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Evaluation of CRS-207 With Pembrolizumab in Previously Treated Malignant Pleural Mesothelioma (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 DateJanuary 26, 2019
Start DateMay 31, 2017
Actual Primary Completion DateJanuary 9, 2018
Primary Outcome Measures

Overall Response Rate (ORR) [Time Frame: BOR was assessed from the first dose of study treatment until documented disease progression, initiation of new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.]

Secondary Outcome Measures

Disease Control Rate (DCR) [Time Frame: BOR was assessed from the first dose of study treatment until documented disease progression, initiation of new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.]

Progression-Free Survival (PFS) [Time Frame: Subjects followed for disease progression from first dose of study treatment until documented disease progression, initiation of new cancer treatment, death, or study termination, whichever is earlier, assessed up to 9 weeks.]

Improvement in Pulmonary Function [Time Frame: Subjects followed until initiation of new cancer treatment, death, or study termination.]

Overall Survival (OS) [Time Frame: OS was assessed from the first dose of study treatment until death or study termination, whichever is earlier, assessed up to 25 weeks.]

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 StatusTerminated
Actual Enrollment10
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. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

4. Adequate organ and marrow function

5. 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 tumor necrosis factor (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 PartySponsor
SponsorAduro Biotech, Inc.
Verification DateJanuary 2019
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