Condition category
Cancer
Date applied
06/05/2011
Date assigned
06/05/2011
Last edited
20/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Debbie Hamid

ORCID ID

Contact details

Clinical Trials Unit
MP 131
Tremona Road
Southampton
SO16 6YD
United Kingdom
-
d.hamid@soton.ac.uk

Additional identifiers

EudraCT number

2010-021863-34

ClinicalTrials.gov number

NCT01331525

Protocol/serial number

9618

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

Acronym

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

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Intervention

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

Drug

Phase

Phase II

Drug names

Ipilumimab, carboplatin, etoposide

Primary outcome measures

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

01/05/2011

Overall trial end date

29/05/2014

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

30/06/2011

Recruitment end date

29/05/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trials Unit
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust (UK)

Sponsor details

Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

Bristol Myers Squibb Pharmaceuticals Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes