Trial · NCT02709889
Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
NCT02709889, Phase 1, Phase 2, Terminated, AbbVie; results first posted 2020-10-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors. Trials, record NCT02709889. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02709889
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
- NCT number
- NCT02709889
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 200 participants, actual
- Lead sponsor
- AbbVie
- Conditions
Malignant Melanoma, Medullary Thyroid Cancer, Glioblastoma, Large-Cell Neuroendocrine Carcinoma, Neuroendocrine Prostate Cancer, High Grade Gastroenteropancreatic Neuroendocrine Carcinoma, Other Neuroendocrine Carcinoma, Other Solid Tumors
- Interventions
- Rovalpituzumab tesirine, Dexamethasone
- First posted
- 2016-03-16
- Last updated
- 2020-10-19
- Results first posted
- 2020-10-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups | From first dose of study drug through 30 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0). | The number of participants with TEAEs, serious TEAEs, study drug-related TEAEs, and study drug discontinuations or dose reductions due to TEAEs, summarized by dose received and neuroendocrine (NEC) or non-NEC disease groups. An adverse event (AE) is defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: is fatal or life-threatening; results in death or hospitalization; is disabling/incapacitating or a congenital anomaly/birth defect; is medically significant. AE severity was graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03 terminology: grade 1=mild; grade 2=moderate; grade 3=severe; grade 4 life-threatening; grade 5=death. TEAEs were defined as AEs that were newly occurring or worsened following study treatment. |
| Secondary | Objective Response Rate (ORR) | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months. | ORR is defined as percentage of participants whose best overall response was either complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Clinical Benefit Rate (CBR) | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months. | CBR is defined as the percentage of participants with best overall response (confirmed or unconfirmed) of CR, PR or stable disease (SD) per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressed disease (PD), taking as reference the smallest sum diameters while on study. SD criteria must have met at least once after study entry at a minimum interval of 42 days (-7 days to allow for scheduled visit window per the protocol). |
| Secondary | Duration of Response (DOR) | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months. | DOR is defined as the time from the first assessment on therapy of a CR or PR response (per RECIST v1.1) to the date of progressive disease or death. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not have progression were censored at the last non-missing response assessment on-therapy or baseline. Based on Kaplan-Meier estimates. |
| Secondary | Progression Free Survival (PFS) | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months. | PFS is defined as the time from the first dose date to the date of disease progression or death. Participants who did not have progression or death are censored at the last non-missing response assessment on-therapy or baseline. Based on Kaplan-Meier estimates. |
| Secondary | Overall Survival (OS) | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months. | Overall survival is defined as the time from the first dose date to death for any reason. Subjects who were alive at the clinical data cut-off are censored at the last known alive date. Based on Kaplan-Meier estimates. |
| Secondary | Serum Concentrations of Rovalpituzumab Tesirine Over Time | Cycle 1: 0, 0.5, 6, 48, 168, 336, 672 hours postdose | |
| Secondary | Number of Participants With Anti-therapeutic Antibodies (ATA) | Day 1 and 42 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0). | Number of participants treated across each dose level reported to potentially have ATAs against rovalpituzumab tesirine at any time during the study. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups | From first dose of study drug through 30 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0). | Safety Analysis Set: participants who received any amount of study drug. Presented by NEC/Non-NEC groups, inclusive of participants in parts A and B. | participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months. | Full Analysis Set: All enrolled participants who received any amount of study drug. Presented by disease-specific groups, inclusive of participants in parts A and B. | percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months. | Full Analysis Set: All enrolled participants who received any amount of study drug. Presented by disease-specific groups, inclusive of participants in parts A and B. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months. | Full Analysis Set: All enrolled participants who received any amount of study drug. Responders (CR or PR response). Presented by disease-specific groups, inclusive of participants in parts A and B. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months. | Full Analysis Set: All enrolled participants who received any amount of study drug. Presented by disease-specific groups, inclusive of participants in parts A and B. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months. | Full Analysis Set: All enrolled participants who received any amount of study drug. Presented by disease-specific groups, inclusive of participants in parts A and B. | months | MEDIAN |
| SECONDARY | Serum Concentrations of Rovalpituzumab Tesirine Over Time | Cycle 1: 0, 0.5, 6, 48, 168, 336, 672 hours postdose | Participants who received at least 1 dose of study drug and had an assessment at given time point. Presented by dose-specific groups, inclusive of participants in parts A and B. | ug/mL | MEAN |
| SECONDARY | Number of Participants With Anti-therapeutic Antibodies (ATA) | Day 1 and 42 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0). | Participants who received at least 1 dose of study drug with available ATA data. Presented by dose-specific groups, inclusive of participants in parts A and B. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group232
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups | NEC: 0.2 mg/kg | ≥ 1 TEAE | 24 | participants | |
| Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups | NEC: 0.3 mg/kg | ≥ 1 TEAE | 69 | participants | |
| Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups | NEC: 0.4 mg/kg | ≥ 1 TEAE | 8 | participants | |
| Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups | NEC: Any Dose | ≥ 1 TEAE | 101 | participants | |
| Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups | Non-NEC: 0.2 mg/kg | ≥ 1 TEAE | 18 | participants | |
| Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups | Non-NEC: 0.3 mg/kg | ≥ 1 TEAE | 75 | participants | |
| Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups | Non-NEC: 0.4 mg/kg | ≥ 1 TEAE | 4 | participants | |
| Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups | Non-NEC: Any Dose | ≥ 1 TEAE | 97 | participants | |
| Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups | NEC: 0.2 mg/kg | ≥ 1 TEAE, Grade 3-4 | 20 | participants | |
| Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups | NEC: 0.3 mg/kg | ≥ 1 TEAE, Grade 3-4 | 40 | participants |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 results by groupParticipant flow44
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: Rovalpituzumab Tesirine 0.2 mg/kg | 43 | |
| Overall Study | STARTED | Part A: Rovalpituzumab Tesirine 0.3 mg/kg | 57 | |
| Overall Study | STARTED | Part A: Rovalpituzumab Tesirine 0.4 mg/kg | 12 | |
| Overall Study | STARTED | Part B: Rovalpituzumab Tesirine 0.3 mg/kg | 88 | |
| Overall Study | Large Cell Neuroendocrine Carcinoma(NEC) | Part A: Rovalpituzumab Tesirine 0.2 mg/kg | 3 | |
| Overall Study | Large Cell Neuroendocrine Carcinoma(NEC) | Part A: Rovalpituzumab Tesirine 0.3 mg/kg | 4 | |
| Overall Study | Large Cell Neuroendocrine Carcinoma(NEC) | Part A: Rovalpituzumab Tesirine 0.4 mg/kg | 2 | |
| Overall Study | Large Cell Neuroendocrine Carcinoma(NEC) | Part B: Rovalpituzumab Tesirine 0.3 mg/kg | 4 | |
| Overall Study | Neuroendocrine Prostate Cancer | Part A: Rovalpituzumab Tesirine 0.2 mg/kg | 4 | |
| Overall Study | Neuroendocrine Prostate Cancer | Part A: Rovalpituzumab Tesirine 0.3 mg/kg | 7 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 participant flowAdverse events9,702
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 | 0.2_mg_kg_(LCNEC) | 2 | 3 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | 0.2_mg_kg_(NEPC) | 0 | 4 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 0.2_mg_kg_(GEPNEC) | 1 | 6 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | 0.2_mg_kg_(Other_NEC) | 4 | 11 | 17 |
| other | Anaemia | Blood and lymphatic system disorders | 0.2_mg_kg_(MM) | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 0.2_mg_kg_(MTC) | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 0.2_mg_kg_(GBM) | 0 | 4 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 0.2_mg_kg_(Other_Solid) | 1 | 9 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | 0.3_mg_kg_(LCNEC) | 2 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | 0.3_mg_kg_(NEPC) | 5 | 14 |
1 to 10 of 9,702Source ClinicalTrials.gov
See all 9,702 adverse eventsAdverse event totals66
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.2_mg_kg_(LCNEC) | 1 | 3 |
| Total, all-cause mortality | 0.2_mg_kg_(NEPC) | 3 | 4 |
| Total, all-cause mortality | 0.2_mg_kg_(GEPNEC) | 5 | 6 |
| Total, all-cause mortality | 0.2_mg_kg_(Other_NEC) | 9 | 11 |
| Total, all-cause mortality | 0.2_mg_kg_(MM) | 3 | 3 |
| Total, all-cause mortality | 0.2_mg_kg_(MTC) | 0 | 3 |
| Total, all-cause mortality | 0.2_mg_kg_(GBM) | 4 | 4 |
| Total, all-cause mortality | 0.2_mg_kg_(Other_Solid) | 6 | 9 |
| Total, all-cause mortality | 0.3_mg_kg_(LCNEC) | 6 | 8 |
| Total, all-cause mortality | 0.3_mg_kg_(NEPC) | 11 | 14 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32372416 | 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 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.
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