Small Cell Lung CancerPhase 1/2NCT03026166
A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer
A Phase 1/2 study testing Ipilimumab, Nivolumab and Rovalpituzumab tesirine in people with Small Cell Lung Cancer, run by AbbVie at 35 sites in 5 countries.
Trial summary
The purpose of this study is to assess the safety and efficacy of rovalpituzumab tesirine administered in combination with nivolumab or nivolumab and ipilimumab in participants with extensive-stage small cell lung cancer (SCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Ipilimumab, Nivolumab and Rovalpituzumab tesirine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 35 sitesin 5 countries
- Study dates
- 30 Mar 2017to 3 Jul 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with histologically or cytologically confirmed extensive-stage small cell lung cancer (SCLC) with progressive disease after at least one platinum-based chemotherapeutic regimen and with evaluable or measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic, hepatic, and renal function
Who cannot join
- Has active, known, or suspected autoimmune disease
- Had prior exposure to an immuno-oncology or pyrrolobenzodiazepine (PBD)-based drug
Trial locations and contacts
35 sites in 5 countries.
35 sites in 5 countries
United States15 sites
University Cancer & Blood Cent /ID# 161028
Athens, Georgia, 30607
Medical University of South Carolina /ID# 161007
Charleston, South Carolina, 29425
University of Chicago /ID# 161006
Chicago, Illinois, 60637-1443
Duke University Medical Center /ID# 161009
Durham, North Carolina, 27710-3000
The University of Kansas Clini /ID# 162915
Fairway, Kansas, 66205
Ucsd /Id# 161030
La Jolla, California, 92093
University of Wisconsin Clinic /ID# 161013
Madison, Wisconsin, 53705
Tennessee Oncology, PLLC /ID# 161012
Nashville, Tennessee, 37203
Vanderbilt University Med Ctr /ID# 162916
Nashville, Tennessee, 37232-6307
Rutgers Cancer Institute of NJ /ID# 161032
New Brunswick, New Jersey, 08903
Memorial Sloan Kettering Cancer Center /ID# 161010
New York, New York, 10065-6007
Florida Hospital /ID# 161017
Orlando, Florida, 32803
Oregon Health and Science University /ID# 161029
Portland, Oregon, 97239
Virginia Cancer Institute /ID# 161025
Richmond, Virginia, 23230
Washington University-School of Medicine /ID# 161011
St Louis, Missouri, 63110
France6 sites
Institut Sainte Catherine /ID# 165172
Avignon, 84082
CHU de Besancon - Jean Minjoz /ID# 165173
Besançon, Doubs, 25000
CHRU de Brest - Hospital Morva /ID# 165170
Brest, 29609
Centre Oscar Lambret /ID# 165169
Lille, Hauts-de-France, 59020
Hopital La Timone /ID# 165171
Marseille, 13005
Institut Gustave Roussy /ID# 165168
Villejuif, Val-de-Marne, 94800
Italy5 sites
Centro di Riferimento Oncologi /ID# 165174
Aviano, 33081
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele /ID# 165178
Catania, 95123
Istituto Europeo di Oncologia /ID# 165175
Milan, 20141
AO Univ di Modena /ID# 165177
Modena, 41100
Istituto Clinico Humanitas /ID# 165176
Rozzano, Milano, 20089
Spain5 sites
Hosp Univ Quiron Dexues /ID# 165166
Barcelona, 08028
Hospital Genl Gregorio Maranon /ID# 165162
Madrid, 28007
Hospital Universitario Fundacion Jimenez Diaz /ID# 165164
Madrid, 28040
Hospital Universitario Madrid /ID# 165163
Madrid, 28050
Clinica Universitar de Navarra - Pamplona /ID# 165165
Pamplona, Navarra, Comunidad, 31008
Germany4 sites
Asklepios Fachkliniken M. Gaut /ID# 165183
Gauting, 82131
Lungen Clinic Grosshansdorf /ID# 165182
Großhansdorf, 22927
KH Martha-Maria Halle Dolau /ID# 165180
Halle, Saxony-Anhalt, 06120
Lungenfachklinik Immenhausen /ID# 165181
Immenhausen, 34376
About this study
Official title: A Phase 1/2 Study on the Safety of Rovalpituzumab Tesirine Administered in Combination With Nivolumab or Nivolumab and Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer
The purpose of this study is to assess the safety and efficacy of rovalpituzumab tesirine administered in combination with nivolumab or nivolumab and ipilimumab in participants with extensive-stage small cell lung cancer (SCLC).
Read the detailed description
The study planned to enroll three cohorts with approximately 30 participants in each, including a dose-limiting toxicity (DLT) evaluation phase (the first 12 weeks of any treatment) and an expansion phase. Initially, up to 12 participants were to be enrolled into Cohort 1 in order to obtain 6 evaluable participants through the DLT evaluation period of 12 weeks. Safety data were reviewed by a Safety Monitoring Committee (SMC) for each cohort during the DLT evaluation phase before the next cohort opened. Once a new cohort was opened, the previously opened cohort was permitted to continue enrolling participants for the expansion phase for a total of 30 participants per cohort.
