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A phase 2, open label study to evaluate safety and clinical activity of balstilimab in monotherapy in patients with advanced/metastatic non-melanoma skin cancers (AGENONMELA).

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517380-22-00
Acronym
AGENONMELA
Enrollment
80
Registered
2024-11-11
Start date
2021-06-18
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced basal cell carcinoma not amenable to local therapy or after progression on at least one line of systemic therapy Advanced squamous cell carcinoma (basosquamous/metatypicus type) or other skin cancers not amenable to local therapy

Brief summary

Clinical benefit rate (CBR), defined as a stable disease (SD; partial response (PR) or complete response (CR) as determined by the investigator according to criteria –RECIST 1.1

Detailed description

Clinical benefit rate (CBR), defined as a stable disease (SD; partial response (PR) or complete response (CR) on two consecutive examinations >= 4 weeks apart, as determined by the investigator according to criteria ir - RECIST, Duration of Response (DoR), Progression free/Overall survival rate at 12 and 24 month, Incidence of and severity of AEs according to scale NCI CTCAE v 5.0. Changes in vital signs, physical findings, ECG/ECHO parameters, and clinical laboratory results, Change from day 1 in patient-reported outcomes (QLQ): : QLQ-C30, EQ-5D-3L, FACT-ICM, In patients +65 year old, Comprehensive Geriatric Assessment (CGA) will be performed at screening (SCR) and end of treatment (EOT)

Interventions

DRUGBalstilimab

Sponsors

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Clinical benefit rate (CBR), defined as a stable disease (SD; partial response (PR) or complete response (CR) as determined by the investigator according to criteria –RECIST 1.1

Secondary

MeasureTime frame
Clinical benefit rate (CBR), defined as a stable disease (SD; partial response (PR) or complete response (CR) on two consecutive examinations >= 4 weeks apart, as determined by the investigator according to criteria ir - RECIST, Duration of Response (DoR), Progression free/Overall survival rate at 12 and 24 month, Incidence of and severity of AEs according to scale NCI CTCAE v 5.0. Changes in vital signs, physical findings, ECG/ECHO parameters, and clinical laboratory results, Change from day 1 in patient-reported outcomes (QLQ): : QLQ-C30, EQ-5D-3L, FACT-ICM, In patients +65 year old, Comprehensive Geriatric Assessment (CGA) will be performed at screening (SCR) and end of treatment (EOT)

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026