pembrolizumab biosimilar (QL2107) / Qilu Pharma - LARVOL DELTA

Adding a Probiotic (CBM588) to Pembrolizumab for the Treatment of Renal Cell Cancer After Surgery (clinicaltrials.gov) - P2 | N=62 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Sarcoma • Solid Tumor • CXCL8

Diclofenac for the Treatment of Patients With Metastatic Non-small Cell Lung Cancer on Single Agent Immunotherapy (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Emory University | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

GT103 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic STK11 Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=28 | Not yet recruiting | Sponsor: Roswell Park Cancer Institute

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Darolutamide Alone or in Combination With Standard Therapy Before Surgery for the Treatment of Stage II-IIIA, Androgen Receptor Positive, Triple-Negative Breast Carcinoma (clinicaltrials.gov) - P2 | N=51 | Not yet recruiting | Sponsor: Vandana Abramson

New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Dec 2025 ➔ Jun 2025

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

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) | Trial completion date: Jun 2025 ➔ Jun 2027 | Trial primary completion date: Jun 2025 ➔ Jun 2027

Trial completion date • Trial primary completion 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 • PD-L1

A Study to Evaluate Efficacy, and Safety of QL2107 Plus Chemo and Compare With Keytruda in Participants With IV nqNSCLC (clinicaltrials.gov) - P3 | N=808 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | N=464 ➔ 808

Enrollment change • Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ETCTN 10183: Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • PD-L1

KEYNOTE-868: Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer (clinicaltrials.gov) - P3 | N=813 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Apr 2029 ➔ May 2026

dMMR • pMMR • Trial completion date • Carcinosarcoma • Endometrial Adenocarcinoma • Endometrial Cancer • Endometrial Serous Adenocarcinoma • Oncology • Sarcoma • Solid Tumor • Uterine Cancer

Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: NRG Oncology | Trial completion date: Jun 2032 ➔ Jun 2028

IO biomarker • Trial completion date • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer (clinicaltrials.gov) - P2 | N=32 | Recruiting | Sponsor: OHSU Knight Cancer Institute | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2024 ➔ Apr 2025

Enrollment open • IO biomarker • Trial initiation date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • PD-L1

External Beam Radiation Therapy and Brachytherapy With Chemotherapy and Immunotherapy for the Treatment of Stage IVB Cervical Cancer (clinicaltrials.gov) - P1/2 | N=35 | Not yet recruiting | Sponsor: Jonsson Comprehensive Cancer Center | Trial completion date: Jan 2031 ➔ Jan 2032 | Initiation date: Jan 2025 ➔ Jan 2026 | Trial primary completion date: Jan 2030 ➔ Jan 2031

Trial completion date • Trial initiation date • Trial primary completion date • Cervical Adenocarcinoma • Cervical Cancer • Cervical Squamous Cell Carcinoma • Oncology • Solid Tumor • Squamous Cell Carcinoma

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

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

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

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

A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination With Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation (clinicaltrials.gov) - P1/2 | N=240 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1/2 trial • Solid Tumor • KRAS

Combination of QLS31905, QL2107 and Chemotherapy as First-line Therapy in CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P2 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology

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

QLP2117-201: A Study of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients (clinicaltrials.gov) - P1/2 | N=90 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1/2 trial • Oncology • Solid Tumor

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