A Trial Evaluating the Safety & Efficacy of Intra-Tumoral Ipilimumab in

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

The study aims to evaluate the 6 month-treatment tolerance defined as the immune related grade 3-4 adverse event-free survival of the combination therapy IT ipilimumab + IV nivolumab. The IV ipilimumab + IV nivolumab (same doses than in Phase I) arm will be used as an internal control to interpret the results obtained in the IT ipilimumab arm.

See also
	Status	Clinical Trial	Phase
	Active, not recruiting	`NCT03132675` - Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Either Pembrolizumab or Nivolumab Treatment	Phase 2

NCT number	NCT02857569
Study type	Interventional
Source	Gustave Roussy, Cancer Campus, Grand Paris
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	December 5, 2016
Completion date	May 20, 2022

A Trial Evaluating the Safety & Efficacy of Intra-Tumoral Ipilimumab in Combination With Intra-venous Nivolumab in Patients With Metastatic Melanoma — NIVIPIT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms