A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer

Part of paid clinical trials in La Jolla, California.

Sponsor
AbbVie
Study ID
NCT03026166
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    Administered by intravenous infusion
  • Nivolumab — DRUG
    Administered by intravenous infusion
  • Rovalpituzumab tesirine — DRUG
    Administered by intravenous infusion

Study Details

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).

Key Dates

Start date
Mar 30, 2017
Status verified
Jul 2020
Primary completion
Jul 3, 2019
Completion
Jul 3, 2019

Study Design

Enrollment
42 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Rovalpituzumab Tesirine and Nivolumab
    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.
  • Experimental: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 1 mg/kg
    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.
  • Experimental: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 3 mg/kg
    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.

Primary Outcome Measure

Number of Participants With Dose-limiting Toxicities (DLT) [ Time Frame: Up to 12 weeks ]

Locations (15)

FacilityCityStateZIPSite coordinators
Ucsd /Id# 161030La JollaCalifornia92093-
Florida Hospital /ID# 161017OrlandoFlorida32803-
University Cancer & Blood Cent /ID# 161028AthensGeorgia30607-
University of Chicago /ID# 161006ChicagoIllinois60637-1443-
The University of Kansas Clini /ID# 162915FairwayKansas66205-
Washington University-School of Medicine /ID# 161011St LouisMissouri63110-
Rutgers Cancer Institute of NJ /ID# 161032New BrunswickNew Jersey08903-
Memorial Sloan Kettering Cancer Center /ID# 161010New YorkNew York10065-6007-
Duke University Medical Center /ID# 161009DurhamNorth Carolina27710-3000-
Oregon Health and Science University /ID# 161029PortlandOregon97239-
Medical University of South Carolina /ID# 161007CharlestonSouth Carolina29425-
Tennessee Oncology, PLLC /ID# 161012NashvilleTennessee37203-
Vanderbilt University Med Ctr /ID# 162916NashvilleTennessee37232-6307-
Virginia Cancer Institute /ID# 161025RichmondVirginia23230-
University of Wisconsin Clinic /ID# 161013MadisonWisconsin53705-

Find similar trials in La Jolla, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Ucsd· La Jolla, CAFlorida Hospital· Orlando, FLUniversity Cancer & Blood Cent· Athens, GAUniversity of Chicago· Chicago, ILThe University of Kansas Clini· Fairway, KSWashington University-School of Medicine· St Louis, MO

Related Studies