Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program (ENCOMPASS STUD)
2026年4月24日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (推定)
120
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Envafolimab (200mg/ml)
|
In this study, there is no active intervention because it is an observational, non-interventional study.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Disease Control Rate (DCR)
時間枠：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)
時間枠：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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (TEAEs)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月1日
一次修了 (推定)
2027年1月1日
研究の完了 (推定)
2027年10月1日
試験登録日
最初に提出
2026年4月24日
QC基準を満たした最初の提出物
2026年4月24日
最初の投稿 (実際)
2026年5月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月1日
QC基準を満たした最後の更新が送信されました
2026年4月24日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NIS/2025/40 (その他の識別子：Glenmark Pharmaceuticals Ltd.)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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