ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of CRS-207 With Pembrolizumab in Previously Treated MPM

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.
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.

June 1, 2017
June 5, 2017
December 14, 2017
June 15, 2017
December 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03175172 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Evaluation of CRS-207 With Pembrolizumab in Previously Treated MPM
A Phase 2 Single-arm Study to Evaluate Safety and Efficacy of CRS-207 With Pembrolizumab in Adults With Previously-Treated Malignant Pleural Mesothelioma
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.
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Malignant Pleural Mesothelioma
  • Biological: CRS-207
    Intravenous infusion
  • Biological: Pembrolizumab
    intravenous infusion
    Other Name: MK-3475
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.
Interventions:
  • Biological: CRS-207
  • Biological: Pembrolizumab
Byrne MJ, Nowak AK. Modified RECIST criteria for assessment of response in malignant pleural mesothelioma. Ann Oncol. 2004 Feb;15(2):257-60.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
35
Same as current
March 2019
December 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03175172
ADU-CL-13
KEYNOTE KN-701 ( Other Identifier: (Other Identifier: Merck Sharp & Dohme Corp) )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Aduro Biotech, Inc.
Aduro Biotech, Inc.
Merck Sharp & Dohme Corp.
Not Provided
Aduro Biotech, Inc.
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP