← Back to Search

Monoclonal Antibodies

Personalized Immunotherapy for Advanced Cancers

Phase 1

Waitlist Available

Led By Erza Cohen, MD

Research Sponsored by Ezra Cohen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Progressed on or be intolerant to therapies that are known to provide clinical benefit

Non-measurable disease by RECIST 1.1 and high-risk (>50% over 5 years) of mortality

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing a new, personalized cancer vaccine in patients who have advanced cancer and are not candidates for curative therapy.

Who is the study for?

This trial is for adults with advanced, incurable solid tumors who have measurable disease or high risk of mortality. They must have a tumor site accessible for biopsy, good organ function, and agree to use contraception. Excluded are those with certain immune conditions, recent immunotherapy or major surgery, active hepatitis or HIV infection, untreated brain metastases, pregnancy/breastfeeding women.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of a personalized vaccine combined with Pembrolizumab in treating advanced cancers. The vaccine is tailored to each patient's tumor makeup and aims to boost the body's immune response against cancer cells.See study design

What are the potential side effects?

Potential side effects may include typical reactions from vaccines such as soreness at injection site and flu-like symptoms. Pembrolizumab can cause immune-related adverse effects like fatigue, skin rash, diarrhea/colitis; it might also affect liver function and hormone levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My condition worsened or I couldn't tolerate previous beneficial treatments.

Select...

My cancer can't be measured by scans and I have a high risk of dying within 5 years.

Select...

My cancer is not lymphoma and cannot be cured with surgery.

Select...

I have a tumor that can be easily biopsied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Treatment-related Adverse Events

Quantitative frequency of TCR

Secondary outcome measures

Overall Response

Overall Survival

Progression-free survival (PFS)

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: vaccine and anti-PD-1Experimental Treatment2 Interventions

personalized vaccine and anti-PD-1 administered concurrently at the start of study therapy

Group II: vaccineExperimental Treatment1 Intervention

personalized vaccine therapy

Group III: anti-PD1 before vaccineExperimental Treatment2 Interventions

anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy

Group IV: anti-PD1 and vaccineExperimental Treatment2 Interventions

anti-PD-1 antibody followed by personalized vaccine therapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ezra CohenLead Sponsor

4 Previous Clinical Trials

63 Total Patients Enrolled

Erza Cohen, MDPrincipal InvestigatorUniversity of California, San Diego

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03568058 — Phase 1

Cancer Research Study Groups: vaccine and anti-PD-1, vaccine, anti-PD1 before vaccine, anti-PD1 and vaccine

Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03568058 — Phase 1

Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03568058 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aim of this medical experiment?

"The purpose of this medical study is to assess the number and type of adverse events that can be attributed to treatment over a period of 12 months. Secondary endpoints such as time-to progression, progression-free survival, and overall response (as classified by RECIST 1.1) will also be evaluated during the trial's duration."

Answered by AI

What sicknesses can personalized vaccine be employed to alleviate?

"Personalized vaccines are routinely administered to treat cancerous growths, and have been demonstrated effective for unresectable melanoma, microsatellite instability high cases, and as a form of chemotherapy augmentation."

Answered by AI

What other investigations have been done exploring tailored inoculation?

"Presently, 961 personalized vaccine clinical trials are in progress; 122 of these have reached the third phase. Although many studies for this treatment occur in Houston, TX, a total of 35731 sites run experiments related to this medication."

Answered by AI

How many individuals are being included in this research endeavor?

"Unfortunately, this medical trial is not currently recruiting. It was first posted on July 26th 2018 and last edited on September 20th 2022. For those interested in alternative studies, 2467 trials for cancer patients at an advanced stage are open to participants as well as 961 personalized vaccine clinicals that are actively enrolling volunteers."

Answered by AI

Has the federal drug administration approved a tailored vaccine yet?

"Due to the limited data available for this personalized vaccine, it was given a score of 1 with regards to safety. This Phase 1 trial has little evidence proving efficacy and only some preliminary research supporting its safety."

Answered by AI

Does this medical experiment currently have the capacity to accept new participants?

"Data from clinicaltrials.gov indicates that this medical experiment is no longer searching for participants as it was last amended on September 20th 2022. Despite the fact that recruitment has ceased, there are still 3428 other trials actively recruiting patients now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Personalized Immunotherapy in Adults With Advanced Cancers Immunotherapy in Adults With Advanced Cancers

Ezra Cohen 2018. "Personalized Immunotherapy in Adults With Advanced Cancers Immunotherapy in Adults With Advanced Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03568058.

All > Immunotherapy > Vaccine