MK-3475

Phase 2Small molecule

Pfizer

MK-3475 is one of 421 small molecule programs targeting Esophageal Squamous Cell Carcinoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

420

Competitors

Pipeline

Status by Indication[3][1]

Indication

Esophageal Squamous Cell CarcinomaActive, not recruiting

Lung CancerActive, not recruiting

T-Cell Non-Hodgkin LymphomaActive, not recruiting

Ovarian Squamous Cell CarcinomaActive, not recruiting

Thymic CarcinomaActive, not recruiting

Metastatic MelanomaActive, not recruiting

Malignant GliomaActive, not recruiting

Endometrial CarcinomaActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Breast CancerActive, not recruiting

Esophageal Squamous Cell CarcinomaPhase 2

Active, not recruiting

Lung CancerPhase 1

Active, not recruiting

T-Cell Non-Hodgkin LymphomaPhase 1/Phase 2

Active, not recruiting

Ovarian Squamous Cell CarcinomaPhase 2

Active, not recruiting

Thymic CarcinomaPhase 2

Active, not recruiting

Metastatic MelanomaPhase 1/Phase 2

Active, not recruiting

Malignant GliomaPhase 1/Phase 2

Active, not recruiting

Endometrial CarcinomaPhase 1

Active, not recruiting

Non-Small Cell Lung CancerPhase 1/Phase 2

Active, not recruiting

Breast CancerPhase 1/Phase 2

Active, not recruiting

Showing 10 of 16 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

MK-3475

Pfizer

Phase 2

1 2

Adriamycin

GGynecologic Oncology Group

Preclinical

87 3

Gemzar

GGynecologic Oncology Group

Preclinical

22 4

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 5

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 6

Nubain

AAultman Health Foundation

Preclinical

1 7

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 8

Vfend

PPrism Pharmaceuticals

Preclinical

—9

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Preclinical

1 10

Beta Blocker

WWeill Medical College of Cornell University

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1Active, not recruiting

Glioblastoma

NCT02852655

Q4 2026

Phase 1/2Active, not recruiting

Non-Small Cell Lung Cancer

NCT02422381

Q3 2027

Phase 2Recruiting

Radiation Therapy

NCT05879653

Q2 2028

Phase 2Active, not recruiting

Ovarian Squamous Cell Carcinoma

NCT05737199

Phase 2Recruiting

Thymic Carcinoma

NCT05832827

Clinical

Trials by Indication[1]

Pembrolizumab3 trials

Study of MK-3475 (Pembrolizumab) in Patients With Microsatellite Unstable (MSI) Tumors (Cohort D)

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT04098068·12 enrolled

Reirradiation With Pembrolizumab in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck

Completed·DDan Zandberg·Phase 2·NCT02289209·48 enrolled

Optimal Sequencing of Pembrolizumab (MK-3475) and Standard Platinum-based Chemotherapy in First-Line NSCLC

Completed·AAlliance Foundation Trials, LLC.·Phase 2·NCT02591615·91 enrolled

Non-Small Cell Lung Cancer3 trials

Pembrolizumab + Imprime PGG for Metastatic Non-small Cell Lung Cancer After Progression on First-Line Therapy: Big Ten Cancer Research Consortium BTCRC-LUN15-017

Completed·UUnknown Sponsor·Phase 1/2·NCT03003468·35 enrolled

MK-3475 and Gemcitabine in Non-Small Cell Lung Cancer (NSCLC)

Active, not recruiting·PProvidence Health & Services·Phase 1/2·NCT02422381·16 enrolled

MK-3475 in Combination With Docetaxel vs Docetaxel Alone in Non-Small Cell Lung Cancer Patients

Completed·IInstituto Nacional de Cancerologia de Mexico·Phase 2·NCT02574598·78 enrolled

Melanoma2 trials

Treatment of Advanced Melanoma With MK-3475 and Peginterferon

Completed·HHassane M. Zarour, MD·Phase 1·NCT02112032·43 enrolled

MK-3475 in Melanoma and NSCLC Patients With Brain Metastases

Completed·YYale University·Phase 2·NCT02085070·65 enrolled

Glioblastoma2 trials

Evaluation Of The Treatment Effectiveness Of Glioblastoma / Gliosarcoma Through The Suppression Of The PI3K/Akt Pathway In Compared With MK-3475

Unknown status·MMedical Research Council·Phase 1/2·NCT02430363·58 enrolled

A Pilot Surgical Trial To Evaluate Early Immunologic Pharmacodynamic Parameters For The PD-1 Checkpoint Inhibitor, Pembrolizumab (MK-3475), In Patients With Surgically Accessible Recurrent/Progressive Glioblastoma

Active, not recruiting·—·Phase 1·NCT02852655·60 enrolled

Renal Cell Carcinoma2 trials

Phase Ib and Phase II Studies of MK-3475 in Combination + for Renal Cell Carcinoma:

Completed·—·Phase 1/2·NCT02348008·61 enrolled

Safety and Efficacy Study of Pazopanib and MK 3475 in Advanced Renal Cell Carcinoma (RCC; KEYNOTE-018)

Completed· Novartis logo

Novartis·Phase 1·NCT02014636·42 enrolled

20 more indications

Multiple Myeloma2 trials

Phase 2 Multi-center Study of Anti-PD-1 During Lymphopenic State After HDT/ASCT for Multiple Myeloma

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT02331368·32 enrolled

1454GCC: Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma

Terminated·AAshraf Badros·Phase 1/2·NCT02289222·48 enrolled

Metastatic Melanoma1 trial

Evaluating the Combination of MK-3475 and Sterotactic Body Radiotherapy in Patients With Metastatic Melanoma or NSCLC

Completed·YYale University·Phase 1/2·NCT02407171·61 enrolled

Lung Cancer1 trial

Radiation Therapy and MK-3475 for Patients With Recurrent/Metastatic Head and Neck Cancer, Renal Cell Cancer, Melanoma, and Lung Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1·NCT02318771·41 enrolled

T-cell non-Hodgkin lymphoma1 trial

Study of MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma

Terminated·FFox Chase Cancer Center·Phase 1/2·NCT02535247·17 enrolled

Renal Cell Cancer1 trial

A Dose Finding Study To Evaluate Safety, Drug Interaction, Tumor Markers Of Axitinib In Combination With MK-3475 In Adult Patients With Previously Untreated Advanced Renal Cell Cancer

Completed· Pfizer logo

Pfizer·Phase 1·NCT02133742·52 enrolled

Colorectal Cancer1 trial

A Study of Enhancing Response to MK-3475 in Advanced Colorectal Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT02512172·27 enrolled

Thymic Carcinoma1 trial

First-line CBDCA/PTX/LEN/Pembrolizumab Combination for Previously Untreated Advanced or Recurrent Thymic Carcinomas (Artemis)

Recruiting·NNational Cancer Center, Japan·Phase 2·NCT05832827·35 enrolled

Malignant Glioma1 trial

MK-3475 in Combination With MRI-guided Laser Ablation in Recurrent Malignant Gliomas

Completed·WWashington University School of Medicine·Phase 1/2·NCT02311582·55 enrolled

Tumors1 trial

Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors (Cohorts A, B and C)

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT01876511·113 enrolled

Efficacy1 trial

Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers

Completed· Incyte logo

Incyte·Phase 1/2·NCT02178722·444 enrolled

Chemotherapy1 trial

Phase I Study MK-3475 With Chemotherapy in Patients With Advanced GI Cancers

Terminated·UUniversity of Utah·Phase 1·NCT02268825·39 enrolled

Breast Cancer1 trial

Anti-PD-1 Monoclonal Antibody in Advanced, Trastuzumab-resistant, HER2-positive Breast Cancer

Completed·EETOP IBCSG Partners Foundation·Phase 1/2·NCT02129556·58 enrolled

Anti-PD-1 Antibody1 trial

Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475

Completed·PPeter MacCallum Cancer Centre, Australia·Phase 1·NCT02303366·15 enrolled

Radiation Therapy1 trial

Pembrolizumab and EV With Radiation Therapy for MIBC Patients (PEVRAD)

Recruiting·—·Phase 2·NCT05879653·30 enrolled

Endometrial Carcinoma1 trial

MK-3475 Immunotherapy in Endometrial Carcinoma

Completed·WWashington University School of Medicine·Phase 1·NCT02630823·10 enrolled

Patients With Solid Tumors1 trial

A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)

Completed· Pfizer logo

Pfizer·Phase 1·NCT02179918·23 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma

Completed·WWashington University School of Medicine·Phase 2·NCT02296684·67 enrolled

Nab-paclitaxel1 trial

Carboplatin/Nab-Paclitaxel and Pembrolizumab in NSCLC

Terminated·NNisha Mohindra, MD·Phase 1/2·NCT02382406·46 enrolled

Esophageal Squamous Cell Carcinoma1 trial

Preoperative Chemoradiotherapy and MK-3475 for Esophageal Squamous Cell Carcinoma (ACTS-29)

Completed·YYonsei University·Phase 2·NCT02844075·28 enrolled

Ovarian Squamous Cell Carcinoma1 trial

Assessment of the Efficacy and Safety of Pembrolizumab for Ovarian Squamous Cell Carcinoma

Active, not recruiting·NNiigata University Medical & Dental Hospital·Phase 2·NCT05737199·21 enrolled

Sources

References

[1]
ClinicalTrials.gov — 33 trial records for MK-3475. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — MK-3475 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for MK-3475. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Pfizer

MK-3475

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q3 2027

Q2 2028

Trials by Indication[1]

Pembrolizumab3 trials

Non-Small Cell Lung Cancer3 trials

Melanoma2 trials

Glioblastoma2 trials

Renal Cell Carcinoma2 trials

Multiple Myeloma2 trials

Metastatic Melanoma1 trial

Lung Cancer1 trial

T-cell non-Hodgkin lymphoma1 trial

Renal Cell Cancer1 trial

Colorectal Cancer1 trial

Thymic Carcinoma1 trial

Malignant Glioma1 trial

Tumors1 trial

Efficacy1 trial

Chemotherapy1 trial

Breast Cancer1 trial

Anti-PD-1 Antibody1 trial

Radiation Therapy1 trial

Endometrial Carcinoma1 trial

Patients With Solid Tumors1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Nab-paclitaxel1 trial

Esophageal Squamous Cell Carcinoma1 trial

Ovarian Squamous Cell Carcinoma1 trial

References

Drug Info

Quick Facts

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