Only two of the planned three cohorts enrolled participants in the study based on the SMC recommendation after DLTs were identified in Cohort 2.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Ipilimumab, Nivolumab, Rovalpituzumab tesirine
- Keywords
- Cancer, Extensive-Stage Small Cell Lung Cancer, Nivolumab, Ipilimumab, Rovalpituzumab tesirine
- Medical subject headings
- Small Cell Lung Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
Also called Yervoy®
Administered by intravenous infusion
NivolumabDrug
Also called Opdivo®
Administered by intravenous infusion
Rovalpituzumab tesirineDrug
Also called SC16LD6.5
Administered by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Rovalpituzumab Tesirine and Nivolumab | Experimental | Participants will receive 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3).
Participants will then receive maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression. Receives: Drug: Nivolumab; Drug: Rovalpituzumab tesirine |
| Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 1 mg/kg | Experimental | Participants will receive 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5).
After a 6-week washout, participants will then receive maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression. Receives: Drug: Ipilimumab; Drug: Nivolumab; Drug: Rovalpituzumab tesirine |
| Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 3 mg/kg | Experimental | Participants will receive 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 3 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5).
After an 8-week washout, participants will then receive maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression. Receives: Drug: Ipilimumab; Drug: Nivolumab; Drug: Rovalpituzumab tesirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-limiting Toxicities (DLT)
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
Measured: Up to 12 weeks
Number of Participants With Adverse Events (AEs)
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.
Measured: 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.
Secondary outcomes (4)
Objective Response Rate (ORR)
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.
Measured: 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 Response (DOR)
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.
Measured: 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.
Progression-free Survival (PFS)
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.
Measured: 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 (OS)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start30 Mar 2017
- Primary completion3 Jul 2019
- Study completion3 Jul 2019
Why it stopped: Enrollment was stopped after the dose-limiting toxicity (DLT) evaluation phase of Cohort 2.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026166
- Sponsor's protocol ID
- M16-300
- Other IDs
- 2016-003686-26, 2016
- Status last verified
- Jul 2020
- First submitted
- 18 Jan 2017
- Last updated
- 17 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study on the Safety of Rovalpituzumab Tesirine Administered in Combination With Nivolumab or Nivolumab and Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03026166
- Acronym / sponsor ID
- M16-300
- Conditions
- Small Cell Lung Cancer
- Keywords
- Cancer, Extensive-Stage Small Cell Lung Cancer, Nivolumab, Ipilimumab, Rovalpituzumab tesirine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was stopped after the dose-limiting toxicity (DLT) evaluation phase of Cohort 2.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Posted 1 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and efficacy of rovalpituzumab tesirine administered in combination with nivolumab or nivolumab and ipilimumab in participants with extensive-stage small cell lung cancer (SCLC).
Detailed description
The study planned to enroll three cohorts with approximately 30 participants in each, including a dose-limiting toxicity (DLT) evaluation phase (the first 12 weeks of any treatment) and an expansion phase. Initially, up to 12 participants were to be enrolled into Cohort 1 in order to obtain 6 evaluable participants through the DLT evaluation period of 12 weeks. Safety data were reviewed by a Safety Monitoring Committee (SMC) for each cohort during the DLT evaluation phase before the next cohort opened. Once a new cohort was opened, the previously opened cohort was permitted to continue enrolling participants for the expansion phase for a total of 30 participants per cohort.
Only two of the planned three cohorts enrolled participants in the study based on the SMC recommendation after DLTs were identified in Cohort 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rovalpituzumab Tesirine and Nivolumab | Experimental | Drug: Nivolumab, Drug: Rovalpituzumab tesirineParticipants will receive 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3). Participants will then receive maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression. |
| Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 1 mg/kg | Experimental | Drug: Ipilimumab, Drug: Nivolumab, Drug: Rovalpituzumab tesirineParticipants will receive 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5). After a 6-week washout, participants will then receive maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression. |
| Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 3 mg/kg | Experimental | Drug: Ipilimumab, Drug: Nivolumab, Drug: Rovalpituzumab tesirineParticipants will receive 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 3 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5). After an 8-week washout, participants will then receive maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants with histologically or cytologically confirmed extensive-stage small cell lung cancer (SCLC) with progressive disease after at least one platinum-based chemotherapeutic regimen and with evaluable or measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic, hepatic, and renal function
Key exclusion criteria (2 listed)
- Has active, known, or suspected autoimmune disease
- Had prior exposure to an immuno-oncology or pyrrolobenzodiazepine (PBD)-based drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IpilimumabAlso: Yervoy®Administered by intravenous infusion | Drug | Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 1 mg/kg, Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 3 mg/kg |
| NivolumabAlso: Opdivo®Administered by intravenous infusion | Drug | Rovalpituzumab Tesirine and Nivolumab, Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 1 mg/kg, Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 3 mg/kg |
| Rovalpituzumab tesirineAlso: SC16LD6.5Administered by intravenous infusion | Drug | Rovalpituzumab Tesirine and Nivolumab, Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 1 mg/kg, Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 3 mg/kg |
Primary outcome
Number of Participants With Dose-limiting Toxicities (DLT)
Time frame: 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
Number of Participants With Adverse Events (AEs)
Time frame: 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.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: 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 Response (DOR)
Time frame: 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.
Progression-free Survival (PFS)
Time frame: 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 (OS)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
35 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ipilimumab, Nivolumab and Rovalpituzumab tesirine in people with Small Cell Lung Cancer, run by AbbVie at 35 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, France, Italy, Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-limiting Toxicities (DLT) (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.