Arfleyda (pembrolizumab biosimilar) / R-Pharm - LARVOL DELTA

TMV Vaccine Therapy Alone and With Pembrolizumab for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Emory University | Initiation date: Mar 2025 ➔ Jul 2025

Trial initiation date • Tumor mutational burden • Head and Neck Cancer • Hypopharyngeal Cancer • Laryngeal Cancer • Nasopharyngeal Carcinoma • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Carcinoma of Unknown Primary • Squamous Cell Skin Cancer

NRG GY020: Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment for Newly Diagnosed Early Stage High Intermediate Risk Endometrial Cancer (clinicaltrials.gov) - P3 | N=168 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Feb 2025 ➔ Dec 2025 | Trial primary completion date: Feb 2025 ➔ Dec 2025

dMMR • Mismatch repair • Trial completion date • Trial primary completion date • Carcinosarcoma • Endometrial Cancer • Oncology • Sarcoma • Solid Tumor • Uterine Cancer • MSI

Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Nov 2025 ➔ May 2025

Trial initiation date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • PD-L1

A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy of Treatment in Patients With Operable Melanoma (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Biomarker • Trial completion date • Trial primary completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF

Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial) (clinicaltrials.gov) - P=N/A | N=8300 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CTLA4 • PD-1 • PD-L1

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - P1 | N=32 | Suspended | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Suspended

Trial suspension • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PD-L1 • PGR

NCI-2021-13902: Testing the Addition of an Anti-cancer Drug, Ipatasertib, to the Usual Immunotherapy Treatment (Pembrolizumab) in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (clinicaltrials.gov) - P2 | N=52 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Enrollment closed • Head and Neck Cancer • Hypopharyngeal Cancer • Laryngeal Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Results of phase III clinical trial of novel biosimilar of pembrolizumab (RPH-075). (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT06320353 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • P3 data • Genetic Disorders • Melanoma • Oncology • Skin Cancer • Solid Tumor

SWOG S2001: Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations (clinicaltrials.gov) - P2 | N=88 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2025 ➔ Oct 2026 | Trial primary completion date: Mar 2025 ➔ Oct 2026

Trial completion date • Trial primary completion date • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • BRCA • BRCA1

NCI-2022-03215: Testing of Tazemetostat in Combination With Topotecan and Pembrolizumab in Patients With Recurrent Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: National Cancer Institute (NCI) | Suspended ➔ Recruiting | Trial completion date: Apr 2025 ➔ Apr 2027 | Trial primary completion date: Apr 2025 ➔ Apr 2027

Enrollment open • Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD4

Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment (clinicaltrials.gov) - P3 | N=158 | Recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Aug 2025 ➔ Mar 2025

Trial initiation date • Head and Neck Cancer • Hypopharyngeal Cancer • Laryngeal Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Carcinoma of Unknown Primary • Squamous Cell Skin Cancer

Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Roswell Park Cancer Institute | Initiation date: Apr 2025 ➔ Jul 2025

Trial initiation date • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • PD-L1

Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, the PARRC Trial (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: National Cancer Institute (NCI) | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2025 ➔ Dec 2025

Enrollment open • Trial initiation date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Testing the Safety and Efficacy of the Combination of the Antibody Pembrolizumab and Entinostat in Patients With Myelodysplastic Syndrome Who Are Not Responding to Hypomethylating Agents (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • CD4

SWOG S1404: Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery (clinicaltrials.gov) - P3 | N=1301 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jan 2025 ➔ Jan 2026

Trial completion date • Cutaneous Melanoma • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor • CD4

Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - P2 | N=161 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2025 ➔ Mar 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Tumor mutational burden • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

TMV Vaccine Therapy Alone and with Pembrolizumab for the Treatment of Recurrent And/or Metastatic Head and Neck Squamous Cell Cancer (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Emory University

New P1 trial • Tumor mutational burden • Head and Neck Cancer • Hypopharyngeal Cancer • Laryngeal Cancer • Nasopharyngeal Carcinoma • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Carcinoma of Unknown Primary • Squamous Cell Skin Cancer

Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Roswell Park Cancer Institute

New P2 trial • Tumor mutational burden • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • PD-L1

Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: National Cancer Institute (NCI) | Not yet recruiting ➔ Recruiting | Initiation date: Feb 2025 ➔ Nov 2025

Enrollment open • IO biomarker • Trial initiation date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • CD68 • CRP • PD-L1

SWOG 1512: Pembrolizumab in Treating Patients With Desmoplastic Melanoma That Can or Cannot Be Removed by Surgery (clinicaltrials.gov) - P2 | N=57 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jan 2025 ➔ May 2026

IO biomarker • Trial completion date • Tumor mutational burden • Melanoma • Oncology • Solid Tumor • CD4 • CD8 • TMB

Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy (clinicaltrials.gov) - P1 | N=25 | Not yet recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Oct 2025 ➔ Jun 2027 | Trial primary completion date: Oct 2025 ➔ Jun 2027

IO biomarker • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • CD68 • CRP • PD-L1

Enfortumab Vedotin and Pembrolizumab With Cystectomy and/or Ureterectomy for Locally Advanced or Metastatic Bladder and Upper Urothelial Tract Cancer, CAST-AI Trial (clinicaltrials.gov) - P4 | N=75 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

NCI-2019-08626: BLAST MRD AML-1: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Intensive Chemotherapy as Frontline Therapy in Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - P2 | N=48 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jul 2025 ➔ Jan 2026 | Trial primary completion date: Jul 2025 ➔ Nov 2024

IO biomarker • Trial completion date • Trial primary completion date • Tumor mutational burden • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • CD47 • CD8 • FOXP3 • GZMB • PD-1 • PD-L1 • TMB

BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Aug 2025 ➔ Jan 2026

IO biomarker • Trial completion date • Tumor mutational burden • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • CD8 • FOXP3 • GZMB • IFNG • PD-1 • PD-L1

Pembrolizumab in Treating Younger Patients With Recurrent, Progressive, or Refractory High-Grade Gliomas, Diffuse Intrinsic Pontine Gliomas, Hypermutated Brain Tumors, Ependymoma or Medulloblastoma (clinicaltrials.gov) - P1 | N=110 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2026 ➔ Dec 2025 | Trial primary completion date: Dec 2026 ➔ Dec 2025

Trial completion date • Trial primary completion date • Tumor mutational burden • Brain Cancer • CNS Tumor • Diffuse Intrinsic Pontine Glioma • Ependymoma • Genetic Disorders • Glioma • Malignant Glioma • Medulloblastoma • Oncology • Solid Tumor • PD-L1 • TMB