Trial · NCT05508737
Pembrolizumab and Trifluridine/Tipiracil With Previously Treated Advanced Gastric Cancer
NCT05508737, Phase 1, Phase 2, Active not recruiting, Yonsei University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Pembrolizumab and Trifluridine/Tipiracil With Previously Treated Advanced Gastric Cancer. Trials, record NCT05508737. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05508737
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab and Trifluridine/Tipiracil With Previously Treated Advanced Gastric Cancer
- NCT number
- NCT05508737
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 75 participants, estimated
- Lead sponsor
- Yonsei University
- Conditions
- Gastric and Gastroesophageal Junction Adenocarcinoma
- Interventions
- Pembrolizumab (Keytruda®), Trifluridine/Tipiracil (Lonsurf®)
- First posted
- 2022-08-19
- Last updated
- 2025-07-11
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase Ib (DLT) | within first 6weeks | Phase Ib (Lead-in safety cohort): Dose-limiting toxicity (DLT) |
| Primary | Phase Ib (RP2D) | within first 6weeks | Phase Ib (Lead-in safety cohort): Recommended Phase 2 dose (RP2D) |
| Primary | Objective response rate (ORR) | 6months after the last treatment of the last subject | The proportion of patients in complete remission (CR) or partial remission (PR) among the best response (BOR) assessed by the investigator according to RECIST 1.1. |
| Secondary | Overall survival (OS) | 6months after the last treatment of the last subject | Defined as the time start of study treatment until death by cause. Any subject not known to have died at the time of the analysis will be censored on the last recorded date on which the subject was known to be alive. |
| Secondary | Progression-free survival (PFS) as assessed per RECIST 1.1 | 6months after the last treatment of the last subject | Defined as the time from start of study treatment until the date of objective disease progression or death. Progression is defined in accordance with RECIST v1.1 criteria. |
| Secondary | Disease control rate (DCR) as assessed per RECIST 1.1 | 6months after the last treatment of the last subject | Defined as the proportion of subjects with a best objective response (BOR) of complete response (CR) or Partial response (PR), or stable disease maintained for a minium of twelve weeks from start of treatment, as defined by the RECIST 1.1. |
| Secondary | Duration of response (DOR) as assessed per RECIST 1.1 | 6months after the last treatment of the last subject | Defined as the time from the investigator's first determination of objective response to the first of disease progression or death according to RECIST 1.1. |
| Secondary | Number of participants with Adverse Events that are related to treatment | Throughout the overall trial period as well as up to 3months after the last dose study treatment for each subject | Safety and tolerability of the pembrolizumab and TAS-120 combination therapy as determined by adverse events categorized in accordance with CTCAE 5.0 Criteria. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05508737
GET https://conductscience.org/api/trials/v1/NCT05508737/registered