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

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ClinicalTrials.gov Identifier: NCT03026166
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : April 26, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AbbVie

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: ipilimumab Drug: nivolumab Drug: rovalpituzumab tesirine Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 31, 2017
Estimated Primary Completion Date : February 4, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Rovalpituzumab Tesirine and nivolumab
Rovalpituzumab tesirine 0.3 mg/kg intravenous (various dose regimens) and nivolumab intravenous (various doses and dose regimens)
Drug: ipilimumab
Intravenous
Other Name: Yervoy
Drug: nivolumab
Intravenous
Other Name: Opdivo
Drug: rovalpituzumab tesirine
Intravenous
Other Name: SC16LD6.5
Experimental: Rovalpituzumab Tesirine and nivolumab plus ipilimumab 1 mg/kg
Rovalpituzumab tesirine 0.3 mg/kg intravenous (various dose regimens) and nivolumab intravenous (various doses and dose regimens) plus ipilimumab 1 mg/kg intravenous
Drug: ipilimumab
Intravenous
Other Name: Yervoy
Drug: nivolumab
Intravenous
Other Name: Opdivo
Drug: rovalpituzumab tesirine
Intravenous
Other Name: SC16LD6.5
Experimental: Rovalpituzumab Tesirine and nivolumab plus ipilimumab 3 mg/kg
Rovalpituzumab tesirine 0.3 mg/kg intravenous (various dose regimens) and nivolumab intravenous (various doses and dose regimens) plus ipilimumab 3 mg/kg intravenous
Drug: ipilimumab
Intravenous
Other Name: Yervoy
Drug: nivolumab
Intravenous
Other Name: Opdivo
Drug: rovalpituzumab tesirine
Intravenous
Other Name: SC16LD6.5



Primary Outcome Measures :
  1. Number of participants with dose-limiting toxicities (DLT) [ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures :
  1. Clinical benefit rate (CBR) [ Time Frame: Approximately 2 years ]
    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.

  2. Duration of response (DOR) [ Time Frame: Approximately 2 years ]
    DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.

  3. PFS status after 6 months from the initiation of study treatment [ Time Frame: Approximately 2 years ]
  4. Objective Response Rate (ORR) [ Time Frame: Approximately 2 years ]
    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.

  5. Progression-free survival (PFS) [ Time Frame: Approximately 2 years ]
    PFS time is defined as the time from the first dose of study drug to progression or death, whichever occurs first.

  6. Overall survival (OS) [ Time Frame: Approximately 2 years ]
    OS is defined as number of days from the date of first dose to the date of death.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026166


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

  Show 38 Study Locations
Sponsors and Collaborators
AbbVie
Bristol-Myers Squibb
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03026166     History of Changes
Other Study ID Numbers: M16-300
2016-003686-26 ( EudraCT Number )
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Cancer
Extensive-Stage Small Cell Lung Cancer
Nivolumab
Ipilimumab
Rovalpituzumab tesirine

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs