Efficacy Study of TLN-232 in Patients With Recurring Metastatic Melanoma

Study Overview
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Brief Summary
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The objective of this study is to assess the efficacy and safety of TLN-232 used to treat patients with metastatic melanoma that recur/progress after receiving first line systemic therapy.

Official Title
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A Phase IIa Study of TLN-232 as Second-line Therapy for Patients With Metastatic Melanoma

Conditions
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Melanoma

Intervention / Treatment
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* Drug: TLN-232


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed stage IV (M1a, M1b, and M1c) unresectable metastatic melanoma (cutaneous, mucosal or acral lentiginous) First progression after treatment by one first line systemic therapy for metastatic melanoma (immunotherapy or targeted therapy or chemotherapy or any combination of them) Measurable recurrent/progressive disease by radiological scan ≤ 21 days prior to Day 1, Cycle 1 Age ≥ 18 years ECOG ≤ 2 Normal organ and marrow function as defined below: Leukocytes ≥2.5 x 109/L Absolute neutrophil count ≥1.5 x 109/L Platelets ≥100 x 109/L Hemoglobin ≥100 g/L (10g/dL) Total bilirubin ≤1.5 X institutional ULN AST(SGOT)/ALT(SGPT) ≤2.5 X institutional ULN Creatinine ≤1.5 X institutional ULN Exclusion Criteria: Patients with a life expectancy ≤ 16 weeks Patients with ocular melanoma Patients with symptomatic and/or unstable brain metastasis during the last 3 months (90 days) prior to Day 1, Cycle 1 Patients with a history of allergic reactions or hypersensitivity to somatostatin analogues Patients with a documented history of HIV, active hepatitis B or C infection Female patients who are pregnant or lactating Patients who are receiving hormonal therapy (with the exception of hormone replacement therapy and hormonal contraceptives), systemic steroids, immunosuppressive therapy or coumadin (low molecular weight heparin is permitted) Patients with grade ≥2 peripheral neuropathy (CTCAE criteria) Patients in whom a proper central line cannot be established

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-Arm<br> | Drug: TLN-232<br>* 21 day continuous IV administration of TLN-232 followed by a 7-day recovery period<br>* Other names: Formerly CAP-232;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of TLN-232 in patients with recurrent metastatic melanoma measured by overall response rate at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1). |  | Complete response, partial response or stable disease at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the safety and tolerability of TLN-232 in patients with recurrent metastatic melanoma |  | Maximum 13 months from date of initial infusion of TLN-232 (Day 1, Cycle 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma, Metastatic Melanoma, Phase II, Skin Cancer