Dr. Nina Bhardwaj is a professor of medicine, hematology, and medical oncology, and a professor of urology at the Icahn School of Medicine at Mount Sinai. She is currently one of the two study chairs of the clinical trial “A Phase 1/2 Study of In Situ Vaccination With Tremelimumab and IV Durvalumab Plus PolyICLC in Subjects With Advanced, Measurable, Biopsy-accessible Cancers” (NCT02643303).
This study examines combinations of two checkpoint immunotherapies, plus an immune-stimulating adjuvant, in a wide variety of patients diagnosed with breast cancer, sarcoma, head and neck cancer, lymphoma, melanoma, bladder cancer, kidney cancer, prostate cancer, among other types of cancer. One checkpoint inhibitor, durvalumab (Imfinzi™), blocks the PD-L1 pathway, whereas the other, tremelimumab, blocks the CTLA-4 pathway. The adjuvant, poly ICLC, promotes an immune system response similar to that of vaccines.
Additional investigators working on this trial include:
- Craig Slingluff Jr., M.D., University of Virginia Health (Other study chair)
- Danae Hamouda, M.D., Toledo University
- Elizabeth Gaughan, M.D., University of Virginia Health
- Igor Puzanov, M.D., Roswell Park Cancer Institute
- Keisuke Shirai M.D., Dartmouth University
- Megan Kruse, M.D., Cleveland Clinic
- Michael Lowe, M.D., Emory University
Projects and Grants
A Phase 1/2 Study of In Situ Vaccination With Tremelimumab and IV Durvalumab Plus PolyICLC in Subjects With Advanced, Measurable, Biopsy-accessible Cancers (NCT02643303)
Icahn School of Medicine at Mount Sinai | Bladder Cancer, Breast Cancer, Head and Neck Cancer, Kidney Cancer, Lymphoma, Melanoma, Other Cancer, Prostate Cancer, Sarcoma, Skin Cancer | 2015
Analysis of immune responses induced by in situ, autologous therapeutic vaccination against solid cancers with intratumoral hiltonol (Poly-ICLC).
Icahn School of Medicine at Mount Sinai | Melanoma, Sarcoma | 2016
The mutation-derived tumor antigen landscape of advanced bladder cancer: A platform to optimize cancer immunotherapy
Icahn School of Medicine at Mount Sinai | Bladder Cancer | 2015
Adaptive and innate immune responses induced by therapeutic PGV_001 multi-peptide personalized neoantigen vaccine in Phase-I clinical trial, across various types of cancers in adjuvant setting
Icahn School of Medicine at Mount Sinai | All Cancers | 2022