- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 4
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
Wird als IV-Infusion verabreicht
Andere Namen:
Wird als IV-Infusion verabreicht
Andere Namen:
Administered as an IV infusion
Andere Namen:
Administered as an IV infusion
Andere Namen:
Administered as an oral tablet
Andere Namen:
|
|
Experimental: 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.
|
Wird als IV-Infusion verabreicht
Andere Namen:
Administered as an IV infusion
Andere Namen:
Administered as an IV infusion
Andere Namen:
|
|
Experimental: 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.
|
Wird als IV-Infusion verabreicht
Andere Namen:
Administered as an IV infusion
Andere Namen:
External beam radiation per the Radiation Manual
Internal radiation - brachytherapy per the Radiation Manual
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants Who Experienced One or More Adverse Events (AEs)
Zeitfenster: 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.
|
Up to approximately 27 months
|
|
Number of Participants Who Discontinued Study Intervention Due to an AE
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Medical Director, Merck Sharp & Dohme LLC
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Erkrankungen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Magenerkrankungen
- Uteruserkrankungen
- Genitalerkrankungen, weiblich
- Genitale Neubildungen, weiblich
- Gebärmutterhalskrankheiten
- Uterusneoplasmen
- Neubildungen
- Magenneoplasmen
- Gebärmutterhalstumoren
- Organische Chemikalien
- Heterocyclische Verbindungen, 1-Ring
- Heterocyclische Verbindungen
- Therapeutika
- Nukleinsäuren, Nukleotide und Nukleoside
- Anorganische Chemikalien
- Chlorverbindungen
- Stickstoffverbindungen
- Koordinationskomplexe
- Desoxycytidin
- Cytidin
- Pyrimidin -Nucleoside
- Pyrimidine
- Nukleoside
- Uracil
- Pyrimidinone
- Platinverbindungen
- Strahlentherapie
- Desoxyribonukleoside
- Capecitabin
- Oxaliplatin
- Gemcitabin
- Fluoruracil
- Cisplatin
- Pembrolizumab
- Brachytherapie
Andere Studien-ID-Nummern
- 3475-G44
- MK-3475-G44 (Andere Kennung: MSD)
- KEYNOTE-G44 (Andere Kennung: MSD)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .