Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease

doi:10.1136/jitc-2023-008378

. 2024 Apr 18;12(4):e008378.

doi: 10.1136/jitc-2023-008378.

Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease

Jason J Luke¹, Diwakar Davar², Robert H Andtbacka³, Nina Bhardwaj⁴, Joshua D Brody⁵, Jason Chesney⁶, Robert Coffin⁷, Thierry de Baere⁸, Tanja D de Gruijl^{9

10

11}, Matthew Fury¹², Gregory Goldmacher¹³, Kevin J Harrington¹⁴, Howard Kaufman^{15

16}, Ciara M Kelly¹⁷, Anuradha D Khilnani¹³, Ke Liu¹⁸, Sherene Loi^{19

20}, Georgina V Long²¹, Ignacio Melero²², Mark Middleton²³, Bart Neyns²⁴, David J Pinato^{25

26}, Rahul A Sheth²⁷, Stephen B Solomon^{28

29}, Philippe Szapary³⁰, Aurelien Marabelle³¹

Affiliations

¹ UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, USA lukejj@upmc.edu.
² UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, USA.
³ HiFiBiO Therapeutics, Cambridge, Massachusetts, USA.
⁴ Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
⁵ Marc and Jennifer Lipschultz Precision Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
⁶ James Graham Brown Cancer Center, University of Louisville, Louisville, Kentucky, USA.
⁷ Replimune Inc, Woburn, Massachusetts, USA.
⁸ Center for Biotherapies In Situ (BIOTHERIS), INSERM CIC1428, Interventional Radiology Unit, Department of Medical Imaging, Gustave Roussy Cancer Center, University of Paris Saclay, Villejuif, France.
⁹ Department of Medical Oncology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
¹⁰ Cancer Biology and Immunology, Cancer Center Amsterdam, Amsterdam, Netherlands.
¹¹ Cancer Immunology, Amsterdam Institute for Infection and Immunology, Amsterdam, Netherlands.
¹² Oncology Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.
¹³ Merck & Co Inc, Rahway, New Jersey, USA.
¹⁴ The Institute of Cancer Research, The Royal Marsden National Institute for Health and Care Research Biomedical Research Centre, London, UK.
¹⁵ Department of Surgery, Massachusetts General Hospital, Boston, Massachusetts, USA.
¹⁶ Ankyra Therapeutics, Boston, Massachusetts, USA.
¹⁷ Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
¹⁸ Marengo Therapeutics, Inc, Cambridge, Massachusetts, USA.
¹⁹ Division of Cancer Research, Peter MacCallum Cancer Center, Melbourne, Victoria, Australia.
²⁰ The Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia.
²¹ Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, North Sydney, New South Wales, Australia.
²² CIMA, Universidad de Navarra, Pamplona, Spain.
²³ Department of Oncology, University of Oxford, Oxford, UK.
²⁴ Department of Medical Oncology, Universitair Ziekenhuis Brussel, Jette, Belgium.
²⁵ Department of Surgery and Cancer, Imperial College London, Hammersmith Hospital, London, UK.
²⁶ Division of Oncology, Department of Translational Medicine, University of Piemonte Orientale, Novara, Italy.
²⁷ Department of Interventional Radiology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
²⁸ Chief of Interventional Radiology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
²⁹ Professor of Radiology, Weill Cornell Medical College, New York, New York, USA.
³⁰ Interventional Oncology, Johnson & Johnson, New Brunswick, New Jersey, USA.
³¹ Center for Biotherapies In Situ (BIOTHERIS), INSERM CIC1428, Department for Therapeutic Innovation and Early Phase Trials (DITEP), Gustave Roussy Cancer Center, University of Paris Saclay, Villejuif, France.

PMID: 38641350
PMCID: PMC11029323
DOI: 10.1136/jitc-2023-008378

Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease

Jason J Luke et al. J Immunother Cancer. 2024.

. 2024 Apr 18;12(4):e008378.

doi: 10.1136/jitc-2023-008378.

Authors

Affiliations

¹ UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, USA lukejj@upmc.edu.
² UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, USA.
³ HiFiBiO Therapeutics, Cambridge, Massachusetts, USA.
⁴ Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
⁵ Marc and Jennifer Lipschultz Precision Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
⁶ James Graham Brown Cancer Center, University of Louisville, Louisville, Kentucky, USA.
⁷ Replimune Inc, Woburn, Massachusetts, USA.
⁸ Center for Biotherapies In Situ (BIOTHERIS), INSERM CIC1428, Interventional Radiology Unit, Department of Medical Imaging, Gustave Roussy Cancer Center, University of Paris Saclay, Villejuif, France.
⁹ Department of Medical Oncology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
¹⁰ Cancer Biology and Immunology, Cancer Center Amsterdam, Amsterdam, Netherlands.
¹¹ Cancer Immunology, Amsterdam Institute for Infection and Immunology, Amsterdam, Netherlands.
¹² Oncology Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.
¹³ Merck & Co Inc, Rahway, New Jersey, USA.
¹⁴ The Institute of Cancer Research, The Royal Marsden National Institute for Health and Care Research Biomedical Research Centre, London, UK.
¹⁵ Department of Surgery, Massachusetts General Hospital, Boston, Massachusetts, USA.
¹⁶ Ankyra Therapeutics, Boston, Massachusetts, USA.
¹⁷ Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
¹⁸ Marengo Therapeutics, Inc, Cambridge, Massachusetts, USA.
¹⁹ Division of Cancer Research, Peter MacCallum Cancer Center, Melbourne, Victoria, Australia.
²⁰ The Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia.
²¹ Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, North Sydney, New South Wales, Australia.
²² CIMA, Universidad de Navarra, Pamplona, Spain.
²³ Department of Oncology, University of Oxford, Oxford, UK.
²⁴ Department of Medical Oncology, Universitair Ziekenhuis Brussel, Jette, Belgium.
²⁵ Department of Surgery and Cancer, Imperial College London, Hammersmith Hospital, London, UK.
²⁶ Division of Oncology, Department of Translational Medicine, University of Piemonte Orientale, Novara, Italy.
²⁷ Department of Interventional Radiology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
²⁸ Chief of Interventional Radiology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
²⁹ Professor of Radiology, Weill Cornell Medical College, New York, New York, USA.
³⁰ Interventional Oncology, Johnson & Johnson, New Brunswick, New Jersey, USA.
³¹ Center for Biotherapies In Situ (BIOTHERIS), INSERM CIC1428, Department for Therapeutic Innovation and Early Phase Trials (DITEP), Gustave Roussy Cancer Center, University of Paris Saclay, Villejuif, France.

PMID: 38641350
PMCID: PMC11029323
DOI: 10.1136/jitc-2023-008378

Abstract

Background: Intratumorally delivered immunotherapies have the potential to favorably alter the local tumor microenvironment and may stimulate systemic host immunity, offering an alternative or adjunct to other local and systemic treatments. Despite their potential, these therapies have had limited success in late-phase trials for advanced cancer resulting in few formal approvals. The Society for Immunotherapy of Cancer (SITC) convened a panel of experts to determine how to design clinical trials with the greatest chance of demonstrating the benefits of intratumoral immunotherapy for patients with cancers across all stages of pathogenesis.

Methods: An Intratumoral Immunotherapy Clinical Trials Expert Panel composed of international key stakeholders from academia and industry was assembled. A multiple choice/free response survey was distributed to the panel, and the results of this survey were discussed during a half-day consensus meeting. Key discussion points are summarized in the following manuscript.

Results: The panel determined unique clinical trial designs tailored to different stages of cancer development-from premalignant to unresectable/metastatic-that can maximize the chance of capturing the effect of intratumoral immunotherapies. Design elements discussed included study type, patient stratification and exclusion criteria, indications of randomization, study arm determination, endpoints, biological sample collection, and response assessment with biomarkers and imaging. Populations to prioritize for the study of intratumoral immunotherapy, including stage, type of cancer and line of treatment, were also discussed along with common barriers to the development of these local treatments.

Conclusions: The SITC Intratumoral Immunotherapy Clinical Trials Expert Panel has identified key considerations for the design and implementation of studies that have the greatest potential to capture the effect of intratumorally delivered immunotherapies. With more effective and standardized trial designs, the potential of intratumoral immunotherapy can be realized and lead to regulatory approvals that will extend the benefit of these local treatments to the patients who need them the most.

Keywords: Clinical Trials as Topic; Guidelines as Topic; Immunotherapy; Melanoma.

PubMed Disclaimer

Conflict of interest statement

Competing interests: JJL: Researcher: AbbVie, Astellas, Astrazeneca, Bristol-Myers Squibb, Corvus, Day 1, EMD Serono, Fstar, Genmab, Ikena, Immatics, Incyte, Kadmon, KAHR, Macrogenics, Merck, Moderna, Nektar, Next Cure, Numab, Palleon, Pfizer, Replimmune, Rubius, Servier, Scholar Rock, Synlogic, Takeda, Trishula, Tizona, XencorConsultant/Advisor/Speaker: Abbvie, Agenus, Alnylam, Atomwise, Bayer, Bristol-Myers Squibb, Castle, Checkmate, Codiak, Crown, Cugene, Curadev, Day One, Eisai, EMD Serono, Endeavor, Flame, G1 Therapeutics, Genentech, Gilead, Glenmark, HotSpot, Kadmon, KSQ, Janssen, Ikena, Inzen, Immatics, Immunocore, Incyte, Instil, IO Biotech, Macrogenics, Merck, Mersana, Nektar, Novartis, Partner, Pfizer, Pioneering Medicines, PsiOxus, Regeneron, Replimmune, Ribon, Roivant, Servier, STINGthera, Synlogic, Synthekine, 7 Hills, Affivant, Bright Peak, Exo, Fstar, Inzen, RefleXion, Xilio (stock) Actym, Alphamab Oncology, Arch Oncology, Duke Street Bio, Kanaph, Mavu, NeoTx, Onc.AI, OncoNano, physIQ, Pyxis, Saros, STipe, Tempest, Abbvie, Agenus, Amgen, Immutep, Evaxion. DD: Grants/Research Support (institutional): Arcus, Immunocore, Merck, Regeneron Pharmaceuticals, Tesaro/GSK. Consultant: ACM Bio, Ascendis, Castle, Clinical Care Options (CCO), Gerson Lehrman Group (GLG), Immunitas, Medical Learning Group (MLG), Replimmune, Trisalus, Xilio Therapeutics. CE Speakers’ Bureau: Castle Biosciences. Stockholder: None. Intellectual Property: US Patent 63/124,231, "Compositions and Methods for Treating Cancer", December 11, 2020 US Patent 63/208,719, "Compositions and Methods For Responsiveness to Immune Checkpoint Inhibitors (ICI), Increasing Effectiveness of ICI and Treating Cancer", June 9, 2021. AM: Owner: HiFiBio, Deka Bio, Hotspot Therapeutics, Shattuck Labs, Researcher: Astra Zeneca, BMS, Sanofi, Consultant/Advisor/Speaker: Gritstone, Innate Pharma, Neogene, Deka Bio, Hotspot therapeutics, J&J, Medicxi, Depth Charge, BiolineRx, Clover Pharma, Grey Wolf, Lytix, RedX, HiFiBio, ImCheck, Applied Materials, Takeda, Shattuck Labs, Marengo therapeutics, Pierre Fabre, Third Rock Ventures, SotioPublicly Traded Stocks: Centessa. RHA–Employee: Seven & Eight Biopharmaceuticals. Ownership Interest Less Than 5 Percent: Seven & Eight Biopharmaceuticals. NB: Consulting Fees: Novartis, Apricity, Rome Therapeutics, BreakBio, Carisma Therapeutics, CureVac, BioNTech, Gilead, Tempest Therapeutics, Boehringer Ingelheim, Contracted Research: Regeneron Pharmaceutics, Dragonfly Therapeutics, Harbour Biomed Sciences, Ownership Interest Less Than 5 Percent: BreakBio, Apricity. JDB: Researcher: Merck, Genentech, Astrazeneca, Kite/Gilead, BMS, Celldex, Oncovir, Seattle Genetics, ADC Therapeutics, Epizyme, Consultant/Advisor/Speaker: Merck, Genentech, Astrazeneca, Kite/Gilead, BMS, Seattle Genetics, ADC Therapeutics, Epizyme, Asgaard Therapeutics, Global BioAccess, SIRPant Immunotherapeutics. JC: Executive Role: UofL Health, Researcher: Amgen, Iovance, Fate, Replimune, Consultant/Advisor/Speaker: Replimune advisory board 2020-21, Royalties or Patent Beneficiary: US Patents: University of Louisville. RC: Employee: Replimune. TdB: Consultant/Advisor/Speaker: Terumo, Boston Scientific, Astra Zeneca, Nanobiotix, Quantum Surgical, Guerbet, Cook medical, Johnson & Johnson. TDdG: Patents: (1) The use of cytostatics for the accelerated differentiation of DC; WO2009019320-A2; WO2009019320-A3; AU2008285598-A1; EP2281030-A2; CA2724018-A1; US2011117051-A1. US8,470,789B2; DCprime BV. (2) Immunoglobulins binding human VÎ³9VÎ’2 T cell receptors; P31885NL00. Consulting Fees: Mendus (formerly Immunicum, formerly DCPrime BV), Partner Therapeutics, GE Health, LAVA Therapeutics, Contracted Research: Idera Pharmaceuticals, Macrophage Parma, Ownership Interest Less Than 5 Percent: LAVA Therapeutics. MGF: Employee: Regeneron. GVG: Employee: Merck. Publicly Traded Stocks: Immunogen, Aveo, Beta Bionics. KJH: Researcher: AstraZeneca, Boehringer-Ingelheim, Replimune, Consultant/Advisor/Speaker: Arch Oncology, AstraZeneca, BMS, Boehringer-Ingelheim, Codiak, Eisai, Inzen, Merck-Serono, MSD, Oncolys, Pfizer, Replimune. HK: Employee: Ankyra Therapeutics. Consultant/Advisor/Speaker: Castle Biosciences, Marengo Therapeutics. CMK: Researcher: Amgen, Merck & Co., Kartos Pharmaceuticals, EMD Serono, Deciphera Pharmaceuticals, Eily lilly, Blueprint Medicines, Incyte Corporation, Clovis Oncology, BMS, Aadi Bioscience, Pfizer, Iterion Therapeutics, Springworks Therapeutics, Nektar Therapeutics, GSK, Adaptimmune, Medimmune, Bioatla, Oncternal Therapeutics, Daiichi- Sankyo Co. Traycon Pharm, Eisai. Ascentage Pharma, Hutchison Medipharma, Salarius Pharmaceuticals, Loxo Oncology, -BTG Specialty Pharmaceuticals, AStex Pharmaceuticals, Xencor, bayer healthcare, Athenex pharmaceuticals, servier, K- group Beta, Trilliium Pharmaceuticals, Ayala Pharmaceuticals, Ningbo Newbay Technology Development, Rain Therapeutics, Inhibrx, C4 Therapeutics, Foghorn Therapeutics, Theseus Pharmaceuticals, Cogent Therapeutics, Curadev PharmaRegeneron, Consultant/Advisor/Speaker: Chemocentryx, Kartos, Servier, Immunicom, Other: Spouse employed by Daichii Sankyo with stock options. ADK: Employee: Merck. KL: Employee: Marengo Therapeutics. SL: Executive Role: Big Against Cancer (Belgium), Breast Cancer Trials (Australia), International Breast Cancer Study Group (Switzerland) Researcher: Research funding to institution from Novartis, Bristol Meyers Squibb, Merck, Puma Biotechnology, Eli Lilly, Nektar Therapeutics, Astra Zeneca, Roche-Genentech and Seattle Genetics, Consultant/Advisor/Speaker: Consultant (not compensated) to Seattle Genetics, Novartis, Bristol Meyers Squibb, Merck, AstraZeneca, Eli Lilly, Pfizer, Gilead Therapeutics and Roche-Genentech. Consultant (paid to institution) to Aduro Biotech, Novartis, GlaxoSmithKline, Roche-Genentech, Astra Zeneca, Silverback Therapeutics, G1 Therapeutics, PUMA Biotechnologies, Pfizer, Gilead Therapeutics, Seattle Genetics, Daiichi Sankyo, Merck, Amunix, Tallac Therapeutics, Eli Lilly and Bristol Meyers Squibb, Role: Presenter (Speaker). GVL: Consultant/Advisor/Speaker: Consultant Advisor for Agenus, Amgen, Array Biopharma, AstraZeneca UK, Boehringer Ingelheim International, Bristol Myers Squibb, Evaxion Biotech A/S, Hexal AG (Sandoz Company), Highlight Therapeutics S.L., Innovent Biologics USA, Merck Sharpe & Dohme (Australia), Merck Sharpe & Dohme, Novartis Pharma AG, PHMR, Pierre Fabre, Provectus Australia, Qbiotics Group Limited, Regeneron Pharmaceuticals. IM: Consulting Fees: Bristol-Myers Squibb, F-STAR, Alligator, Pharma Mar, AstraZeneca, Numab Therapeutics, Roche, Amunix, Gossamer, Molecular Partners, Merck-Serono, Genmab, PharmaMar, Contracted Research: Roche, Bristol-Myers Squibb, Highlight Therapeutics, Alligator, Genmab, Astrazeneca. MRM: Researcher : Roche, Astrazeneca, Novartis, Immunocore, BMS, Pfizer, Merck/MSD, Regeneron, BiolineRx, Replimune, GRAIL, Alkermes, iOx, Vaccitech, Consultant/Advisor/Speaker: Infinitopes. BN: Researcher: As a principal investigator for clinical trials sponsored by UZ Brussel, my institution received support from Novartis, Pfizer, Bayer, BMS, MSD, Pierre-Fabre, Amgen, Consultant/Advisor/Speaker: Novartis, BMS, MSD, Pfizer, Pierre-Fabre, Amgen. DJP: Consulting Fees: ViiV Healthcare, Bayer, Hoffman La Roche, EISAI, H3B, MiNa Alpha Therapeutics, DaVolterra, Fees for Non CE Services: Hoffmann La Roche, EISAI, Contracted Research: Merck Sharpe and Dohme, Bristol Myers Squibb (to institution). RAS: Researcher: Boston ScientificConsultant/Advisor/Speaker: Cook Medical, TriSalus, Replimune, Medtronic. SBS: Owner: Aperture Medical Technology, Executive Role: Aperture Medical Technology, Researcher: GE Healthcare, Johnson & Johnson, Elesta, Consultant/Advisor/Speaker: GE Healthcare, XACT Robotics, Microbot, Candel Therapeutics, Varian, Merck & Co., Royalty and Patent Beneficiary: Aperture Medical Technology, Publicly Traded Stocks: Johnson & Johnson, Poseidx Therapeutics, Motus GI, Sientra, Avadel, Lantheus. PS: Employee: Johnson & Johnson, Publicly Traded Stocks: Johnson & Johnson. SITC staff members SMW, CG, AK, NL, EG and KJ have no disclosures.

