Gastric CancerPhase 2NCT03382600
Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With TS-1+Cisplatin or TS-1+Oxaliplatin as First Line Chemotherapy in Gastric Cancer (MK-3475-659/KEYNOTE-659)
A Phase 2 study testing Pembrolizumab, Oxaliplatin and TS-1 in people with Gastric Cancer, run by Merck Sharp & Dohme LLC at 25 sites in Japan.
Trial summary
The purpose of this study is to estimate objective response rates (ORRs) of pembrolizumab + oxaliplatin + TS-1 and pembrolizumab + cisplatin + TS-1, as first-line treatment for gastric cancer in programmed death-ligand 1 (PD-L1) positive, human epidermal growth factor receptor 2 (HER2/neu)-negative participants with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Pembrolizumab, Oxaliplatin and TS-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 25 sitesJapan
- Study dates
- 26 Mar 2018to 30 May 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma
- Has a PD-L1 positive tumor as determined by immunohistochemistry (IHC) at a central laboratory
- Has measurable disease as defined by RECIST 1.1 as determined by investigator assessment. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
- Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at the timing of enrollment
- Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication
- Has adequate organ function
Who cannot join
- Has squamous cell or undifferentiated gastric cancer
- HER2-positive status
- Has had previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation
- Has received prior therapy with a platinum-based anti-cancer drug
- Has had major surgery, open biopsy or significant traumatic injury within 28 days prior to enrollment, or anticipation of the need for major surgery during the course of study treatment
Show all 25Show fewer
- Has had radiotherapy within 14 days of enrollment
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active autoimmune disease that has required systemic treatment in the past 2 years with use of disease modifying agents, corticosteroids, or immunosuppressive drugs
- 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 a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- Has any active infection requiring systemic therapy
- Will be on flucytosine at the time of enrollment
- Has grade ≥ 2 peripheral sensory neuropathy
- Has poorly controlled diarrhea (e.g., watery stool, uncontrollable bowel movement with drugs, grade ≥ 2 and number of defecations, ≥ 5/day)
- Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage within 2 weeks prior to enrollment
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with participation for the full duration of the trial, or is not in the best interest of the participant, in the opinion of the treating investigator
- 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 study, starting with the screening visit through 120 days after the last dose of study treatment
- Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- Has known history of human immunodeficiency virus (HIV) [HIV1/2 antibodies]
- Has a known history of Hepatitis B
- Has received live vaccine within 30 days of the planned start of study therapy
- Is currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of trial treatment
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Japan25 sites
Hyogo Cancer Center ( Site 0016)
Akashi, Hyōgo, 673-8558
Chiba Cancer Center ( Site 0012)
Chiba, 260-8717
National Hospital Organization Kyushu Cancer Center ( Site 0017)
Fukuoka, 811-1395
Kyushu University Hospital ( Site 0014)
Fukuoka, 812-8582
Gifu University Hospital ( Site 0021)
Gifu, 501-1194
Ibaraki Prefectural Central Hospital ( Site 0018)
Kasama, Ibaraki, 309-1793
National Cancer Center Hospital East ( Site 0001)
Kashiwa, Chiba, 277-8577
Saitama Cancer Center ( Site 0004)
Kitaadachi-gun, Saitama, 362-0806
Kobe City Medical Center General Hospital ( Site 0015)
Kobe, Hyōgo, 650-0047
Kochi Health Sciences Center ( Site 0022)
Kochi, 781-8555
Kumamoto University Hospital ( Site 0002)
Kumamoto, 860-8556
National Hospital Organization Shikoku Cancer Center ( Site 0024)
Matsuyama, Ehime, 791-0280
Gunma Prefectural Cancer Center ( Site 0005)
Ohta, Gunma, 373-8550
Osaka International Cancer Institute ( Site 0011)
Osaka, 541-8567
Kitasato University Hospital ( Site 0019)
Sagamihara, Kanagawa, 252-0375
Hokkaido University Hospital ( Site 0006)
Sapporo, Hokkaido, 060-8648
Kindai University Hospital ( Site 0013)
Sayama, Osaka, 589-8511
Tohoku University Hospital ( Site 0023)
Sendai, Miyagi, 980-8574
Jichi Medical University Hospital ( Site 0009)
Shimotsuke, Tochigi, 329-0498
Osaka University Hospital ( Site 0010)
Suita, Osaka, 565-0871
Shizuoka Cancer Center Hospital and Research Institute ( Site 0020)
Sunto-gun, Shizuoka, 411-8777
National Cancer Center Hospital ( Site 0025)
Tokyo, 104-0045
Tokyo Metropolitan Komagome Hospital ( Site 0008)
Tokyo, 113-8677
The Cancer Institute Hospital of JFCR ( Site 0007)
Tokyo, 135-8550
Kanagawa Cancer Center ( Site 0003)
Yokohama, Kanagawa, 241-8515
About this study
Official title: A Phase IIb, Clinical Trial to Study the Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With TS-1+Cisplatin or TS-1+Oxaliplatin as a First Line Chemotherapy in Participants With Advanced or Recurrent Gastric Cancer (KEYNOTE-659)
The purpose of this study is to estimate objective response rates (ORRs) of pembrolizumab + oxaliplatin + TS-1 and pembrolizumab + cisplatin + TS-1, as first-line treatment for gastric cancer in programmed death-ligand 1 (PD-L1) positive, human epidermal growth factor receptor 2 (HER2/neu)-negative participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Read the detailed description
Approximately 45 participants will be assigned to pembrolizumab + oxaliplatin + TS-1 combination therapy (Cohort 1) first, and then 45 participants will be assigned to pembrolizumab + cisplatin + TS-1 combination therapy (Cohort 2).
- Conditions
- Gastric Cancer
- Being tested
- Pembrolizumab, Oxaliplatin, TS-1, Cisplatin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabBiological
Also called MK-3475
200 mg Q3W on Day 1 by IV infusion
OxaliplatinDrug
130 mg/m^2 Q3W on Day 1 by IV infusion
TS-1Drug
40 to 60 mg orally according to Body Surface Area (BSA) BID Q3W on Days 1-14
CisplatinDrug
60 mg/m^2 Q3W on Day 1 by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Experimental | Participants receive pembrolizumab 200 mg every 3 weeks (Q3W) plus oxaliplatin 130 mg/m^2 Q3W by intravenous (IV) infusion plus TS-1 twice daily (BID) by continuous oral administration for 14 days, followed by a recovery period of 7 days. Study treatment will be started on Day 1 of each 3-week course, and will continue for up to ~3 years. Receives: Biological: Pembrolizumab; Drug: Oxaliplatin; Drug: TS-1 |
| Pembrolizumab + Cisplatin +TS-1 (Cohort 2) | Experimental | Participants receive pembrolizumab 200 mg Q3W plus cisplatin 60 mg/m^2 Q3W by IV infusion plus TS-1 BID by continuous oral administration for 14 days, followed by a recovery period of 7 days. Study treatment will be started on Day 1 of each 3-week course, and will continue for up to ~3 years. Receives: Biological: Pembrolizumab; Drug: TS-1; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR)
For the primary efficacy analysis, ORR was defined as the percentage of participants who have a best response of complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) per RECIST 1.1 as assessed by BICR.
Measured: Up to ~36 months
Secondary outcomes (12)
ORR According to Immune-related Response Evaluation Criteria In Solid Tumors (iRECIST) Assessed by BICR
For the secondary efficacy analysis, ORR was defined as the percentage of participants whose best response based on imaging is CR (disappearance of all target lesions) or PR (≥30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to iRECIST as assessed by BICR. iRECIST is a modification to RECIST that takes into account unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.
Measured: Up to ~36 months
Duration of Response (DOR) According to RECIST 1.1 Assessed by BICR
For participants who demonstrated complete response (CR, disappearance of all target lesions) or partial response (PR, ≥30% decrease in the SOD of target lesions) according to RECIST 1.1 as assessed by BICR, DOR was defined as the time from the earliest date of qualifying response (CR or PR) until earliest date of progressive disease (PD, ≥20% increase in the SOD of target lesions) or death from any cause, whichever came first. DOR was censored at the last tumor assessment date if a responder did not have PD or death.
Measured: Up to ~36 months
DOR According to iRECIST Assessed by BICR
For participants who demonstrated complete response (CR, disappearance of all target lesions) or partial response (PR, ≥30% decrease in the SOD of target lesions) according to iRECIST as assessed by BICR, DOR was defined as the time from the earliest date of qualifying response (CR or PR) until earliest date of progressive disease (PD, ≥20% increase in the SOD of target lesions) or death from any cause, whichever came first. DOR was censored at the last tumor assessment date if a responder did not have PD or death. iRECIST is a modification to RECIST that takes into account unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.
