EVM14 alone and with pembrolizumab for selected advanced solid tumors

A Phase I/IIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Solid Tumors

This trial tests whether the cancer vaccine EVM14, given by muscle injection alone or together with pembrolizumab, is safe and provokes an immune response in people with selected advanced solid tumors.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 94 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Everest Medicines (China) Co.,Ltd. (industry)
• Drugs / interventions: prednisone, pembrolizumab
• Locations: 7 sites (New York, New York and 6 other locations)
• Trial ID: NCT07095868 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, open-label, multiregional Phase I/Phase IIa trial that gives EVM14 intramuscularly either as monotherapy or combined with pembrolizumab. Phase I will enroll monotherapy and combination cohorts to define safety, tolerability, immunogenicity, and preliminary signs of efficacy and to select a dose for Phase IIa. In Phase IIa the selected EVM14 dose will be tested with pembrolizumab to further characterize safety, immune response, and early clinical activity. Eligible participants have pathologically confirmed unresectable, recurrent, or metastatic selected solid tumors with at least one measurable lesion per RECIST v1.1 and ECOG 0–1.

Who should consider this trial

Good fit: Adults with pathologically confirmed unresectable, recurrent, or metastatic selected solid tumors, at least one measurable lesion per RECIST v1.1, ECOG performance status 0–1, adequate organ function, and life expectancy of three months or more.

Not a fit: Patients whose disease is amenable to curative local therapy, those with recent additional malignancies within five years, poor performance status, or inadequate organ function are unlikely to benefit or be eligible for this trial.

Why it matters

Potential benefit: If successful, this approach could provide a new immunotherapy option that stimulates tumor-directed immune responses and may improve disease control when combined with pembrolizumab.

How similar studies have performed: Other cancer vaccines combined with checkpoint inhibitors have produced promising immune responses and occasional clinical benefit in some settings, but results have been mixed and this specific vaccine is being tested in humans for the first time.

Eligibility criteria

Inclusion Criteria:

1. Selected types of solid tumor that are pathologically confirmed unresectable advanced, recurrent, or metastatic.
2. Patients with at least 1 evaluable lesion assessed by Investigators within 28 days prior to the first dose of study treatment as defined per RECIST v1.1.
3. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 at Screening.
4. Life expectancy ≥ 3 months.
5. Patients must have adequate organ function.
6. At screening, patients must agree to provide, if available, tumor tissue for biomarker analysis. When archival tumor tissue is not available, it is optional for the patient to undergo a fresh biopsy to collect tumor tissue if deemed medically safe by the Investigator.

Exclusion Criteria:

1. Has disease that is suitable for local treatment administered with curative intent.
2. Has a diagnosed and/or treated additional malignancy within 5 years prior to the first dose of study treatment except for: curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, and curatively resected in situ breast, cervical cancer, and prostate cancer.
3. Histologically/cytologically confirmed nasopharynx cancer. Has non-squamous histology NSCLC. If small cell elements are present, the patient is ineligible.
4. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
5. Has a diagnosis of immunodeficiency.
6. Use of systemic corticosteroid (\> 10 mg/day prednisone or equivalent) or other immunosuppressive medication within 14 days before the first dose of study treatment.
7. Has active autoimmune disease that has required systemic treatment in past 2 years or history of autoimmune disease that has possibility of relapse or at risk of having these conditions.
8. Poorly controlled co-morbidity, including but not limited to poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) and poorly controlled type 2 diabetes, or other serious conditions requiring systemic treatment. Active gastric or duodenal ulcer.
9. Cerebrovascular events (stroke, transient ischemic attack, etc.) within 6 months prior to the first dose of study treatment.
10. QTcF interval male \> 450 msec; female \> 470 msec Or serious cardiovascular disease within 6 months prior to the first dose of study treatment
11. The left ventricular ejection fraction (LVEF) \< 50% during the screening period.
12. History of Stevens-Johnson syndrome or toxic epidermal necrolysis syndrome.
13. Patients known to be human immunodeficiency virus (HIV)-positive or have acquired immune deficiency syndrome (AIDS).

Where this trial is running

New York, New York and 6 other locations

• Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
• MD Anderson Cancer Center — Houston, Texas, United States (NOT_YET_RECRUITING)
• NEXT Oncology — Fairfax, Virginia, United States (RECRUITING)
• Hunan Cancer Hospital — Changsha, Hunan, China (NOT_YET_RECRUITING)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital With Nanjing Medical University — Nanjing, Jiangsu, China (NOT_YET_RECRUITING)
• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Jueying Li

Conditions: Selected Types of Solid Tumor, Solid Tumor, Cancer Vaccine