Sac-TMT in Vaginal and Vulvar Cancers
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLatin American Cooperative Oncology Group
About this trial
The ARCANA trial (LACOG 1724) is a single-arm, non-randomized, multi-center, parallel, two-cohort Phase II clinical study designed to evaluate the efficacy and safety of sacituzumab tirumotecan (sac-TMT, MK-2870) as a second-line or subsequent treatment in patients with advanced or metastatic vaginal and vulvar squamous cell carcinomas. Given the rarity of these cancers and the lack of standard second-line therapies, this study explores sac-TMT, a novel TROP-2-directed antibody-drug conjugate (ADC). TROP-2 is highly expressed in both vulvar and vaginal squamous cell carcinomas, making it a promising therapeutic target.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has a histologically- or cytologically confirmed diagnosis of squamous cell carcinoma of vagina (cohort A) or vulvar (cohort B) origin
Advanced disease, defined as presence of metastatic disease or locally advanced disease not amenable to curative therapy in the opinion of the investigator
Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously-irradiated area are considered measurable if progression has been shown in such lesions.
Has received up to 2 prior lines of systemic therapy. Disease progression to first-line or second-line platinum-based chemotherapy for locally advanced/metastatic disease. Previous anti-PD-1/anti-PD-L1 therapy is allowed. Disease progression within 6 months of (neo) adjuvant chemotherapy completion is considered first-line of therapy. The participant may have received prior radiation with or without radio-sensitizing chemotherapy at least >2 weeks before the start of study treatment.
Disqualifiers
Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention. Prior/Concomitant Therapy
Received prior treatment with a TROP2-targeted ADC.
Received prior treatment with a topoisomerase 1 inhibitor-containing ADC.
Trial design
Design model
Parallel
Treatments tested in this trial
Sacituzumab Tirumotecan (sac-TMT)
DrugSacituzumab tirumotecan is a TROP-2-directed antibody-drug conjugate (ADC) consisting of a humanized anti-TROP2 IgG1 monoclonal antibody linked to a topoisomerase 1 inhibitor payload (KL610023). It will be administered intravenously at a dose of $4\\text{ mg/kg}$ on Days 1 and 15 of every 28-day cycle until disease progression, unacceptable toxicity, or up to a maximum duration of approximately 2 years.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Cohort A: Vaginal CancerExperimental treatment 1 intervention
Group B: Cohort B: Vulvar CancerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR) by Investigator Assessment
Proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by local site investigator/radiology.
Time frame
Up to Week 24Secondary outcomes
1
Objective Response Rate by Independent Central Review (ORR-ICR)
Proportion of participants achieving complete response (CR) or partial response (PR) as evaluated by Independent Central Review using RECIST v1.1 criteria.
Time frame
Up to 24 weeks.2
Disease Control Rate (DCR)
Proportion of participants achieving a best overall response of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1 by investigator assessment..
Time frame
Up to 24 weeks.3
Duration of Response (DoR)
Time from the first documented evidence of complete response (CR) or partial response (PR) until the date of first documented disease progression or death due to any cause, whichever occurs first.
Time frame
Up to approximately 40 months.4
Progression-Free Survival (PFS)
Time from the date of enrollment until the date of first documented disease progression (radiographically or clinically confirmed per RECIST 1.1) by investigator assessment, or death due to any cause, whichever occurs first.
Time frame
Up to approximately 40 months.Sponsors and contacts
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Source ClinicalTrials.gov
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