NCT05572463

A Platform Study of Novel Immunotherapy Products in Participants With Previously Treated Unresectable or Metastatic Cutaneous Melanoma

A Randomized, Open-label, Multicenter, Multi-arm, Phase 1b/2 Platform Study to Evaluate Safety and Efficacy of Investigational Immunotherapies in Participants With Previously Treated Unresectable or Metastatic Melanoma

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a platform study evaluating the safety and efficacy of multiple novel investigational products (IPs) that target unresectable or metastatic cutaneous melanoma in participants who have failed standard treatment.

Detailed description

This is a Phase 1b/2, randomized, open label, multicenter, platform study evaluating the safety and efficacy of multiple novel investigational products (IPs) that target mechanisms implicated in resistance to immunotherapy in participants with unresectable or metastatic cutaneous melanoma who have resistance to anti-PD-1/L1 agents. This study will include multiple treatment arms that can be added sequentially or in parallel. Each arm consists of a selection and expansion part. The selection part is used for evaluation of safety and preliminary efficacy in each arm. The selection part may also include a safety run-in portion for preliminary safety evaluation and dose confirmation prior to proceeding. If the criteria for safety and preliminary efficacy are met, the arm will open for additional enrollment in an expansion phase.

Conditions

• Unresectable Cutaneous Melanoma
• Metastatic Cutaneous Melanoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Sintilimab + IBI110	IBI110 infusion in combination with Sintilimab (IBI308) infusion will be given on a Q3W schedule

Timeline

• Start date: 2022-11-01
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2022-10-07
• Last updated: 2022-11-18

Locations

13 sites across 7 countries: United States, Australia, France, Germany, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study