2023-509307-33-00
Recruiting
Phase 1/2
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
Merck Sharp & Dohme LLC12 sites in 4 countries26 target enrollmentStarted: August 13, 2024Last updated:
Interventions-
Overview
- Phase
- Phase 1/2
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 26
- Locations
- 12
- Primary Endpoint
- Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
Overview
Brief Summary
- Safety Lead-In Phase: To evaluate the safety and tolerability of MK-2870 plus pembrolizumab plus chemotherapy.
- To estimate the ORR as assessed by BICR per RECIST 1.1 for selected dose.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Has histologically and/or cytologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic 1L gastroesophageal adenocarcinoma
- •Who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization
- •Who has history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
- •Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
- •Is not expected to require tumor resection during the treatment course
- •Has gastroesophageal adenocarcinoma that is not human epidermal growth factor receptor 2 (HER2)/neu positive
- •Has provided an archival tumor tissue sample or most recently obtained core, or incisional, or excisional biopsy for a tumor lesion
- •Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤ Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible
- •Has adequate organ function
- •Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by the local site investigator/radiology assessment and verified by blind independent review committee (BICR)
Exclusion Criteria
- •Has squamous cell or undifferentiated gastroesophageal cancer
- •Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- •Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- •Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ/esophageal adenocarcinoma
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Has Severe hypersensitivity (≥Grade 3) to pembrolizumab, sacituzumab tirumotecan, or other biologic therapy, chemotherapy (ie, oxaliplatin, fluorouracil, capecitabine), leucovorin, levoleucovorin, or any of their excipients
- •Has active autoimmune disease that has required systemic treatment in the past 2 years
- •Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •Has an active infection requiring systemic therapy
- •Has concurrent active hepatitis B (defined as Hepatitis B surface antigen [HBsAg] positive and/or detectable HBV DNA) and hepatitis C virus (defined as anti-hepatitis C virus [HCV] Ab positive and detectable HCV ribonucleic acid [RNA] infection
Arms & Interventions
-
Auxiliary
Participants receiving -
Intervention: - (Drug)
Outcomes
Primary Outcomes
Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
Safety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE)
Safety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE)
Safety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE
Safety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blind Independent Review Committee (BICR)
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blind Independent Review Committee (BICR)
Secondary Outcomes
- Number of Participants Who Discontinue Study Treatment Due to an AE
- Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR
- Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
- Overall Survival (OS)
- Number of Participants Who Experience an Adverse Event (AE)
- Incidence of Antidrug Antibodies (ADA) to sacituzumab tirumotecan (sac-TMT, MK-2870)
Investigators
Sucharita Bhaumik
Scientific
Merck Sharp & Dohme LLC
Study Sites (12)
Loading locations...
Similar Trials
Completed
Phase 3
Pembrolizumab with Lenvatinib versus Docetaxel for Metastatic NSCLC after Platinum Doublet Chemotherapy and Immunotherapy2022-501439-18-00Merck Sharp & Dohme LLC206
Active, not recruiting
Phase 3
A study of MK7684A versus Pembrolizumab in PD-L1 Positive Metastatic NSCLC (KEYVIBE-003)2023-505362-28-00Merck Sharp & Dohme LLC156
Recruiting
Phase 2
A Trial to Determine The Safety and Efficacy of CC-92480 Alone and When Combined With Dexamethasone in People Who Have Myeloma That is Not Responsive After Treatment or Who Had Myeloma Which Has Returned After a Period of Treatment2023-508727-12-00Celgene Corp.46
Active, not recruiting
Phase 3
A Phase 3 randomized clinical Study of Pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen as first line treatment for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma2024-512015-47-00Incyte Corp.42
Completed
Not Applicable
An Autologous NK/CIK Cell Product (PB101) in Combination With EGFR-TKI for Treating Lung CancerNCT07271446Precision Biotech Taiwan Corp.8