Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program

NCT07562347 | Not Yet Recruiting

• 1 other identifier: NIS/2025/40
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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 (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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From first dose through up to 6 months follow-up

Secondary Outcomes (5)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  From first dose through up to 6 months follow-up

• Incidence of Grade ≥3 AEs

  From first dose through up to 6 months follow-up

• Incidence of Serious Adverse Events (SAEs)

  From first dose through up to 6 months follow-up

• Incidence of immune-related adverse events (irAEs)

  From first dose through up to 6 months follow-up

• Treatment discontinuation due to AEs

  From first dose through up to 6 months follow-up

Study Arms (1)

Envafolimab (200mg/ml)

Drug: Envafolimab

Interventions

Envafolimab DRUG

In this study, there is no active intervention because it is an observational, non-interventional study.

Envafolimab (200mg/ml)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• IR INNOVATE RESEARCH PRIVATE LIMITED: lead
• Glenmark Pharmaceuticals Ltd. India: collaborator

MeSH Terms

Interventions

envafolimab

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04