NCT04913025

REduced Frequency ImmuNE Checkpoint Inhibition in Cancers

REduced Frequency ImmuNE Checkpoint Inhibition in Cancers: A Multi Arm Phase II Basket Protocol Testing Reduced Intensity Immunotherapy Across Different Cancers

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The REFINE trial aims to asses whether giving an immunotherapy drug less-often to patients with advanced cancer, results in fewer side effects whilst continuing to be an effective treatment. The question will be assessed in different tumour types by means of different cohorts within an overarching trial protocol.

Detailed description

In stage I eligible participants will be randomly assigned to either the standard interval (either 4 or 6 weeks) or the extended interval (either 8 or 12 weeks) following an initial 12 weeks of standard of care immunotherapy. Disease recurrence and survival will be assessed, along with quality of life and health economic outcomes. The trial includes a feasibility outcome by which recruitment feasibility will be assessed. Immunotherapy drugs are a standard treatment option for advanced kidney cancer, melanoma, and some lung cancers. These drugs work by stimulating the body's own immune system to fight against cancer cells. Clinical trials have proven the effectiveness of immunotherapy drugs, such as ipilimumab, nivolumab or pembrolizumab, in the treatment of different cancers. However the best way to give these drugs is not known.

Conditions

• Renal Cell Carcinoma
• Melanoma

Interventions

Type	Name	Description
DRUG	Nivolumab	60-minute IV infusion, as a flat dose of 480mg
DRUG	Pembrolizumab	60-minute IV infusion, as a flat dose of 400mg

Timeline

• Start date: 2022-05-26
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2021-06-04
• Last updated: 2022-09-21

Locations

3 sites across 1 country: United Kingdom