- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07801027
A Trial of Pembrolizumab With Chemotherapy or Chemoradiotherapy in Participants From India With Different Types of Cancer (MK-3475-G44/KEYNOTE-G44)
A Prospective, Open-label, Phase 4 Study to Evaluate the Safety of Pembrolizumab (KEYTRUDA®) in Combination With Indication-specific Chemotherapy or Chemoradiotherapy in Participants Across Multiple Indications in India (KEYNOTE-G44)
The goal of this study is to assess the safety of pembrolizumab with chemotherapy or chemoradiotherapy in participants in India for:
- Advanced gastric or gastroesophageal junction [GEJ] cancer that is (human epidermal growth factor receptor 2 [HER2]-negative and has a programmed death-ligand 1 [PD-L1] combined positive score [CPS] ≥1
- Advanced and/or unresectable biliary tract cancer [BTC], and
- High-risk, locally advanced cervical cancer
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
Cohort 1:
- The participant must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, with locally confirmed programmed death-ligand 1 (PD-L1) CPS ≥1.
- Has locally confirmed human epidermal growth factor receptor 2 (HER2) negative cancer.
Cohort 2:
- Has a histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (BTC) (intra or extrahepatic cholangiocarcinoma or gallbladder cancer).
Cohort 3:
- Has high-risk locally advanced cervical cancer.
- Has histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.
All Cohorts:
- If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it.
- If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.
Exclusion Criteria:
Cohort 1:
- Has squamous cell or undifferentiated gastric cancer.
- Has had previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to first dose of study.
- Had active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks or tumor bleeding within 2 weeks prior to the first dose of study intervention.
Cohort 2:
- Has ampullary cancer.
- Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and/or mucinous cystic neoplasms.
- Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) BTC (intra or extrahepatic cholangiocarcinoma or gallbladder cancer), with the exception of neoadjuvant/adjuvant therapy, which is allowed.
- Has known active CNS metastases and/or carcinomatous meningitis.
- Had active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks or tumor bleeding within 2 weeks prior to the first dose of study intervention.
Cohort 3:
- Has undergone a previous hysterectomy defined as removal of the entire uterus or will have a hysterectomy as part of their initial cervical cancer therapy.
All Cohorts:
- Has hypokalemia.
- Has hypomagnesemia.
- Has hypocalcemia.
- Received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-PD-L1, or anti-programmed death-ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
- Has active autoimmune disease that has required systemic treatment in the past 2 years.
- Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease.
- Has a known additional invasive malignancy that is progressing or has required active treatment within the past 3 years.
- Has history of human immunodeficiency virus (HIV) infection.
- Has known active tuberculosis.
- Has not adequately recovered from major surgery or is having ongoing surgical complications.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Cohort 1 (Gastric)
Participants with human epidermal growth factor receptor 2 (HER2)-negative advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma with programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 will receive 200 mg of pembrolizumab intravenously (IV) every 3 weeks (Q3W) for maximum of 35 cycles plus either 800mg/m^2/day of 5-fluorouracil (5-FU) IV on Days 1 through 5, Q3W and 80mg/m^2 of cisplatin IV on Day 1, Q3W OR 1000mg/m^2 of capecitabine orally twice daily on Days 1 through 14, Q3W and 130mg/m^2 oxaliplatin IV on Day 1, Q3W.
A cycle is 21 days.
|
Administreras som en IV-infusion
Andra namn:
Administreras som en IV-infusion
Andra namn:
Administered as an IV infusion
Andra namn:
Administered as an IV infusion
Andra namn:
Administered as an oral tablet
Andra namn:
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Experimentell: Cohort 2 (Biliary)
Participants with advanced/unresectable biliary tract cancer (BTC) will receive 200 mg pembrolizumab IV Q3W for a maximum of 35 cycles plus 1000 mg/m^2 of gemcitabine IV on Days 1 and 8, Q3W and 25 mg/m^2 of cisplatin IV on Days 1 and 8, Q3W for a maximum of 8 cycles.
A cycle is 21 days.
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Administreras som en IV-infusion
Andra namn:
Administered as an IV infusion
Andra namn:
Administered as an IV infusion
Andra namn:
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Experimentell: Cohort 3 (Cervical)
Participants with high-risk locally advanced cervical cancer will receive 200 mg pembrolizumab IV Q3W for a maximum of 35 cycles plus 40 mg/m^2 of cisplatin IV weekly for up to 5 infusions concurrent with radiotherapy (RT) and external beam RT and brachytherapy (BT).
A cycle is 21 days.
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Administreras som en IV-infusion
Andra namn:
Administered as an IV infusion
Andra namn:
External beam radiation per the Radiation Manual
Internal radiation - brachytherapy per the Radiation Manual
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Participants Who Experienced One or More Adverse Events (AEs)
Tidsram: Up to approximately 27 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants that experience AEs will be reported.
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Up to approximately 27 months
|
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Number of Participants Who Discontinued Study Intervention Due to an AE
Tidsram: Up to approximately 24 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants who discontinue study intervention due to AEs will be reported.
|
Up to approximately 24 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Medical Director, Merck Sharp & Dohme LLC
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Magsjukdomar
- Livmodersjukdomar
- Genitala sjukdomar, kvinnor
- Genitala neoplasmer, hona
- Livmoderhalssjukdomar
- Uterina neoplasmer
- Neoplasmer
- Neoplasmer i magen
- Uterina cervikala neoplasmer
- Organiska kemikalier
- Heterocykliska föreningar, 1-ring
- Heterocykliska föreningar
- Terapeutik
- Nukleinsyror, nukleotider och nukleosider
- Oorganiska kemikalier
- Klorföreningar
- Kväveföreningar
- Koordinationskomplex
- Deoxycytidin
- Cytidin
- Pyrimidin nukleosider
- Pyrimidiner
- Nukleosider
- Uracil
- Pyrimidinoner
- Platinaföreningar
- Strålbehandling
- Deoxyribonukleosider
- Capecitabin
- Oxaliplatin
- Gemcitabin
- Fluorouracil
- Cisplatin
- pembrolizumab
- Brachyterapi
Andra studie-ID-nummer
- 3475-G44
- MK-3475-G44 (Annan identifierare: MSD)
- KEYNOTE-G44 (Annan identifierare: MSD)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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