A Study of IMM-101 in Combination With Checkpoint Inhibitor Therapy in Advanced Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03711188|
Recruitment Status : Completed
First Posted : October 18, 2018
Last Update Posted : April 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Nivolumab Drug: Ipilimumab Drug: IMM-101||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of the Safety and Efficacy of IMM-101 in Combination With Checkpoint Inhibitor Therapy in Patients With Advanced Melanoma|
|Actual Study Start Date :||October 4, 2018|
|Actual Primary Completion Date :||December 2, 2021|
|Actual Study Completion Date :||December 2, 2021|
Experimental: IMM-101 (and nivolumab or ipilimumab)
IMM-101 given in combination with nivolumab. Patients in cohort B who fail to respond to treatment with IMM-101 and nivolumab, and who meet certain criteria, have the option to change treatment on study to IMM-101 and ipilimumab.
Nivolumab is to be administered as a 3 mg/kg IV infusion every two weeks in accordance with the prescribing information.
Other Name: Opdivo
Ipilimumab, when used as subsequent treatment for patients in cohort B, is to be administered as a 3 mg/kg IV infusion over 90 minutes every three weeks for a maximum of 4 doses, in accordance with the prescribing information.
Other Name: Yervoy
A single 0.1 mL intradermal injection of IMM 101 (10 mg/mL) given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
- Overall Response Rate (ORR) using RECIST 1.1 [ Time Frame: 18 months ]ORR is calculated from Best Overall Response recorded during treatment with IMM-101 + nivolumab
- The profile of adverse events experienced [ Time Frame: 18 months ]
- Progression free survival (PFS) [ Time Frame: 18 months ]
- Overall survival (OS) [ Time Frame: Approximately 30 months ]
- Overall survival (OS) at one year [ Time Frame: 12 months ]
- Patients with values outside normal range and within normal range at post baseline assessments [ Time Frame: 18 months ]
- Local tolerability measured as injection site reactions [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711188
|St George's University Hospitals NHS Foundation Trust|
|London, United Kingdom, SW17 0QT|
|The Christie Hospital|
|Manchester, United Kingdom, M20 4BX|
|Principal Investigator:||Alberto Fusi||St George's University Hospitals NHS Foundation Trust|