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Trial Title:
Phase II Study of Pembrolizumab (Keytruda®) and Trifluridine/Tipiracil (Lonsurf®) With Previously Treated Advanced Gastric Cancer
NCT ID:
NCT05508737
Condition:
Gastric and Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Trifluridine
Pembrolizumab
Conditions: Keywords:
Pembrolizumab(Keytruda®), Trifluridine/Tipiracil (Lonsurf®)
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pembrolizumab (Keytruda®), Trifluridine/Tipiracil (Lonsurf®)
Description:
Single arm: 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)
Arm group label:
Single arm, Pembrolizumab, trifluridine/tipiracil
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 safety and tolerability of this
combination treatment.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Has provided written informed consent fo the trial.
2. Is male or female at least 18 years of age.
3. Has a histologically or cytologically confirmed diagnosis of advanced or metastatic
gastric/gastroesophageal junction (GEJ) adenocarcinoma.
4. Has previously received at least 2 prior regiments.
5. Has a life expectancy of at least 3 months.
6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Have 1 or more measurable disease as determined by RECIST 1.1.
8. Is able to take medications orally.
9. Has adequate organ function as defined by the following criteria.
10. Is willing to follow and follow research procedures.
11. 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.
12. A female participant is eligible to participate if she is not pregnant or
breastfeeding.
Exclusion Criteria:
1. Has other concurrently active malignancies.
2. Has received prior therapy with TAS-102.
3. Is contraindicated for pembrolizumab and/or TAS-102, or have severe hypersensitivity
to any of those drugs and/or their excipients.
4. Has any unresolved ≥Grade 2 toxicity (per CTCAE v5.0) attributed to any prior
therapies at the time of enrollment.
5. Has had major surgery within 2 weeks prior to first dose of study interventions.
6. Has known active central nervous system (CNS) metastases.
7. Has received radiotherapy for gastric cancer treatment within 2 weeks prior to the
first dose of study drugs.
8. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the
first dose of study drug.
9. 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.
10. Has participated has used an investigational device within 4 weeks prior to the
first dose of study intervention.
11. Has a history of uncontrollable or significant cardiovascular disease.
12. Has active (significant or uncontrolled) gastrointestinal bleeding.
13. Has active autoimmune disease that has required systemic treatment in the past 2
years.
14. Has a history of (non-infectious) pneumonitis/interstitial lung disease that
required steroids or has current pneumonitis/interstitial lung disease.
15. Has an active, unresolved infection requiring systemic therapy.
16. Has a known history of Human Immunodeficiency Virus (HIV) infection.
17. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg]
reactive) or known active Hepatitis C virus infection.
18. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
19. Has had an allogenic tissue/solid organ transplant.
20. Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the study.
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 1, 2022
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Yonsei University
Agency class:
Other
Source:
Yonsei University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05508737
