転移性黒色腫および肝転移に対するHepzatoキットとOpdualag
転移性メラノーマおよび肝転移を有する患者におけるメルファラン経皮的肝灌流療法（HEPZATO KIT™）とニボルマブおよびレラトリマブ（Opdualag）の安全性、忍容性、および予備的有効性を評価する第1b/2相試験
This study is being done to see if combining HEPZATO KIT™ with nivolumab and relatlimab (Opdualag™) in patients with metastatic melanoma with liver metastasis is safe, tolerable, and will have a synergistic effect leading to improved clinical outcomes compared to the historic cohort of patients with liver metastasis treated with combination immune checkpoint inhibitor therapy.
調査の概要
詳細な説明
Co-Primary Objectives
- To evaluate the safety and tolerability of HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™) in subjects with metastatic melanoma and liver metastasis (LM).
- To evaluate the preliminary systemic efficacy of HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™), as measured by objective response rate (ORR), in subjects with metastatic melanoma and LM.
Secondary Objectives
- To evaluate the preliminary systemic efficacy of HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™), as measured by ORR, in both hepatic and non-hepatic target lesions in subjects with metastatic melanoma and LM.
- To evaluate the disease control rate (DCR) in subjects with metastatic melanoma and LM receiving HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™).
- To evaluate the PFS in subjects with metastatic melanoma and LM receiving HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™).
- To evaluate the overall survival (OS) in subjects with metastatic melanoma and LM receiving HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™).
- To evaluate the duration of response (DOR) in subjects with metastatic melanoma and LM receiving HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™).
- To evaluate the tumor reduction at any time during treatment in subjects with metastatic melanoma and LM receiving HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™).
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Cancer Connect
- 電話番号：800-622-8922
- メール：clinicaltrials@cancer.wisc.edu
研究場所
-
-
Wisconsin
-
Madison、Wisconsin、アメリカ、53792
- 募集
- UW Hospital and Clinics
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic melanoma with liver metastasis (LM). Liver biopsy positive for presence of melanoma metastases is required.
- 0-1 line of prior systemic therapy in the unresectable/metastatic setting - prior adjuvant anti-programmed cell death-1 (anti-PD-1) or BRAF/MEK targeted therapy is considered 1 line of prior systemic therapy if less than 6 months from the last treatment.
- Evaluable/measurable disease according to RECIST v1.1.
- Demonstrate adequate organ function; all screening labs to be obtained within 28 days prior to registration.
- Patients must weigh greater than or equal to 35 kilograms (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System).
Exclusion Criteria:
- Prior treatment with HEPZATO KIT™ or nivolumab and relatlimab (Opdualag™)
- Radiotherapy is permitted within 30 days prior to C1D1 as long as radiation is given with palliative intent and towards a non-target lesion.
- History of hypersensitivity or treatment discontinuation due to grade 3+ immune-related adverse events (irAEs) from prior anti-PD-(L)1 therapy. Patients who are able to successfully resume immune checkpoint therapy without recurrence of grade 3 irAEs are eligible to participate.
- Symptomatic or uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation.
- Prednisone use greater than or equal to 10 mg/d or equivalent
- Organ transplant recipients
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：転移性黒色腫の参加者
|
Relatlimab is a human IgG4 LAG-3 blocking antibody. Nivolumab is a human IgG4 PD-1 blocking antibody. Nivolumab 480 mg and relatlimab 160 mg in a fixed-dose combination will be administered on Day 1 of each 28-day cycle that the participant is on treatment and will be given for up to 2 years from start of treatment.
他の名前：
The recommended HEPZATO dose is 3 mg/kg based on ideal body weight (IBW), infusion every 6 to 8 weeks for up to 2 total infusions
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
治療関連有害事象の発生率
時間枠：最大2年間
|
最大2年間
|
|
|
重篤な治療関連有害事象の発現率
時間枠：最長2年間
|
最長2年間
|
|
|
有害事象による治療中止参加者数
時間枠：最大2年間
|
最大2年間
|
|
|
Incidence and Severity of Dose Limiting Toxicities (DLTs)
時間枠：up to 12 weeks
|
A DLT is defined as any grade 4+ non-hematologic event lasting greater than 3 days (despite appropriate medical management) considered possibly related to study treatment (HEPZATO KIT™ or Opdualag™) within 12 weeks of Cycle 1 Day 1. |
up to 12 weeks
|
|
Overall Response Rate (ORR)
時間枠：After treatment plus follow up for 2 years (up to 4 years)
|
The objective response rate is the proportion of all participants with confirmed Partial Response (PR) or Complete Response (CR) according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). |
After treatment plus follow up for 2 years (up to 4 years)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
いずれかの時点で腫瘍縮小が見られた参加者数
時間枠：治療後2年間（最大4年間）の追跡調査を加えて
|
治療後2年間（最大4年間）の追跡調査を加えて
|
|
|
ORR in Hepatic and Non-Hepatic Lesions
時間枠：After treatment plus follow up for 2 years (up to 4 years)
|
The proportion of all participants with confirmed PR or CR according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment) in Hepatic and Non-Hepatic Target Lesions. |
After treatment plus follow up for 2 years (up to 4 years)
|
|
Disease Control Rate (DCR)
時間枠：After treatment plus follow up for 2 years (up to 4 years)
|
The disease control rate is the proportion of all subjects with SD for 8 weeks, or PR, or CR according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). |
After treatment plus follow up for 2 years (up to 4 years)
|
|
Progression Free Survival (PFS)
時間枠：After treatment plus follow up for 2 years (up to 4 years)
|
A measurement from the date of randomization until the criteria for disease progression is met as defined by RECIST 1.1 or death occurs. Participants who have not progressed will be right-censored at the date of the last disease evaluation. |
After treatment plus follow up for 2 years (up to 4 years)
|
|
Overall Survival (OS)
時間枠：After treatment plus follow up for 2 years (up to 4 years)
|
Overall survival is defined by the date of randomization to date of death from any cause. |
After treatment plus follow up for 2 years (up to 4 years)
|
|
Duration of Response (DOR)
時間枠：After treatment plus follow up for 2 years (up to 4 years)
|
Duration of overall response-the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started). |
After treatment plus follow up for 2 years (up to 4 years)
|
協力者と研究者
捜査官
- 主任研究者：Vincent Ma, MD、UW Carbone Cancer Center
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2025-1424
- SMPH/MEDICINE/HEM-ONC (その他の識別子：UW Madison)
- UW25072 (その他の識別子：OnCore ID)
- Protocol Version 6/23/26 (その他の識別子：UW Madison)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Researchers must have local IRB approval for their study that is to include study of the biospecimens and accompanying data. Release of biospecimens to non-UW researchers will be performed according to all UW regulatory policies. Tissue (including blood) specimen as part of this research will be primarily stored at UW and may be sent to an outside lab/facility to achieve the objectives of the study. No study data or patient health information will be shared with a third party.
IPD 共有アクセス基準
Researchers who are doing biomedical research may apply to the PI for access to blood and tissue (no patient identifiers on tubes or slides). Only de-identified information will be released with the specimens
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。