A Study of IMM-101 in Combination With Checkpoint Inhibitor Therapy in Advanced Melanoma
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ClinicalTrials.gov Identifier: NCT03711188 |
Recruitment Status :
Completed
First Posted : October 18, 2018
Last Update Posted : April 7, 2022
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Tracking Information | |||||
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First Submitted Date ICMJE | October 4, 2018 | ||||
First Posted Date ICMJE | October 18, 2018 | ||||
Last Update Posted Date | April 7, 2022 | ||||
Actual Study Start Date ICMJE | October 4, 2018 | ||||
Actual Primary Completion Date | December 2, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of IMM-101 in Combination With Checkpoint Inhibitor Therapy in Advanced Melanoma | ||||
Official Title ICMJE | A Study of the Safety and Efficacy of IMM-101 in Combination With Checkpoint Inhibitor Therapy in Patients With Advanced Melanoma | ||||
Brief Summary | The purpose of this study is to assess the safety and efficacy of the combination of IMM-101 with nivolumab. | ||||
Detailed Description | This open-label study will assess the safety and efficacy of the combination of IMM-101 with nivolumab in patients with unresectable stage III, or stage IV melanoma who are either treatment-naive (cohort A) or whose disease has progressed during PD-1 blockade (cohort B). Ipilimumab may be used as a subsequent treatment in place of nivolumab alongside IMM-101 for patients in cohort B if their disease progresses on study. Eighteen patients will be enrolled into cohort A and 8 patients into cohort B. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Melanoma | ||||
Intervention ICMJE |
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Study Arms ICMJE | 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.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
16 | ||||
Original Estimated Enrollment ICMJE |
26 | ||||
Actual Study Completion Date ICMJE | December 2, 2021 | ||||
Actual Primary Completion Date | December 2, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
For cohort A, the following key inclusion criteria apply: 1. Patient is treatment-naive (i.e. no prior systemic anticancer therapy for unresectable or metastatic melanoma). For cohort B, the following key inclusion criteria apply: 1. Patient is either currently receiving treatment with an anti-PD-1 therapy (monotherapy or in combination with ipilimumab), for advanced melanoma and has progressive disease by RECIST 1.1 after 4 or more doses; or has previously received at least 4 doses of PD-1 targeted therapy, alone or in combination with ipilimumab, had disease progression by RECIST 1.1 during this therapy and has not received any further therapy for advanced melanoma. Key Exclusion Criteria:
For cohort A, patients meeting the following key criteria are also ineligible to participate in this study: 1. Patient has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-PD ligand-1 (PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) agent. For cohort B, patients meeting the following key criteria are also ineligible to participate in this study: 1. Patient has received more than one treatment regimen for advanced (stage III/IV) disease prior to their anti PD-1 therapy. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03711188 | ||||
Other Study ID Numbers ICMJE | IMM-101-015 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Immodulon Therapeutics Ltd | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Immodulon Therapeutics Ltd | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Immodulon Therapeutics Ltd | ||||
Verification Date | May 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |