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Trial record 1 of 1 for:    NCT02600949
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Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02600949
Recruitment Status : Active, not recruiting
First Posted : November 9, 2015
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This pilot phase I trial studies the side effects and best way to give personalized peptide vaccine in patients with pancreatic or colorectal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Personalized peptide vaccine is a vaccine developed from patient's own tumor cells and blood in order to use as a biological therapy. Biological therapies, such as personalized peptide vaccine may attack tumor cells and stop them from growing or kill them.

Condition or disease Intervention/treatment Phase
Colorectal Adenocarcinoma Pancreatic Ductal Adenocarcinoma Stage IV Colorectal Cancer AJCC v7 Stage IV Pancreatic Cancer AJCC v6 and v7 Stage IVA Colorectal Cancer AJCC v7 Stage IVB Colorectal Cancer AJCC v7 Drug: Imiquimod Other: Laboratory Biomarker Analysis Biological: Pembrolizumab Biological: Synthetic Tumor-Associated Peptide Vaccine Therapy Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. Demonstrate that developing a custom vaccine for metastatic pancreatic ductal adenocarcinoma (PDA) and colorectal cancer (CRC) patients is feasible.

II. Show that a custom peptide-based vaccine in combination with pembrolizumab is safe.

SECONDARY OBJECTIVES:

I. Determine preliminary clinical efficacy. II. Demonstrate the antigenicity of each vaccine.

OUTLINE:

Patients receive personalized synthetic tumor-associated peptide vaccine therapy subcutaneously (SC) on day 1 of weeks 0, 1, 3, 4 and 6, then every 3 weeks until week 30, then at weeks 39 and 51. Beginning 30 minutes after each vaccine is administered, patients then receive imiquimod cream topically after 30 minutes. Patients also receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses with pembrolizumab repeat every 3 weeks until week 51 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up 2 times in 6 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the Feasibility and Safety of a Personalized Peptide Vaccine in Patients With Advanced Pancreatic Ductal Adenocarcinoma or Colorectal Adenocarcinoma
Actual Study Start Date : May 11, 2016
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Arm Intervention/treatment
Experimental: Treatment (synthetic tumor-associated peptide vaccine therapy)
Patients receive personalized synthetic tumor-associated peptide vaccine therapy SC on day 1 of weeks 0, 1, 3, 4 and 6, then every 3 weeks until week 30, then at weeks 39 and 51. Beginning 30 minutes after each vaccine is administered, patients then receive imiquimod cream topically after 30 minutes. Patients also receive pembrolizumab IV over 30 minutes on day 1. Courses with pembrolizumab repeat every 3 weeks until week 51 in the absence of disease progression or unacceptable toxicity.
Drug: Imiquimod
Applied topically
Other Names:
  • Aldara
  • R 837
  • S 26308
  • Zyclara

Other: Laboratory Biomarker Analysis
Correlative studies

Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • Lambrolizumab
  • MK-3475
  • SCH 900475

Biological: Synthetic Tumor-Associated Peptide Vaccine Therapy
Given SC




Primary Outcome Measures :
  1. Proportion of enrolled patients for whom a personalized vaccine is developed and ready to administer [ Time Frame: Up to 12 weeks post-enrollment ]
  2. Proportion of enrolled patients who receive at least 1 dose of vaccine at any time post-enrollment [ Time Frame: Up to 44 weeks ]
  3. Incidence of toxicity defined as the proportion of subjects who experience at least one toxicity event per National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0 [ Time Frame: Up to 24 weeks ]
    A toxicity event is defined as at least one grade 3 or 4 non-hematologic or grade 4 hematologic toxicity.


Secondary Outcome Measures :
  1. Proportion of patients who have received at least one dose of vaccine that is alive and progression free defined based on response criteria according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: At 12 weeks post-vaccination (second re-staging scan) ]
    Progression free includes complete response (CR), partial response (PR), and stable disease (SD). The target proportion is 45%, and a proportion of 20% or lower will be considered as not having the desired efficacy.

  2. Progression-free survival [ Time Frame: The time between the date of first vaccination and evidence of progression on computed tomography scan or the date of death due to any cause, assessed up to 6 months after the last dose of vaccine ]
  3. Response rate [ Time Frame: Up to 12 weeks ]
    Response rate includes both CR and PR and will be evaluated using a Simon optimal two-stage design.

