Mesothelioma.com Resources for Patients and their Families

Evaluation of CRS-207 With Pembrolizumab in Previously Treated MPM

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.

Tracking Information
First Received DateJune 1, 2017
Last Changed DateAugust 25, 2017
Start DateJune 15, 2017
Anticipated Primary Completion DateDecember 2018
Primary Outcome Measures

Objective Response Rate [Time Frame: Through study completion, an average of 18 months]

Secondary Outcome Measures

Disease Control Rate [Time Frame: Through study completion, an average of 18 months]

Progression Free Survival [Time Frame: Through study completion, an average of 18 months]

Improvement in pulmonary function (FVC) [Time Frame: Through study completion, an average of 18 months]

Overall Survival (OS) [Time Frame: Through study completion, an average of 18 months]

Descriptive Information
PhasePhase 2
Study TypeInterventional
Condition
  • Malignant Pleural Mesothelioma
Intervention
  • Biological: CRS-207
  • Biological: Pembrolizumab
Study Arms / Comparison Groups1 / 0
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.

Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment35
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility 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.

Administrative Information
NCTIDNCT03175172
Responsible Party,
SponsorAduro Biotech, Inc.
Verification DateAugust 2017
Mesothelioma Doctors by State
  • Breaking News
  • Emerging Clinical Trials
  • Delivered within 24 hrs

Yes   No

Mesothelioma Cancer Alliance Blog

FEATURED CONTENT:


RECENT POSTS:

Warren Zevon: Music, Family & Mesothelioma

Champion for Mesothelioma: CURE Magazine Profiles 11-Year Survivor

Fall 2017 Mesothelioma Cancer Alliance Scholarship Winner Natalia Jaramillo

Mesothelioma Treatment Guide

Free Mesothelioma Treatment Guide

Please fill in the form below to request our FREE Mesothelioma Treatment Guide. It will be sent to you within 24 hours.

Have you or someone you know been diagnosed with mesothelioma?

Get Access To: