NCT04131621

Nivolumab/Ipilimumab in Second Line CUP-syndrome

A Phase II, Open-label, Non-randomized, Multi-center Study Evaluating the Efficacy and Safety of Nivolumab Plus Ipilimumab in Patients With Cancer of Unknown Primary Site Who Are Relapsed After or Refractory to Platinum-based Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 194 (estimated)
• Sponsor: University Hospital Heidelberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Cancer of Unknown Primary Site

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab/Ipilimumab	Immune checkpoint inhibitor combination

Timeline

• Start date: 2019-12-12
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2019-10-18
• Last updated: 2020-04-15

Locations

1 site across 1 country: Germany