  4. Change in tumor biomarker (CA19-9, carcinoembryonic antigen [CEA] or circulating free deoxyribonucleic acid [cfDNA] mutation) [ Time Frame: Up to 6 months ]
  5. Overall survival [ Time Frame: The time from first vaccination to death, assessed up to 6 months after the last dose of vaccine ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have metastatic pancreatic ductal adenocarcinoma (PDA) or metastatic colorectal cancer (CRC) to be eligible; (PDA patients with an elevated tumor marker following a primary pancreatic surgery would be eligible)
  • Patients can have any lines (including zero) of prior therapy to sign consent prior to tissue harvest; vaccination will not take place until at least one line of standard chemotherapy is given
  • Patients must have adequate fresh or frozen tissue available; if tissue is needed, then subjects may have had it collected previously under protocol PA15-0176
  • Eastern Cooperative Oncology Group (ECOG) performance status < 1 (Karnofsky > 70%)
  • Life expectancy of greater than 6 months
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count (ANC) >= 1,000/mcL
  • Platelets >= 75,000/mcL
  • Total bilirubin =< 2.0 x institutional upper limit of normal
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (except in Gilbert's disease where direct bilirubin will be used)
  • Calculated creatinine clearance >= 50 mL/min/1.73 m^2
  • Patients must demonstrate an ability to understand and the willingness to sign a written informed consent document
  • The effects of a peptide based vaccine on the developing human fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception at study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; birth control specifications: unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), sexually active participants must use birth control during and for > 120 days after the study; abstinence is also an acceptable form of birth control
  • JUST PRIOR TO FIRST VACCINATION (WITHIN 21 DAYS): ECOG performance status =< 2 (Karnofsky >= 60%)
  • JUST PRIOR TO FIRST VACCINATION (WITHIN 21 DAYS): life expectancy of greater than 4 months
  • JUST PRIOR TO FIRST VACCINATION (WITHIN 21 DAYS): patients must have either measurable disease per Response Criteria in Solid Tumors (RECIST) version (v)1.1 or evaluable disease defined as an elevated tumor biomarker (CA19-9, carcinoembryonic antigen [CEA] or circulating free deoxyribonucleic acid [cfDNA] mutation); pancreatic cancer patients with an elevated tumor marker following a primary pancreatic surgery would be eligible

Exclusion Criteria:

  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for lack of efficacy of therapeutic cancer vaccine
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus (ribonucleic acid or hepatitis C virus [HCV] antibody) indicating acute or chronic infection
  • Subjects with active, known or suspected autoimmune disease; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications; inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
  • Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Women of child bearing potential who are pregnant or breastfeeding; women with a positive pregnancy test at enrollment or prior to administration of vaccine
  • Has history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis
  • Known history of active TB (Bacillus tuberculosis)
  • Hypersensitivity to pembrolizumab or any of its excipients
  • Has a known additional malignancy that is progressing or requires active treatment
  • Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
  • JUST PRIOR TO FIRST VACCINATION (WITHIN 21 DAYS): patients who have had chemotherapy or radiotherapy within 2 weeks prior to first treatment or those who have not recovered to baseline from adverse events due to agents administered more than 2 weeks earlier (washout period)
  • JUST PRIOR TO FIRST VACCINATION (WITHIN 21 DAYS):

    • Women of child bearing potential who are pregnant or breastfeeding
    • Women with a positive pregnancy test prior to administration of vaccine
  • JUST PRIOR TO FIRST VACCINATION (WITHIN 21 DAYS): uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • JUST PRIOR TO FIRST VACCINATION (WITHIN 21 DAYS): patients may not be receiving any other investigational agents within 2 weeks prior to first treatment
  • JUST PRIOR TO FIRST VACCINATION (WITHIN 21 DAYS): in addition to above exclusion criteria unless specified differently below: has received a live vaccine within 30 days of planned start of study therapy; NOTE: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600949


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Michael J Overman M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02600949     History of Changes
Other Study ID Numbers: 2014-1029
NCI-2016-00015 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2014-1029 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenocarcinoma
Pancreatic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Pembrolizumab
Imiquimod
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents
Adjuvants, Immunologic
Interferon Inducers