Trial · NCT03026166
A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer
NCT03026166, Phase 1, Phase 2, Terminated, AbbVie; results first posted 2020-07-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer. Trials, record NCT03026166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03026166
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer
- NCT number
- NCT03026166
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Small Cell Lung Cancer
- Interventions
- Ipilimumab, Nivolumab, Rovalpituzumab tesirine
- First posted
- 2017-01-20
- Last updated
- 2020-07-17
- Other registries' IDs
- eudract:2016-003686-26
- Results first posted
- 2020-07-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicities (DLT) | Up to 12 weeks | Dose-limiting toxicities were defined as any of the following in the 12-week DLT-evaluation period, graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03: * Grade 4 thrombocytopenia (or Grade 3 thrombocytopenia with bleeding) lasting more than 7 days and/or requiring platelet transfusion * Grade 4 neutropenia lasting more than 7 days, and/or requiring hematopoietic growth factor rescue, or any febrile neutropenia (Grade 3 or 4 neutropenia with concurrent fever ≥ 38.3°C) * Grade 4 anemia unrelated to underlying disease * Clinically significant Grade 3 or 4 non-hematologic laboratory abnormality that did not resolve to Grade 0/1 or baseline within 7 days * Grade 3 or 4 non-laboratory adverse event (AE), except fatigue, asthenia, nausea, or other manageable constitutional symptom |
| Primary | Number of Participants With Adverse Events (AEs) | From the first dose of study drug until 100 days after the last dose of study drug; median duration of treatment was 65 days and 53 days in each cohort respectively. | The investigator rated the severity of each AE according to the NCI CTCAE Version 4.03 and according to the following: Grade 1: The AE is transient and easily tolerated by the subject (mild). Grade 2: The AE causes the subject discomfort and interrupts the subject's usual activities (moderate). Grade 3/4: The AE causes considerable interference with the subject's usual activities and may be incapacitating or life-threatening (severe). Grade 5: The AE resulted in death of the subject (severe). The maximum severity AE for each participant is reported. A serious adverse event was defined as an AE meeting any of the following: * Death * Life-threatening * Resulted in hospitalization or prolongation of hospitalization * Resulted in congenital abnormality * Resulted in persistent or significant disability or incapacity * Was an important medical event requiring medical intervention to prevent a serious outcome. Relationship to study drug was assessed by the Investigator. |
| Secondary | Objective Response Rate (ORR) | Cohort 1: at Week 6, Week 13, and every 8 weeks thereafter; Cohort 2: at Week 6, Week 12, Week 18, and every 8 weeks thereafter, to the end of follow-up; median duration on follow-up was 31.7 and 48.0 weeks in each cohort respectively. | Treatment response was assessed by radiographic tumor evaluations conducted by a central radiology review. Objective response rate (ORR) is defined as the percentage of participants whose best overall response is either a confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1. Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. Partial response (PR): A ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR or PR must have been confirmed at least 4 weeks (28 days) from the initial determination per RECIST v 1.1. |
| Secondary | Duration of Response (DOR) | Cohort 1: at Week 6, Week 13, and every 8 weeks thereafter; Cohort 2: at Week 6, Week 12, Week 18 and every 8 weeks thereafter, to the end of follow-up; median duration on follow-up was 31.7 and 48.0 weeks in each cohort respectively. | Duration of overall response is defined as the time from the date of first documented CR or PR, assessed by central radiology review and based on RECIST v. 1.1, to the documented date of progressive disease (PD) or death, whichever occurred first. Participants who neither progressed nor died were censored at the last evaluable disease assessment. Duration of response was evaluated using Kaplan-Meier methodology. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 0.5 cm, or the unequivocal progression of non-target lesions, or the appearance of one or more new lesions. |
| Secondary | Progression-free Survival (PFS) | From first dose of study drug to the end of follow-up; median duration on follow-up was 31.7 and 48.0 weeks in each cohort respectively. | Progression-free survival is defined as the time from the first dose date to the documented date of PD or death, whichever occurred first, based on central radiology review according to RECIST v 1.1. Progression-free survival was evaluated using Kaplan-Meier methodology. Participants who neither progressed nor died were censored at the last evaluable disease assessment. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 0.5 cm, or the unequivocal progression of non-target lesions, or the appearance of one or more new lesions. |
| Secondary | Overall Survival (OS) | From first dose of study drug to the end of follow-up; median duration on follow-up was 31.7 and 48.0 weeks in each cohort respectively. | Overall survival is defined as the time from the first dose date to death for any reason. Participants who were still alive were censored at the last known alive date. Overall survival was evaluated using Kaplan-Meier methodology. |
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 | Number of Participants With Dose-limiting Toxicities (DLT) | Up to 12 weeks | DLT-evaluable participants were those who completed 4 cycles treatment during the DLT period or stopped treatment earlier due to DLT. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events (AEs) | From the first dose of study drug until 100 days after the last dose of study drug; median duration of treatment was 65 days and 53 days in each cohort respectively. | All participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | Cohort 1: at Week 6, Week 13, and every 8 weeks thereafter; Cohort 2: at Week 6, Week 12, Week 18, and every 8 weeks thereafter, to the end of follow-up; median duration on follow-up was 31.7 and 48.0 weeks in each cohort respectively. | The Efficacy Analysis Set includes participants who received at least one dose of study drug, had a target lesion identified at Baseline, and either had at least 1 post-dose tumor assessment or discontinued treatment due to AE, progressive disease (PD) or death. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Cohort 1: at Week 6, Week 13, and every 8 weeks thereafter; Cohort 2: at Week 6, Week 12, Week 18 and every 8 weeks thereafter, to the end of follow-up; median duration on follow-up was 31.7 and 48.0 weeks in each cohort respectively. | The analysis includes participants in the Efficacy Analysis Set with a best overall response of unconfirmed CR or PR. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | From first dose of study drug to the end of follow-up; median duration on follow-up was 31.7 and 48.0 weeks in each cohort respectively. | Efficacy Analysis Set | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From first dose of study drug to the end of follow-up; median duration on follow-up was 31.7 and 48.0 weeks in each cohort respectively. | The Full Analysis Set includes participants who received at least one dose of study drug. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLT) | Rovalpituzumab Tesirine and Nivolumab | 1 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLT) | Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | 3 | Participants | ||
| Number of Participants With Adverse Events (AEs) | Rovalpituzumab Tesirine and Nivolumab | Any adverse event | 30 | Participants | |
| Number of Participants With Adverse Events (AEs) | Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | Any adverse event | 12 | Participants | |
| Number of Participants With Adverse Events (AEs) | Rovalpituzumab Tesirine and Nivolumab | Drug-related adverse event | 29 | Participants | |
| Number of Participants With Adverse Events (AEs) | Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | Drug-related adverse event | 12 | Participants | |
| Number of Participants With Adverse Events (AEs) | Rovalpituzumab Tesirine and Nivolumab | Serious adverse event | 23 | Participants | |
| Number of Participants With Adverse Events (AEs) | Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | Serious adverse event | 9 | Participants | |
| Number of Participants With Adverse Events (AEs) | Rovalpituzumab Tesirine and Nivolumab | Drug-related serious adverse event | 13 | Participants | |
| Number of Participants With Adverse Events (AEs) | Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | Drug-related serious adverse event | 6 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rovalpituzumab Tesirine and Nivolumab | 30 | |
| Overall Study | STARTED | Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | 12 | |
| Overall Study | COMPLETED | Rovalpituzumab Tesirine and Nivolumab | 0 | |
| Overall Study | COMPLETED | Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | 0 | |
| Overall Study | NOT COMPLETED | Rovalpituzumab Tesirine and Nivolumab | 30 | |
| Overall Study | NOT COMPLETED | Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | 12 |
Source ClinicalTrials.gov
Adverse events336
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 | Cohort 1: Rovalpituzumab Tesirine and Nivolumab | 10 | 30 | 17 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | 6 | 12 | 6 |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort 1: Rovalpituzumab Tesirine and Nivolumab | 1 | 30 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | 1 | 12 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort 1: Rovalpituzumab Tesirine and Nivolumab | 2 | 30 | 2 |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | 0 | 12 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 1: Rovalpituzumab Tesirine and Nivolumab | 1 | 30 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | 2 | 12 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 1: Rovalpituzumab Tesirine and Nivolumab | 9 | 30 | 14 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | 5 | 12 | 7 |
1 to 10 of 336Source ClinicalTrials.gov
See all 336 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Rovalpituzumab Tesirine and Nivolumab | 26 | 30 |
| Total, all-cause mortality | Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | 8 | 12 |
| Total, other adverse events | Cohort 1: Rovalpituzumab Tesirine and Nivolumab | 30 | 30 |
| Total, other adverse events | Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | 12 | 12 |
| Total, serious adverse events | Cohort 1: Rovalpituzumab Tesirine and Nivolumab | 23 | 30 |
| Total, serious adverse events | Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | 9 | 12 |
Source ClinicalTrials.gov
Papers0
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rovalpituzumab Tesirine and Nivolumab vs Rovalpituzumab Tesirine and Nivolumab + Ipilimumab: Number of Participants With Dose-limiting Toxicities (DLT) | Trial comparisons |
| Cohort 1: Rovalpituzumab Tesirine and Nivolumab vs Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab: deaths from any cause | Trial comparisons |
| Cohort 1: Rovalpituzumab Tesirine and Nivolumab vs Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab: serious adverse events | 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/NCT03026166
GET https://conductscience.org/api/trials/v1/NCT03026166/results?page=2