Advanced Solid TumorENCOMPASS STUDNCT07562347
Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program
An observational study of Advanced Solid Tumor, run by IR INNOVATE RESEARCH PRIVATE LIMITED at 4 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Envafolimab
- How many people
- 120 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 7 Aug 2026to Oct 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Philippines2 sites, 2 recruiting
- Not yet recruiting
The Medical City South Luzon and Calamba Medical Center
Laguna
Dr. Nick Radovan
- Not yet recruiting
St. Luke's Quezon City and National Kidney Transplant Institute
Quezon City
devesh.kumar@innovate-research.com
Dr. Gloria Luna
Kenya1 site, 1 recruiting
- Recruiting
Nairobi South Hospital
Nairobi
Research, devesh.kumar@innovate-research.com
Dr Calvin Abuya
Mauritius1 site, 1 recruiting
- Not yet recruiting
C-Care Darny
Floréal
Dr. Sohawon Mohammad Sahiboullah
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- Envafolimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnvafolimabDrug
In this study, there is no active intervention because it is an observational, non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Envafolimab (200mg/ml) | Not described Receives: Drug: Envafolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate (DCR)
: 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.
Measured: From first dose through up to 6 months follow-up
Progression-Free Survival (PFS)
: 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.
Measured: From first dose through up to 6 months follow-up
Overall Survival (OS)
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.
Measured: From first dose through up to 6 months follow-up
Secondary outcomes (5)
Incidence of Treatment-Emergent Adverse Events (TEAEs)
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.
Measured: From first dose through up to 6 months follow-up
Incidence of Grade ≥3 AEs
The frequency of patients who experienced severe or lifethreatening adverse events (Grade 3 or higher, as per CTCAE v5.0) during Envafolimab treatment.
Measured: From first dose through up to 6 months follow-up
Incidence of Serious Adverse Events (SAEs)
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.
Measured: From first dose through up to 6 months follow-up
Incidence of immune-related adverse events (irAEs)
The proportion of patients who experienced immune-mediated toxicities (e.g., autoimmune manifestations such as pneumonitis, colitis, etc.) attributed to Envafolimab.
Measured: From first dose through up to 6 months follow-up
Treatment discontinuation due to AEs
The percentage of patients who had Envafolimab therapy permanently stopped as a result of adverse events.
Measured: From first dose through up to 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start7 Aug 2026
- Primary completionJan 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- IR INNOVATE RESEARCH PRIVATE LIMITED
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Glenmark Pharmaceuticals Ltd. India
- Responsible party
- Sponsor
- Investigators
- ENCOMPASS, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562347
- Sponsor's protocol ID
- NIS/2025/40
- Other IDs
- NIS/2025/40
- Acronym
- ENCOMPASS STUD
- Status last verified
- Nov 2026
- First submitted
- 24 Apr 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Observational, Non-interventional Outcomes From a Multi-country Named Patient Access Program (ENCOMPASS STUDY)
- ClinicalTrials.gov ID
- NCT07562347
- Acronym / sponsor ID
- ENCOMPASS STUD / NIS/2025/40
- Conditions
- Advanced Solid Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- IR INNOVATE RESEARCH PRIVATE LIMITEDIndustry (pharma, biotech, devices)
- Collaborators
- Glenmark Pharmaceuticals Ltd. India
- Study start
- 7 Aug 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Envafolimab (200mg/ml) | – | Drug: Envafolimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnvafolimabIn this study, there is no active intervention because it is an observational, non-interventional study. | Drug | Envafolimab (200mg/ml) |
Primary outcome
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.
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.
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.
5 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 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
Incidence of Serious Adverse Events (SAEs)
Time frame: 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
Treatment discontinuation due to AEs
Time frame: From first dose through up to 6 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ENCOMPASS study director
Director
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Solid Tumor, run by IR INNOVATE RESEARCH PRIVATE LIMITED at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Philippines, Kenya, Mauritius. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr.Devesh Kumar, Doctor (+91-9971169602, devesh.kumar@innovate-research.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate (DCR) (time frame: From first dose through up to 6 months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.