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Ipilimumab

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05401786Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLCPHASE2 ACTIVE NOT_RECRUITING 54Jan 3, 2023Jun 1, 2026Mar 12, 20261 Netherlands
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05401786primaryCompletionDate: changed
LOWMay 24, 2026NCT05401786studyFirstPostDate: changed