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KEYTRUDA 25 mg/mL concentrate for solution for infusion.

DRUG19 trials

Sponsors

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC), F. Hoffmann-La Roche AG, Janssen Cilag International, Merck Sharp & Dohme LLC, IRCCS Istituto Nazionale Tumori Fondazione Pascale

Conditions

Advanced Solid TumorAdvanced or Metastatic Nonsquamous NSCLCCancer (all types)Colorectal cancer (CRC)Gastric AdenocarcinomaGastric CancerGastroesophageal Junction AdenocarcinomaHead and Neck Squamous Cell Carcinoma

Phase 1

A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination with Other Anti-Cancer Therapies in Patients with Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer with a KRAS G12C Mutation
RecruitingCTIS2023-507171-22-00
F. Hoffmann-La Roche AGUntreated Advanced or Metastatic Non-Small Cell Lung Cancer
Start: 2023-06-21Target: 116Updated: 2025-10-27
A Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Other Therapeutic Agents in Participants with Head and Neck Squamous Cell Carcinoma OrigAMI-4
RecruitingCTIS2023-508418-40-00
Janssen Cilag InternationalHead and Neck Squamous Cell Carcinoma
Start: 2024-12-16Target: 55Updated: 2026-01-19
A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers
RecruitingCTIS2023-508703-21-00
Merck Sharp & Dohme LLCbiliary tract cancer (BTC), Colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC)
Start: 2024-08-01Target: 20Updated: 2025-10-29
An Open-Label, Multicenter, Phase 1 Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of TLN-372 as a Single Agent and in Combination with Other Anti-Tumor Agents, in Patients with Advanced KRAS Mutant Solid Tumors
Not yet recruitingCTIS2025-523086-22-00
Treeline Biosciences Inc.Locally advanced or metastatic solid tumors
Target: 20Updated: 2026-01-07
A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04–Substudy 04D
Not yet recruitingCTIS2025-522253-19-00
Merck Sharp & Dohme LLCUrothelial carcinoma
Target: 6Updated: 2026-02-03
A Phase 1/2 Trial of RPTR-1-201, a T Cell Receptor Bispecific Therapy, in Advanced Solid Tumors
Not yet recruitingCTIS2025-524010-28-00
Repertoire Immune Medicines Inc.Advanced Solid Tumor
Target: 52Updated: 2026-03-17

Phase 2

Immune-Related Rheumatological and neurological Adverse Events study (IRRAE study)
RecruitingCTIS2024-516631-27-00
Stichting Amsterdam UMCCancer (all types)
Start: 2023-05-05Target: 495Updated: 2026-01-22
Pembrolizumab plus Lenvatinib in vulvar cancer patients: The prospective, multi-cohorts and multicentre, phase 2 MITO VULVA-01 study.
Not yet recruitingCTIS2023-509180-24-00
IRCCS Istituto Nazionale Tumori Fondazione Pascalevulvar cancer
Target: 80Updated: 2025-09-30
A Phase II single arm open label study of Pembrolizumab and Lenvatinib in patients with high risk locally advanced cervix cancer: an EMBRACE high risk study initiative
Not yet recruitingCTIS2023-506982-73-00
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)high risk or poor response after chemoradiation and brachytherapy for locally advanced cervix cancer
Target: 20Updated: 2025-11-25
A Phase 1/2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects with Front-line Advanced NSCLC and Other Selected Indications
Not yet recruitingCTIS2025-522632-14-00
Synthekine Inc.Non-small cell lung cancer (NSCLC)
Target: 56Updated: 2026-01-13
A phase 2, three-arm, randomized study of the efficacy of intratumorally administered L19IL2 or L19TNF or L19IL2/L19TNF, all in combination with systemic anti-PD1 pembrolizumab, in stage III and IV unresectable melanoma patients with resistance to or progressing upon anti-PD1 checkpoint inhibitors and with presence of injectable metastases
Not yet recruitingCTIS2024-519326-20-00
Philogen S.p.A.Patients with diagnosis of unresectable clinical stage III or IV metastatic melanoma, subcutaneous or nodal lesions and resistant to or progressing upon anti-PD1 immunotherapy, with presence of injectable cutaneous
Target: 65Updated: 2026-01-15
KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
Not yet recruitingCTIS2025-521939-36-00
Merck Sharp & Dohme LLCAdvanced or Metastatic Nonsquamous NSCLC, Participants with KRAS G12C-Mutant
Target: 15Updated: 2026-02-25
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)
Not yet recruitingCTIS2025-520902-37-00
Merck Sharp & Dohme LLCNon-small cell lung cancer stage IV
Target: 15Updated: 2026-03-23

Phase 3

A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination with Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-positive
RecruitingCTIS2024-519773-19-00
Astellas Pharma Global Development Inc.Gastric Adenocarcinoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Start: 2025-07-31Target: 201Updated: 2026-01-26
A randomized, open-label, multicenter, Phase 3 trial of ivonescimab alone or ivonescimab with ligufalimab versus pembrolizumab for the first-line treatment of recurrent and/or metastatic head and neck squamous cell carcinoma(HNSCC)
Not yet recruitingCTIS2025-522996-27-00
Groupe Oncologie Radiotherapie Tete Courecurrent and/or metastatic squamous cell carcinoma of the head and neck
Target: 310Updated: 2025-12-19
A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)
Not yet recruitingCTIS2025-521514-26-00
Merck Sharp & Dohme LLCor Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1, Persistent, Recurrent
Target: 317Updated: 2026-01-19
PembroLizumab Adjuvant in patients with early-stage Triple NEgaTive breast cancer with residual disease after neoadjuvant pembrolizumab plus chemotherapy – the multicenter, randomized phase III, pragmatic PLANET trial
Not yet recruitingCTIS2025-524229-41-00
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingTriple negative breast cancer
Target: 1000Updated: 2026-04-01
A Phase 3 Multicenter, Randomized, Open-label Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab Versus Standard of Care in the First-line Treatment of Patients With Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC) With No Distant Metastases
Not yet recruitingCTIS2025-523017-28-00
Rakuten Medical Inc.Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC)
Target: 30Updated: 2026-04-03

Phase 4