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Evaluation of CRS-207 With Pembrolizumab in Previously Treated MPM

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ClinicalTrials.gov Identifier: NCT03175172
Recruitment Status : Active, not recruiting
First Posted : June 5, 2017
Last Update Posted : December 14, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Aduro Biotech, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Malignant Pleural Mesothelioma Biological: CRS-207 Biological: Pembrolizumab Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
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
Actual Study Start Date : June 15, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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)

  2. 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

  3. 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

  4. 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



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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.

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
San Francisco, California, United States, 94115
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Maryland
NIH National Cancer Institute
Bethesda, Maryland, United States, 20892
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Laura & Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Aduro Biotech, Inc.
Merck Sharp & Dohme Corp.

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 Posted: June 5, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 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