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Trial record 1 of 677 for:    Pembrolizumab
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Pembrolizumab and Paclitaxel in Refractory Small Cell Lung Cancer (MISP-MK3475)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02551432
First Posted: September 16, 2015
Last Update Posted: September 12, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Bhumsuk Keam, Seoul National University Hospital
  Purpose
Patients with refractory SCLC. Patients will be treated with paclitaxel and pembrolizumab.

Condition Intervention Phase
Small Cell Lung Cancer Drug: pembrolizumab, paclitaxel Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Pembrolizumab and Paclitaxel in Refractory Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Bhumsuk Keam, Seoul National University Hospital:

Primary Outcome Measures:
  • Response rate, NCI CTCAE [ Time Frame: 3 months ]
    Intravenous administration of pembrolizumab and paclitaxel has clinically meaningful benefit in RR based on RECIST v1.1 One cycle of paclitaxel prior to pembrolizumab can play a role as an inducer of PD-L1 expression of tumor


Secondary Outcome Measures:
  • PFS, NCI CTCAE [ Time Frame: 3 months ]
    Intravenous administration of Pembrolizumab and paclitaxel has clinically meaningful benefit in PFS and OS based on RECIST and irRECIST

  • OS, NCI CTCAE [ Time Frame: 3 months ]
    meaningful benefit in PFS and OS based on RECIST and irRECIST

  • toxicity (meaningful benefit in PFS and OS based on RECIST and irRECIST) [ Time Frame: 3 months ]
    meaningful benefit in PFS and OS based on RECIST and irRECIST


Other Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 months ]
    find out predictive biomarker for pembrolizumab. Factors potentially associated with pembrolizumab response will b analyzed for providing the rationale for future patient selection.


Estimated Enrollment: 26
Study Start Date: September 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel pembrolizumab
  • PD-L1 Induction phase : Paclitaxel 175 mg/m2, Day 1 q 3weeks, intravenous,
  • Post Induction treatment phase: Paclitaxel 175 mg/m2, Day 1 q 3weeks (maximum up to total 6 cycles) + pembrolizumab 200 mg D1 q 3 weeks, intravenous,
  • Maintenance phase: pembrolizumab 200 mg D1 q 3 weeks, intravenous till PD or unacceptable toxicity
Drug: pembrolizumab, paclitaxel
pembrolizumab, paclitaxel
Other Name: keytruda, taxol

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

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.


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

Inclusion Criteria:

  1. Be willing and able to provide written informed consent/assent for the trial.
  2. Be 20 years of age on day of signing informed consent.
  3. Have measurable lesions based on RECIST 1.1.
  4. Have provided tissue from an archival tissue sample obtained after the last previous treatment or newly obtained core or excisional biopsy of a tumor lesion.
  5. Have a performance status of 0 or 1 on the ECOG Performance Scale.
  6. Demonstrate adequate organ function as defined below 'adequate organ fuction laboratory values', all screening labs should be performed within 10 days of treatment initiation.

    'adequate organ fuction laboratory values' System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥ 1,500 /mcL Platelets ≥100,000 / mcL Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L Renal Serum creatinine OR Measured or calculateda creatinine clearance (GFR can also be used in place of creatinine or CrCl)≤1.5 X upper limit of normal (ULN) OR ≥ 60 mL/min for subject with creatinine levels >1.5 X institutional ULN Hepatic Serum total bilirubin≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR

    • 5 X ULN for subjects with liver metastases Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT)
    • 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants aCreatinine clearance should be calculated per institutional standard.
  7. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  8. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (Reference Section 5.7.2). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  9. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.

Exclusion Criteria:

  1. Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
  2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  3. Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  4. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.

    • Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
    • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  5. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  6. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.
  7. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  8. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
  9. Has an active infection requiring systemic therapy.
  10. 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.
  11. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  12. 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 after the last dose of trial treatment.
  13. 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 (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  14. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  15. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). (inactive HBsAg carriers with prophylactic antiviral agent are allowed)
  16. Has received a live vaccine within 30 days prior to the first dose of trial treatment.
  17. Has a known history of active TB (Bacillus Tuberculosis)
  18. Has known hypersensitivity to MK-3475 or any of its excipients
  Contacts and Locations
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): NCT02551432


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Bhumsuk Keam, Ph.D Seoul National University Hospital
  More Information

Responsible Party: Bhumsuk Keam, Clinical assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02551432     History of Changes
Other Study ID Numbers: MISP MK3475
First Submitted: July 7, 2015
First Posted: September 16, 2015
Last Update Posted: September 12, 2017
Last Verified: September 2017

Keywords provided by Bhumsuk Keam, Seoul National University Hospital:
pembrolizumab
paclitaxel

Additional relevant MeSH terms:
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
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action