MK-2870
Sponsors
Merck Sharp & Dohme LLC
Conditions
Advanced Urothelial CarcinomaAdvanced esophageal squamous cell carcinomaBreast Cancer: triple negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2 negative breast cancerColorectal cancer (CRC)Endometrial cancerGastroesophageal cancerHormone receptor positive breast cancerIIIA or IIIB (with nodal involvement [N2])
Phase 1
A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK‑3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B
RecruitingCTIS2023-505189-26-00
Start: 2023-03-28Target: 10Updated: 2025-11-18
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
Start: 2024-08-01Target: 20Updated: 2025-10-29
A Phase 1/2 Open-Label, Umbrella Platform Design Study of MK-2870 With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally
Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal
Adenocarcinoma): Substudy 06C
RecruitingCTIS2023-509307-33-00
Start: 2024-09-26Target: 26Updated: 2025-11-03
A Phase 1/2 Randomized, Umbrella Study to Evaluate the Efficacy and
Safety of MK-2870 Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab, as Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04C
Active, not recruitingCTIS2023-506387-14-00
Start: 2024-09-24Target: 29Updated: 2025-04-29
Protocol Title: KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
Not yet recruitingCTIS2024-512248-47-00
Target: 32Updated: 2026-03-05
Phase 2
Phase 3
A Randomized, Open-label, Phase 3 Study of MK-2870 vs Chemotherapy (Docetaxel or Pemetrexed) in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) with EGFR Mutations or Other Genomic Alterations
RecruitingCTIS2023-503539-16-00
Start: 2025-11-11Target: 104Updated: 2025-11-17
A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician’s Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (MK-2870-005/ENGOT-en23/GOG-3095)
Active, not recruitingCTIS2023-504816-14-00
Start: 2024-03-08Target: 378Updated: 2025-09-04
A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater than or Equal to 50% (TroFuse-007)
RecruitingCTIS2023-503376-24-00
Start: 2024-03-20Target: 196Updated: 2025-12-01
An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physician’s Choice in Participants with HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
RecruitingCTIS2023-504918-29-00
Start: 2024-08-22Target: 438Updated: 2026-01-26
A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery
RecruitingCTIS2023-508012-35-00
Start: 2024-10-02Target: 258Updated: 2025-12-19
A Phase 3, Multicenter, Open-label, Randomized Study to Compare the Efficacy and Safety of MK-2870 Versus Treatment of Physician’s Choice in 3L+ Advanced/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma)
RecruitingCTIS2023-505423-31-00
Start: 2024-08-08Target: 115Updated: 2025-08-20
A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician’s Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery
RecruitingCTIS2023-504962-52-00
Start: 2024-07-10Target: 616Updated: 2026-01-12
A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants with EGFR-mutated, Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors
RecruitingCTIS2023-504910-31-00
Start: 2024-07-15Target: 90Updated: 2025-08-04
A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer
RecruitingCTIS2023-510128-66-00
Start: 2024-09-02Target: 288Updated: 2025-12-19
A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse 022/ENGOT ov84/GOG-3103)
RecruitingCTIS2023-508015-23-00
Start: 2025-04-11Target: 235Updated: 2025-12-30
A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan in Combination with Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants with Mismatch Repair Proficient Endometrial Cancer (TroFuse-033/GOG-3119/ENGOT-en29)
RecruitingCTIS2024-519331-42-00
Start: 2025-08-22Target: 355Updated: 2025-10-28
A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC) or Hormone Receptor-low positive/HER2-negative Breast Cancer
RecruitingCTIS2024-520190-12-00
Start: 2025-11-10Target: 389Updated: 2026-01-19
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
Target: 317Updated: 2026-01-19