Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Resected MMR-p Colorectal and Pancreatic Cancer
|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: NCT04117087|
Recruitment Status : Not yet recruiting
First Posted : October 7, 2019
Last Update Posted : October 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Pancreatic Cancer||Drug: KRAS peptide vaccine Drug: Nivolumab Drug: Ipilimumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Resected MMR-p Colorectal and Pancreatic Cancer|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
|Experimental: KRAS peptide vaccine, Nivolumab, and Ipilimumab||
Drug: KRAS peptide vaccine
Other Name: Hiltonol® (Poly-ICLC)
Other Name: OPDIVO
Other Name: YERVOY®
- Number of participants experiencing study drug-related toxicities [ Time Frame: 4 years ]Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0
- Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 16 weeks [ Time Frame: Baseline, 16 weeks ]Evaluated by the fold change in interferon-producing mutant-KRAS-specific cluster of differentiation 8 (CD8) and cluster of differentiation 4 (CD4) T cells after vaccination at 16 weeks compare to pre-vaccination baseline.
- Number of months from the date of first treatment until first documented disease recurrence or death [ Time Frame: 4 years ]Number of months from the date of first treatment until first documented disease recurrence or death. This will be used to assess Disease-free Survival (DFS).
- Percentage change of interferon (IFN)-γ-producing mutant-KRAS-specific CD8 and CD4 T cells [ Time Frame: Baseline, 4 years ]Percent change pre-vaccination baseline compared to end of study.
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): NCT04117087
|Contact: Susan Sartorius-Mergenthaler, RN||410-614-3644||Sartosu@jhmi.edu|
|Contact: Ellen Lilly-Forman, RNemail@example.com|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Nilofer Azad, MD||Johns Hopkins Medical Institution|