Study Summary
This trial is testing whether gene transfer therapy can shrink tumors in people with metastatic cancer.
- Gastrointestinal/Genitourinary Cancer
- Endocrine Tumors
- Non-Small Cell Lung Cancer
- Gastrointestinal/Genitourinary Cancers
- Breast Cancer
- Multiple Myeloma
- Neuroendocrine Tumors
- Ovarian Cancer
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per PI discretion
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
1/iTCR
1 of 2
2/iTCR + Pembro
1 of 2
Experimental Treatment
270 Total Participants · 2 Treatment Groups
Primary Treatment: Pembrolizumab (KEYTRUDA ) · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 72 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Robbins, Paul F, Yong-Chen Lu, Mona El-Gamil, Yong F Li, Colin Gross, Jared Gartner, Jimmy C Lin, et al.. 2013. “Mining Exomic Sequencing Data to Identify Mutated Antigens Recognized by Adoptively Transferred Tumor-reactive T Cells”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/nm.3161.
- Tran, Eric, Simon Turcotte, Alena Gros, Paul F. Robbins, Yong-Chen Lu, Mark E. Dudley, John R. Wunderlich, et al.. 2014. “Cancer Immunotherapy Based on Mutation-specific CD4+ T Cells in a Patient with Epithelial Cancer”. Science. American Association for the Advancement of Science (AAAS). doi:10.1126/science.1251102.
- Lu, Yong-Chen, Xin Yao, Jessica S. Crystal, Yong F. Li, Mona El-Gamil, Colin Gross, Lindy Davis, et al.. 2014. “Efficient Identification of Mutated Cancer Antigens Recognized by T Cells Associated with Durable Tumor Regressions”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-14-0433.
- Tran, Eric, Simon Turcotte, Alena Gros, Paul F. Robbins, Yong-Chen Lu, Mark E. Dudley, John R. Wunderlich, et al.. 2014. “Cancer Immunotherapy Based on Mutation-specific CD4+ T Cells in a Patient with Epithelial Cancer”. Science. American Association for the Advancement of Science (AAAS). doi:10.1126/science.1251102.
- Kooragayala, Keshav, Johanna Lou, and Young Ki Hong. 2022. “Current State of Cell Therapies for Gastrointestinal Cancers”. The Cancer Journal. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ppo.0000000000000611.
- Kooragayala, Keshav, Johanna Lou, and Young Ki Hong. 2022. “Current State of Cell Therapies for Gastrointestinal Cancers”. The Cancer Journal. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ppo.0000000000000611.
- Levy, Pierre L., and Alena Gros. 2022. “Fast Track to Personalized TCR T Cell Therapies”. Cancer Cell. Elsevier BV. doi:10.1016/j.ccell.2022.04.013.
- 2018. "Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03412877.
Frequently Asked Questions
Has the FDA accorded its blessing to Pembrolizumab (KEYTRUDA)?
"Our experts at Power rated Pembrolizumab's safety a 2, as the available data suggests its security but has yet to validate efficacy." - Anonymous Online Contributor
Are there any prior studies that have utilized Pembrolizumab (KEYTRUDA )?
"Presently, Pembrolizumab (KEYTRUDA ) has 1838 clinical trials underway with 283 of them being in the advanced Phase 3. These studies are largely based in Philadelphia, Pennsylvania yet can be found at 63644 different sites across the globe." - Anonymous Online Contributor
How many participants are currently being evaluated in this research investigation?
"That is correct. According to information available at clinicaltrials.gov, this experiment commenced recruitment on September 6th 2018 and was last modified on October 19th 2022. At present, it requires the participation of 270 patients from a single location." - Anonymous Online Contributor
Could I be included among the participants of this research?
"The prerequisites for this medical trial necessitate that participants suffer from neuroendocrine tumors and are aged 18 to 70. The total number of people expected to join is 270." - Anonymous Online Contributor
Does this research endeavor include individuals aged 75 and older?
"This medical trial can accept participants between 18 and 70 years of age, in accordance with the inclusion criteria." - Anonymous Online Contributor
Are there any available slots for participating in this research study?
"Confirmed. The clinical trial is indeed seeking participants for enrollment as indicated on the data hosted on clinicaltrials.gov; this study was first introduced on September 6th 2018 and underwent its most recent edit October 19th 2022. 270 patients will be recruited from a single facility." - Anonymous Online Contributor
To what maladies is Pembrolizumab (KEYTRUDA) typically used as an efficacious remedy?
"Physicians often administer pembrolizumab (KEYTRUDA) to patients with non-Hodgkins lymphoma. This medication has also been known to successfully treat malignant melanoma of the skin, recurrent cervical cancer, and leukemia." - Anonymous Online Contributor