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Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer (TRINITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02674568
Recruitment Status : Completed
First Posted : February 4, 2016
Results First Posted : October 23, 2019
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Small Cell Lung Cancer
Intervention Drug: Rovalpituzumab tesirine
Enrollment 342
Recruitment Details  
Pre-assignment Details A total of 342 participants were enrolled; 3 participants were not dosed.
Arm/Group Title Rovalpituzumab Tesirine
Hide Arm/Group Description 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (every 6 weeks; Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
Period Title: Overall Study
Started 339 [1]
Delta-like Protein 3 (DLL3) High [2] 238
DLL3 Positive [3] 287
Completed [4] 0
Not Completed 339
Reason Not Completed
Withdrawal by Subject             5
Death             303
Physician Decision             2
Lost to Follow-up             9
Other, Not Specified             20
[1]
Enrolled and dosed.
[2]
DLL3 High Participants: tumors with ≥75% of cells expressing DLL3 are classified as "DLL3 high"
[3]
DLL3 Positive Participants: tumors with ≥25% cells expressing DLL3 are classified as "DLL3 positive"
[4]
'Completed'=still on study; 'Not Completed'=discontinued study
Arm/Group Title Rovalpituzumab Tesirine
Hide Arm/Group Description 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
Overall Number of Baseline Participants 339
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 339 participants
61.9  (9.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 339 participants
Female
169
  49.9%
Male
170
  50.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 339 participants
Hispanic or Latino
10
   2.9%
Not Hispanic or Latino
272
  80.2%
Unknown or Not Reported
57
  16.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 339 participants
American Indian or Alaska Native
1
   0.3%
Asian
3
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
11
   3.2%
White
265
  78.2%
More than one race
3
   0.9%
Unknown or Not Reported
56
  16.5%
1.Primary Outcome
Title Objective Response Rate
Hide Description

Objective response is defined as a participant with the best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, prior to receiving any subsequent anticancer therapy and retreatment, and is confirmed by a consecutive response assessment at least 4 weeks (28 days) from the initial determination of CR/PR. Analyzed based on response assessments from both the Independent Review Committee (IRC) and investigators.

CR: disappearance of all target lesions.Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Time Frame up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat Population: all participants who received any amount of study drug.
Arm/Group Title Rovalpituzumab Tesirine: DLL3 High Rovalpituzumab Tesirine: DLL3 Positive
Hide Arm/Group Description:
'DLL3 High' (tumors with ≥75% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
'DLL3 Positive' (tumors with ≥25% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
Overall Number of Participants Analyzed 238 287
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
IRC
15.5
(11.2 to 20.8)
14.6
(10.8 to 19.3)
Investigator
19.3
(14.5 to 24.9)
18.8
(14.5 to 23.8)
2.Primary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from the first dose date to death for any reason. Participants who were alive at the clinical data cut-off were censored at the last known alive date. Based on Kaplan-Meier estimates.
Time Frame up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat Population: all participants who received any amount of study drug.
Arm/Group Title Rovalpituzumab Tesirine: DLL3 High Rovalpituzumab Tesirine: DLL3 Positive
Hide Arm/Group Description:
'DLL3 High' (tumors with ≥75% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
'DLL3 Positive' (tumors with ≥25% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
Overall Number of Participants Analyzed 238 287
Median (95% Confidence Interval)
Unit of Measure: months
5.3
(4.7 to 5.8)
5.3
(4.7 to 5.8)
3.Secondary Outcome
Title Overall Response Rate
Hide Description

Overall response rate is defined as the percentage of participants with a response of CR or PR, regardless of confirmation, per RECIST v 1.1 prior to receiving any subsequent anticancer therapy and retreatment. Any participants not exhibiting a response (CR or PR) as defined above were considered non-responders. Analyzed based on response assessments from both the IRC and investigators.

