A Study Combining NeoVax, a Personalized NeoAntigen Cancer Vaccine, With Ipilimumab to Treat High-risk Renal Cell Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02950766|
Recruitment Status : Recruiting
First Posted : November 1, 2016
Last Update Posted : April 12, 2019
This research study is evaluating a new type of Kidney Cancer vaccine called "Personalized NeoAntigen Cancer Vaccine"as a possible treatment for Kidney Cancer.
The following intervention will be involved in this study:
- Personalized Neoantigen Vaccine
- Poly-ICLC (Hiltonol)
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: NeoVax Drug: Ipilimumab||Phase 1|
This research study is a Phase I clinical trial, which tests the safety of an investigational kidney cancer vaccine and also tries to define the appropriate dose of the investigational kidney cancer vaccine to use for further studies. "Investigational" means that the kidney cancer vaccine, in this case the Personalized Neoantigen Cancer Vaccine, is being studied. It also means that the FDA (the U.S. Food and Drug Administration) has not approved the Personalized Cancer Vaccine for any use in patients, including people with kidney cancer.
Poly-ICLC (also called Hiltonol) is an experimental "viral mimic" and an activator of immunity. Poly-ICLC is an investigational drug, meaning the FDA has not approved it as a treatment for any disease.
Personalized NeoAntigen Cancer Vaccine: The purpose of this study is to determine if it is possible to make and administer safely a vaccine against kidney cancer by using information gained from specific characteristics of the participant's own kidney cancer. It is known that kidney cancers have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the kidney cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.
Ipilimumab (Yervoy™) is an antibody that has been approved by the United States Food and Drug Administration (FDA) for the treatment of melanoma.
In this research study, the investigators are looking at the safety and tolerability of the Personalized NeoAntigen Cancer Vaccine combined with Ipilimumab as well as the body's immune response to the vaccine. Ipilimumab will be delivered as an injection given underneath the skin rather than injected in the vein in proximity to each vaccination site in order to 1) direct anti-CTLA4 activity to the vaccine-draining lymph nodes and 2) limit potential toxic effects.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study Combining NeoVax, a Personalized NeoAntigen Cancer Vaccine, With Ipilimumab to Treat High-risk Renal Cell Carcinoma|
|Actual Study Start Date :||March 3, 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||September 2022|
Experimental: Neovax in Combination with Ipilimumab
Patients will undergo surgery with the intent to resect the primary kidney tumor
Neovax is a combination of Poly-ICLC and Neoantigen Peptides
Priming doses of NeoVax will be administered on days 1, 4, 8, 15, and 22
Ipilimumab will be injected within 1 cm of each NeoVax administration
combination of Neoantigen peptides and poly-ICLC
Other Name: neoantigen vaccine
local administration of ipilimumab
Other Name: Yervoy
- Number of participants with dose-limiting toxicity (DLT) experienced within 49 days (7 weeks) of treatment initiation as assessed by CTCAE v4.0 [ Time Frame: 49 days ]
- Number of participants with NeoVax induced IFN γ (interferon γ) T-cell Response against neoepitopes measured by ELISPOT at week 16 [ Time Frame: 16 weeks ]
- Number of participants alive at 2 years [ Time Frame: 2 years ]
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): NCT02950766
|Contact: Patrick Ott, MDfirstname.lastname@example.org|
|Contact: Toni Choueiri, MD||617-632-5456|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Patrick Ott, MD, PhD 617-582-9030|
|Principal Investigator: Patrick Ott, MD|
|Principal Investigator:||Patrick Ott, MD||Dana-Farber Cancer Institute|
|Principal Investigator:||Toni Choueiri, MD||Dana-Farber Cancer Institute|