Pembrolizumab (Immunotherapy Drug) in Combination With Guadecitabine and Mocetinostat (Epigenetic Drugs) for Patients With Advanced Lung Cancer.
NCT03220477 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2025-08-06
Summary
The purpose of this study is to test the safety of a combination of three drugs, pembrolizumab, guadecitabine and mocetinostat. Pembrolizumab is a drug given by vein and all patients will receive the same dose. Guadecitabine and mocetinostat will be given at different doses to find out what effects, if any, they have on treating your cancer and side effects.
Conditions
Interventions
- DRUG
-
Pembrolizumab will be administered at 200mg IV on day 1 of each 21 day cycle.
- DRUG
-
Guadecitabine
Guadecitabine will be administered subcutaneously given daily on days 1-5 of each cycle with escalating doses by cohort.
- DRUG
-
Mocetinostat
Mocetinostat will be administered orally with escalating doses on days 8, 10, 13, 15, 17 and 20 of each cycle with escalating doses by cohort.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Astex Pharmaceuticals, Inc.
collaborator INDUSTRY -
Mirati Therapeutics Inc.
collaborator INDUSTRY -
Stand Up To Cancer
collaborator OTHER -
Van Andel Research Institute
collaborator OTHER -
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Kathryn Arbour, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-08-04
- Primary Completion
- 2026-07-31
- Completion
- 2026-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604)
NCT03066778 ·Status: COMPLETED ·Phase: PHASE3
-
Pembrolizumab + Platinum Doublets Without Radiation for Programmed Death-ligand 1 (PD-L1) ≥50% Locally Advanced NSCLC
NCT04153734 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024)
NCT02142738 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)
NCT03425643 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799)
NCT03631784 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)
NCT02578680 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)
NCT05722015 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Study of Pembrolizumab (MK-3475) in Participants With Advanced Non-small Cell Lung Cancer (MK-3475-025/KEYNOTE-025)
NCT02007070 ·Status: COMPLETED ·Phase: PHASE1
-
Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008)
NCT05224141 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
NCT05226598 ·Status: COMPLETED ·Phase: PHASE3
-
Biomarkers of Response to Pembrolizumab Combined With Chemotherapy in Non-Small Cell Lung Cancer (KEYNOTE-782, MK-3475-782)
NCT03664024 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Epacadostat (INCB024360) Alone and In Combination With Pembrolizumab (MK-3475) With Chemotherapy and Pembrolizumab Without Chemotherapy in Participants With Advanced Solid Tumors (MK-3475-434)
NCT02862457 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598)
NCT03302234 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)
NCT04956692 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05)
NCT03322540 ·Status: COMPLETED ·Phase: PHASE2
-
Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer
NCT04533451 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)
NCT03829319 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407)
NCT02775435 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)
NCT01905657 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small Cell Lung Cancer After Resection With or Without Standard Adjuvant Therapy (MK-3475-091/KEYNOTE-091)
NCT02504372 ·Status: COMPLETED ·Phase: PHASE3
-
Pembrolizumab in Combination With Plinabulin and Docetaxel For Metastatic NSCLC After ICIs (KeyPemls-004)
NCT05599789 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)
NCT03337698 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Ramucirumab and Pembrolizumab Versus Standard of Care in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Non-Match Treatment Trial)
NCT03971474 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)
NCT04938817 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Pembrolizumab and Trametinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer and KRAS Gene Mutations
NCT03299088 ·Status: COMPLETED ·Phase: PHASE1