CR: disappearance of all target lesions.Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Time Frame up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat Population: all participants who received any amount of study drug.
Arm/Group Title Rovalpituzumab Tesirine: DLL3 High Rovalpituzumab Tesirine: DLL3 Positive
Hide Arm/Group Description:
'DLL3 High' (tumors with ≥75% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
'DLL3 Positive' (tumors with ≥25% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
Overall Number of Participants Analyzed 238 287
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
IRC
23.1
(17.9 to 29.0)
22.0
(17.3 to 27.2)
Investigator
26.9
(21.4 to 33.0)
25.8
(20.8 to 31.3)
4.Secondary Outcome
Title Duration of Objective Response
Hide Description

Duration of objective response is defined as the time from the date of first documented CR or PR of participants with a confirmed response to the documented date of progressive disease (PD) or death, whichever occurred first. Participants who neither progressed nor died are censored at the last evaluable disease assessment. Analyzed based on response assessments from both the IRC and investigators. Based on Kaplan-Meier estimates.

CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (The appearance of one or more new lesions is also considered progression.)

Time Frame up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat Population: all participants who received any amount of study drug and had an objective response.
Arm/Group Title Rovalpituzumab Tesirine: DLL3 High Rovalpituzumab Tesirine: DLL3 Positive
Hide Arm/Group Description:
'DLL3 High' (tumors with ≥75% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
'DLL3 Positive' (tumors with ≥25% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
Overall Number of Participants Analyzed 46 54
Median (95% Confidence Interval)
Unit of Measure: months
IRC Number Analyzed 37 participants 42 participants
4.0
(3.0 to 4.2)
4.1
(3.0 to 4.2)
Investigator Number Analyzed 46 participants 54 participants
4.0
(2.9 to 4.2)
4.0
(2.9 to 4.3)
5.Secondary Outcome
Title Progression-Free Survival
Hide Description

Progression-free survival is defined as the time from the first dose date to the documented date of PD or death, whichever occurred first. Participants who neither progressed nor died were censored at the last evaluable disease assessment. Analyzed based on response assessments from both the IRC and investigators. Based on Kaplan-Meier estimates.

PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (The appearance of one or more new lesions is also considered progression.)

Time Frame up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat Population: all participants who received any amount of study drug.
Arm/Group Title Rovalpituzumab Tesirine: DLL3 High Rovalpituzumab Tesirine: DLL3 Positive
Hide Arm/Group Description:
'DLL3 High' (tumors with ≥75% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
'DLL3 Positive' (tumors with ≥25% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
Overall Number of Participants Analyzed 238 287
Median (95% Confidence Interval)
Unit of Measure: months
IRC
3.8
(3.3 to 4.1)
3.8
(3.3 to 4.0)
Investigator
3.9
(3.3 to 4.1)
3.9
(3.3 to 4.0)
6.Secondary Outcome
Title Clinical Benefit Rate
Hide Description

Clinical benefit rate is defined as the percentage of participants with an overall response of CR or PR or stable disease (SD) with SD of a minimum duration of 42 days from the first dose date. Analyzed based on response assessments from both the IRC and investigators.

CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

PR: at least 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 PD, taking as reference the smallest sum diameters while on study.

PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (The appearance of one or more new lesions is also considered progression.)

Time Frame up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat Population: all participants who received any amount of study drug.
Arm/Group Title Rovalpituzumab Tesirine: DLL3 High Rovalpituzumab Tesirine: DLL3 Positive
Hide Arm/Group Description:
'DLL3 High' (tumors with ≥75% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
'DLL3 Positive' (tumors with ≥25% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
Overall Number of Participants Analyzed 238 287
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
IRC
73.9
(67.9 to 79.4)
72.1
(66.6 to 77.2)
Investigator
71.0
(64.8 to 76.7)
68.6
(62.9 to 74.0)
7.Secondary Outcome
Title Duration of Clinical Benefit
Hide Description

Duration of clinical benefit is defined as time from the date of first documented CR or PR or SD of ≥ 42 days from first dose date (-7 days to allow for scheduled visit window per the protocol) to the documented date PD or death, whichever occurs first. Analyzed based on response assessments from both the IRC and investigators.

CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

PR: at least 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 PD, taking as reference the smallest sum diameters while on study.

Time Frame up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat Population: all participants who received any amount of study drug with best overall response of CR or PR or SD.
Arm/Group Title Rovalpituzumab Tesirine: DLL3 High Rovalpituzumab Tesirine: DLL3 Positive
Hide Arm/Group Description:
'DLL3 High' (tumors with ≥75% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
'DLL3 Positive' (tumors with ≥25% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
Overall Number of Participants Analyzed 176 207
Median (95% Confidence Interval)
Unit of Measure: months
IRC Number Analyzed 176 participants 207 participants
2.9
(2.8 to 3.2)
2.9
(2.8 to 3.0)
Investigator Number Analyzed 169 participants 197 participants
3.0
(2.9 to 3.3)
3.0
(2.9 to 3.2)
8.Secondary Outcome
Title Rovalpituzumab Tesirine Antibody-Drug Conjugate Plasma Concentrations by Study Visit
Hide Description [Not Specified]
Time Frame Cycle 1: Day 1, 30 minutes pre-infusion; Day 1, 30 minutes post-infusion; Day 3; Day 15; Day 29. Cycle 2: Day 1, 30 minutes pre-infusion; Day 1, 30 minutes post-infusion; Day 3; Day 15; Day 29; End of Treatment (up to Day 29).
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Population: all participants who receive at least 1 dose of study treatment and at least 1 post-baseline blood sample following a dose of study treatment and had an assessment at given time point.
Arm/Group Title Rovalpituzumab Tesirine: Initial Treatment Period Rovalpituzumab Tesirine: Re-Treatment 1 Rovalpituzumab Tesirine: Re-Treatment 2
Hide Arm/Group Description:
0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles.
0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of retreatment Cycle 1
0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of retreatment Cycle 2
Overall Number of Participants Analyzed 329 20 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1: Day 1, 30 minutes pre-infusion Number Analyzed 329 participants 20 participants 2 participants
180.9  (1215.03) 236.6  (923.44) 148.2  (81.81)
Cycle 1: Day 1, 30 minutes post-infusion Number Analyzed 329 participants 20 participants 2 participants
7611.6  (1980.49) 6365.5  (1763.08) 6690.0  (2050.61)
Cycle 1: Day 3 Number Analyzed 317 participants 20 participants 2 participants
4535.2  (1398.49) 3740.5  (1454.87) 4630.0  (1866.76)
Cycle 1: Day 15 Number Analyzed 300 participants 15 participants 2 participants
1472.8  (573.90) 1323.3  (504.33) 1390.0  (381.84)
Cycle 1: Day 29 Number Analyzed 279 participants 18 participants 2 participants
816.3  (379.15) 793.8  (322.90) 956.5  (61.52)
Cycle 2: Day 1, 30 minutes pre-infusion Number Analyzed 223 participants 15 participants 1 participants
532.2  (592.90) 518.6  (226.45) 601.0 [1]   (NA)
Cycle 2: Day 1, 30 minutes post-infusion Number Analyzed 216 participants 15 participants 1 participants
7535.6  (1928.74) 6602.7  (1508.23) 7880.0 [1]   (NA)
Cycle 2: Day 3 Number Analyzed 205 participants 13 participants 1 participants
4791.1  (1373.70) 4670.8  (1539.65) 3840.0 [1]   (NA)
Cycle 2: Day 15 Number Analyzed 206 participants 13 participants 1 participants
1845.5  (688.47) 1857.7  (599.65) 2030.0 [1]   (NA)
Cycle 2: Day 29 Number Analyzed 175 participants 14 participants 1 participants
1029.3  (362.28) 1077.7  (362.33) 1300.0 [1]   (NA)
End of Treatment Number Analyzed 213 participants 15 participants 2 participants
558.5  (296.09) 686.9  (354.68) 679.5  (64.35)
[1]
1 participant was analyzed.
9.Secondary Outcome
Title Number of Anti-Therapeutic Antibody (ATA) Positive Participants
Hide Description [Not Specified]
Time Frame up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received rovalpituzumab tesirine and had at least one sample screened for ATA against rovalpituzumab tesirine antibody-drug conjugate concentration.
Arm/Group Title Rovalpituzumab Tesirine
Hide Arm/Group Description:
0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
Overall Number of Participants Analyzed 336
Measure Type: Count of Participants
Unit of Measure: Participants
Positive at Any Study Visit Number Analyzed 336 participants
11
   3.3%
Positive After First Dose of Study Drug Number Analyzed 276 participants
3
   1.1%
10.Secondary Outcome
Title Number of Participants With Treatment-Related Adverse Events (TEAEs) During Initial Treatment
Hide Description 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.
Time Frame From first dose of study drug through the end of the initial treatment period (84 ± 6 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population: all participants who received any amount of study drug.
Arm/Group Title Rovalpituzumab Tesirine
Hide Arm/Group Description:
0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
Overall Number of Participants Analyzed 339
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
335
  98.8%
Treatment Emergent SAE
171
  50.4%
TEAE Maximum Severity Grade 3/4
179
  52.8%
TEAE Leading to Drug WIthdrawal
25
   7.4%
TEAE Leading to Dose Interruption
33
   9.7%
TEAE Leading to Dose Reduction
32
   9.4%
TEAE Reasonably Possibly Related to Study Drug
308
  90.9%
Fatal AE
34
  10.0%
11.Secondary Outcome
Title Number of Participants With TEAEs Occurring in at Least 10% of All Participants During Initial Treatment
Hide Description TEAEs were defined as AEs that were newly occurring or worsened following study treatment.
Time Frame From first dose of study drug through the end of the initial treatment period (84 ± 6 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population: all participants who received any amount of study drug.
Arm/Group Title Rovalpituzumab Tesirine
Hide Arm/Group Description:
0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
Overall Number of Participants Analyzed 339
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
335
  98.8%
Fatigue
129
  38.1%
Photosensitivity Reaction
123
  36.3%
Pleural effusion
113
  33.3%
Oedema peripheral
105
  31.0%
Decreased appetite
102
  30.1%
Nausea
88
  26.0%
Dyspnoea
83
  24.5%
Thrombocytopenia
83
  24.5%
Constipation
75
  22.1%
Vomiting
59
  17.4%
Anaemia
58
  17.1%
Cough
54
  15.9%
Hypoalbuminaemia
52
  15.3%
Pericardial effusion
50
  14.7%
Abdominal pain
50
  14.7%
Asthenia
50
  14.7%
Diarrhoea
47
  13.9%
Time Frame From first dose of study drug through the end of treatment (EOT; 42 ± 3 days after last dose, or within 7 days of documentation of the decision to discontinue treatment, whichever was later) or 30 days after last study treatment, whichever was later. Mean (SD) duration of follow-up (ie, from the first dose date to the last known date alive or death date) was 29.0 (23.77) weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rovalpituzumab Tesirine
Hide Arm/Group Description 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
All-Cause Mortality
Rovalpituzumab Tesirine
Affected / at Risk (%)
Total   303/339 (89.38%)    
Hide Serious Adverse Events
Rovalpituzumab Tesirine
Affected / at Risk (%) # Events
Total   178/339 (52.51%)    
Blood and lymphatic system disorders   
Anaemia  1  7/339 (2.06%)  7
Febrile neutropenia  1  1/339 (0.29%)  1
Thrombocytopenia  1  11/339 (3.24%)  13
Cardiac disorders   
Atrial fibrillation  1  6/339 (1.77%)  6
Cardiac arrest  1  1/339 (0.29%)  1
Cardiac failure congestive  1  1/339 (0.29%)  1
Cardiac tamponade  1  4/339 (1.18%)  4
Cardiopulmonary failure  1  1/339 (0.29%)  2
Pericardial effusion  1  14/339 (4.13%)  19
Sinus bradycardia  1  1/339 (0.29%)  1
Gastrointestinal disorders   
Abdominal pain  1  9/339 (2.65%)  10
Ascites  1  4/339 (1.18%)  4
Colitis  1  2/339 (0.59%)  2
Constipation  1  1/339 (0.29%)  1
Diarrhoea  1  1/339 (0.29%)  2
Gastrointestinal haemorrhage  1  1/339 (0.29%)  1
Intestinal ischaemia  1  1/339 (0.29%)  2
Intestinal obstruction  1  1/339 (0.29%)  1
Nausea  1  7/339 (2.06%)  8
Pancreatitis  1  2/339 (0.59%)  2
Small intestinal obstruction  1  1/339 (0.29%)  1
Vomiting  1  1/339 (0.29%)  1
General disorders   
Asthenia  1  4/339 (1.18%)  6
Fatigue  1  5/339 (1.47%)  5
Gait disturbance  1  1/339 (0.29%)  1
General physical health deterioration  1  8/339 (2.36%)  14
Generalised oedema  1  8/339 (2.36%)  10
Oedema peripheral  1  8/339 (2.36%)  10
Pain  1  3/339 (0.88%)  4
Pyrexia  1  3/339 (0.88%)  3
Hepatobiliary disorders   
Cholangitis  1  1/339 (0.29%)  1
Drug-induced liver injury  1  1/339 (0.29%)  2
Hepatic pain  1  1/339 (0.29%)  1
Hepatocellular injury  1  3/339 (0.88%)  4
Hepatotoxicity  1  2/339 (0.59%)  2
Hyperbilirubinaemia  1  1/339 (0.29%)  2
Infections and infestations   
Bacterial infection  1  1/339 (0.29%)  1
Bronchitis  1  2/339 (0.59%)  2
Cellulitis  1  1/339 (0.29%)  1
Cerebral toxoplasmosis  1  1/339 (0.29%)  1
Clostridium difficile colitis  1  2/339 (0.59%)  3
Device related infection  1  1/339 (0.29%)  1
Diverticulitis  1  1/339 (0.29%)  1
Infection  1  1/339 (0.29%)  1
Infective exacerbation of chronic obstructive airways disease  1  1/339 (0.29%)  1
Lung infection  1  1/339 (0.29%)  1
Oesophageal candidiasis  1  1/339 (0.29%)  1
Pneumonia  1  12/339 (3.54%)  16
Pulmonary sepsis  1  1/339 (0.29%)  1
Respiratory tract infection  1  3/339 (0.88%)  4
Sepsis  1  6/339 (1.77%)  8
Septic shock  1  1/339 (0.29%)  2
Urinary tract infection  1  1/339 (0.29%)  1
Injury, poisoning and procedural complications   
Fall  1  1/339 (0.29%)  1
Femur fracture  1  1/339 (0.29%)  1
Head injury  1  1/339 (0.29%)  1
Humerus fracture  1  1/339 (0.29%)  1
Ligament sprain  1  1/339 (0.29%)  1
Pneumonitis chemical  1  1/339 (0.29%)  2
Tracheal haemorrhage  1  1/339 (0.29%)  1
Investigations   
Alanine aminotransferase increased  1  1/339 (0.29%)  2
Blood uric acid increased  1  1/339 (0.29%)  1
Ejection fraction decreased  1  1/339 (0.29%)  1
Liver function test increased  1  2/339 (0.59%)  2
Platelet count decreased  1  1/339 (0.29%)  1
Metabolism and nutrition disorders   
Decreased appetite  1  2/339 (0.59%)  2
Dehydration  1  1/339 (0.29%)  1
Diabetes mellitus  1  1/339 (0.29%)  1
Hypoalbuminaemia  1  1/339 (0.29%)  1
Hypokalaemia  1  2/339 (0.59%)  2
Hyponatraemia  1  6/339 (1.77%)  6
Musculoskeletal and connective tissue disorders   
Back pain  1  1/339 (0.29%)  1
Flank pain  1  1/339 (0.29%)  1
Musculoskeletal pain  1  1/339 (0.29%)  1
Myalgia  1  2/339 (0.59%)  2
Rheumatoid arthritis  1  1/339 (0.29%)  1
Spinal pain  1  1/339 (0.29%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Malignant neoplasm progression  1  1/339 (0.29%)  2
Metastases to pancreas  1  1/339 (0.29%)  1
Metastasis  1  1/339 (0.29%)  1
Nervous system disorders   
Hemiparesis  1  1/339 (0.29%)  1
Seizure  1  1/339 (0.29%)  1
Spinal cord compression  1  2/339 (0.59%)  2
Product Issues   
Device occlusion  1  1/339 (0.29%)  1
Psychiatric disorders   
Confusional state  1  5/339 (1.47%)  5
Delirium  1  2/339 (0.59%)  2
Disorientation  1  1/339 (0.29%)  1
Mental status changes  1  4/339 (1.18%)  4
Renal and urinary disorders   
Acute kidney injury  1  3/339 (0.88%)  3
