Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program (ENCOMPASS STUD)
24 aprile 2026 aggiornato da: IR INNOVATE RESEARCH PRIVATE LIMITED
Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Observational, Non-interventional Outcomes From a Multi-country Named Patient Access Program (ENCOMPASS STUDY)
Envafolimab is a novel PD-L1 inhibitor administered via subcutaneous (SC) injection - notably the first such checkpoint inhibitor approved for use worldwide.[1]
In November 2021, Envafolimab received its first approval in China for adults with advanced microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) solid tumors that have progressed after standard therapies.
This SC route offers substantial practical advantages, significantly shortening treatment administration time and sparing patients from the adverse effects associated with intravenous infusions.
Early clinical trials have demonstrated that Envafolimab can induce durable tumor responses, with objective response rates ~45% (including ~12% complete responses) observed in dMMR/MSI-H cancers.
The therapy has also shown a favorable tolerability profile, with no infusion-related reactions and low rates of severe immune-mediated adverse events reported in initial studies.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The ENCOMPASS Study, designed to evaluate the real-world safety and effectiveness of Envafolimab in patients with advanced solid tumors.
It is an observational, non-interventional, multicenter study sponsored by Glenmark Pharmaceuticals and will collect retrospective patient data from five countries: Kenya, Mauritius, Saudi Arabia, Philippines, and Sri Lanka.
Approximately 120 adult patients treated under the Named Patient Program between June 2025 and December 2026 will be included.
The primary endpoints focus on treatment effectiveness through Objective Response Rate (ORR), Disease Control Rate (DCR), Progression-Free Survival (PFS), and Overall Survival (OS).
Secondary endpoints assess safety outcomes such as adverse events, serious adverse events, immune-related toxicities, and treatment discontinuation.
Data will be gathered from anonymized medical records using electronic case report forms without any direct patient intervention.
Statistical analysis will mainly be descriptive, with Kaplan-Meier methods used for survival outcomes.
The study aims to generate evidence on Envafolimab use in non-Chinese populations where limited data currently exist.
Ethical approvals, patient confidentiality, and regulatory compliance will be strictly maintained throughout the study.
Tipo di studio
Osservativo
Iscrizione (Stimato)
120
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
The study population comprises adult cancer patients (aged ≥18 years) who were treated with Envafolimab through the NPP during the defined study period across the five countries.
Descrizione
Inclusion Criteria:
- Adult patients (≥ 18 years) who received at least one dose of Envafolimab under the NPP between June, 2025 and Dec 31, 2026.
- Histologically or cytologically confirmed diagnosis of a malignancy for which Envafolimab was prescribed under the NPP (e.g., an advanced solid tumor with MSI-H/dMMR or other approved/compassionate indications).
- Measurable or evaluable disease at baseline, with at least one disease assessment (e.g. imaging or clinical evaluation) performed within 8 weeks before the first Envafolimab dose (to establish baseline tumor status).
- At least one post-baseline disease assessment after starting Envafolimab, and a minimum follow-up duration of 6 months from the first dose (unless the patient has documented disease progression or died within 6 months).
- Availability of sufficient clinical data in the medical records to evaluate baseline characteristics, treatment administration, tumor response, and safety outcomes. This includes baseline demographics, disease status, treatment dates, and follow-up assessments as required by the CRF.
- Permission/approval for data use: Patient data can be utilized for research as per local ethical and regulatory requirements (e.g., institutional review board approval or waiver of consent for retrospective data collection, and compliance with data privacy laws).
Exclusion Criteria:
- No evidence of Envafolimab administration: Patients for whom Envafolimab was requested or planned under NPP but never actually received a dose.
- Insufficient follow-up: Patients with no post-baseline tumor assessment and less than 6 months of follow-up without documented disease progression or death. (Such patients would not contribute evaluable data for effectiveness.)
- Missing critical baseline information in records, such as unknown index (start) date of Envafolimab therapy or lack of documented cancer diagnosis, precluding assessment of outcomes.
- Prior Envafolimab exposure outside the NPP (e.g., via a clinical trial or other program) before the index date, unless specifically allowed (pre-specified exceptions, if any, will be outlined for instance, patients who switched from a clinical trial to NPP might be handled on a case by case basis).
- Concurrent participation in any other interventional clinical trial at the time of starting Envafolimab (index date), to avoid confounding effects of other investigational treatments on outcomes.
- Legal or ethical prohibitions on using the patient's data for research. For example, if local regulations or the patient's prior consent status prevent inclusion of their de-identified data in this study, they will not be enrolled.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Envafolimab (200mg/ml)
|
In this study, there is no active intervention because it is an observational, non-interventional study.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Disease Control Rate (DCR)
Lasso di tempo: From first dose through up to 6 months follow-up
|
: The proportion of patients who achieve CR, PR, or Stable Disease (SD) as the best response.
DCR provides a measure of the fraction of patients who derive any tumor control (no progression) from the therapy.
|
From first dose through up to 6 months follow-up
|
|
Progression-Free Survival (PFS)
Lasso di tempo: From first dose through up to 6 months follow-up
|
: Defined as the time from first Envafolimab dose to the first occurrence of disease progression or death from any cause, whichever occurs first.
PFS for each patient (in months) will be calculated based on dates recorded in the CRF.
Patients without documented progression who are alive at the last follow-up will be censored at the date of the previous disease assessment.
|
From first dose through up to 6 months follow-up
|
|
Overall Survival (OS)
Lasso di tempo: From first dose through up to 6 months follow-up
|
Defined as the time from first Envafolimab dose to death from any cause.
OS (in months) will be determined for each patient; living patients will be censored at the date of last contact or last known alive date.
|
From first dose through up to 6 months follow-up
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Lasso di tempo: From first dose through up to 6 months follow-up
|
The proportion of patients experiencing any adverse event (of any grade) during the observation period after starting Envafolimab.
This will be captured by whether "Any Adverse Events reported" is marked on the CRF.
|
From first dose through up to 6 months follow-up
|
|
Incidence of Grade ≥3 AEs
Lasso di tempo: From first dose through up to 6 months follow-up
|
The frequency of patients who experienced severe or lifethreatening adverse events (Grade 3 or higher, as per CTCAE v5.0) during Envafolimab treatment.
|
From first dose through up to 6 months follow-up
|
|
Incidence of Serious Adverse Events (SAEs)
Lasso di tempo: From first dose through up to 6 months follow-up
|
The proportion of patients with any serious adverse event (as defined by standard criteria: results in death, is life-threatening, requires/prolongs hospitalization, or other medically important events) reported during treatment.
|
From first dose through up to 6 months follow-up
|
|
Incidence of immune-related adverse events (irAEs)
Lasso di tempo: From first dose through up to 6 months follow-up
|
The proportion of patients who experienced immune-mediated toxicities (e.g., autoimmune manifestations such as pneumonitis, colitis, etc.) attributed to Envafolimab.
|
From first dose through up to 6 months follow-up
|
|
Treatment discontinuation due to AEs
Lasso di tempo: From first dose through up to 6 months follow-up
|
The percentage of patients who had Envafolimab therapy permanently stopped as a result of adverse events.
|
From first dose through up to 6 months follow-up
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 maggio 2026
Completamento primario (Stimato)
1 gennaio 2027
Completamento dello studio (Stimato)
1 ottobre 2027
Date di iscrizione allo studio
Primo inviato
24 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
24 aprile 2026
Primo Inserito (Effettivo)
1 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
1 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 aprile 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NIS/2025/40 (Altro identificatore: Glenmark Pharmaceuticals Ltd.)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .