |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CIT Experienced: Sitravatinib and Nivolumab | 124 | |
| Overall Study | STARTED | CIT Naïve: Sitravatinib and Nivolumab | 32 | |
| Overall Study | STARTED | Glesatinib and Nivolumab | 5 | |
| Overall Study | Received Any Study Treatment | CIT Experienced: Sitravatinib and Nivolumab | 124 | |
| Overall Study | Received Any Study Treatment | CIT Naïve: Sitravatinib and Nivolumab | 32 | |
| Overall Study | Received Any Study Treatment | Glesatinib and Nivolumab | 5 | |
| Overall Study | COMPLETED | CIT Experienced: Sitravatinib and Nivolumab | 0 | |
| Overall Study | COMPLETED | CIT Naïve: Sitravatinib and Nivolumab | 0 | |
| Overall Study | COMPLETED | Glesatinib and Nivolumab | 0 | |
| Overall Study | NOT COMPLETED | CIT Experienced: Sitravatinib and Nivolumab | 124 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events507
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 | Anaemia | Blood and lymphatic system disorders | CIT Experienced: Sitravatinib and Nivolumab | 27 | 124 | 27 |
| other | Anaemia | Blood and lymphatic system disorders | CIT Naive: Sitravatinib and Nivolumab | 11 | 32 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Glesatinib and Nivolumab | 0 | 5 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | CIT Experienced: Sitravatinib and Nivolumab | 7 | 124 | 7 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | CIT Naive: Sitravatinib and Nivolumab | 2 | 32 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Glesatinib and Nivolumab | 0 | 5 | 0 |
| other | Sinus tachycardia | Cardiac disorders | CIT Experienced: Sitravatinib and Nivolumab | 12 | 124 | 12 |
| other | Sinus tachycardia | Cardiac disorders | CIT Naive: Sitravatinib and Nivolumab | 4 | 32 | 4 |
| other | Sinus tachycardia | Cardiac disorders | Glesatinib and Nivolumab | 0 | 5 | 0 |
| other | Hyperthyroidism | Endocrine disorders | CIT Experienced: Sitravatinib and Nivolumab | 5 | 124 | 5 |
1 to 10 of 507Source ClinicalTrials.gov
See all 507 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CIT Experienced: Sitravatinib and Nivolumab | 92 | 124 |
| Total, all-cause mortality | CIT Naive: Sitravatinib and Nivolumab | 11 | 32 |
| Total, all-cause mortality | Glesatinib and Nivolumab | 2 | 5 |
| Total, other adverse events | CIT Experienced: Sitravatinib and Nivolumab | 122 | 124 |
| Total, other adverse events | CIT Naive: Sitravatinib and Nivolumab | 31 | 32 |
| Total, other adverse events | Glesatinib and Nivolumab | 5 | 5 |
| Total, serious adverse events | CIT Experienced: Sitravatinib and Nivolumab | 62 | 124 |
| Total, serious adverse events | CIT Naive: Sitravatinib and Nivolumab | 17 | 32 |
| Total, serious adverse events | Glesatinib and Nivolumab | 1 | 5 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39198847 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| CIT Experienced: Sitravatinib and Nivolumab vs CIT Naïve: Sitravatinib and Nivolumab: Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
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/NCT02954991
GET https://conductscience.org/api/trials/v1/NCT02954991/events?page=2