A Phase 2 interventional study of Pembrolizumab and Oxaliplatin in Gastric Cancer, sponsored by Merck Sharp & Dohme LLC. Completed at 25 sites in Japan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment
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Among 41 studies testing pembrolizumab in Stomach Neoplasms — 7 open to participants now, 13 under way, 1 of them phase 3. pembrolizumab · Stomach Neoplasms.
Among the 41 studies testing pembrolizumab in Stomach Neoplasms, this one is the 12th largest by enrollment, is one of 8 that started in 2018, is one of 22 in phase 2, and was the 17th registered.
3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.
Browse Stomach Neoplasms studies →7 of the 41 studies testing pembrolizumab in Stomach Neoplasms are open now, in 3 countries. Recruiting first, the newest first:
Fudan University · Sites in China
Ages 18–75
Shanghai Minimally Invasive Surgery Center · Sites in China
Ages 18–75
Second Affiliated Hospital of Guangzhou Medical University · Sites in China
Ages 18–70
Yonsei University · Sites in Korea, Republic of
Ages 19+
Fudan University · Sites in China
Ages 18+
By country, each count listing its studies:
pembrolizumab: first FDA approval 2014 (KEYTRUDA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, pembrolizumab is the treatment under test here. Read study by study →
41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 27 · Phase 3 10 · Phase 4 1
First in 2014; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 100 is above the median of 66 across 2,500 interventional studies indexed under Stomach Neoplasms.
Median enrollment 41 across the 41 interventional studies. Of the 25 that completed or were terminated, 22 (88%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 41 have an industry lead sponsor. The 10 most frequent:
This study is registered under Merck Sharp & Dohme LLC, one of the names counted as Merck & Co., Inc. Under that name alone:
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 503 completed or terminated interventional studies of FDA-regulated products, 371 (74%) have results posted.
18 studies in Stomach Neoplasms by Merck & Co., Inc: 1 open now, 1 under way, none of them phase 3. Of 14 finished, 13 (93%) have results posted.
Among the 18 studies in Stomach Neoplasms by Merck & Co., Inc, this one is the 12th largest by enrollment, is one of 4 that started in 2018, is one of 6 in phase 2, and was the 9th registered.
Merck & Co., Inc’s Stomach Neoplasms studies by the year they started, since 2007.
3 of the studies testing pembrolizumab in Stomach Neoplasms that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04997837Phase 3Fudan UniversityStudy of Adjuvant Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy in Resected pN3 Gastric (G) or GEJ Adenocarcinoma | 2027-07-21 |
| NCT05041153M.D. Anderson Cancer CenterPembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma | 2026-12-30 |
| NCT04069273Harry H YoonNovel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma | 2027-08-11 |
Add all 3 to your calendar (.ics) → With an account.
Among the 41 studies testing pembrolizumab in Stomach Neoplasms, from their registry updates:
Among Merck & Co., Inc’s 18 in Stomach Neoplasms:
This tab as a report to print or save as PDF → With an account.
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.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Pembrolizumab · Drug: Oxaliplatin · Drug: TS-1
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.
Biological: Pembrolizumab · Drug: TS-1 · Drug: Cisplatin
200 mg Q3W on Day 1 by IV infusion
Also known as: MK-3475
130 mg/m\^2 Q3W on Day 1 by IV infusion
Drug pages: Tegafur · Gimeracil · Oxonic Acid
40 to 60 mg orally according to Body Surface Area (BSA) BID Q3W on Days 1-14
60 mg/m\^2 Q3W on Day 1 by IV infusion
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.
Time frame: Up to ~36 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Up to ~36 months
Programmed cell death ligand 1 (PD-L1) positive, human epidermal growth factor receptor 2 (HER2)/neu negative participants 18 to 75 years of age with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma were recruited at 25 study sites in Japan.
| Milestone | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) |
|---|---|---|
| Started | 54 | 46 |
| Completed | 0 | 0 |
| Not completed | 54 | 46 |
| Withdrew: Adverse event | 3 | 3 |
| Withdrew: Clinical disease progression | 2 | 4 |
| Withdrew: Radiological progression | 40 | 31 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Other | 9 | 7 |
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.
| Percentage of participants | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) |
|---|---|---|
| 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) | 72.2 (58.4 to 83.5) | 80.4 (66.1 to 90.6) |
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.
| Percentage of participants | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) |
|---|---|---|
| ORR According to Immune-related Response Evaluation Criteria In Solid Tumors (iRECIST) Assessed by BICR | 72.2 (58.4 to 83.5) | 80.4 (66.1 to 90.6) |
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.
| months | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) |
|---|---|---|
| Duration of Response (DOR) According to RECIST 1.1 Assessed by BICR | 10.6 (5.6 to NA) | 9.5 (4.7 to 15.3) |
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.
| months | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) |
|---|---|---|
| DOR According to iRECIST Assessed by BICR | 10.6 (5.6 to NA) | 9.5 (4.7 to NA) |
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.
| Percentage of participants | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) |
|---|---|---|
| Disease Control Rate (DCR) According to RECIST 1.1 Assessed by BICR | 96.3 (87.3 to 99.5) | 97.8 (88.5 to 99.9) |
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.
| Percentage of participants | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) |
|---|---|---|
| DCR According to iRECIST 1.1 Assessed by BICR | 96.3 (87.3 to 99.5) | 97.8 (88.5 to 99.9) |
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.
| months | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) |
|---|---|---|
| Time to Response (TTR) According to RECIST 1.1 Assessed by BICR | 1.5 (1.3 to 5.5) | 1.5 (1.2 to 2.9) |
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.
| months | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) |
|---|---|---|
| TTR According to iRECIST 1.1 Assessed by BICR | 1.5 (1.3 to 5.5) | 1.5 (1.2 to 2.9) |
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.
| months | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) |
|---|---|---|
| Progression-free Survival (PFS) According to RECIST 1.1 Assessed by BICR | 9.4 (6.6 to 12.6) | 8.3 (5.8 to 15.3) |
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.
| months | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) |
|---|---|---|
| PFS According to iRECIST 1.1 Assessed by BICR | 9.4 (6.6 to 12.6) | 10.9 (6.7 to NA) |
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.
| months | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) |
|---|---|---|
| Overall Survival (OS) | 16.9 (13.4 to 20.0) | 17.1 (12.6 to 23.1) |
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
| Participants | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) |
|---|---|---|
| Number of Participants With ≥1 Adverse Event (AE) | 54 | 46 |
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.
| Participants | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) |
|---|---|---|
| Number of Participants Discontinuing From Study Treatment Due to AE(s) | 3 | 3 |
Collected over Up to ~36 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | 3/54 (5.6%) | 27/54 (50%) | 54/54 (100%) |
| Pembrolizumab + Cisplatin +TS-1 (Cohort 2) | 0/46 (0%) | 22/46 (47.8%) | 46/46 (100%) |
| Event | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) |
|---|---|---|
| Adrenal insufficiencyEndocrine disorders | 3/54 | 3/46 |
| PneumoniaInfections and infestations | 0/54 | 3/46 |
| Abdominal painGastrointestinal disorders | 0/54 | 2/46 |
| HyponatraemiaMetabolism and nutrition disorders | 0/54 | 2/46 |
| RashSkin and subcutaneous tissue disorders | 0/54 | 2/46 |
| Febrile neutropeniaBlood and lymphatic system disorders | 2/54 | 0/46 |
| ColitisGastrointestinal disorders | 2/54 | 0/46 |
| EnterocolitisGastrointestinal disorders | 2/54 | 0/46 |
| VomitingGastrointestinal disorders | 2/54 | 0/46 |
| DehydrationMetabolism and nutrition disorders | 2/54 | 0/46 |
| Event | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) |
|---|---|---|
| Peripheral sensory neuropathyNervous system disorders | 51/54 | 14/46 |
| Decreased appetiteMetabolism and nutrition disorders | 38/54 | 31/46 |
| Neutrophil count decreasedInvestigations | 24/54 | 32/46 |
| ConstipationGastrointestinal disorders | 24/54 | 30/46 |
| NauseaGastrointestinal disorders | 34/54 | 28/46 |
| Platelet count decreasedInvestigations | 29/54 | 11/46 |
| DiarrhoeaGastrointestinal disorders | 24/54 | 22/46 |
| MalaiseGeneral disorders | 22/54 | 15/46 |
| AnaemiaBlood and lymphatic system disorders | 13/54 | 18/46 |
| StomatitisGastrointestinal disorders | 16/54 | 17/46 |
| Age, Continuous(years) | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) | Total |
|---|---|---|---|
| Mean | 61.5 ± 11.6 | 62.9 ± 10.2 | 62.1 ± 10.9 |
| Sex: Female, Male(Participants) | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) | Total |
|---|---|---|---|
| Female | 11 | 18 | 29 |
| Male | 43 | 28 | 71 |
| Race (NIH/OMB)(Participants) | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 54 | 46 | 100 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from Mar 2018 to primary completion in May 2021, 38 months.
Results were first posted in Dec 2023, 2 years 6 months after primary completion.
Of 65 industry-sponsored phase 2 interventional studies under Stomach Neoplasms, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 68. This study's 38 months is close to that.
Counting every sponsor, half of 360 studies reached it within 50 months; a quarter within 31 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pembrolizumab