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Gastric and Gastroesophageal Junction AdenocarcinomaPhase 1/2NCT05508737

Pembrolizumab and Trifluridine/Tipiracil With Previously Treated Advanced Gastric Cancer

A Phase 1/2 study testing Pembrolizumab (Keytruda®), Trifluridine/Tipiracil (Lonsurf®) in people with Gastric and Gastroesophageal Junction Adenocarcinoma, run by Yonsei University at 2 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a two-part, Phase II, open-label, single arm, multi-center study to determine the efficacy of pembrolizumab in combination with TAS-102 (trifluridine/tipiracil) in patients with advanced gastric cancer who have progressed after prior treatment with or without anti-PD-1/PD-L1 agent, and to further assess the… Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Pembrolizumab (Keytruda®), Trifluridine/Tipiracil (Lonsurf®)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
2 sitesSouth Korea
Study dates
1 Dec 2022to 1 Dec 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has provided written informed consent fo the trial.
  • Is male or female at least 18 years of age.
  • Has a histologically or cytologically confirmed diagnosis of advanced or metastatic gastric/gastroesophageal junction (GEJ) adenocarcinoma.
  • Has previously received at least 2 prior regiments.
  • Has a life expectancy of at least 3 months.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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  • Have 1 or more measurable disease as determined by RECIST 1.1.
  • Is able to take medications orally.
  • Has adequate organ function as defined by the following criteria.
  • Is willing to follow and follow research procedures.
  • A male participant must agree to use a contraception of this protocol during the treatment period and for at least 120 days post TAS-102.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding.

Who cannot join

  • Has other concurrently active malignancies.
  • Has received prior therapy with TAS-102.
  • Is contraindicated for pembrolizumab and/or TAS-102, or have severe hypersensitivity to any of those drugs and/or their excipients.
  • Has any unresolved ≥Grade 2 toxicity (per CTCAE v5.0) attributed to any prior therapies at the time of enrollment.
  • Has had major surgery within 2 weeks prior to first dose of study interventions.
  • Has known active central nervous system (CNS) metastases.
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  • Has received radiotherapy for gastric cancer treatment within 2 weeks prior to the first dose of study drugs.
  • Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Has participated has used an investigational device within 4 weeks prior to the first dose of study intervention.
  • Has a history of uncontrollable or significant cardiovascular disease.
  • Has active (significant or uncontrolled) gastrointestinal bleeding.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years.
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active, unresolved infection requiring systemic therapy.
  • Has a known history of Human Immunodeficiency Virus (HIV) infection.
  • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus infection.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Has had an allogenic tissue/solid organ transplant.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study.

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Severance Hospital

    Seoul, 03722

  • Severance Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Open-label Phase II Study With Lead-in Safety Cohort of Pembrolizumab (Keytruda®) and Trifluridine/Tipiracil (Lonsurf®) Combination Treatment in Patients With Previously Treated Advanced Gastric Cancer

This is a two-part, Phase II, open-label, single arm, multi-center study to determine the efficacy of pembrolizumab in combination with TAS-102 (trifluridine/tipiracil) in patients with advanced gastric cancer who have progressed after prior treatment with or without anti-PD-1/PD-L1 agent, and to further assess the safety and tolerability of this combination treatment.

Read the detailed description

This is a two-part, Phase II, open-label, single arm, multi-center study to determine the efficacy of pembrolizumab in combination with TAS-102 (trifluridine/tipiracil) in patients with advanced gastric cancer who have progressed after prior treatment with or without anti-PD-1/PD-L1 agent, and to further assess the safety and tolerability of this combination treatment. In lead-in-safety cohort, recommended dose of trifluridine/tipiracil combined with pembrolizumab will be determined with dose-limiting toxicity (DLT) and safety. Pembrolizumab dose will be fixed with current recommended dose of 400mg IV every 6 weeks (Q6W). There will be 2 dose cohort for trifluridine/tipiracil; dose level 1 is trifluridine/tipiracil 35mg/m2 BID, D1-5, D8-12, every 4 weeks (Q4W) and dose level 0 is trifluridine/tipiracil 30mg/m2 BID, D1-5, D8-12, every 4 weeks (Q4W). DLT will be evaluated during first 6 weeks. In the subsequent expansion Phase II part, patients will be recruited from four sites to evaluate the efficacy and safety of the combination therapy in 2 cohorts, anti-PD-1/PD-L1 inhibitor naive and exposure cohorts.

Being tested
Pembrolizumab (Keytruda®), Trifluridine/Tipiracil (Lonsurf®)
Keywords
Pembrolizumab(Keytruda®), Trifluridine/Tipiracil (Lonsurf®)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab (Keytruda®), Trifluridine/Tipiracil (Lonsurf®)Drug

    Also called Pembrolizumab (Keytruda®), Trifluridine/Tipiracil (Lonsurf®)

    arms : Pembrolizumab 400 mg every 6 weeks (Q6W), trifluridine/tipiracil at 35 or 30 mg/m2 twice daily (BID) for 5 days a week (D1-5, D8-12) with 2 days rest for 2 weeks, followed by a 14-day rest, repeated every 4 weeks (Q4W)

Study groups in NCT05508737
Study groupRoleWhat they receive
IO experiencedExperimentalPembrolizumab 400 mg every 6 weeks (Q6W), trifluridine/tipiracil at 35 or 30 mg/m2 twice daily (BID) for 5 days a week (D1-5, D8-12) with 2 days rest for 2 weeks, followed by a 14-day rest, repeated every 4 weeks (Q4W)
Receives: Drug: Pembrolizumab (Keytruda®), Trifluridine/Tipiracil (Lonsurf®)
IO non-experiencedExperimentalPembrolizumab 400 mg every 6 weeks (Q6W), trifluridine/tipiracil at 35 or 30 mg/m2 twice daily (BID) for 5 days a week (D1-5, D8-12) with 2 days rest for 2 weeks, followed by a 14-day rest, repeated every 4 weeks (Q4W)
Receives: Drug: Pembrolizumab (Keytruda®), Trifluridine/Tipiracil (Lonsurf®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase Ib (DLT)

    Phase Ib (Lead-in safety cohort): Dose-limiting toxicity (DLT)

    Measured: within first 6weeks

  2. Phase Ib (RP2D)

    Phase Ib (Lead-in safety cohort): Recommended Phase 2 dose (RP2D)

    Measured: within first 6weeks

  3. Objective response rate (ORR)

    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.

    Measured: 6months after the last treatment of the last subject

Secondary outcomes (5)

  1. Overall survival (OS)

    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.

    Measured: 6months after the last treatment of the last subject

  2. Progression-free survival (PFS) as assessed per RECIST 1.1

    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.

    Measured: 6months after the last treatment of the last subject

  3. Disease control rate (DCR) as assessed per RECIST 1.1

    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.

    Measured: 6months after the last treatment of the last subject

  4. Duration of response (DOR) as assessed per RECIST 1.1

    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.

    Measured: 6months after the last treatment of the last subject

  5. Number of participants with Adverse Events that are related to treatment

    Safety and tolerability of the pembrolizumab and TAS-120 combination therapy as determined by adverse events categorized in accordance with CTCAE 5.0 Criteria.

    Measured: Throughout the overall trial period as well as up to 3months after the last dose study treatment for each subject

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2022
  2. Study start1 Dec 2022
  3. Primary completion2 Nov 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05508737
Sponsor's protocol ID
4-2022-0582
Status last verified
Jul 2025
First submitted
7 Jul 2022
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pembrolizumab (Keytruda®), Trifluridine/Tipiracil (Lonsurf®) in people with Gastric and Gastroesophageal Junction Adenocarcinoma, run by Yonsei University at 2 sites in South Korea.

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 12 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

This study is still under way. Results are not available in the source record yet.

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?

Phase Ib (DLT) (time frame: within first 6weeks). The study lists 3 primary outcomes in all. 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 NCT05508737.

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 Jul 2025.

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