Harriet Kluger, MD

Professor of Medicine (Medical Oncology); Director, Yale SPORE in Skin Cancer, Yale Cancer Center; Director, , Yale Immuno-Oncology Training Program; Associate Cancer Center Director for Education, Training and Faculty Development, Yale Cancer Center; Deputy Section Chief, Medical Oncology

Research Departments & Organizations

Internal Medicine: Medical Oncology: Subset Medical Oncology Faculty

Discovery to Cure Internship

SPORE in Skin Cancer

WHRY Pilot Project Program Investigators

Yale Cancer Center: Developmental Therapeutics

Office of Cooperative Research

Research Interests

Medical Oncology; Melanoma

Research Summary

Dr. Kluger is a medical oncologist and the Associate Director for Education, Training and Faculty Development at Yale Cancer Center, as well as the Deputy Section Chief for Medical Oncology. She sees patients with melanoma and renal cell carcinoma. Approximately half of her time is spent conducting laboratory-based clinical and translational research. She runs an active laboratory focusing on melanoma-related studies, and has been an integral member of the Yale SPORE in Skin Cancer since it was initially awarded in 2006, having co-led four projects during this time. Dr. Kluger collaborates with basic and clinical scientists as evidenced by her funding and publication record. Her particular focus is on predictive biomarkers and development of novel therapies, both directly anti-neoplastic and immune activating. She has extensive experience in conducting correlative predictive and prognostic biomarker studies using a variety of technologies, including exome sequencing, expression arrays, tissue microarrays and others. Her lab conducts pre-clinical targeted drug testing and knock-down studies. She also has experience in designing and conducting clinical trials with laboratory correlates, including investigator initiated trials. All of these trials involve specimen collection (tumor and blood) and analysis. She has been very involved in development of single drug and combination checkpoint regimens, and is well versed with aspects of biomarker development for predicting response to this class of drugs. 

Clinical Trials

Conditions Study Title
Other Skin A Phase III Randomized Trial Comparing Adjuvant MK-3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma
Melanoma, skin, Other Skin A Randomized Phase II Study of Anti-PD1 Antibody [MK-3475 (Pembrolizumab)] Alone Versus Anti-PD1 Antibody Plus Stereotactic Body Radiation Therapy in Advanced Merkel Cell Carcinoma
Phase I A Phase 1 Study of an Autologous ACTR T Cell Product in Combination With Trastuzumab, a Monoclonal Antibody, in Subjects With HER2-Positive Advanced Malignancies
Kidney Phase II Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma
Melanoma, skin A Phase 1/1b Open-Label Multi-Center Study to Characterize the Safety and Tolerability of TRQ15-01 in Patients With Relapsed/Refractory Solid Tumors and Lymphomas
Melanoma, skin A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants With Advanced Melanoma (LEAP-003)
Melanoma, skin Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)
Advanced Cardiovascular Magnetic Resonance for Detection of Programmed Cell Death Protein-1 Deficient Myocarditis
Colon, Kidney, Melanoma, skin, Other Urinary, Ovary, Breast A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-262 in Combination With NKTR-214 and in Combination With NKTR-214 Plus Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumor Malignancies
Phase I A Multicenter, Open Label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial
Lung, Melanoma, skin, Other Skin, Other Urinary A Phase I/Ib Study of APX005M in Combination With Nivolumab and Cabiralizumab in Patients With Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma Whose Disease Has Progressed on Anti-PD- 1/PD-L1 Therapy
Lung, Melanoma, skin, Other Skin First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of Axl-specific Antibody-drug Conjugate (HuMax®-AXL-ADC) in Patients With Solid Tumors
Melanoma, skin A Pilot Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Melanoma
Kidney, Other Urinary A Phase 3 Randomized Study Comparing Perioperative Nivolumab vs. Observation in Patients With Localized Renal Cell Carcinoma Undergoing Nephrectomy
Lung, Melanoma, skin A Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody APX005M Administered in Combination With Nivolumab in Subjects With Non-small Cell Lung Cancer and Subjects With Metastatic Melanoma
Brain and Nervous System, Lung, Melanoma, skin A Phase II Trial of Pembrolizumab Plus Bevacizumab in Patients With Metastatic Melanoma or Non-small Cell Lung Cancer With Untreated Brain Metastases
Melanoma, skin A Phase II, Multicenter, Single-arm Study to Assess the Safety, Feasibility, and Efficacy of Cell Transfer Therapy Using Autologous Tumor Infiltrating Lymphocytes (LN-144) Followed by IL-2 for Treatment of Metastatic Melanoma

Selected Publications

  • PD-L1 Studies Across Tumor Types, Its Differential Expression and Predictive Value in Patients Treated with Immune Checkpoint Inhibitors.

