Pembrolizumab
Head And Neck Squamous Cell Carcinoma
Explore 249 assets in Head And Neck Squamous Cell Carcinoma →Floatz Rating
BB66/100
Confidence
Indicative
Sponsor
UNC Lineberger Comprehensive Cancer Center
Modality
monoclonal_antibody
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
66High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT04266730CT.gov Trial of a Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine Concurrently With Pembrolizumab | — | Suspended | — | — | — |
NCT07623642CT.gov A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors. | — | Not Yet Recruiting | — | — | — |
NCT07218003CT.gov A Phase 1/1b of RNDO-564 Single Agent or in Combination With Pembrolizumab in Bladder Cancer and Other Solid Tumors Associated With Nectin-4 | — | Enrolling By Invitation | — | — | — |
NCT07227168CT.gov A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer | — | Recruiting | — | — | — |
NCT07106827CT.gov A Study of GV20-0251 in Advanced or Refractory Solid Tumors | — | Recruiting | — | — | — |
NCT07070518CT.gov Study of GV20-0251 in Participants With Solid Tumor Malignancies | — | Recruiting | — | — | — |
NCT05879484CT.gov Study of Front Line Pembrolizumab and Valemetostat in PD-L1 Positive, HPV-Negative Recurrent/Metastatic Squamous Cell Carcinoma (SCC) of the Head and Neck: The PANTHERAS | — | Withdrawn | — | — | — |
NCT06736379CT.gov Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer | — | Recruiting | — | — | — |
NCT06789172CT.gov A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors | — | Recruiting | — | — | — |
NCT06422403CT.gov A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers | — | Recruiting | — | — | — |
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NCT06545331CT.gov Study of XB010 in Subjects With Solid Tumors | — | Recruiting | — | — | — |
NCT05913388CT.gov GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma | — | Recruiting | — | — | — |
NCT05280314CT.gov Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors | — | Recruiting | — | — | — |
NCT06047379CT.gov Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis | — | Recruiting | — | — | — |
NCT06022757CT.gov Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19) | — | Recruiting | — | — | — |
NCT05877430CT.gov Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer | — | Recruiting | — | — | — |
NCT05985655CT.gov Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors | — | Recruiting | — | — | — |
NCT04987996CT.gov GR-MD-02 + Pembrolizumab Versus Pembrolizumab Monotherapy in Melanoma and Squamous Cell Head and Neck Cancer Patients | — | Withdrawn | — | — | — |
NCT05859074CT.gov A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer | — | Recruiting | — | — | — |
NCT05669430CT.gov A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies | — | Recruiting | — | — | — |
NCT05383170CT.gov A Study to Evaluate the Safety and Efficacy of CyPep-1 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic Cancers | — | Completed | — | — | — |
NCT05784688CT.gov Study of TU2218 in Combination With KEYTRUDA®(Pembrolizumab) in Patients With Advanced Solid Tumors | — | Recruiting | — | — | — |
NCT05714553CT.gov NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours | — | Terminated | — | — | — |
NCT06307093CT.gov Study Comparing the Pharmacokinetics, Safety, and Efficacy of RPH-075 and Keytruda® in Patients With Malignant Neoplasms | — | Unknown | — | — | — |
NCT05576077CT.gov A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors | — | Terminated | — | — | — |
NCT05653882CT.gov A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors | — | Active Not Recruiting | — | — | — |
NCT05585034CT.gov Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors | — | Completed | — | — | — |
NCT05544929CT.gov A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers | — | Active Not Recruiting | — | — | — |
NCT05208762CT.gov A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors | — | Recruiting | — | — | — |
NCT05581004CT.gov A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors | — | Recruiting | — | — | — |
NCT05620134CT.gov Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer | — | Active Not Recruiting | — | — | — |
NCT05393635CT.gov ITIL-168 in Advanced Solid Tumors | — | Withdrawn | — | — | — |
NCT05311618CT.gov Study of NGM438 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors | — | Unknown | — | — | — |
NCT05070247CT.gov A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors | — | Terminated | — | — | — |
NCT05077709CT.gov IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC | — | Completed | — | — | — |
NCT05329532CT.gov Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer | — | Recruiting | — | — | — |
NCT05215574CT.gov Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors | — | Active Not Recruiting | — | — | — |
NCT05269381CT.gov Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors | — | Recruiting | — | — | — |
NCT05234606CT.gov A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors | — | Withdrawn | — | — | — |
NCT05145907CT.gov Study to Evaluate Safety and Efficacy of TJ107 Combine With PD-1 in Patients With Solid Tumors | — | Unknown | — | — | — |
NCT05007106CT.gov MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) | — | Completed | — | — | — |
NCT04879849CT.gov A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers | — | Completed | — | — | — |
NCT05086692CT.gov A Beta-only IL-2 ImmunoTherapY Study | — | Recruiting | — | — | — |
NCT04815720CT.gov Pepinemab in Combination With Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck | — | Completed | — | — | — |
NCT04787042CT.gov Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067 | — | Recruiting | — | — | — |
NCT04913337CT.gov Study of NGM707 As Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies | — | Active Not Recruiting | — | — | — |
NCT04799054CT.gov A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors | — | Terminated | — | — | — |
NCT04609566CT.gov Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors | — | Completed | — | — | — |
NCT04305795CT.gov An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors | — | Active Not Recruiting | — | — | — |
NCT04357873CT.gov Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations | — | Completed | — | — | — |
NCT04489888CT.gov A Study of Pembrolizumab (MK-3475) Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (MK-3475-B10/KEYNOTE B10) | — | Completed | — | — | — |
NCT04452214CT.gov A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors | — | Completed | — | — | — |
NCT04370587CT.gov A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors | — | Recruiting | — | — | — |
NCT04555837CT.gov Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer | — | Completed | — | — | — |
NCT04114136CT.gov Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies | — | Recruiting | — | — | — |
NCT04428151CT.gov Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009) | — | Completed | — | — | — |
NCT04389632CT.gov A Study of Sigvotatug Vedotin in Advanced Solid Tumors | — | Recruiting | — | — | — |
NCT04429542CT.gov Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors | — | Recruiting | — | — | — |
NCT04348916CT.gov Study of ONCR-177 Alone and in Combination With PD-1 Blockade in Adult Subjects With Advanced and/or Refractory Cutaneous, Subcutaneous or Metastatic Nodal Solid Tumors or With Liver Metastases of Solid Tumors | — | Terminated | — | — | — |
NCT04344795CT.gov Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors | — | Completed | — | — | — |
NCT03993353CT.gov Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer | — | Completed | — | — | — |
NCT04354246CT.gov COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies | — | Completed | — | — | — |
NCT04220866CT.gov Study of Intratumoral (IT) Ulevostinag (MK-1454) in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002) | — | Completed | — | — | — |
NCT04007744CT.gov Sonidegib and Pembrolizumab in Treating Patients With Advanced Solid Tumors | — | Active Not Recruiting | — | — | — |
NCT04244552CT.gov A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies | — | Terminated | — | — | — |
NCT04144517CT.gov A Study of ALKS 4230 (Nemvaleukin Alfa) With Pembrolizumab in Head and Neck Cancer | — | Completed | — | — | — |
NCT04187872CT.gov LITT and Pembrolizumab in Recurrent Brain Metastasis | — | Terminated | — | — | — |
NCT04099277CT.gov A Study of LY3435151 in Participants With Solid Tumors | — | Terminated | — | — | — |
NCT04032704CT.gov A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors | — | Terminated | — | — | — |
NCT04083599CT.gov GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors | — | Active Not Recruiting | — | — | — |
NCT04060342CT.gov GB1275 Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma | — | Terminated | — | — | — |
NCT04234113CT.gov Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors | — | Terminated | — | — | — |
NCT03849469CT.gov A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors | — | Completed | — | — | — |
NCT03474497CT.gov UCDCC#272: IL-2, Radiotherapy, and Pembrolizumab in Patients Refractory to Checkpoint Blockade | — | Active Not Recruiting | — | — | — |
NCT03645928CT.gov Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors | — | Terminated | — | — | — |
NCT03789097CT.gov Vaccination With Flt3L, Radiation, and Poly-ICLC | — | Completed | — | — | — |
NCT03625323CT.gov Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC | — | Completed | — | — | — |
NCT03809624CT.gov Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer | — | Terminated | — | — | — |
NCT03476681CT.gov Study of NEO-201 in Solid Tumors Expansion Cohorts | — | Recruiting | — | — | — |
NCT03589339CT.gov NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy | — | Active Not Recruiting | — | — | — |
NCT03735290CT.gov A Study to Evaluate the Safety and Effectiveness of ILIxadencel Administered Into Tumors in Combination With Checkpoint Inhibitor (CPI) in Patients With ADvanced Cancer | — | Terminated | — | — | — |
NCT03684785CT.gov Intratumoral Cavrotolimod Combined With Pembrolizumab or Cemiplimab in Patients With Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors | — | Terminated | — | — | — |
NCT03228667CT.gov QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors | — | Active Not Recruiting | — | — | — |
NCT03621982CT.gov Study of ADCT-301 in Patients With Selected Advanced Solid Tumors | — | Terminated | — | — | — |
NCT03666273CT.gov Phase 1 Study of BAY1905254 - An Early Clinical Research Study to Evaluate a New Drug Called Bapotulimab (BAY1905254) in the Expansion Cohort in Combination With Pembrolizumab in Head and Neck Cancer That Has Returned or is Discovered to be Metastatic and is Expressing PDL1. | — | Completed | — | — | — |
NCT03633110CT.gov Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine | — | Completed | — | — | — |
NCT03236935CT.gov Phase Ib of L-NMMA and Pembrolizumab | — | Completed | — | — | — |
NCT03590054CT.gov Abexinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumor Malignancies | — | Completed | — | — | — |
NCT03485209CT.gov Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors | — | Active Not Recruiting | — | — | — |
NCT03556228CT.gov VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma | — | Recruiting | — | — | — |
NCT03526835CT.gov A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors | — | Recruiting | — | — | — |
NCT03454451CT.gov CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers | — | Completed | — | — | — |
NCT03265080CT.gov A Study of ADXS-NEO Expressing Personalized Tumor Antigens | — | Terminated | — | — | — |
NCT03383094CT.gov Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer | — | Active Not Recruiting | — | — | — |
NCT03229278CT.gov Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma | — | Completed | — | — | — |
NCT03049618CT.gov Recombinant EphB4-HSA Fusion Protein and Pembrolizumab, MK-3475 | — | Completed | — | — | — |
NCT02952989CT.gov A Safety Study of SGN-2FF for Patients With Advanced Solid Tumors | — | Terminated | — | — | — |
NCT02955290CT.gov CIMAvax Vaccine, Nivolumab, and Pembrolizumab in Treating Patients With Advanced Non-small Cell Lung Cancer or Squamous Head and Neck Cancer | — | Active Not Recruiting | — | — | — |
NCT02432963CT.gov Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy | — | Active Not Recruiting | — | — | — |
NCT02575404CT.gov GR-MD-02 Plus Pembrolizumab in Melanoma, Non-small Cell Lung Cancer, and Squamous Cell Head and Neck Cancer Patients | — | Completed | — | — | — |
NCT02644369CT.gov Study of the Effects of Pembrolizumab in Patients With Advanced Solid Tumors | — | Active Not Recruiting | — | — | — |
NCT02452424CT.gov A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors | — | Terminated | — | — | — |
NCT02376699CT.gov Safety Study of SEA-CD40 in Cancer Patients | — | Terminated | — | — | — |
NCT02252042CT.gov Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040) | — | Completed | — | — | — |
NCT02255097CT.gov Study of MK-3475 (Pembrolizumab) in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Treatment With Platinum-based and Cetuximab Therapy (MK-3475-055/KEYNOTE-055) | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Head And Neck Squamous Cell Carcinoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Pembrolizumab (this asset) | UNC Lineberger Comprehensive Cancer Center | Approved | BB · 66 |
| Cis-Diamminedichloroplatinum Ii | Akeso | P3 | BB |
| Carboplatin | Akeso | P4 | BB |
| Irinotecan | Neonc Technologies, Inc. | P2 | BB |
| Tisotumab Vedotin | Seagen, a wholly owned subsidiary of Pfizer | P2 | BB |
| Capecitabine | Merck Sharp & Dohme LLC | P2 | BB |
| Cyclophosphamide | UNC Lineberger Comprehensive Cancer Center | P4 | BB |
| Fluorouracilum | Akeso | P2 | BB |
| Lenvatinib | Salubris Biotherapeutics Inc | P2 | B |
+42 more in the Head And Neck Squamous Cell Carcinoma cohort
Other indications for Pembrolizumab
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Her2-Receptor Negative Breast Cancer | — | P2 | BBB · 72 |
| Estrogen-Receptor Negative Breast Cancer | — | P2 | BB · 71 |
| Progesterone-Receptor Negative Breast Cancer | — | P2 | BB · 71 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Pembrolizumab in Head And Neck Squamous Cell Carcinoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/pembrolizumab-head-and-neck-squamous-cell-carcinoma
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