CD8+ T Cell Therapy and Pembrolizumab in Treating Patients With Metastatic Gastrointestinal Tumors
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|ClinicalTrials.gov Identifier: NCT02757391|
Recruitment Status : Recruiting
First Posted : May 2, 2016
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Adenocarcinoma Metastatic Cholangiocarcinoma Metastatic Colorectal Carcinoma Metastatic Digestive System Carcinoma Metastatic Esophageal Carcinoma Metastatic Gastric Carcinoma Metastatic Pancreatic Adenocarcinoma Stage IV Colorectal Cancer AJCC v7 Stage IV Esophageal Cancer AJCC v7 Stage IV Gastric Cancer AJCC v7 Stage IV Pancreatic Cancer AJCC v6 and v7 Stage IVA Colorectal Cancer AJCC v7 Stage IVB Colorectal Cancer AJCC v7||Biological: Adoptive Immunotherapy Biological: Aldesleukin Drug: Cyclophosphamide Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 1|
I. Assess the safety of using a personalized adoptive T cell therapy in patients with advanced gastrointestinal malignancies.
I. Assess the persistence of an immune response after T cell infusion. II. Determine the clinical benefit of adoptive T cell therapy in advanced gastrointestinal cancers.
Beginning 2 days prior to CD8+ T cell infusion, patients receive cyclophosphamide intravenously (IV) over 30 minutes. Patients undergo CD8+ T cell infusion IV over 2 hours on day 0 and receive aldesleukin subcutaneously (SC) twice daily (BID) on days 1-14. Beginning on day 1 about 24 hours after CD8+ T cell infusion, patients receive pembrolizumab IV over 30-60 minutes on weeks 3, 6, 12, and 15.
After completion of study treatment, patients are followed up for 24 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Feasibility and Safety of Personalized Autologous CD8+ T Cell Therapy Plus Anti-PD1 Antibody in Advanced Solid Malignancies|
|Actual Study Start Date :||August 9, 2019|
|Estimated Primary Completion Date :||August 1, 2024|
|Estimated Study Completion Date :||August 1, 2025|
Experimental: Treatment (CD8 +T cell therapy, pembrolizumab)
Beginning 2 days prior to CD8+ T cell infusion, patients receive cyclophosphamide IV over 30 minutes. Patients undergo CD8+ T cell infusion IV over 2 hours on day 0 and receive aldesleukin SC BID on days 1-14. Beginning on day 1 about 24 hours after CD8+ T cell infusion, patients receive pembrolizumab IV over 30-60 minutes on weeks 3, 6, 12, and 15.
Biological: Adoptive Immunotherapy
Undergo CD8 +T cell therapy
Other: Laboratory Biomarker Analysis
- Incidence of toxicity defined as grade 3 or 4 non-hematologic or grade 4 hematologic toxicity per Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 24 weeks ]Will monitor toxicity of the personalized vaccines in using cohorts of size of 5, starting from the 1st patient using the Bayesian approach of Thall, Simon, Estey.
- Persistence of an immune response defined by level of tetramer positive T cell population over time after T cell infusion [ Time Frame: Up to 24 weeks ]
- Persistence of an immune response defined by T cell interferon gamma release in response to selected personalized peptide antigens [ Time Frame: Up to 24 weeks ]
- Persistence of an immune response defined by levels of intracellular cytokine staining of T cells in response to stimulation with personalized peptide antigens [ Time Frame: Up to 24 weeks ]
- Persistence of an immune response defined by detection of antigen spreading [ Time Frame: Up to 24 weeks ]
- Proportion of patients who have received T cell infusion that is alive and progression free (complete response [CR] + partial response [PR] + stable disease) defined based on response criteria according to Response Evaluation Criteria in Solid Tumors 1.1 [ Time Frame: At 12 weeks post infusion ]
- Time to progression [ Time Frame: Up to 24 weeks ]
- Response rate (CR + PR) [ Time Frame: Up to 24 weeks ]The response rate will be evaluated using a Simon optimal two-stage design.
- Overall survival [ Time Frame: Up to 24 weeks ]
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): NCT02757391
|Contact: Michael Overmanfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Michael J. Overman 713-563-3750|
|Principal Investigator: Michael J. Overman|
|Principal Investigator:||Michael Overman||M.D. Anderson Cancer Center|