    Kluger HM, Zito CR, Turcu G, Baine MK, Zhang H, Adeniran A, Sznol M, Rimm DL, Kluger Y, Chen L, Cohen JV, Jilaveanu LB. Clin Cancer Res. 2017 Aug 1;23(15):4270-4279 2017

  • Phase II randomised discontinuation trial of the MET/VEGF receptor inhibitor cabozantinib in metastatic melanoma.

    Daud A, Kluger HM, Kurzrock R, Schimmoller F, Weitzman AL, Samuel TA, Moussa AH, Gordon MS, Shapiro GI. Br J Cancer. 2017 Feb 14;116(4):432-440 2017

  • Melanoma central nervous system metastases: current approaches, challenges, and opportunities.

    Cohen JV, Tawbi H, Margolin KA, Amravadi R, Bosenberg M, Brastianos PK, Chiang VL, de Groot J, Glitza IC, Herlyn M, Holmen SL, Jilaveanu LB, Lassman A, Moschos S, Postow MA, Thomas R, Tsiouris JA, Wen P, White RM, Turnham T, Davies MA, Kluger HM. Pigment Cell Melanoma Res. 2016 Nov;29(6):627-642 2016

  • Timing and type of immune checkpoint therapy affect the early radiographic response of melanoma brain metastases to stereotactic radiosurgery.

    Qian JM, Yu JB, Kluger HM, Chiang VL. Cancer. 2016 Oct;122(19):3051-8 2016

  • Pembrolizumab for patients with melanoma or non-small-cell lung cancer and untreated brain metastases: early analysis of a non-randomised, open-label, phase 2 trial.

    Goldberg SB, Gettinger SN, Mahajan A, Chiang AC, Herbst RS, Sznol M, Tsiouris AJ, Cohen J, Vortmeyer A, Jilaveanu L, Yu J, Hegde U, Speaker S, Madura M, Ralabate A, Rivera A, Rowen E, Gerrish H, Yao X, Chiang V, Kluger HM. Lancet Oncol. 2016 Jul;17(7):976-983. 2016

  • Renalase Expression by Melanoma and Tumor-Associated Macrophages Promotes Tumor Growth through a STAT3-Mediated Mechanism.

    Hollander L, Guo X, Velazquez H, Chang J, Safirstein R, Kluger H, Cha C, Desir GV. Cancer Res. 2016 Jul 1;76(13):3884-94 2016

  • PD-1 Blockade with Pembrolizumab in Advanced Merkel-Cell Carcinoma.

    Nghiem PT, Bhatia S, Lipson EJ, Kudchadkar RR, Miller NJ, Annamalai L, Berry S, Chartash EK, Daud A, Fling SP, Friedlander PA, Kluger HM, Kohrt HE, Lundgren L, Margolin K, Mitchell A, Olencki T, Pardoll DM, Reddy SA, Shantha EM, Sharfman WH, Sharon E, Shemanski LR, Shinohara MM, Sunshine JC, Taube JM, Thompson JA, Townson SM, Yearley JH, Topalian SL, Cheever MA. N Engl J Med. 2016 Jun 30;374(26):2542-52 2016

  • Melanoma Brain Metastasis Pseudoprogression after Pembrolizumab Treatment.

    Cohen JV, Alomari AK, Vortmeyer AO, Jilaveanu LB, Goldberg SB, Mahajan A, Chiang VL, Kluger HM. Cancer Immunol Res. 2016 Mar;4(3):179-82 2016

See list of PubMed publications

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Contact Info

Harriet Kluger, MD
Mailing Address
Medical OncologyPO Box 208032
New Haven, CT 06520-8028