Phase II Multicenter Study of Talimogene Laherparepvec in Classic or Endemic Kaposi Sarcoma (KAPVEC)
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|ClinicalTrials.gov Identifier: NCT04065152|
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Kaposi Sarcoma (KS) is a lymphangioproliferation associated with human herpes virus 8 (HHV8) promoted by immunosuppression. HIV-related KS and iatrogenic posttransplantation KS are treated by immune restoration, in association with local or systemic therapies as chemotherapies if required. Conversely in classic and endemic KS, the underlying relative immunosuppression cannot be directly targeted. Treatment is poorly codified, mostly based on surgery or radiotherapy for localized KS. Most aggressive forms with visceral involvement are treated with chemotherapies or interferon, which give at best 30-60% of transient responses and may not be well tolerated in elderly patients.
Talimogene laherparepvec is the first oncolytic immunotherapy approved by the FDA, in metastatic or unresectable melanoma with injectable nodal or cutaneous lesions. It is designed to induce tumor regression of injected lesions through direct lytic effects, and of uninjected lesions through induction of systemic antitumor immunity.
In Merkel cell carcinoma (MCC), another virus-induced tumor, treatment with PD-1/PD-L1 axis inhibitors have proven efficacy, thus providing a proof of principle that immunotherapy could be effective in virus-induced tumors. Two cases of metastatic MCC successfully treated with talimogene laherparepvec were recently reported, suggesting that talimogene laherparepvec may also be an effective therapeutic option. Considering the high immunogenicity of viral epitopes in KS tumors, the role of the immune evasion in the development of KS, and the cutaneous manifestations (>90% of patients) that can be easily injected, classic and endemic KS is a good tumor model to be targeted with talimogene laherparepvec. The main objective is to assess whether talimogene laherparepvec is clinically inactive (partial+complete response probability π0<10%) or truly active (partial+complete response probability π1>40%) in classic and endemic Kaposi sarcoma.
|Condition or disease||Intervention/treatment||Phase|
|Kaposi Sarcoma||Drug: Talimogene laherparepvec||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Multicenter Study of Talimogene Laherparepvec in Classic or Endemic Kaposi Sarcoma - KAPVEC|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||March 1, 2022|
Experimental: oncolytic immunotherapy
Talimogene laherparepvec Dose: 10^6 pfu/ml at week 1 then 10^8/ml at week 4 and every 2 weeks (up to 4ml for each injection) Route: intralesional injection Duration of treatment: 6 months (12 cycles)
Drug: Talimogene laherparepvec
- Best overall response [ Time Frame: 6 months ]
Best overall response rate (BORR) defined by the occurrence of complete response or partial response of the injected lesions following PGA criteria (PGA 0 to 4) recorded from the start of treatment until 6 months or the beginning of any other specific therapy for Kaposi sarcoma if it occurs before 6 months.
Score and category Description 0: completely clear Complete relief of symptoms; 100% of improvement
- almost clear Marked improvement of all clinical symptoms as compared with baseline with residual signs (≥90% and <100%)
- marked improvement Significant improvement of symptoms (≥75% and <90%)
- moderate improvement Moderate improvement between score 2 and 4.
- slight improvement Improvement of signs and symptoms as compared with baseline (<50% and ≥25%) but remaining signs of active KS
- no change Clinical signs and symptoms unchanged from baseline (+-25%)
- worse Clinical signs and symptoms deteriorated from baseline (≥25% of deterioration)
- Overall survival [ Time Frame: 6 months ]delay between inclusion and death from any cause
- Best overall response M3 [ Time Frame: 3 months ]Best overall response rate (BORR) defined by the occurrence of complete response or partial response of the injected lesions following PGA criteria (PGA 0 to 4) recorded from the start of treatment until 6 months or the beginning of any other specific therapy for Kaposi sarcoma if it occurs before 3 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065152
|Contact: Julie Delyon, MD PhD||142385311 ext +email@example.com|
|Contact: Matthieu RESCHE-RIGON, MD PhD||142499742 ext +firstname.lastname@example.org|