Brief Summary:
The purpose of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and immunogenicity of EVM14 administered intramuscularly (IM) alone and in combination with pembrolizumab in patients with selected solid tumors.
Selected types of solid tumor that are pathologically confirmed unresectable advanced, recurrent, or metastatic.
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.
Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 at Screening.
Life expectancy ≥ 3 months.
Has disease that is suitable for local treatment administered with curative intent.
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.
Histologically/cytologically confirmed nasopharynx cancer. Has non-squamous histology NSCLC. If small cell elements are present, the patient is ineligible.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Sequential
EVM14
Biological/VaccineCancer Vaccine
Pembrolizumab
Combination productAnti-PD1 antibody
7
Treatment groupsSee each treatment group below.
Phase I and Phase IIa: Incidence and severity of adverse events
Phase I: Incidence of dose-limiting toxicities (DLT)
Phase IIa tumor type 1: Progression-free survival (PFS)
The time from date of randomization to the first documented disease progression per RECIST 1.1 evaluated by Investigators or death due to any cause, whichever occurs first.
Phase I and Phase IIa: Objective response rate (ORR)
The percentage of patients meeting the criteria of best overall response as complete response (CR) or partial response (PR) evaluated by Investigators based on RECIST v1.1.
Phase I and Phase IIa: Disease control rate (DCR)
The percentage of patients meeting criteria of best overall response as stable disease (SD), PR, or CR evaluated by Investigators based on RECIST v1.1.
Phase I and Phase IIa: Duration of response (DOR)
The time between the date of earliest determination of CR or PR to the date of earliest documented progressive disease (PD), or to the date of death due to any cause, whichever occurs first.
Phase I and Phase IIa tumor type 2: Progression Free Survival (PFS)
The time from date of randomization or date of first dose to the first documented disease progression per RECIST 1.1 evaluated by Investigators or death due to any cause, whichever occurs first.
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