2023-509307-33-00招募中2 期
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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 12
- 主要终点
- Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
研究概览
简要总结
- 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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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)
- •Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 3 days before allocation/randomization
- •Has a life expectancy of at least 6 months
排除标准
- •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
- •Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study
- •Has received prior treatment with a trophoblast antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC)
- •Has GI obstruction, poor oral intake, or difficulty in taking oral medication
- •Has poorly controlled diarrhea
- •Has had a major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention
- •Has experienced weight loss >20% over 3 months before the first dose of study intervention
- •Has history of allogeneic tissue/solid organ transplant
- •Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
- •Has Grade >2 peripheral neuropathy
- •Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- •Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within 6 months preceding study intervention
- •Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment
- •Has received prior treatment with a topoisomerase I inhibitor-based ADC and/or a topoisomerase I inhibitor-based chemotherapy
- •HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
- •Have not adequately recovered from major surgery or have ongoing surgical complications
- •Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
- •Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1), anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (TCR)
- •Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids
- •Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- •Has received a strong inducer/inhibitor of CYP3A4 that cannot be discontinued
- •Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
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)
次要结局
- 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)
研究者
Sucharita Bhaumik
Scientific
Merck Sharp & Dohme LLC
研究点 (12)
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