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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03026166
Recruitment Status : Completed
First Posted : January 20, 2017
Last Update Posted : July 17, 2019
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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 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 30, 2017
Actual Primary Completion Date : July 3, 2019
Actual Study Completion Date : July 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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 Adverse Events (AEs) [ Time Frame: Approximately 2 years ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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


Locations
Show Show 35 study locations
Sponsors and Collaborators
AbbVie
Bristol-Myers Squibb
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03026166    
Other Study ID Numbers: M16-300
2016-003686-26 ( EudraCT Number )
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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:
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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
Ipilimumab
Immunoconjugates
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs