KEYTRUDA®

DRUG12 trials

Sponsors

Genexine, Inc., Nouscom SRL, Daiichi Sankyo, Dragonfly Therapeutics, TILT Biotherapeutics Ltd.

Conditions

Advanced Solid TumorAdvanced or Metastatic NSCLCCarcinoma, Non-Small-Cell LungCervical CancerHead and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell CarcinomaLaryngeal CancerLaryngeal Neoplasms

Phase 1

The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer

CompletedNCT03444376

Genexine, Inc.Cervical Cancer

Start: 2018-06-19End: 2023-12-21Updated: 2025-07-30

Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors

Active, not recruitingNCT04041310

Nouscom SRLSolid Tumor, Adult

Start: 2019-10-21End: 2026-10-30Target: 115Updated: 2026-02-13

Datopotamab Deruxtecan (Dato-DXd) in Combination With Pembrolizumab With or Without Platinum Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung02)

Active, not recruitingNCT04526691

Daiichi SankyoAdvanced or Metastatic NSCLC

Start: 2020-09-15End: 2026-04-15Updated: 2025-05-20

Study of DF6215 in Patients With Advanced Solid Tumors

CompletedNCT06108479

Dragonfly TherapeuticsSolid Tumor, Adult, Solid Tumor Cancer

Start: 2023-11-28End: 2025-12-04Updated: 2026-03-18

Oncolytic Adenovirus TILT-123 With Pembrolizumab as Treatment for Refractory Non-Small Cell Lung Cancer

Active, not recruitingNCT06125197

TILT Biotherapeutics Ltd.Lung Cancer

Start: 2024-07-23End: 2026-05-30Target: 22Updated: 2025-12-23

Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab

RecruitingNCT06249048

Strand Therapeutics Inc.Advanced Solid Tumor

Start: 2024-05-03End: 2028-11-30Target: 108Updated: 2025-10-29

Study Comparing the Pharmacokinetics, Safety, and Efficacy of RPH-075 and Keytruda® in Patients With Malignant Neoplasms

Active, not recruitingNCT06307093

R-PharmHead and Neck Squamous Cell Carcinoma, Skin Melanoma, Squamous Non-small-cell Lung Cancer

Start: 2023-03-01End: 2025-07-31Updated: 2024-03-12

Phase 2

European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]

RecruitingNCT06137378

University of LeipzigHypopharyngeal Squamous Cell Carcinoma, Laryngeal Cancer, Laryngeal Neoplasms +9

Start: 2024-04-17End: 2030-12-31Target: 140Updated: 2024-09-20

Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination with Pembrolizumab, in Unresectable Melanoma Patients

RecruitingNCT06284590

Philogen S.p.A.Melanoma Stage III, Melanoma Stage IV

Start: 2024-07-12End: 2028-07-31Target: 162Updated: 2024-10-26

Phase 3

Study сomparing the Efficacy and Safety of RPH-075 and Keytruda® in Patients With Unresectable or Metastatic Skin Melanoma

Active, not recruitingNCT06320353

R-PharmSkin Melanoma

Start: 2023-09-27End: 2026-01-31Updated: 2024-03-20

A Study to Evaluate Efficacy, and Safety of QL2107 Plus Chemo and Compare With Keytruda in Participants With IV nqNSCLC

RecruitingNCT06754644

Qilu Pharmaceutical Co., Ltd.NSCLC

Start: 2025-01-15End: 2026-12-31Target: 808Updated: 2025-06-10

Pharmacokinetic Study of QL2107 Versus Keytruda® for Adjuvant Therapy of Non-Small Cell Lung Cancer (NSCLC)

Not yet recruitingNCT07162883

Qilu Pharmaceutical Co., Ltd.Carcinoma, Non-Small-Cell Lung

Start: 2025-09-01End: 2027-05-31Target: 122Updated: 2025-09-09

Related Papers

TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC).

Journal of Clinical Oncology2025-05-2811 citations

Phase I dose escalation trial of STX-001, an LNP-encapsulated self-replicating mRNA expressing IL-12, in patients (pts) with advanced solid tumors.

Journal of Clinical Oncology2025-05-281 citations

Results of phase III clinical trial of novel biosimilar of pembrolizumab (RPH-075).

Journal of Clinical Oncology2025-05-28

Abstract 6427: Nous-209 off-the-shelf neoantigen immunotherapy induces robust neoantigen T cell response with the potential to intercept cancer in Lynch syndrome carriers

Cancer Research2025-04-213 citations

Single intravenous administration of oncolytic adenovirus TILT-123 results in systemic tumor transduction and immune response in patients with advanced solid tumors.

2024-11-0610 citations

TROPION-Lung07: Phase III study of Dato-DXd + pembrolizumab ± platinum-based chemotherapy as 1L therapy for advanced non-small-cell lung cancer

Future Oncology2024-10-2911 citations

The European Larynx Organ Preservation Study [MK-3475-C44]

Frontiers in Oncology2024-08-226 citations

GX-188E DNA vaccine plus pembrolizumab in HPV 16- and/or 18-positive recurrent or advance cervical cancer: a phase 2 trial.

2024-07-1310 citations

Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC): Subgroup analysis from TROPION-Lung02.

Journal of Clinical Oncology2024-06-016 citations

A phase I trial of intratumoral STX-001: A novel self-replicating mRNA expressing IL-12 alone or with pembrolizumab in advanced solid tumors.

Journal of Clinical Oncology2024-06-015 citations

A phase 1/1b, first-in-human, multi-part study of DF6215, an engineered IL-2Rα-active agonist, to investigate the safety, tolerability, pharmacokinetics, and biological and clinical activity in patients with advanced solid tumors.

Journal of Clinical Oncology2024-06-011 citations

Abstract CT139: Immunological activity of oncolytic adenovirus encoding TNFα and IL-2 (TILT-123) in combination with pembrolizumab in platinum resistant or refractory ovarian cancer patients

Cancer Research2024-04-051 citations

Safety, Efficacy, and Biological Data of T-Cell–Enabling Oncolytic Adenovirus TILT-123 in Advanced Solid Cancers from the TUNIMO Monotherapy Phase I Trial

Clinical Cancer Research2024-03-2723 citations

1526 Nous-209 genetic vaccine encoding shared cancer neoantigens is safe and elicits robust immune response in healthy Lynch syndrome carriers: interim results from Phase 1 cancer interception trial

2023-10-315 citations

TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) in advanced non-small cell lung cancer (aNSCLC).

Journal of Clinical Oncology2023-06-0150 citations

Results of phase I-II bridging study for Nous-209, a neoantigen cancer immunotherapy, in combination with pembrolizumab as first line treatment in patients with advanced dMMR/MSI-h colorectal cancer.

Journal of Clinical Oncology2023-06-0116 citations

Abstract 2932: Datopotamab deruxtecan (Dato-DXd) enhances antitumor response to PD-1/PD-L1 inhibitors in TROP2-expressing tumors in mice

Cancer Research2023-04-044 citations

First clinical and immunogenicity results including all subjects enrolled in a phase I study of Nous-209, an off-the-shelf immunotherapy, with pembrolizumab, for the treatment of tumors with a deficiency in mismatch repair/microsatellite instability (dMMR/MSI).

Journal of Clinical Oncology2022-06-019 citations

Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab in treatment-naive advanced/metastatic (adv/met) non–small cell lung cancer (NSCLC) with PD-L1 ≥ 50% and without actionable genomic alterations.

Journal of Clinical Oncology2022-06-015 citations

410 Phase I interim study results of Nous-209, an off-the-shelf immunotherapy, with pembrolizumab, for the treatment of tumors with a deficiency in mismatch repair/microsatellite instability (dMMR/MSI)

Regular and Young Investigator Award Abstracts2021-11-0113 citations

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