Clinical Trials /

Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma

NCT04209686

Description:

The purpose of this study is to evaluate the safety and clinical activity of paclitaxel plus olaparib and pembrolizumab in patients with previously treated advanced Gastric Cancer (GC).

Related Conditions:
  • Esophagogastric Carcinoma
  • Gastric Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma
  • Official Title: Phase 2 Study of Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma

Clinical Trial IDs

  • ORG STUDY ID: J19135
  • SECONDARY ID: IRB00209006
  • NCT ID: NCT04209686

Conditions

  • Advanced Gastric Adenocarcinoma

Interventions

DrugSynonymsArms
Paclitaxelnab-paclitaxel, TaxolAll Participants
OlaparibLynparzaAll Participants
PembrolizumabMK-3475; KeytrudaAll Participants

Purpose

The purpose of this study is to evaluate the safety and clinical activity of paclitaxel plus olaparib and pembrolizumab in patients with previously treated advanced Gastric Cancer (GC).

Trial Arms

NameTypeDescriptionInterventions
All ParticipantsExperimentalAll Participants will receive Paclitaxel, Olaparib and Pembrolizumab.
  • Paclitaxel
  • Olaparib
  • Pembrolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥18 years.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Must have advanced gastric or gastroesophageal cancer.

          -  Must have received only one line of systemic therapy.

          -  Must have the presence of measurable lesion.

          -  Must agree to have a biopsy.

          -  Life expectancy of greater than 3 months.

          -  Patients must have adequate organ and marrow function defined by study - specified
             laboratory tests.

          -  Woman of childbearing potential must have a negative pregnancy test.

          -  Must use acceptable form of birth control while on study.

          -  Ability to understand and willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
             Require any antineoplastic therapy.

          -  Require any other form of systemic or localized antineoplastic therapy

          -  Received prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or with
             an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.,
             CTLA-4, OX 40, CD137).

          -  Has received prior therapy with taxane or PARP (Poly (ADP-Ribose) Polymerase)
             inhibitor.

          -  Hypersensitivity reaction to any paclitaxel, pembrolizumab or related compounds and/or
             to any of the components.

          -  Allergy to dexamethasone, diphenhydramine and famotidine.

          -  Is taking a moderate or strong CYP3A inhibitor.

          -  Has uncontrolled intercurrent acute or chronic medical illness.

          -  Has a known additional malignancy that is progressing and has required active
             treatment within the past 1 year.

          -  Has received prior systemic anti-cancer therapy including investigational agents
             within 2 weeks prior to study treatment.

          -  Has received prior radiotherapy within 2 weeks of start of study treatment.

          -  Has received a live vaccine within 30 days prior to the first dose of study drug.

          -  Is currently or has participated in another investigational study within 4 weeks prior
             to receiving study drug.

          -  Has an active known or suspected autoimmune disease.

          -  Has a diagnosis of immunodeficiency.

          -  Prior tissue or organ allograft or allogeneic bone marrow transplantation.

          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality
             that might confound the results of the study, interfere with the subject's
             participation for the full duration of the study, or is not in the best interest of
             the subject to participate, in the opinion of the treating investigator. .

          -  Requires daily supplemental oxygen.

          -  History of (non-infectious) pneumonitis that required steroids or has current
             pneumonitis.

          -  History of encephalitis, meningitis, or uncontrolled seizures in the year prior to
             informed consent.

          -  Infection with HIV or hepatitis B or C at screening.

          -  Has uncontrolled infection requiring systemic therapy..

          -  Subjects unable to undergo venipuncture and/or tolerate venous access.

          -  Has known psychiatric or substance abuse disorder that would interfere with
             cooperation with the requirements of the trial.

          -  Woman who are pregnant or breastfeeding.

          -  A woman of childbearing potential (WOCBP) who has a positive urine pregnancy test
             within 72 hours prior to study drug initiation.
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival (OS)
Time Frame:4 years
Safety Issue:
Description:OS will be measured from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.

Secondary Outcome Measures

Measure:Number of participants experiencing a grade 3 or above study drug-related adverse event
Time Frame:4 years
Safety Issue:
Description:When calculating the incidence of adverse events (AEs), each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject. Estimation based on the Kaplan-Meier curve.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Trial Keywords

  • Nab-Paclitaxel
  • Olaparib
  • Pembrolizumab
  • Immunotherapy
  • Anti-PD-1
  • PARP inhibitors
  • Gastric Cancer

Last Updated

December 20, 2019