Cryoablation Combined With Tislelizumab Plus Lenvatinib in Patients With Melanoma Liver Metastasis

NCT05406466 | Unknown Phase 2

• 1 other identifier: CASTLE-05
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Tislelizumab plus lenvatinib in patients with melanoma liver metastasis.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate according to RECIST 1.1

  max 24 months

Secondary Outcomes (6)

• DCR

  max 24 months

• DoR

  max 24 months

• TTR

  max 24 months

• PFS

  max 24 months

• OS

  max 24 months

Study Arms (1)

Cryoablation in combination with Tislelizumab plus lenvatinib

EXPERIMENTAL

Cryoablation treatment starts at day 0. Tislelizumab plus lenvatinib will be initiated on day 14 after cryoablation. Tislelizumab will be administered at 200 mg i.v. every 3 weeks plus a lenvatinib (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Drug: Tislelizumab; Drug: Lenvatinib; Drug: Cryoablation

Interventions

Tislelizumab DRUG

a PD-1 immune check inhibitor

Cryoablation in combination with Tislelizumab plus lenvatinib

Lenvatinib DRUG

multitargeted receptor tyrosine kinase inhibitor

Cryoablation in combination with Tislelizumab plus lenvatinib

Cryoablation DRUG

Cryoablation will be performed with a two-cycle freeze-thaw phase protocol; US or non-contrast CT images will be obtained to visualize the evolving ablation zone

Cryoablation in combination with Tislelizumab plus lenvatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained.
• Age ≥ 18 years at time of study entry.
• Participants must have melanoma liver metastasis.
• Participants must have failed 1 line of systemic regimens due to disease progression or toxicity.
• Participants who had received previous antiangiogenic therapy were eligible.
• At least one measurable site of disease as defined by RECIST criteria with spiral CT scan or MRI.
• Performance status (PS) ≤ 2 (ECOG scale).
• Life expectancy of at least 12 weeks.
• Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥75 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula )
• Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
• Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.

You may not qualify if:

• History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment
• Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
• Prior treatment with cryoablation.
• RFA and resection administered less then 4 weeks prior to study treatment start.
• Radiotherapy administered less then 4 weeks prior to study treatment start.
• Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.
• Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.
• Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).
• Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to:
• history of interstitial lung disease
• Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection)
• known acute or chronic pancreatitis
• active tuberculosis
• any other active infection (viral, fungal or bacterial) requiring systemic therapy
• history of allogeneic tissue/solid organ transplant

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

tislelizumab; lenvatinib; Cryosurgery

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Peng Wang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Wang, MD

CONTACT

86-21-64175590; wangp413@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 6, 2022
• Study Start: July 15, 2022
• Primary Completion: July 10, 2024
• Study Completion: August 16, 2024
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

CN (1)