Figures

**Figure 1**
Intratumoral drug deposition. (A) Examples of poor intratumoral drug deposition. (B) Example of simple solutions to improve delivery. Percutaneous delivery using a conventional end-hole needle led to minimal drug deposition within the tumor (B1). Repeat injection was performed using a multipronged needle (B2). Injection via multipronged needle led to substantial improvement in intratumoral drug delivery (B3).

**Figure 2**
Variables affecting injection technique. (A) Ultrasound images demonstrating vascularity of a tumor-containing LN. (B) Liver metastasis with gray scale (B1) and contrast-enhanced (B2) ultrasound revealing hypervascularity relative to liver parenchyma. (C) Liver metastases with extensive internal necrosis. (D) LN with gray scale and contrast-enhanced ultrasound. Gray scale (D1) and contrast-enhanced (D2) ultrasounds of a subcutaneous LN demonstrating an arterially enhanced, without parenchymal washout, LN (white arrows) and a non-enhanced, likely necrotic LN (yellow arrows). LN, lymph node.

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References

1. Andtbacka RHI, Kaufman HL, Collichio F, et al. . Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol 2015;33:2780–8. 10.1200/JCO.2014.58.3377 - DOI - PubMed
1. Chesney JA, Ribas A, Long GV, et al. . Randomized, double-blind, placebo-controlled, global phase III trial of talimogene laherparepvec combined with pembrolizumab for advanced melanoma. J Clin Oncol 2023;41:528–40. 10.1200/JCO.22.00343 - DOI - PMC - PubMed
1. Idera Pharmaceuticals, Inc . Idera pharmaceuticals announces results from illuminate-301 trial of Tilsotolimod + Ipilimumab in anti-PD-1 refractory advanced Melanoma. news release; 2021.
1. Oncosec Immunotherapies . Oncosec announces clinical data of the KEYNOTE-695 trial assessing TAVO-EP in combination with KEYTRUDA (Pembrolizumab) in patients with advanced melanoma refractory to anti-PD-1 treatment. press release; 2023.
1. Sakhiya J, Sakhiya D, Kaklotar J, et al. . Intralesional agents in dermatology: pros and cons. J Cutan Aesthet Surg 2021;14:285–95. 10.4103/JCAS.JCAS_109_20 - DOI - PMC - PubMed

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[1] Andtbacka RHI, Kaufman HL, Collichio F, et al. . Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol 2015;33:2780–8. 10.1200/JCO.2014.58.3377 - DOI - PubMed

[2] Andtbacka RHI, Kaufman HL, Collichio F, et al. . Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol 2015;33:2780–8. 10.1200/JCO.2014.58.3377 - DOI - PubMed

[3] Chesney JA, Ribas A, Long GV, et al. . Randomized, double-blind, placebo-controlled, global phase III trial of talimogene laherparepvec combined with pembrolizumab for advanced melanoma. J Clin Oncol 2023;41:528–40. 10.1200/JCO.22.00343 - DOI - PMC - PubMed

[4] Chesney JA, Ribas A, Long GV, et al. . Randomized, double-blind, placebo-controlled, global phase III trial of talimogene laherparepvec combined with pembrolizumab for advanced melanoma. J Clin Oncol 2023;41:528–40. 10.1200/JCO.22.00343 - DOI - PMC - PubMed

[5] Idera Pharmaceuticals, Inc . Idera pharmaceuticals announces results from illuminate-301 trial of Tilsotolimod + Ipilimumab in anti-PD-1 refractory advanced Melanoma. news release; 2021.

[6] Idera Pharmaceuticals, Inc . Idera pharmaceuticals announces results from illuminate-301 trial of Tilsotolimod + Ipilimumab in anti-PD-1 refractory advanced Melanoma. news release; 2021.

[7] Oncosec Immunotherapies . Oncosec announces clinical data of the KEYNOTE-695 trial assessing TAVO-EP in combination with KEYTRUDA (Pembrolizumab) in patients with advanced melanoma refractory to anti-PD-1 treatment. press release; 2023.

[8] Oncosec Immunotherapies . Oncosec announces clinical data of the KEYNOTE-695 trial assessing TAVO-EP in combination with KEYTRUDA (Pembrolizumab) in patients with advanced melanoma refractory to anti-PD-1 treatment. press release; 2023.

[9] Sakhiya J, Sakhiya D, Kaklotar J, et al. . Intralesional agents in dermatology: pros and cons. J Cutan Aesthet Surg 2021;14:285–95. 10.4103/JCAS.JCAS_109_20 - DOI - PMC - PubMed

[10] Sakhiya J, Sakhiya D, Kaklotar J, et al. . Intralesional agents in dermatology: pros and cons. J Cutan Aesthet Surg 2021;14:285–95. 10.4103/JCAS.JCAS_109_20 - DOI - PMC - PubMed

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Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease

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Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease

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