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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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by AbbVie
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT03026166
First received: January 18, 2017
Last updated: May 31, 2017
Last verified: May 2017
  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).

Condition Intervention Phase
Small Cell Lung Cancer Drug: rovalpituzumab tesirine Drug: nivolumab Drug: ipilimumab Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by AbbVie:

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

Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • PFS status after 6 months from the initiation of study treatment [ Time Frame: Approximately 2 years ]
  • 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.


Estimated Enrollment: 90
Actual Study Start Date: April 13, 2017
Estimated Study Completion Date: April 15, 2020
Estimated Primary Completion Date: April 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rovalpituzumab Tesirine and nivolumab
Rovalpituzumab tesirine 0.3 mg/kg intravenous (various dose regimens) and nivolumab intravenous (various doses and dose regimens)
Drug: rovalpituzumab tesirine
Intravenous
Other Name: SC16LD6.5
Drug: nivolumab
Intravenous
Other Name: Opdivo
Drug: ipilimumab
Intravenous
Other Name: Yervoy
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: rovalpituzumab tesirine
Intravenous
Other Name: SC16LD6.5
Drug: nivolumab
Intravenous
Other Name: Opdivo
Drug: ipilimumab
Intravenous
Other Name: Yervoy
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: rovalpituzumab tesirine
Intravenous
Other Name: SC16LD6.5
Drug: nivolumab
Intravenous
Other Name: Opdivo
Drug: ipilimumab
Intravenous
Other Name: Yervoy

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03026166

Contacts
Contact: AbbVie_Call Center 847-283-8955 AbbVieClinicalTrials@AbbVie.com

Locations
United States, Missouri
Washington University School of Medicine /ID# 161011 Recruiting
Saint Louis, Missouri, United States, 63110
United States, Tennessee
Tennessee Oncology, PLLC /ID# 161012 Recruiting
Nashville, Tennessee, United States, 37203
United States, Virginia
Virginia Cancer Institute /ID# 161025 Recruiting
Richmond, Virginia, United States, 23226
Sponsors and Collaborators
AbbVie
Bristol-Myers Squibb
Investigators
Study Director: Charity Scripture, PharmD AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03026166     History of Changes
Other Study ID Numbers: M16-300
2016-003686-26 ( EudraCT Number )
Study First Received: January 18, 2017
Last Updated: May 31, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

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

ClinicalTrials.gov processed this record on June 23, 2017