A Phase II study of Pembrolizumab in Previously Treated Subjects with Advanced/Metastatic Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus
- Conditions
- Esophageal CarcinomaMedDRA version: 18.1 Level: PT Classification code 10030155 Term: Oesophageal carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002427-26-FR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Subjects must:
- Be = 18 years of age on the day of signing the informed consent.
- Have an ECOG performance status of 0 or 1.
- Have a life expectancy greater than 3 months.
- Have histologically proven advanced/metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the EGJ.
- Have experienced documented objective radiographic or clinical disease progression during or after receiving two lines of locally or globally recommended therapies.
- Have measurable disease based on RECIST 1.1 as determined by central imaging vendor assessment.
- Provide a tissue sample for intratumoral immune-related GEP and PD-L1 by Immunohistochemistry analysis.
- Have demonstrated adequate organ function.
- Negative pregnancy test for females of child bearing potential prior to starting study and male and female subjects of childbearing potential must be willing to use an adequate method of contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
The subject will be excluded from participating in the trial if the subject:
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of treatment.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has had prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to a previously administered agent.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or if the subject has previously participated in Merck pembrolizumab (MK-3475) clinical trials.
- Has a diagnosed additional malignancy within 5 years prior to treatment allocation with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancers.
- Has received a live vaccine within 30 days of planned start of study therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has known history of, or any evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
- Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific subject.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the Overall Response Rate (ORR) per RECIST 1.1 assessed by central imaging vendor of the 200 mg Q3W dose of pembrolizumab in all subjects and in subjects with high gene expression profile score (GEP high).;Secondary Objective: To evaluate safety and tolerability of pembrolizumab. To evaluate Duration of Response (DOR), and Progression-free Survival (PFS) per RECIST 1.1 assessed by central imaging vendor and Overall Survival (OS). ;Primary end point(s): Overall response rate (ORR) - RECIST 1.1 assessed by central imaging vendor;Timepoint(s) of evaluation of this end point: No interim analysis is currently planned. This end point will be evaluated at end of study.
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): (1)Objective:To evaluate safety and tolerability of pembrolizumab. <br> (2)Objective: To evaluate Duration of Response (DOR), and Progression-free Survival (PFS) per RECIST 1.1 assessed by central imaging vendor and Overall Survival (OS).<br> ;Timepoint(s) of evaluation of this end point: No interim analysis is currently planned. These end points will be evaluated at end of study.