Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program (ENCOMPASS STUD)

April 24, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  1. Adult patients (≥ 18 years) who received at least one dose of Envafolimab under the NPP between June, 2025 and Dec 31, 2026.
  2. 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).
  3. 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).
  4. 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).
  5. 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.
  6. 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:

  1. No evidence of Envafolimab administration: Patients for whom Envafolimab was requested or planned under NPP but never actually received a dose.
  2. 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.)
  3. 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.
  4. 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).
  5. 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.
  6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Envafolimab (200mg/ml)
Drug: Envafolimab
In this study, there is no active intervention because it is an observational, non-interventional study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IR INNOVATE RESEARCH PRIVATE LIMITED

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Glenmark Pharmaceuticals Ltd. India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIS/2025/40 (Other Identifier: Glenmark Pharmaceuticals Ltd.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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