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Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209686
Recruitment Status : Not yet recruiting
First Posted : December 24, 2019
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Advanced Gastric Adenocarcinoma Drug: Paclitaxel Drug: Olaparib Drug: Pembrolizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All Participants
All Participants will receive Paclitaxel, Olaparib and Pembrolizumab.
Drug: Paclitaxel
  1. Patients will receive treatment on Day 1 and 8.
  2. Paclitaxel (80 mg) will be administered IV on days 1 and 8 (21 day cycle).
  3. Drug - Paclitaxel - 80mg IV
Other Name: nab-paclitaxel, Taxol

Drug: Olaparib
  1. Olaparib will be taken by mouth daily for 3 weeks (21 day cycle).
  2. Drug - 100 mg or 300mg
Other Name: Lynparza

Drug: Pembrolizumab
  1. Patients will receive treatment every 21 days.
  2. Pembrolizumab (200 mg) will be administered IV on day 1 (21 day cycle).
  3. Drug - 200mg IV
Other Name: MK-3475; Keytruda




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 4 years ]
    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 :
  1. Number of participants experiencing a grade 3 or above study drug-related adverse event [ Time Frame: 4 years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209686


Contacts
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Contact: Susan Sartorius-Mergenthaler, RN 410-614-3644 Sartosu@jhmi.edu
Contact: Ellen Foreman-Lilly, RN 443-287-4961 lillyel@jhmi.edu

Locations
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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
Contact: Susan Sartorius-Mergenthaler, RN    410-614-3644    Sartosu@jhmi.edu   
Contact: Ellen Foreman-Lilly, RN    443-287-4961    lillyel@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Katherine Bever, MD Johns Hopkins Medical Institution
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT04209686    
Other Study ID Numbers: J19135
IRB00209006 ( Other Identifier: Johns Hopkins Medical Institution )
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Nab-Paclitaxel
Olaparib
Pembrolizumab
Immunotherapy
Anti-PD-1
PARP inhibitors
Gastric Cancer
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Pembrolizumab
Olaparib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors