Nivolumab/Ipilimumab in Second Line CUP-syndrome
- Sponsor
- University Hospital Heidelberg
- Study ID
- NCT04131621
- Phase
- PHASE2
- Status
- Unknown
Conditions
- Cancer of Unknown Primary Site
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab/Ipilimumab — BIOLOGICALImmune checkpoint inhibitor combination
Study Details
To compare the efficacy of nivolumab plus ipilimumab in subjects with high vs. Intermediate/low TMB poor-prognosis CUP (non-specific subset) who are relapsed or refractory to platinum-based first-line chemotherapy. To evaluate the efficacy of nivolumab plus ipilimumab in subjects with poor-prognosis CUP (non-specific subset) who are relapsed or refractory to platinum-based first-line chemotherapy
Key Dates
- Start date
- Dec 12, 2019
- Status verified
- Apr 2020
- Primary completion
- Dec 31, 2022
- Completion
- Dec 31, 2022
Study Design
- Enrollment
- 194 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Nivolumab/Ipilimumab
Primary Outcome Measure
Progression-free survival [ Time Frame: 3 months ]
Central Contacts
- Alwin Kraemer0049622142
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