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Evaluation of CRS-207 With Pembrolizumab in Previously Treated MPM

This study is currently recruiting participants.
Verified November 2017 by Aduro Biotech, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03175172
First Posted: June 5, 2017
Last Update Posted: November 20, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Aduro Biotech, Inc.
  Purpose
The purpose of this study is to evaluate whether CRS-207 with pembrolizumab is safe and effective in adults with MPM who have failed prior anti-cancer therapy.

Condition Intervention Phase
Malignant Pleural Mesothelioma Biological: CRS-207 Biological: Pembrolizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Single-arm Study to Evaluate Safety and Efficacy of CRS-207 With Pembrolizumab in Adults With Previously-Treated Malignant Pleural Mesothelioma

Resource links provided by NLM:


Further study details as provided by Aduro Biotech, Inc.:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: Through study completion, an average of 18 months ]
    Defined as the proportion of subjects with complete response (CR) or partial response (PR); Modified RECIST (Response Evaluation Criteria in Solid Tumors) for MPM (Byrne and Nowak, 2004) will be used to assess tumor response and progression.


Secondary Outcome Measures:
  • Disease Control Rate [ Time Frame: Through study completion, an average of 18 months ]
    Defined as the percentage of subjects with CR, PR, or stable disease (SD)

  • Progression Free Survival [ Time Frame: Through study completion, an average of 18 months ]
    Defined as time from first dose of study drug until disease progression or death

  • Improvement in pulmonary function (FVC) [ Time Frame: Through study completion, an average of 18 months ]
    Proportion of subjects with improvement in pulmonary function (FVC), defined as an increase from baseline of either ≥400 mL or ≥20% assessed using spirometry

  • Overall Survival (OS) [ Time Frame: Through study completion, an average of 18 months ]
    As measured from date of first dose of study drug until death


Estimated Enrollment: 35
Actual Study Start Date: June 15, 2017
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
CRS-207 and pembrolizumab will be administered in 3-week cycles. For Cycle 1, pembrolizumab (200 mg) will be administered by intravenous infusion (IV) over 30 minutes on Day 1 and CRS-207 (starting dose 1 × 10^9 colony-forming units [CFU]) will be administered IV over 1 hour on Day 2. If the infusions are well tolerated, pembrolizumab and CRS-207 may be administered on the same day (Day 1) for subsequent cycles. After 4 cycles, pembrolizumab will continue to be administered on Day 1 at each treatment cycle (every 3 weeks); CRS-207 will be administered once every 6 weeks. Treatment cycles will continue for up to 24 months as long as there is adequate safety and potential for clinical benefit.
Biological: CRS-207
Intravenous infusion
Biological: Pembrolizumab
intravenous infusion
Other Name: MK-3475

Detailed Description:
The population for this study will consist of approximately 35 adults with histologically-confirmed MPM (epithelial or biphasic) whose disease has progressed after 1-2 prior anti-cancer therapies.
  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:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically-confirmed epithelial or biphasic MPM; biphasic tumors must have a predominantly (≥50%) epithelial component
  2. No more than 2 prior lines of anti-cancer therapy, one of which must have included pemetrexed and a platinum.
  3. Measurable disease as defined by modified RECIST for MPM (Byrne and Nowak, 2004)
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  5. Adequate organ and marrow function
  6. Adequate lung function; forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) ≥ 45% of predicted value as measured by spirometry; and oxygen saturation ≥ 90% on room air

Exclusion Criteria

  1. Pleurodesis within 14 days prior to first dose of study drug
  2. Receiving TNF pathway inhibitors, PI3 kinase inhibitors, systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
  3. Active secondary malignancy
  4. Prior anti-cancer monoclonal antibody within 4 weeks prior to first dose of study drug, or not recovered from adverse effects due to agents administered more than 4 weeks earlier
  5. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of study drug
  6. History of (non-infectious) pneumonitis that required steroids or current pneumonitis
  7. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent, or agents targeting other checkpoint pathways (e.g. CTLA-4)
  8. Prior immunotherapy with CRS-207 or any other Listeria-based agent, therapeutic cancer vaccine, or adoptive T cell immunotherapy
  9. Implanted medical devices that pose high risks for colonization and cannot be easily removed (e.g., artificial heart valves, pacemakers, prosthetic joints, orthopedic screw(s), metal plate(s)) if infection occurs. Other common devices such as venous access devices (e.g., Port-a-Cath or Mediport) may be permitted as well as arterial and venous stents and dental and breast implants that were placed more than 3 months prior to first dose of study drug.
  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): NCT03175172


Locations
United States, California
UCSF Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Anish Pal    415-514-8194    Anish.Pal@ucsf.edu   
Principal Investigator: Thierry M Jahan, MD         
United States, Florida
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Ashley DeRigo    813-745-5995    Ashley.Derigo@moffitt.org   
Principal Investigator: Tawee Tanvetyanon, MD         
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Buerkely Rose    773-834-4002    Brose@bsd.uchicago.edu   
Principal Investigator: Hedy Kindler, MD         
United States, Maryland
NIH National Cancer Institute Recruiting
Bethesda, Maryland, United States, 20892
Contact: Maria Gracia L Agra, RN    301-594-1106    mariagracia.arga@nih.gov   
Principal Investigator: Raffit Hassan, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jill Burton    507-284-8440    burton@mayo.edu   
Principal Investigator: Tobias Peikert, MD         
United States, New York
Laura & Isaac Perlmutter Cancer Center at NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Jennifer Hull    212-731-5111    jennifer.hull@nyumc.org   
Principal Investigator: Leena Gandhi, MD, PhD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Polly Brogan    216-445-7101    broganp@ccf.org   
Principal Investigator: James Stevenson, MD         
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mona Jacobs-Small    215-662-8632    Mona.Jacobs-Small@uphs.upenn.edu   
Principal Investigator: Evan Alley, MD         
Sponsors and Collaborators
Aduro Biotech, Inc.
Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Aduro Biotech, Inc.
ClinicalTrials.gov Identifier: NCT03175172     History of Changes
Other Study ID Numbers: ADU-CL-13
KEYNOTE KN-701 ( Other Identifier: (Other Identifier: Merck Sharp & Dohme Corp) )
First Submitted: June 1, 2017
First Posted: June 5, 2017
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Pembrolizumab
Antineoplastic Agents