The Addition of Ipilimumab to Carboplatin and Etoposide Chemotherapy for Extensive Stage Small Cell Lung Cancer (ICE)

This study has been completed.
Sponsor:
Collaborators:
Cancer Research UK
Institute of Cancer Research, United Kingdom
Bristol-Myers Squibb
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust.
ClinicalTrials.gov Identifier:
NCT01331525
First received: April 4, 2011
Last updated: April 13, 2016
Last verified: April 2016
  Purpose

This trial will investigate the addition of an antibody (Ipilimumab) to conventional Carboplatin and Etoposide chemotherapy in extensive stage small cell lung cancer.

The primary objective is to establish the progression free survival at 1 year.


Condition Intervention Phase
Extensive Stage Small Cell Lung Cancer
Biological: Ipilimumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of the Addition of Ipilimumab to Carboplatin and Etoposide Chemotherapy for the First Line Treatment of Extensive Stage Small Cell Lung Cancer (ICE)

Resource links provided by NLM:


Further study details as provided by University Hospital Southampton NHS Foundation Trust.:

Primary Outcome Measures:
  • To establish the progression free survival at 1 year in patients with extensive stage small cell lung cancer treated with ipilimumab, carboplatin and etoposide. [ Time Frame: At 1 year from entering trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess tumour response and toxicity of ICE combination. Response measured by RECIST and immune related response criteria. Toxicity via physical exam, adverse event review, assessing signs and symptoms, quality of life assessment and blood testing. [ Time Frame: Throughout clinical trial participation (maximum 6 21 day cycles) plus 100 day follow up from last treatment. ] [ Designated as safety issue: Yes ]

    Response: Assessed via Chest X-ray and CT of chest, abdomen and pelvis at weeks 6, 12, 18, 24, 30, 36, 42, 48, 52 and then 12 weekly until progression.

    Toxicity: targeted physical, adverse event assessment, assessment of signs and symptoms, quality of life assessment, full blood count plus ALT/ASP, ALP, Billi, Ca, Alb, LDH, Creatinine, urea and electrolytes investigation. Serious adverse events will be reported within 24 hours of first knowledge of the event.



Enrollment: 42
Study Start Date: June 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single stage non-randomised

Patients will receive Carboplatin and Etoposide. Both Chemotherapy drugs will be delivered as a 21 day cycle (q21) with up to a maximum of 6 cycles delivered according to response unless progressive disease (RECIST Version 1.0) and or excessive toxicity.

Ipilimumab will be administered at a dose of 10mg/kg IV on day 1 of cycles 3-6 of Chemotherapy.

In the absence of immune related progression of disease or unacceptable toxicity, subsequent maintenance doses of Ipilimumab will be delivered every 12 weeks starting at week 30 at a dose of 10 mg/kg until unacceptable toxicity or immune related disease progression

Biological: Ipilimumab
This trial will investigate the addition of the anti-CTLA4 antibody ipilimumab to conventional carboplatin and etoposide chemotherapy in extensive stage small cell lung cancer.
Other Names:
  • Yervoy
  • MDX-010
  • BMS-734016

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to give written informed consent.
  • Histological or cytological diagnosis of small cell lung cancer.
  • Adequate baseline laboratory tests.
  • No active or chronic infection with HIV, Hepatitis B, or Hepatitis C.
  • Performance status ECOG 0 or 1.
  • Men and women, 18 years of age and above.

Exclusion Criteria:

  • Limited stage small cell lung cancer appropriate for radical treatment with chemoradiation.
  • Symptomatic CNS metastases.
  • A history of prior malignant tumour, unless the patient has been without evidence of disease for at least 5 years, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix.
  • Clinically significant autoimmune disease.
  • Any underlying medical, neurological or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of AEs.
  • Administration of any live vaccine for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab).
  • Previous chemotherapy for small cell lung cancer.
  • A history of prior treatment with immunostimulatory antibodies ipilimumab, prior CD137 agonist or CTLA 4 inhibitor or agonist.
  • Concomitant therapy with any of the following: Interleukin 2, interferon, or other non-study immunotherapy regimens; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids.
  • Women of childbearing potential (WOCBP), as defined in the protocol and who:

    • Are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the duration of their participation in the study and for at least 8 weeks after cessation of study drug, or
    • Have a positive pregnancy test at baseline, or
    • Are pregnant or breastfeeding.
  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: NCT01331525

Locations
United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
Leeds Teaching Hospitals NHS Foundation Trust
Leeds, United Kingdom, LS9 7TF
Barts and The London NHS Trust
London, United Kingdom, EC1M 6BQ
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG5 1PB
Weston Park Clinical Trials Centre
Sheffield, United Kingdom, S10 2SJ
Southampton University Hospitals NHS Trust
Southampton, United Kingdom, SO16 6YD
The Clatterbridge Cancer Centre NHS Foundation Trust
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust.
Cancer Research UK
Institute of Cancer Research, United Kingdom
Bristol-Myers Squibb
Investigators
Study Chair: Christian H Ottensmeier, MD, PhD University Hospital Southampton NHS Foundation Trust.
Principal Investigator: Matthew Wheater, MD University Hospital Southampton NHS Foundation Trust.
  More Information

Responsible Party: University Hospital Southampton NHS Foundation Trust.
ClinicalTrials.gov Identifier: NCT01331525     History of Changes
Other Study ID Numbers: RHM CAN0739 
Study First Received: April 4, 2011
Last Updated: April 13, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by University Hospital Southampton NHS Foundation Trust.:
Small cell lung cancer
Chemotherapy
Immunotherapy
CTLA-4
Ipilimumab

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
Etoposide phosphate
Carboplatin
Etoposide
Antibodies, Monoclonal
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 25, 2016