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Ipilimumab

Phase 2

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Sanofi|Last Updated: Mar 12, 2026

Target and mechanism

Molecular targetCTLA4
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

Ipilimumab · 1 trial · 1 indication

Phase 2 1
NCT05401786Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLCCarcinoma, Non-Small-Cell Lung
ACTIVE NOT_RECRUITING54 Analytics
PHASE2ACTIVE NOT_RECRUITING
Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLC
Carcinoma, Non-Small-Cell LungUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical Benefit Rate
Through study completion, an average of 1 year

Number of participants with complete response or partial response within the first 6 months or stable disease lasting for minimum 6 months

Secondary Endpoints

Objective Response Rate
12 weeks after re-introduction of PD-1 inhibition (day 1 of week 15)
Disease Control Rate
12 weeks after re-introduction of PD-1 inhibition (day 1 of week 15)
Best overall response
Through study completion, an average of 1 year
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Anti-CTLA-4, SBRT and PD1EXPERIMENTALParticipants will receive 1 dose of ipilimumab (1mg/kg intravenously) on day 1. After 1 week the participants will receive SBRT (3x8Gy) on at least 1 but no more than 4 tumor lesions. Within 1 week of the last radiation fraction participants will start with cemiplimab (350mg intravenously every 3 weeks) until disease progression, unacceptable toxicity, patient request for discontinuation, or up to 2 years of treatment

Interventions

NameTypeDescription
IpilimumabDRUGAnti-CTLA-4
CemiplimabDRUGPD-1 inhibition
SBRTRADIATIONStereotactic Body Radiotherapy
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Have proven diagnosis of recurrent advanced NSCLC, irrespective of histological subtype. 2. Be willing and able to provide written informed consent/assent for the trial. 3. Must still have measurable disease based on RECIST 1.1 after application of study SBRT. Lesions that we...

Countries:Netherlands
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Frequently asked questions about Ipilimumab

What is Ipilimumab used for in Non-Small-Cell Lung?

Ipilimumab is being studied for the treatment of carcinoma, non-small-cell lung. It is currently in Phase 2 clinical development as an investigational therapy for this condition.

What does Ipilimumab target?

Ipilimumab is a monoclonal antibody, classified as a -mab antibody. It is being evaluated for its role in immune modulation in the context of non-small-cell lung cancer.

Who is developing Ipilimumab?

Ipilimumab is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker symbol SNY.

What phase is Ipilimumab in?

Ipilimumab is currently in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities for any indication.

What clinical trials is Ipilimumab in?

Ipilimumab is being studied in a Phase 2 clinical trial with the identifier NCT05401786. This trial is titled 'Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLC' and is active but not recruiting participants.

Is Ipilimumab the same as any other drug?

Ipilimumab is a distinct drug entity. It is a monoclonal antibody being investigated for its potential role in treating non-small-cell lung cancer, and no alternative names have been associated with it in the context of this development program.