Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Ms Debbie Hamid


Contact details

Clinical Trials Unit
MP 131
Tremona Road
SO16 6YD
United Kingdom

Additional identifiers

EudraCT number

2010-021863-34 number


Protocol/serial number


Study information

Scientific title

A phase II trial of the addition of Ipilumimab to Carboplatin and Etoposide chemotherapy for the first line treatment of extensive small cell lung cancer


ICE Trial

Study hypothesis

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

Secondary Objectives:
To assess the response to and toxicity of the combination of ipilimumab with carboplatin and etoposide chemotherapy.

Immunological Objectives:
1. To examine whether ipilimumab stimulates a humoral immune response to onco-neuronal self-antigens
The results from the above measurement of antibodies against onco-neuronal antigens will be used to focus the cellular biomarker analysis and identify targets to assess cellular responses
2. To measure the effect of ipilimumab on CD8+ T-cells directed against onco-neuronal antigens, presumed to be responsible for the desired cytotoxic activity against cancer cells
3. To evaluate the immune response to non-neuronal antigens in the presence of ipilimumab

Ethics approval

Southampton & South West Hampshire REC Committee A, First MREC approval date 11/01/2011, 10/H0502/95

Study design

Non-randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet


Topic: National Cancer Research Network; Subtopic: Lung Cancer; Disease: Lung (small cell)


Carboplatin, Combination chemo for 6 cycles; Etoposide, Combination chemotherapy for 6 cycles; Ipilimumab, to be ngiven during cycles 3 - 6 and then as maintenance therapy every 12 weeks; Follow Up Length: 12 month(s); Study Entry : Registration only

Intervention type



Phase II

Drug names

Ipilumimab, carboplatin, etoposide

Primary outcome measure

Progression free survival; Timepoint(s): from consent to patient disease progression

Secondary outcome measures

1 year overall survival; Timepoint(s): survival one year from consent

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Willing and able to give written informed consent
2. Histological or cytological diagnosis of small cell lung cancer
3. Adequate baseline laboratory tests
4. No active or chronic infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
5. Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1
6. Men and women, 18 years of age or more. ; Lower Age Limit 18 no age limit or unit specified

Participant type


Age group




Target number of participants

Planned Sample Size: 40; UK Sample Size: 40; Description: 40 patients to be recruited from 5 sites across the UK

Participant exclusion criteria

1. Limited stage small cell lung cancer appropriate for radical treatment with chemoradiation
2. Symptomatic central nervous system (CNS) metastases
3. 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
4. Clinically significant autoimmune disease
5. 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 adverse effects (AEs).
6. Administration of any live vaccine for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
7. Previous chemotherapy for small cell lung cancer
8. A history of prior treatment with immunostimulatory antibodies ipilimumab, prior CD137 agonist or CTLA 4 inhibitor or agonist
9. 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
10. Women of childbearing potential (WOCBP), as defined in the protocol and who:
10.1. 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
10.2. Have a positive pregnancy test at baseline
10.3. Are pregnant or breastfeeding

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trials Unit
SO16 6YD
United Kingdom

Sponsor information


Southampton University Hospitals NHS Trust (UK)

Sponsor details

Tremona Road
SO16 6YD
United Kingdom

Sponsor type




Funder type


Funder name

Bristol Myers Squibb Pharmaceuticals Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2016 results in:

Publication citations

Additional files

Editorial Notes

11/12/2017: Publication reference added