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
|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|
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.
I. Determine preliminary clinical efficacy. II. Demonstrate the antigenicity of each vaccine.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Other: Laboratory Biomarker Analysis
Biological: Synthetic Tumor-Associated Peptide Vaccine Therapy
- Proportion of enrolled patients for whom a personalized vaccine is developed and ready to administer [ Time Frame: Up to 12 weeks post-enrollment ]
- Proportion of enrolled patients who receive at least 1 dose of vaccine at any time post-enrollment [ Time Frame: Up to 44 weeks ]
- 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.
- 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.
- 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 ]
- 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.
- Change in tumor biomarker (CA19-9, carcinoembryonic antigen [CEA] or circulating free deoxyribonucleic acid [cfDNA] mutation) [ Time Frame: Up to 6 months ]
- Overall survival [ Time Frame: The time from first vaccination to death, assessed up to 6 months after the last dose of vaccine ]
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
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael J Overman||M.D. Anderson Cancer Center|