Nivolumab/Ipilimumab in Second Line CUP-syndrome

Phase 2

• Conditions: Cancer of Unknown Primary Site
• Interventions: Biological: Nivolumab/Ipilimumab

• Registration Number: NCT04131621
• Lead Sponsor: University Hospital Heidelberg

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Study Start: 2019-12-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-14
• Last Update Posted: 2020-04-15
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nivolumab/Ipilimumab	Nivolumab/Ipilimumab	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival	3 months	Months

Trial Locations

Locations (1)

University of Heidelberg; 🇩🇪 Heidelberg, Germany