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Pembrolizumab Plus Amurubicin in Patients With Refractory Small-cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03253068
Recruitment Status : Recruiting
First Posted : August 17, 2017
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Hiroaki Akamatsu, Wakayama Medical University

Brief Summary:
To explore the overall response rate (ORR) per RECIST 1.1 as assessed by investigators in subjects with refractory small cell lung cancer treated with pembrolizumab (Pembro) plus amurubicin (AMR).

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Extensive Stage Drug: Pembrolizumab plus amurubicin Phase 2

Detailed Description:
Open, uncontrolled, multi-center, phase II study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Pembrolizumab Plus Amurubicin in Patients With Refractory Small-cell Lung Cancer
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Pembrolizumab plus amurubicin
Pembrolizumab 200mg/body plus amurubicin 40mg/m2, intravenous, every 3 weeks
Drug: Pembrolizumab plus amurubicin
Pembrolizumab 200mg/body plus amurubicin 40mg/m2, intravenous, every 3 weeks
Other Name: Keytruda, calsed




Primary Outcome Measures :
  1. Overall response rate [ Time Frame: Imaging will be performed every 6 weeks through study completion, an average of 6 months ]
    Overall response rate will be assessed using RECIST ver1.1 by investigators



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have a histologically or cytologically confirmed diagnosis of SCLC.
  2. Confirmed radiological relapse within 90 days from the last day of first-line chemotherapy.
  3. Have adequate tumor tissue sample to test PD-L1 immunohistochemistry.
  4. Have measurable disease based on RECIST 1.1 as determined by the site.
  5. Be ≥20 years of age on day of signing informed consent.
  6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group
  7. Have adequate organ function as indicated by the following laboratory values
  8. Is expected to live more than 90 days.
  9. Be willing and able to provide written informed consent/assent for the trial.
  10. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours from registration.
  11. Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 5.7.2 - Contraception, for the course of the study through 120 days (or longer as specified by local institutional guidelines) after the last dose of study medication.
  12. Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined in Section 5.7.2- Contraception, starting with the first dose of study therapy through 120 days (or longer as specified by local institutional guidelines) after the last dose of study therapy.

Exclusion Criteria:

  1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 30 days from registration.
  2. Is receiving systemic steroid therapy ≤ 3 days from registration or receiving any other form of immunosuppressive medication.
  3. Has received prior systemic cytotoxic chemotherapy, biological therapy, OR major surgery within 3 weeks of the first dose of trial treatment; received thoracic radiation therapy of > 30 Gy within 6 months from registration.
  4. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
  5. Has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
  6. Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
  7. Has had an allogeneic tissue/solid organ transplant.
  8. History of noninfectious pneumonitis that required steroids or current active pneumonitis, or any evidence of interstitial lung disease by CT scan.
  9. Has received or will receive a live vaccine within 30 days from registration.
  10. Has an active infection requiring intravenous systemic therapy and oral administration.
  11. Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  12. Has known active Hepatitis B, or Hepatitis C.
  13. Has any history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
  14. Has Known history of serious allergy.
  15. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  16. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  17. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days (or longer as specified by local institutional guidelines) after the last dose of trial treatment.
  18. Hypersensitivity or allergy to pembrolizumab or any of its excipients, and/or to AMR or any of its excipients.

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): NCT03253068


Contacts
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Contact: Hiroaki Akamatsu, M.D. +81-73-447-2300 h-akamat@wakayama-med.ac.jp
Contact: Nobuyuki Yamamoto, M.D., Ph.D. +81-73-447-2300 nbyamamo@wakayama-med.ac.jp

Locations
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Japan
Wakayama Medical University Recruiting
Wakayama, Japan, 641-8509
Contact: Hiroaki Akamatsu, M.D.    +81-73-441-0619    h-akamat@wakayama-med.ac.jp   
Contact: Nobuyuki Yamamoto, M.D., Ph.D.    +81-73-441-0619    nbyamamo@wakayama-med.ac.jp   
Sponsors and Collaborators
Wakayama Medical University
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Hiroaki Akamatsu, M.D. Third Department of Internal Medicine, Wakayama Medical University
Principal Investigator: Nobuyuki Katakami, M.D., Ph.D. Division of Integrated Oncology, Institute of Biomedical Research and Innovation
Principal Investigator: Kazuhiko Nakagawa, M.D., Ph.D. Department of Medical Oncology, Kinki University, Faculty of Medicine

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Responsible Party: Hiroaki Akamatsu, Assistant Professor, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT03253068     History of Changes
Other Study ID Numbers: MK-3475-IIT-55441
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pembrolizumab
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Immunological
Antineoplastic Agents