Measured: Up to ~36 months
Disease Control Rate (DCR) According to RECIST 1.1 Assessed by BICR
DCR was defined as the percentage of participants in the analysis population who have complete response (CR, disappearance of all target lesions), partial response (PR (≥30% decrease in the SOD of target lesions, taking as reference the baseline SOD), or stable disease (SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD, ≥20% increase in the SOD of target lesions]). Responses are according to RECIST 1.1 as assessed by BICR.
Measured: Up to ~36 months
DCR According to iRECIST 1.1 Assessed by BICR
DCR was defined as the percentage of participants in the analysis population who have CR (disappearance of all target lesions), PR (≥30% decrease in the SOD of target lesions, taking as reference the baseline SOD), or stable disease (SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD [≥20% increase in the SOD of target lesions]). Responses are according to iRECIST 1.1 as assessed by BICR. iRECIST is a modification to RECIST that takes into account unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.
Measured: Up to ~36 months
Time to Response (TTR) According to RECIST 1.1 Assessed by BICR
TTR was defined as the time from the date of enrollment day to the first date of confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the SOD of target lesions, taking as reference the baseline SOD). Responses are according to RECIST 1.1 as assessed by BICR.
Measured: Up to ~36 months
TTR According to iRECIST 1.1 Assessed by BICR
TTR was defined as the time from the date of enrollment day to the first date of confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the SOD of target lesions, taking as reference the baseline SOD). Responses are according to iRECIST 1.1 as assessed by BICR. iRECIST is a modification to RECIST that takes into account unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.
Measured: Up to ~36 months
Progression-free Survival (PFS) According to RECIST 1.1 Assessed by BICR
PFS was defined as the time from the date of enrollment day to the first documented PD (defined as ≥20% increase in the SOD of target lesions) or death due to any cause, whichever occurred first. Responses are according to RECIST 1.1 as assessed by BICR.
Measured: Up to ~36 months
PFS According to iRECIST 1.1 Assessed by BICR
PFS was defined as the time from the date of enrollment day to the first documented PD (defined as ≥20% increase in the SOD of target lesions) or death due to any cause, whichever occurred first. Responses are according to iRECIST 1.1 as assessed by BICR. iRECIST is a modification to RECIST that takes into account unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.
Measured: Up to ~36 months
Overall Survival (OS)
OS was defined as the time from the date of enrollment day to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. For these participants, date of last follow up was last visit date instead of death date.
Measured: Up to ~36 months
Number of Participants With ≥1 Adverse Event (AE)
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment
Measured: Up to ~36 months
Number of Participants Discontinuing From Study Treatment Due to AE(s)
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
Measured: Up to ~36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start26 Mar 2018
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382600
- Sponsor's protocol ID
- 3475-659
- Other IDs
- MK-3475-659, KEYNOTE-659
- Status last verified
- May 2024
- First submitted
- 19 Dec 2017
- Last updated
- 11 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
https://pubmed.ncbi.nlm.nih.gov/35701865/
Kawazoe A, Yamaguchi K, Yasui H, Negoro Y, Azuma M, Amagai K, Hara H, Baba H, Tsuda M, Hosaka H, Kawakami H, Oshima T, Omuro Y, Machida N, Esaki T, Yoshida K, Nishina T, Komatsu Y, Han SR, Shiratori S, Shitara K. Safety and efficacy of pembrolizumab in combination with S-1 plus oxaliplatin as a first-line treatment in patients with advanced gastric/gastroesophageal junction cancer: Cohort 1 data from the KEYNOTE-659 phase IIb study. Eur J Cancer. 2020 Apr;129:97-106. doi: 10.1016/j.ejca.2020.02.002. Epub 2020 Mar 4.
PubMed 32145474
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Clinical Trial to Study the Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With TS-1+Cisplatin or TS-1+Oxaliplatin as a First Line Chemotherapy in Participants With Advanced or Recurrent Gastric Cancer (KEYNOTE-659)
- ClinicalTrials.gov ID
- NCT03382600
- Acronym / sponsor ID
- 3475-659
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Posted 1 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to estimate objective response rates (ORRs) of pembrolizumab + oxaliplatin + TS-1 and pembrolizumab + cisplatin + TS-1, as first-line treatment for gastric cancer in programmed death-ligand 1 (PD-L1) positive, human epidermal growth factor receptor 2 (HER2/neu)-negative participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Detailed description
Approximately 45 participants will be assigned to pembrolizumab + oxaliplatin + TS-1 combination therapy (Cohort 1) first, and then 45 participants will be assigned to pembrolizumab + cisplatin + TS-1 combination therapy (Cohort 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Experimental | Biological: Pembrolizumab, Drug: Oxaliplatin, Drug: TS-1Participants receive pembrolizumab 200 mg every 3 weeks (Q3W) plus oxaliplatin 130 mg/m^2 Q3W by intravenous (IV) infusion plus TS-1 twice daily (BID) by continuous oral administration for 14 days, followed by a recovery period of 7 days. Study treatment will be started on Day 1 of each 3-week course, and will continue for up to ~3 years. |
| Pembrolizumab + Cisplatin +TS-1 (Cohort 2) | Experimental | Biological: Pembrolizumab, Drug: TS-1, Drug: CisplatinParticipants receive pembrolizumab 200 mg Q3W plus cisplatin 60 mg/m^2 Q3W by IV infusion plus TS-1 BID by continuous oral administration for 14 days, followed by a recovery period of 7 days. Study treatment will be started on Day 1 of each 3-week course, and will continue for up to ~3 years. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma
- Has a PD-L1 positive tumor as determined by immunohistochemistry (IHC) at a central laboratory
- Has measurable disease as defined by RECIST 1.1 as determined by investigator assessment. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
- Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at the timing of enrollment
Key exclusion criteria (25 listed)
- Has squamous cell or undifferentiated gastric cancer
- HER2-positive status
- Has had previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation
- Has received prior therapy with a platinum-based anti-cancer drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: MK-3475200 mg Q3W on Day 1 by IV infusion | Biological | Pembrolizumab + Cisplatin +TS-1 (Cohort 2), Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) |
| Oxaliplatin130 mg/m^2 Q3W on Day 1 by IV infusion | Drug | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) |
| TS-140 to 60 mg orally according to Body Surface Area (BSA) BID Q3W on Days 1-14 | Drug | Pembrolizumab + Cisplatin +TS-1 (Cohort 2), Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) |
| Cisplatin60 mg/m^2 Q3W on Day 1 by IV infusion | Drug | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) |
Primary outcome
Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR)
Time frame: Up to ~36 months
For the primary efficacy analysis, ORR was defined as the percentage of participants who have a best response of complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) per RECIST 1.1 as assessed by BICR.
12 secondary outcomes
ORR According to Immune-related Response Evaluation Criteria In Solid Tumors (iRECIST) Assessed by BICR
Time frame: Up to ~36 months
Duration of Response (DOR) According to RECIST 1.1 Assessed by BICR
Time frame: Up to ~36 months
DOR According to iRECIST Assessed by BICR
Time frame: Up to ~36 months
Disease Control Rate (DCR) According to RECIST 1.1 Assessed by BICR
Time frame: Up to ~36 months
DCR According to iRECIST 1.1 Assessed by BICR
Time frame: Up to ~36 months
Time to Response (TTR) According to RECIST 1.1 Assessed by BICR
Time frame: Up to ~36 months
TTR According to iRECIST 1.1 Assessed by BICR
Time frame: Up to ~36 months
Progression-free Survival (PFS) According to RECIST 1.1 Assessed by BICR
Time frame: Up to ~36 months
PFS According to iRECIST 1.1 Assessed by BICR
Time frame: Up to ~36 months
Overall Survival (OS)
Time frame: Up to ~36 months
Number of Participants With ≥1 Adverse Event (AE)
Time frame: Up to ~36 months
Number of Participants Discontinuing From Study Treatment Due to AE(s)
Time frame: Up to ~36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationhttps://pubmed.ncbi.nlm.nih.gov/35701865/
- Derived from this study: PubMed 32145474Kawazoe A, Yamaguchi K, Yasui H, Negoro Y, Azuma M, Amagai K, Hara H, Baba H, Tsuda M, Hosaka H, Kawakami H, Oshima T, Omuro Y, Machida N, Esaki T, Yoshida K, Nishina T, Komatsu Y, Han SR, Shiratori S, Shitara K. Safety and efficacy of pembrolizumab in combination with S-1 plus oxaliplatin as a first-line treatment in patients with advanced gastric/gastroesophageal junction cancer: Cohort 1 data from the KEYNOTE-659 phase IIb study. Eur J Cancer. 2020 Apr;129:97-106. doi: 10.1016/j.ejca.2020.02.002. Epub 2020 Mar 4.
- Merck Oncology Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Oxaliplatin and TS-1 in people with Gastric Cancer, run by Merck Sharp & Dohme LLC at 25 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) (time frame: Up to ~36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03382600, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.