Addition of Ipilumimab to Carboplatin and Etoposide chemotherapy for the first line treatment of extensive small cell lung cancer
ISRCTN | ISRCTN14095893 |
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DOI | https://doi.org/10.1186/ISRCTN14095893 |
EudraCT/CTIS number | 2010-021863-34 |
ClinicalTrials.gov number | NCT01331525 |
Secondary identifying numbers | 9618 |
- Submission date
- 06/05/2011
- Registration date
- 06/05/2011
- Last edited
- 24/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Ms Debbie Hamid
Scientific
Scientific
Clinical Trials Unit, MP 131, Tremona Road
Southampton
SO16 6YD
United Kingdom
d.hamid@soton.ac.uk |
Study information
Study design | Non-randomised; Interventional; Design type: Treatment |
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Primary study design | Interventional |
Secondary study design | Non randomised study |
Study setting(s) | Hospital |
Study type | Treatment |
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 |
Study acronym | ICE Trial |
Study objectives | 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(s) | Southampton & South West Hampshire REC Committee A, First MREC approval date 11/01/2011, 10/H0502/95 |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | 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 study start date | 01/05/2011 |
Completion date | 29/05/2014 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | 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 |
Key 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 |
Key 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 |
Date of first enrolment | 30/06/2011 |
Date of final enrolment | 29/05/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinical Trials Unit
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
https://ror.org/0485axj58 |
Funders
Funder type
Industry
Bristol Myers Squibb Pharmaceuticals Ltd (UK)
No information available
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | To be confirmed at a later date |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/09/2016 | Yes | No | |
Plain English results | 24/03/2022 | No | Yes | ||
HRA research summary | 28/06/2023 | No | No |
Editorial Notes
24/03/2022: Plain English results added.
11/12/2017: Publication reference added