Clinical Focus

  • Oncology

Academic Appointments

Administrative Appointments

  • Director, Phase I Clinical Research Program, Division of Oncology, Stanford School of Medicine (2015 - Present)
  • Professor of Medicine, Department of Medicine (2015 - Present)

Professional Education

  • Medical Education:Lady Hardinge Medical College (1992) India
  • Residency:Emory University Internal Medicine Primary Care ResidencyGA
  • Fellowship:National Institutes of HealthMD
  • Board Certification: Oncology, American Board of Internal Medicine (1998)
  • Internship:Emory University School of MedicineGA

Current Research and Scholarly Interests

Dr. Kummar’s research interests focus on developing novel therapies for cancer. She specializes in conducting pharmacokinetic and pharmacodynamic driven first-in-human trials tailored to make early, informed decisions regarding the suitability of novel molecular agents for further clinical investigation. Her studies integrate genomics and laboratory correlates into early phase trials. She is interested in alternate trial designs to facilitate rational drug selection based on human data and help expedite drug development timelines. She has published numerous articles in medical journals and serves on a number of national and international scientific committees.

Clinical Trials

  • A Phase 2 Study of ABI-009 in Patients With Advanced Malignant PEComa Recruiting

    A phase 2 multi-center investigation of efficacy of ABI-009 (nab-rapamycin) in patients with advanced malignant perivascular epithelioid cell tumor (PEComa)

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  • A Phase III Trial of Anlotinib in Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma Recruiting

    This study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the participants will receive AL3818, one-third of the participants will receive IV dacarbazine.

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  • A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors Recruiting

    To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

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  • A Study of PLX8394 as a Single Agent in Patients With Advanced Unresectable Solid Tumors Recruiting

    The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of PLX8394.

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  • A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Recruiting

    This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with metastatic melanoma. Phase 2 of this study will consist of 4 expansion cohorts to further evaluate the efficacy and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.

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  • Dose Escalation and Expansion of JTX-2011 Alone or in Combination With Anti-PD-1 in Subjects With Advanced Solid Tumors Recruiting

    JTX-2011-101 is a Phase 1/2, open label, dose escalation and expansion clinical study of JTX-2011 alone or in combination with a fixed dose of nivolumab in subjects with advanced solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

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  • Phase 1/1b Study to Evaluate the Safety and Tolerability of CPI-444 Alone and in Combination With Atezolizumab in Advanced Cancers Recruiting

    This is a phase 1/1b open-label, multicenter, dose-selection study of CPI-444, an oral small molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune system. This trial will study the safety, tolerability, and anti-tumor activity of CPI-444 as a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid tumors. CPI-444 blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.

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  • Safety Study of MGD009 in B7-H3-expressing Tumors Recruiting

    The purpose of this study is to evaluate the safety of MGD009 when given to patients with B7-H3-expressing tumors. The study will also evaluate what is the highest dose of MGD009 that can be given safely. Assessments will be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate potential anti-tumor activity of MGD009.

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  • Study of FPA008 in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor Recruiting

    This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of FPA008 in PVNS/dt-TGCT patients. Patients will be enrolled into either Phase 1 (dose escalation) or Phase 2 (dose expansion) of the study, but not both.

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  • Study of LOXO-101 (Larotrectinib) in Subjects With NTRK Fusion Positive Solid Tumors (NAVIGATE) Recruiting

    Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3.

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  • An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma Not Recruiting

    The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.

    Stanford is currently not accepting patients for this trial. For more information, please contact Kristine McGlennen, 650-723-3589.

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  • ATR Kinase Inhibitor VX-970 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery Not Recruiting

    This phase I trial studies the side effects and best dose of ATR kinase inhibitor VX-970 and irinotecan hydrochloride in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or cannot be removed by surgery. ATR kinase inhibitor VX-970 and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    Stanford is currently not accepting patients for this trial. For more information, please contact Shivaani Kummar, 800-411-1222.

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  • Trial of CMB305 and Atezolizumab in Patients With Sarcoma Not Recruiting

    This is an open-label Phase 2 randomized study that will examine the use of the study agents, CMB305 (sequentially administered LV305 [a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene] and G305 [NY-ESO-1 recombinant protein plus GLA-SE]) in combination with atezolizumab or atezolizumab alone, in patients with locally advanced, relapsed or metastatic sarcoma (synovial or myxoid/round cell liposarcoma) expressing the NY-ESO-1 protein. CMB305 is a novel approach designed to stimulate the body's immune system to fight the spread and growth of cancer in patients whose tumors express the NY-ESO-1 protein. LV305 will be given in a prime-boost approach with G305 to induce a potentially synergistic immunotherapeutic response in combination with atezolizumab.

    Stanford is currently not accepting patients for this trial. For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.

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2017-18 Courses

All Publications

  • A phase 2 study of vorinostat in locally advanced, recurrent, or metastatic adenoid cystic carcinoma. Oncotarget Goncalves, P. H., Heilbrun, L. K., Barrett, M. T., Kummar, S., Hansen, A. R., Siu, L. L., Piekarz, R. L., Sukari, A. W., Chao, J., Pilat, M. J., Smith, D. W., Casetta, L., Boerner, S. A., Chen, A., Lenkiewicz, E., Malasi, S., LoRusso, P. M. 2017; 8 (20): 32918-32929


    Vorinostat is a histone deacetylase inhibitor (HDACi). Based on a confirmed partial response (PR) in an adenoid cystic carcinoma (ACC) patient treated with vorinostat in a prior phase 1 trial, we initiated this phase 2 trial.Vorinostat was administered orally 400 mg daily, 28 day cycles. The primary objective was to evaluate response rate (RR). Exploratory studies included whole exome sequencing (WES) of selected patients.Thirty patients were enrolled. Median age of patients was 53 years (range 21-73). Median number of cycles was 5 (range 1-66). Lymphopenia (n = 5), hypertension (n = 3), oral pain (n = 2), thromboembolic events (n = 2) and fatigue (n = 2) were the only grade 3 adverse events (AEs) that occurred in more than 1 patient. Eleven patients were dose reduced secondary to drug-related AEs. Two patients had a partial response (PR), with response durations of 53 and 7.2 months. One patient had a minor response with a decrease in ascites (for 19 cycles). Stable disease was the best response in 27 patients. Targeted and WES of 8 patients in this trial identified mutations in chromatin remodeling genes highlighting the role of the epigenome in ACC.Vorinostat demonstrated efficacy in patients with ACC supporting the inclusion of HDACi in future studies to treat ACC.

    View details for DOI 10.18632/oncotarget.16464

    View details for PubMedID 28415633

  • Clinical Activity of the gamma-Secretase Inhibitor PF-03084014 in Adults With Desmoid Tumors (Aggressive Fibromatosis) JOURNAL OF CLINICAL ONCOLOGY Kummar, S., Coyne, G. O., Do, K. T., Turkbey, B., Meltzer, P. S., Polley, E., Choyke, P. L., Meehan, R., Vilimas, R., Horneffer, Y., Juwara, L., Lih, A., Choudhary, A., Mitchell, S. A., Helman, L. J., Doroshow, J. H., Chen, A. P. 2017; 35 (14): 1561-?
  • The root causes of pharmacodynamic assay failure SEMINARS IN ONCOLOGY Ferry-Galow, K. V., Makhlouf, H. R., Wilsker, D. F., Lawrence, S. M., Pfister, T. D., Marrero, A. M., Bigelow, K. M., Yutzy, W. H., Ji, J. J., Butcher, D. O., Gouker, B. A., Kummar, S., Chen, A. P., Kinders, R. J., Parchment, R. E., Doroshow, J. H. 2016; 43 (4): 484-491


    Robust pharmacodynamic assay results are valuable for informing go/no-go decisions about continued development of new anti-cancer agents and for identifying combinations of targeted agents, but often pharmacodynamic results are too incomplete or variable to fulfill this role. Our experience suggests that variable reagent and specimen quality are two major contributors to this problem. Minimizing all potential sources of variability in procedures for specimen collection, processing, and assay measurements is essential for meaningful comparison of pharmacodynamic biomarkers across sample time points. This is especially true in the evaluation of pre- and post-dose tumor biopsies, which suffer from high levels of tumor insufficiency due to variations in biopsy collection techniques and significant specimen heterogeneity within and across patients. Developing methods to assess heterogeneous biopsies is necessary in order to evaluate a majority of tumor biopsies collected for pharmacodynamic biomarker studies. Improved collection devices and standardization of methods are being sought in order to improve the tumor content and quality of tumor biopsies. In terms of reagent variability, we have found that stringent initial reagent qualification and quality control of R&D-grade reagents is critical to minimize lot-to-lot variability and prevent assay failures, especially for clinical pharmacodynamic questions, which often demand assay performance that meets or exceeds clinical diagnostic assay standards. Rigorous reagent specifications and use of appropriate assay quality control methodologies help to ensure consistency between assay runs, laboratories and trials to provide much needed pharmacodynamic insights into the activity of investigational agents.

    View details for DOI 10.1053/j.seminoncol.2016.06.006

    View details for Web of Science ID 000384870100007

    View details for PubMedID 27663480

  • Establishing proof of mechanism: Assessing target modulation in early-phase clinical trials SEMINARS IN ONCOLOGY Kummar, S., Khanh Do, K., Coyne, G. O., Chen, A., Ji, J., Rubinstein, L., Doroshow, J. H. 2016; 43 (4): 446-452


    Since modulation of the putative target and the observed anti-tumor effects form the basis for the clinical development of a molecularly targeted therapy, early-phase clinical trials should be designed to demonstrate proof-of-mechanism in tissues of interest. In addition to establishing safety and the maximum tolerated dose, first-in-human clinical trials should be designed to demonstrate target modulation, define the proposed mechanism of action, and evaluate pharmacokinetic-pharmacodynamic relationships of a new anti-cancer agent. Assessing target modulation in paired tumor biopsies in patients with solid tumors presents multiple challenges, including procedural issues such as patient safety, ethical considerations, and logistics of sample handling and processing. In addition, the availability of qualified biomarker assay technologies, resources to conduct such studies, and real-time analysis of samples to detect inter-species differences that may affect the determination of optimal sampling time points must be taken into account. This article provides a discussion of the challenges that confront the practical application of pharmacodynamic studies in early-phase clinical trials of anti-cancer agents.

    View details for DOI 10.1053/j.seminoncol.2016.06.002

    View details for Web of Science ID 000384870100003

    View details for PubMedID 27663476

  • Developing therapies for rare tumors: opportunities, challenges and progress EXPERT OPINION ON ORPHAN DRUGS Bradford, D., Reilly, K. M., Widemann, B. C., Sandler, A., Kummar, S. 2016; 4 (1): 93-103
  • Delivering on the promise: poly ADP ribose polymerase inhibition as targeted anticancer therapy. Current opinion in oncology O'Sullivan Coyne, G., Chen, A., Kummar, S. 2015; 27 (6): 475-481


    The article presents the rationale, clinical development, and current status of poly (ADP ribose) polymerase inhibitors (PARPis) as anticancer agents.The recent approval of olaparib in heavily pretreated patients with advanced ovarian cancer carrying a BRCA1/2 mutation represents a significant therapeutic advance for patients with this difficult to treat disease. Though olaparib is the first agent in this class to be approved, multiple PARPis are in various stages of clinical development, including in combination with other treatment modalities such as radiation, antiangiogenic agents, and cytotoxic chemotherapies.Clinical benefit has been observed with PARPis in patients with advanced BRCA1/2 mutant ovarian and breast cancers. Various PARPis, either as single agents or in combination, are being evaluated in the neoadjuvant, adjuvant, and metastatic settings.

    View details for DOI 10.1097/CCO.0000000000000238

    View details for PubMedID 26447876

  • Delivering on the promise: poly ADP ribose polymerase inhibition as targeted anticancer therapy CURRENT OPINION IN ONCOLOGY Coyne, G. O., Chen, A., Kummar, S. 2015; 27 (6): 475-481