A Phase III, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) (SCH-900475) plus Chemotherapy (XP or FP) versus Placebo plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE-585)
- Conditions
- Gastric or Gastroesophageal Junction AdenocarcinomaMedDRA version: 20.0Level: LLTClassification code 10056267Term: Gastroesophageal cancerSystem Organ Class: 100000016799Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004408-76-FR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
1. Have previously untreated localized gastric or GEJ (Stage III or IVa) adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes- N+(clinical nodes) without evidence of metastatic disease. Siewert type 2 or 3 tumors are eligible. Enrollment of subjects with Siewert type 1 tumors will be limited to those for whom the planned treatment is perioperative chemotherapy and resection. Tumor staging prior to enrollment must consist of at least 1 imaging modality: computed tomography (CT) or magnetic resonance imaging (MRI)
2. Plan to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice
3. Be at least 18 years of age on the day of signing informed consent
4. Be willing to provide tissue from a tumor lesion at baseline and at time of surgery
5. Have an ECOG performance status of 0 to 1, to be performed within 3 days prior to the first dose of trial treatment
6. Be willing and able to provide written informed consent/assent for the trial. The subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
7. Have adequate organ function as defined in the protocol. Specimens must be collected within 10 days prior to the start of trial treatment
8. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of trial medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
9. All subjects of childbearing potential must be willing to use an adequate method of contraception, as outlined in protocol Section 5.7.2 - Contraception, for the course of the trial through 120 days after the last dose of trial drug
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
10. Life expectancy of greater than 6 months
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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400
1. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
2. Has an active infection requiring systemic therapy
3. Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment
4. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (i.e., CTLA-4, OX-40, CD137) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial
5. Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy
6. Has received prior radiotherapy within 2 weeks of start of trial treatment for any other condition. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug
8. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
9. Has a known severe hypersensitivity (= Grade 3) to pembrolizumab, its active substance and/or any of its excipients. (Refer to the respective Investigator’s Brochure for a list of excipients.)
10. Has a known severe hypersensitivity (= Grade 3) to any of the study chemotherapy agents and/or to any of their excipients
11. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
12. Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority
13. 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
14. Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
15. 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
16. Has received a live vaccine within 30 days prior to the first dose of trial drug.
Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed
17. 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
18. Has known psychi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method