Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in HER2 Positive Advanced Gastric or GEJ Adenocarcinoma
- Conditions
- Gastric or gastroesophageal junction (GEJ) adenocarcinoma
- Registration Number
- 2023-508253-98-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
1. To compare progression-free survival (PFS) between treatment groups.
2. To compare overall survival (OS) between treatment groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Not specified
- Target Recruitment
- 167
Histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) positive gastric or gastroesophageal junction (GEJ) adenocarcinoma
HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with in-situ hybridization positive (ISH+) or fluorescent in-situ hybridization (FISH), as assessed by central review on primary or metastatic tumor
Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the site investigator
Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of trial treatment
Has a life expectancy of greater than 6 months
Has adequate organ function
Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ cancer
Has an active infection requiring systemic therapy
Has poorly controlled diarrhea
Accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment. If the participant is receiving diuretic drugs for other reasons, it is acceptable
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has peripheral neuropathy > Grade 1
Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
A WOCBP who has a positive urine pregnancy test within 24 hours prior to randomization or treatment allocation
Has active or clinically significant cardiac disease
Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
Has had major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment
Has severe hypersensitivity (≥Grade 3) to pembrolizumab, trastuzumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum-containing products
Has had an allogeneic tissue/solid organ transplant
Has received prior therapy with an anti-programmed cell death1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-programmed cell death-ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, Cluster of Differentiation 137 [CD137])
Has had radiotherapy within 14 days of randomization
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
Has a known history of active tuberculosis (TB; Mycobacterium tuberculosis)
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) per RECIST 1.1 assessed by Blinded Independent Central Review (BICR) Progression-Free Survival (PFS) per RECIST 1.1 assessed by Blinded Independent Central Review (BICR)
Overall Survival (OS) Overall Survival (OS)
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) per RECIST 1.1 assessed by BICR Objective Response Rate (ORR) per RECIST 1.1 assessed by BICR
Duration of Response (DOR) per RECIST 1.1 assessed by BICR Duration of Response (DOR) per RECIST 1.1 assessed by BICR
Number of Participants Who Experience an Adverse Event (AE) Number of Participants Who Experience an Adverse Event (AE)
Number of Participants Who Discontinue Study Treatment Due to an AE Number of Participants Who Discontinue Study Treatment Due to an AE
Trial Locations
- Locations (31)
Centre Leon Berard
🇫🇷Lyon, France
Centre Oscar Lambret
🇫🇷Lille, France
CHU De Rouen
🇫🇷Rouen Cedex, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Centre Hospitalier Regional Et Universitaire De Brest
🇫🇷Brest, France
Hopital Saint Antoine
🇫🇷Paris Cedex 12, France
Besancon University Hospital Center
🇫🇷Besancon Cedex, France
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
🇵🇱Warsaw, Poland
Szpitale Pomorskie Sp. z o.o.
🇵🇱Gdynia, Poland
Beskidzkie Centrum Onkologii Szpital Miejski Im. Jana Pawla II W Bielsku-Bialej
🇵🇱Bielsko-Biala, Poland
Scroll for more (21 remaining)Centre Leon Berard🇫🇷Lyon, FranceClelia CoutzacSite contact+33478785992Clelia.coutzac@lyon.unicancer.fr