Clinical 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Small Cell Lung Cancer
Keywords: Cancer
Extensive-Stage Small Cell Lung Cancer
Nivolumab
Ipilimumab
Rovalpituzumab tesirine
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2017-01-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Has active, known, or suspected autoimmune disease
* Had prior exposure to an immuno-oncology or pyrrolobenzodiazepine (PBD)-based drug

Primary outcomes:
measure: Number of Participants With Dose-limiting Toxicities (DLT)
timeFrame: Up to 12 weeks
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 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:
measure: Objective Response Rate (ORR)
timeFrame: 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.
measure: Duration of Response (DOR)
timeFrame: 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.
measure: Progression-free Survival (PFS)
timeFrame: 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.
measure: Overall Survival (OS)
timeFrame: 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.
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Ucsd /Id# 161030
state: California
city: Orlando
country: United States
facility: Florida Hospital /ID# 161017
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Cent /ID# 161028
state: Georgia
city: Chicago
country: United States
facility: University of Chicago /ID# 161006
state: Illinois
city: Fairway
country: United States
facility: The University of Kansas Clini /ID# 162915
state: Kansas
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 161011
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of NJ /ID# 161032
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center /ID# 161010
state: New York
city: Durham
country: United States
facility: Duke University Medical Center /ID# 161009
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University /ID# 161029
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina /ID# 161007
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC /ID# 161012
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Med Ctr /ID# 162916
state: Tennessee
city: Richmond
country: United States
facility: Virginia Cancer Institute /ID# 161025
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Clinic /ID# 161013
state: Wisconsin
city: Besancon
country: France
facility: CHU de Besancon - Jean Minjoz /ID# 165173
state: Doubs
city: Lille
country: France
facility: Centre Oscar Lambret /ID# 165169
state: Hauts-de-France
city: Villejuif
country: France
facility: Institut Gustave Roussy /ID# 165168
state: Val-de-Marne
city: Avignon
country: France
facility: Institut Sainte Catherine /ID# 165172
city: Brest Cedex
country: France
facility: CHRU de Brest - Hospital Morva /ID# 165170
city: Marseille
country: France
facility: Hopital La Timone /ID# 165171
city: Halle (Saale)
country: Germany
facility: KH Martha-Maria Halle Dolau /ID# 165180
state: Sachsen-Anhalt
city: Gauting
country: Germany
facility: Asklepios Fachkliniken M. Gaut /ID# 165183
city: Grosshansdorf
country: Germany
facility: Lungen Clinic Grosshansdorf /ID# 165182
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen /ID# 165181
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas /ID# 165176
state: Milano
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologi /ID# 165174
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele /ID# 165178
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia /ID# 165175
city: Modena
country: Italy
facility: AO Univ di Modena /ID# 165177
city: Pamplona
country: Spain
facility: Clinica Universitar de Navarra - Pamplona /ID# 165165
state: Navarra, Comunidad
city: Barcelona
country: Spain
facility: Hosp Univ Quiron Dexues /ID# 165166
city: Madrid
country: Spain
facility: Hospital Genl Gregorio Maranon /ID# 165162
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 165164
city: Madrid
country: Spain
facility: Hospital Universitario Madrid /ID# 165163
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: