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

NCT01331525 | Completed Phase 2 DMC

• 1 other identifier: RHM CAN0739
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Extensive Stage Small Cell Lung Cancer

Keywords

Small cell lung cancer; Chemotherapy; Immunotherapy; CTLA-4; Ipilimumab

Outcome Measures

Primary Outcomes (1)

• To establish the progression free survival at 1 year in patients with extensive stage small cell lung cancer treated with ipilimumab, carboplatin and etoposide.

  At 1 year from entering trial

Secondary Outcomes (1)

• 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.

  Throughout clinical trial participation (maximum 6 21 day cycles) plus 100 day follow up from last treatment.

Study Arms (1)

Single stage non-randomised

EXPERIMENTAL

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

Interventions

Ipilimumab BIOLOGICAL

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.

Also known as: Yervoy, MDX-010, BMS-734016

Single stage non-randomised

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Cancer Research UK: collaborator
• Institute of Cancer Research, United Kingdom: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (7)

Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

Leeds Teaching Hospitals NHS Foundation Trust

Leeds, LS9 7TF, United Kingdom

Location

Barts and The London NHS Trust

London, EC1M 6BQ, United Kingdom

Location

The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

Weston Park Clinical Trials Centre

Sheffield, S10 2SJ, United Kingdom

Location

Southampton University Hospitals NHS Trust

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Diabetes Mellitus, Insulin-Dependent, 12

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Christian H Ottensmeier, MD, PhD

  University Hospital Southampton NHS Foundation Trust

  STUDY CHAIR

• Matthew Wheater, MD

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 8, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 14, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (7)