Haematuria  1  1/339 (0.29%)  1
Renal failure  1  1/339 (0.29%)  1
Renal impairment  1  1/339 (0.29%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  1/339 (0.29%)  1
Chronic obstructive pulmonary disease  1  2/339 (0.59%)  2
Dyspnoea  1  4/339 (1.18%)  4
Dyspnoea exertional  1  1/339 (0.29%)  1
Haemoptysis  1  2/339 (0.59%)  2
Haemothorax  1  1/339 (0.29%)  1
Hypoxia  1  1/339 (0.29%)  1
Obstructive airways disorder  1  1/339 (0.29%)  1
Pleural effusion  1  49/339 (14.45%)  62
Pleurisy  1  1/339 (0.29%)  1
Pneumonia aspiration  1  1/339 (0.29%)  1
Pneumonitis  1  2/339 (0.59%)  5
Pneumothorax  1  3/339 (0.88%)  3
Pulmonary embolism  1  1/339 (0.29%)  1
Pulmonary haemorrhage  1  1/339 (0.29%)  1
Respiratory distress  1  1/339 (0.29%)  2
Respiratory failure  1  7/339 (2.06%)  11
Tracheal stenosis  1  1/339 (0.29%)  1
Skin and subcutaneous tissue disorders   
Dermatitis exfoliative  1  1/339 (0.29%)  1
Erythema  1  1/339 (0.29%)  1
Photosensitivity reaction  1  6/339 (1.77%)  7
Vascular disorders   
Capillary leak syndrome  1  2/339 (0.59%)  2
Deep vein thrombosis  1  2/339 (0.59%)  2
Haemorrhage  1  1/339 (0.29%)  1
Hypertension  1  1/339 (0.29%)  1
Hypotension  1  1/339 (0.29%)  1
Intermittent claudication  1  1/339 (0.29%)  1
Orthostatic hypotension  1  1/339 (0.29%)  1
Peripheral ischaemia  1  1/339 (0.29%)  1
Superior vena cava syndrome  1  3/339 (0.88%)  3
Venous thrombosis limb  1  1/339 (0.29%)  1
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rovalpituzumab Tesirine
Affected / at Risk (%) # Events
Total   322/339 (94.99%)    
Blood and lymphatic system disorders   
Anaemia  1  54/339 (15.93%)  88
Thrombocytopenia  1  73/339 (21.53%)  140
Cardiac disorders   
Pericardial effusion  1  38/339 (11.21%)  40
Gastrointestinal disorders   
Abdominal distension  1  20/339 (5.90%)  21
Abdominal pain  1  42/339 (12.39%)  59
Constipation  1  74/339 (21.83%)  87
Diarrhoea  1  46/339 (13.57%)  50
Nausea  1  82/339 (24.19%)  101
Vomiting  1  60/339 (17.70%)  75
General disorders   
Asthenia  1  48/339 (14.16%)  81
Face oedema  1  32/339 (9.44%)  32
Fatigue  1  125/339 (36.87%)  170
Non-cardiac chest pain  1  19/339 (5.60%)  21
Oedema peripheral  1  101/339 (29.79%)  136
Infections and infestations   
Urinary tract infection  1  27/339 (7.96%)  32
Investigations   
Alanine aminotransferase increased  1  20/339 (5.90%)  33
Aspartate aminotransferase increased  1  20/339 (5.90%)  27
Weight decreased  1  32/339 (9.44%)  36
Metabolism and nutrition disorders   
Decreased appetite  1  104/339 (30.68%)  124
Dehydration  1  19/339 (5.60%)  22
Hypoalbuminaemia  1  54/339 (15.93%)  70
Hypokalaemia  1  19/339 (5.60%)  23
Musculoskeletal and connective tissue disorders   
Back pain  1  30/339 (8.85%)  36
Myalgia  1  22/339 (6.49%)  27
Nervous system disorders   
Dizziness  1  33/339 (9.73%)  37
Headache  1  18/339 (5.31%)  18
Psychiatric disorders   
Insomnia  1  26/339 (7.67%)  26
Respiratory, thoracic and mediastinal disorders   
Cough  1  56/339 (16.52%)  67
Dyspnoea  1  83/339 (24.48%)  107
Pleural effusion  1  69/339 (20.35%)  84
Skin and subcutaneous tissue disorders   
Dry skin  1  25/339 (7.37%)  28
Erythema  1  30/339 (8.85%)  37
Photosensitivity reaction  1  119/339 (35.10%)  199
Rash  1  26/339 (7.67%)  30
Vascular disorders   
Hypotension  1  19/339 (5.60%)  21
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02674568    
Other Study ID Numbers: SCRX001-002
2015-004506-42 ( EudraCT Number )
First Submitted: January 29, 2016
First Posted: February 4, 2016
Results First Submitted: September 30, 2019
Results First Posted: October 23, 2019
Last Update Posted: July 7, 2020