EVM14 + Pembrolizumab for Cancer

Recruiting at 6 trial locations

Overseen By rengui zhu, Master

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Everest Medicines (Beijing) Co., Ltd.

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: CNS metastases, Immunodeficiency, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

94 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, EVM14 (an experimental treatment), both alone and in combination with pembrolizumab (a type of immunotherapy), to determine their safety and effectiveness against certain advanced, hard-to-remove, or spreading solid tumors. Researchers aim to discover how well these treatments combat these cancers and how the body responds. Individuals with solid tumors that cannot be surgically removed and have not responded to other treatments may qualify for this study. As a Phase 1, Phase 2 trial, participants will be among the first to receive this new treatment and help assess its effectiveness against their cancer.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you cannot use certain medications like systemic corticosteroids or immunosuppressive drugs within 14 days before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that EVM14, when used alone, can trigger strong immune responses even at low doses, suggesting it might be well-tolerated. However, detailed information on side effects remains unavailable, leaving some uncertainty about its safety.

For the combination of EVM14 with pembrolizumab, studies focus on assessing safety and tolerability. Pembrolizumab is already approved for other uses, so its safety is well-known. The main concern is whether combining it with EVM14 causes any new or unexpected side effects.

Since this trial is in its early stages, the primary goal is to evaluate the safety of both treatments when used together. Participants should know that while early results appear promising, the full safety profile is still under investigation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about EVM14 because it represents a fresh approach to cancer treatment by combining it with pembrolizumab, an established immunotherapy drug. Unlike many traditional treatments which primarily target cancer cells directly, EVM14 may enhance the immune system's ability to combat tumors. This combination could potentially improve response rates and patient outcomes compared to standard chemotherapy or monotherapy with pembrolizumab. Furthermore, EVM14 is administered intramuscularly, which might offer a more convenient option for patients compared to intravenous-only treatments.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that EVM14, when used alone, yields promising results in stopping tumor growth across various cancer types. This vaccine employs mRNA technology to enhance the immune system's ability to fight cancer. Studies have demonstrated that it activates both antibodies and T-cells, which play crucial roles in attacking cancer cells.

In this trial, some participants will receive EVM14 alone, while others will receive a combination of EVM14 and pembrolizumab, a drug already used to treat certain cancers. This combination has shown even better results in combating tumors. Specifically, a related study found that this combination helped patients live longer without their disease worsening, compared to using pembrolizumab alone. These findings suggest that EVM14, both independently and with pembrolizumab, could effectively treat solid tumors. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients with certain types of solid tumors. Participants should be adults who have measurable disease and are able to receive injections or infusions. Specific details about which tumor types are included, as well as other health requirements, would be listed in the full eligibility criteria.

Inclusion Criteria

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

Life expectancy ≥ 3 months

My organs are functioning well.

Exclusion Criteria

My condition can be treated with the goal of curing it.

I haven't had cancer, except for certain skin, bladder, breast, cervical, or prostate cancers treated over 5 years ago.

Has a diagnosis of immunodeficiency

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

EVM14 administered intramuscularly as monotherapy and in combination with pembrolizumab to assess safety, tolerability, and immunogenicity

Up to 3 years

Every 2-3 weeks

Phase IIa Treatment

EVM14 in combination with pembrolizumab administered to further assess safety, tolerability, and preliminary efficacy

Up to 3 years

Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• EVM14
• Pembrolizumab

Trial Overview The trial is testing EVM14 given by a shot into the muscle (IM) on its own and alongside pembrolizumab, an infusion drug. It aims to see how safe they are when used together or alone and if they work against cancer.

How Is the Trial Designed?

Group I: Phase IIa Dose Level B for tumor type 1 Experimental Treatment 2 Interventions

For patients with tumor type 1, EVM14 in Dose Level B will be administered intramuscularly (IM) every 3 weeks (Q3W) + pembrolizumab 200 mg administered intravenously (IV infusion) Q3W if disease progression doesn't occur.

Group II: Phase IIa Dose Level A for tumor type 1 Experimental Treatment 2 Interventions

For patients with tumor type 1, EVM14 in Dose Level A will be administered intramuscularly (IM) every 3 weeks (Q3W) + pembrolizumab 200 mg administered intravenously (IV infusion) Q3W if disease progression doesn't occur.

Group III: Phase IIa Combo therapy for tumor type 2 Experimental Treatment 2 Interventions

Group IV: Phase I Dose Escalation in Monotherapy Cohort Experimental Treatment 1 Intervention

EVM14 will be administered at every 2 weeks (Q2W) if disease progression doesn't occur.

Group V: Phase I Dose Escalation in Combination Therapy Cohort Experimental Treatment 2 Interventions

EVM14 will be administered intramuscularly (IM) every 3 weeks (Q3W) + pembrolizumab 200 mg administered intravenously (IV infusion) Q3W if disease progression doesn't occur.

Group VI: Phase IIa Control for tumor type 2 Active Control 2 Interventions

For patients with tumor type 2, pembrolizumab 200 mg alone will be administered intravenously (IV infusion) every 3 weeks (Q3W) if disease progression doesn't occur.

Group VII: Phase IIa Control arm for tumor type 1 Active Control 1 Intervention

Who Is Running the Clinical Trial?

Everest Medicines (Beijing) Co., Ltd.

Lead Sponsor

Citations

1. jitc.bmj.com jitc.bmj.com/content/13/Suppl_2/A1369

1203 Discovery and pharmacological evaluation of EVM14 ... The efficacy study results demonstrated that EVM14 significantly inhibited tumor growth in multiple tumor models.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12584921/

mRNA vaccines in cancer treatment - PMC This vaccine, EVM14, is an off-the-shelf, preservative-free, sterile mRNA-lipid nanoparticle cancer vaccine made with mRNA that encodes multiple TAAs for the ...

3. researchgate.net researchgate.net/publication/397288941_1203_Discovery_and_pharmacological_evaluation_of_EVM14_a_novel_mRNA_cancer_vaccine_encoding_five_TAAs_targeting_multiple_cancer_types

1203 Discovery and pharmacological evaluation of EVM14 ... Results: mRNA-H5 was shown to effectively stimulate specific humoral and T-cell immune responses.

4. targetedonc.com targetedonc.com/view/fda-clears-ind-application-for-evm14-across-cancers

FDA Clears IND Application for EVM14 Across Cancers Additional preclinical data has shown long-term immune memory and prevention of recurrence as EVM14 demonstrated the ability to induce immune ...

5. prnewswire.com prnewswire.com/apac/news-releases/everest-medicines-announces-first-patient-enrolled-in-a-global-multi-center-phase-i-clinical-trial-of-tumor-associated-antigen-cancer-vaccine-evm14-302582820.html

Everest Medicines Announces First Patient Enrolled in a ... Notably, EVM14 demonstrated the ability to induce immune memory and prevent tumor recurrence, offering hope for long-term cancer-free survival.

6. onco-this-week.com onco-this-week.com/first-patient-enrolled-in-ph-1-trial-of-tumor-associated-antigen-cancer-vaccine-evm14/

First Patient Enrolled in Ph 1 Trial of Tumor-Associated ... As a TAA cancer vaccine, EVM14's unique mechanism offers the potential to complement current treatments by enhancing the efficacy via ...

7. firstwordpharma.com firstwordpharma.com/story/5993088

Everest Medicines Announces Interim Results for First Half ... Early clinical data demonstrated strong immunogenicity and neoantigen-specific T-cell activation, even at a low starting dose, which validates ...

8. synapse.patsnap.com synapse.patsnap.com/drug/4e91f4332b2641cbbebdcb6cf5bcc615

EVM14 - Drug Targets, Indications, Patents A Phase I/IIa Study to Evaluate the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of EVM14 as Monotherapy and in Combination With ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8783878/

Real-world safety and efficacy data of immunotherapy in ... The median OS was 40.5 months (95% CI 27-non-estimable). Objective response to immunotherapy was achieved in 57 of 101 (56.4%) evaluable ...