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

NCT03026166

Description:

The purpose of this multicenter, Phase 1/2, open-label, 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).

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: M16-300
  • SECONDARY ID: 2016-003686-26
  • NCT ID: NCT03026166

Conditions

  • Small Cell Lung Cancer

Interventions

DrugSynonymsArms
ipilimumabYervoyRovalpituzumab Tesirine and nivolumab
nivolumabOpdivoRovalpituzumab Tesirine and nivolumab
rovalpituzumab tesirineSC16LD6.5Rovalpituzumab Tesirine and nivolumab

Purpose

The purpose of this multicenter, Phase 1/2, open-label, 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).

Trial Arms

NameTypeDescriptionInterventions
Rovalpituzumab Tesirine and nivolumabExperimentalRovalpituzumab tesirine 0.3 mg/kg intravenous (various dose regimens) and nivolumab intravenous (various doses and dose regimens)
  • ipilimumab
  • nivolumab
  • rovalpituzumab tesirine
Rovalpituzumab Tesirine and nivolumab plus ipilimumab 1 mg/kgExperimentalRovalpituzumab tesirine 0.3 mg/kg intravenous (various dose regimens) and nivolumab intravenous (various doses and dose regimens) plus ipilimumab 1 mg/kg intravenous
  • ipilimumab
  • nivolumab
  • rovalpituzumab tesirine
Rovalpituzumab Tesirine and nivolumab plus ipilimumab 3 mg/kgExperimentalRovalpituzumab tesirine 0.3 mg/kg intravenous (various dose regimens) and nivolumab intravenous (various doses and dose regimens) plus ipilimumab 3 mg/kg intravenous
  • ipilimumab
  • nivolumab
  • rovalpituzumab tesirine

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) 0-1

          -  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
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with dose-limiting toxicities (DLT)
Time Frame:Up to 12 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Clinical benefit rate (CBR)
Time Frame:Approximately 2 years
Safety Issue:
Description:CBR is defined as the percentage of participants who, after the first dose of study drug, achieve a best response of stable disease (SD) or better for a duration of at least 4 weeks.
Measure:Duration of response (DOR)
Time Frame:Approximately 2 years
Safety Issue:
Description:DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.
Measure:PFS status after 6 months from the initiation of study treatment
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Objective Response Rate (ORR)
Time Frame:Approximately 2 years
Safety Issue:
Description:ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measure:Progression-free survival (PFS)
Time Frame:Approximately 2 years
Safety Issue:
Description:PFS time is defined as the time from the first dose of study drug to progression or death, whichever occurs first.
Measure:Overall survival (OS)
Time Frame:Approximately 2 years
Safety Issue:
Description:OS is defined as number of days from the date of first dose to the date of death.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Cancer
  • Extensive-Stage Small Cell Lung Cancer
  • Nivolumab
  • Ipilimumab
  • Rovalpituzumab tesirine

Last Updated

February 28, 2018