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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
Must not have
Currently receiving or has received anti-PD1 or anti-CTLA4 treatment during the vaccine preparation period
History of receiving a solid organ transplant or allogeneic bone marrow transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

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.
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.
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
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My condition worsened or I couldn't tolerate previous beneficial treatments.
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My cancer can't be measured by scans and I have a high risk of dying within 5 years.
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My cancer is not lymphoma and cannot be cured with surgery.
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I have a tumor that can be easily biopsied.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with anti-PD1 or anti-CTLA4 drugs during the vaccine preparation period.
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I have had a solid organ or bone marrow transplant.
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I have treated and stable brain metastases, no recent steroids, and am neurologically stable.
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I have had pneumonitis treated with steroids or have it now.
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I haven't had major surgery in the last 28 days.
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I am not pregnant or breastfeeding.
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I have been diagnosed with HIV.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Treatment-related Adverse Events
Quantitative frequency of TCR
Secondary study objectives
Overall Response
Overall Survival
Progression-free survival (PFS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~2810

Find a Location

Who is running the clinical trial?

Ezra CohenLead Sponsor
4 Previous Clinical Trials
43 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
~4 spots leftby Dec 2025
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