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Cancer Vaccine

Personalized Cancer Vaccine for Pancreatic and Colorectal Cancer

Phase 1

Recruiting

Led By Michael J Overman

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Age >= 18 years

Calculated creatinine clearance >= 40 mL/min/1.73 m^2

Must not have

Has a known additional malignancy that is progressing or requires active treatment

JUST PRIOR TO FIRST VACCINATION (WITHIN 21 DAYS): Women of child bearing potential who are pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a personalized vaccine made from a patient's own tumor cells to see if it is safe and effective at treating advanced pancreatic or colorectal cancer.

Who is the study for?

This trial is for adults with advanced pancreatic or colorectal cancer who have a life expectancy of more than 6 months and can provide tumor tissue. They must have had at least one line of standard chemotherapy, be able to use birth control, and not be pregnant or breastfeeding. Specific criteria apply for different cohorts within the study.

What is being tested?

The trial is testing a personalized peptide vaccine made from patients' own tumor cells and blood, alongside other treatments like Pembrolizumab and Sotigalimab. It aims to see how well these work as biological therapies against advanced cancers that are hard to treat.

What are the potential side effects?

Potential side effects may include typical reactions to vaccines such as soreness at the injection site, fever, fatigue, allergic responses, as well as any specific side effects related to Pembrolizumab and Sotigalimab which could range from immune-related issues to digestive disturbances.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My kidneys are functioning well enough to filter waste.

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I am mostly active and can care for myself.

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I am very active or able to carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have another cancer that is getting worse or needs treatment.

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I am not pregnant or breastfeeding.

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I am not pregnant or breastfeeding.

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I have had lung inflammation treated with steroids, or I have a lung condition.

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I have an active tuberculosis infection.

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I am HIV positive and not on antiretroviral therapy.

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I do not have any severe illnesses that would stop me from following the study's requirements.

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I do not have brain metastases.

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I do not have any uncontrolled illnesses that could interfere with the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (AEs)

Secondary study objectives

Change in neoantigen-specific T cell response (cohort C and D)

Levels of intracellular cytokine staining of T cells

Overall survival

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort C and D (vaccine, imiquimod, pembrolizumab, APX005M)Experimental Treatment6 Interventions

Patients receive personalized synthetic tumor-associated peptide vaccine therapy SC on day 1 of weeks 0, 1, 3, 4, 6, 9, 12, 15, 18, 21, and 24. Beginning 15 minutes after each vaccine is administered, patients receive imiquimod cream topically. Patients also receive pembrolizumab IV over 30 minutes every 3 weeks until week 24 in the absence of disease progression or unacceptable toxicity. Beginning about 1 hour after each vaccine, patients also receive sotigalimab IV over 60 minutes on day 1 of weeks 0, 1, 3, 4, 6, 12, and 24 in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans at baseline and weeks 6,12, and 24, then every 3 months, and at week 39.

Group II: Cohort B (personalized vaccine, imiquimod, pembrolizumab)Experimental Treatment5 Interventions

Patients receive personalized synthetic tumor-associated peptide vaccine therapy SC on day 1 of weeks 0, 1, 3, 4, 6, 12, and 24. Beginning 15 minutes after each vaccine is administered, patients receive imiquimod cream topically. Patients also receive pembrolizumab IV over 30 minutes every 3 weeks until week 24 in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans at baseline and at weeks 0 and 6, then every 3 months, and at week 39.

Group III: Cohort A (personalized vaccine, imiquimod)Experimental Treatment4 Interventions

Patients receive personalized synthetic tumor-associated peptide vaccine therapy SC on day 1 of weeks 0, 1, 3, 4, 6, 12, and 24. Beginning 15 minutes after each vaccine is administered, patients then receive imiquimod cream topically in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans at baseline and at weeks 0 and 6, then every 3 months, and at week 39.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Imiquimod

2005

Completed Phase 4

~2010

Pembrolizumab

2017

Completed Phase 3

~3130