Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma

Summary

Primary Objective: To evaluate the effectiveness of Thymosin Alpha-1 combined with PD-1 monoclonal antibody in elderly patients with advanced melanoma . Secondary Objective: To evaluate the safety and tolerability of adenpeptide-α1 combined with PD-1 antibody in elderly patients with advanced melanoma . Study Design：Open-label, single-arm, non-controlled clinical trial. Primary Inclusion Criteria: 1. Age ≥60 years old; 2. Pathologically confirmed as inoperable or metastatic melanoma; 3. one or more lesions evaluable by RECIST1.1 standards. 4. The Eastern Cooperative Oncology Group (ECOG) scoring system in the United States scores from 0-2; Main exclusion criteria: 1. Received treatment with a regimen containing PD-1, PD-L1, or CTLA-4 antibodies within the past 6 months; 2. Received thymosin class drug treatment within 3 months before signing the informed consent. 3. Symptomatic, untreated central nervous system metastases. Treatment： Thymosin Alpha 1 1.6mg, sc，QD，d1-7;1.6mg, sc， three times per week, d8-21. Each 21 days is considered one cycle, for a total of 12 weeks. Anti-PD-1 monoclonal antibody (Toripalimab) 240mg per dose,ivdrip，Q3W，4 cycles. Primary study endpoints: Objective Response Rate (ORR: CR+PR) Secondary study endpoints: Progression-Free Survival (PFS), Duration of Response (DOR), Overall Survival (OS) Adverse Events (AEs)

Timeline

Start

2023-05-30

Primary completion

2027-05-30

Completion

2027-09-30

Publications

• Results Garaci E, Pica F, Serafino A, Balestrieri E, Matteucci C, Moroni G, Sorrentino R, Zonfrillo M, Pierimarchi P, Sinibaldi-Vallebona P. Thymosin alpha1 and cancer: action on immune effector and tumor target cells. Ann N Y Acad Sci. 2012 Oct;1269:26-33. doi: 10.1111/j.1749-6632.2012.06697.x.
• Results Romani L, Bistoni F, Perruccio K, Montagnoli C, Gaziano R, Bozza S, Bonifazi P, Bistoni G, Rasi G, Velardi A, Fallarino F, Garaci E, Puccetti P. Thymosin alpha1 activates dendritic cell tryptophan catabolism and establishes a regulatory environment for balance of inflammation and tolerance. Blood. 2006 Oct 1;108(7):2265-74. doi: 10.1182/blood-2006-02-004762. Epub 2006 Jun 1.
• Results Maio M, Mackiewicz A, Testori A, Trefzer U, Ferraresi V, Jassem J, Garbe C, Lesimple T, Guillot B, Gascon P, Gilde K, Camerini R, Cognetti F; Thymosin Melanoma Investigation Group. Large randomized study of thymosin alpha 1, interferon alfa, or both in combination with dacarbazine in patients with metastatic melanoma. J Clin Oncol. 2010 Apr 1;28(10):1780-7. doi: 10.1200/JCO.2009.25.5208. Epub 2010 Mar 1.
• Results Giuliani C, Napolitano G, Mastino A, Di Vincenzo S, D'Agostini C, Grelli S, Bucci I, Singer DS, Kohn LD, Monaco F, Garaci E, Favalli C. Thymosin-alpha1 regulates MHC class I expression in FRTL-5 cells at transcriptional level. Eur J Immunol. 2000 Mar;30(3):778-86. doi: 10.1002/1521-4141(200003)30:33.0.CO;2-I.

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