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A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma

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: NCT03075527
Recruitment Status : Suspended (Criteria not met for second stage at time of interim analysis)
First Posted : March 9, 2017
Results First Posted : November 12, 2019
Last Update Posted : April 3, 2020
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Mark Awad, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mesothelioma
Interventions Drug: Tremelimumab
Drug: Durvalumab
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tremelimumab + Durvalumab
Hide Arm/Group Description

Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.

Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.

Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.

Period Title: Overall Study
Started 19
Completed 17
Not Completed 2
Reason Not Completed
Ongoing treatment             2
Arm/Group Title Tremelimumab + Durvalumab
Hide Arm/Group Description

Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.

Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.

Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.

Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Age Number Analyzed 19 participants
69
(33 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
3
  15.8%
Male
16
  84.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
18
  94.7%
Unknown or Not Reported
1
   5.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
18
  94.7%
More than one race
0
   0.0%
Unknown or Not Reported
1
   5.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
1.Primary Outcome
Title Overall Response Rate
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame ORR was assessed every 8 weeks from Cycle 1 Day 1 until date of documented disease progression or death.
Hide Outcome Measure Data
Hide Analysis Population Description
19 participants were included in the response rate calculation; one patient received at most one cycle of treatment.
Arm/Group Title Tremelimumab + Durvalumab
Hide Arm/Group Description:

Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.

Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.

Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.

Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.3%
2.Secondary Outcome
Title Overall Survival
Hide Description defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive.
Time Frame Overall survival is assessed from date of registration until date of death on-treatment or during follow-up.
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Progression Free Survival
Hide Description Progression-Free Survival (PFS) is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.
Time Frame PFS is measured from time of registration to date of radiographic progression per RECIST1.1 or death.
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Duration of Response
Hide Description Time from documentation of tumor response to disease progression
Time Frame Duration of response will be assessed at study completion, after all participants are off treatment.
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Adverse Events
Hide Description Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.
Time Frame Toxicity is assessed from the time of first dose of study medication until the participant comes off study. Adverse event profile will be assessed at study completion.
Outcome Measure Data Not Reported
Time Frame Adverse events were collected from time of first dose through end of follow-up.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tremelimumab + Durvalumab
Hide Arm/Group Description

Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.

Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.

Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.

All-Cause Mortality
Tremelimumab + Durvalumab
Affected / at Risk (%)
Total   11/19 (57.89%)    
Hide Serious Adverse Events
Tremelimumab + Durvalumab
Affected / at Risk (%) # Events
Total   0/19 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tremelimumab + Durvalumab
Affected / at Risk (%) # Events
Total   19/19 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  2/19 (10.53%)  2
Cardiac disorders   
Sinus bradycardia  1  1/19 (5.26%)  1
Sinus tachycardia  1  2/19 (10.53%)  2
Congenital, familial and genetic disorders   
Congenital, familial and genetic disorders - Other, specify  1  1/19 (5.26%)  1
Ear and labyrinth disorders   
Vertigo  1  1/19 (5.26%)  1
Endocrine disorders   
Hyperthyroidism  1  3/19 (15.79%)  3
Hypothyroidism  1  2/19 (10.53%)  2
Gastrointestinal disorders   
Abdominal distension  1  1/19 (5.26%)  1
Abdominal pain  1  1/19 (5.26%)  1
Ascites  1  1/19 (5.26%)  1
Bloating  1  2/19 (10.53%)  2
Constipation  1  4/19 (21.05%)  4
Diarrhea  1  3/19 (15.79%)  3
Dyspepsia  1  1/19 (5.26%)  1
Dysphagia  1  2/19 (10.53%)  2
Gastrointestinal disorders - Other, specify  1  1/19 (5.26%)  1
Nausea  1  3/19 (15.79%)  3
Vomiting  1  3/19 (15.79%)  3
General disorders   
Chills  1  1/19 (5.26%)  1
Death NOS  1  1/19 (5.26%)  1
Edema limbs  1  3/19 (15.79%)  3
Fatigue  1  7/19 (36.84%)  7
General disorders and administration site conditions - Other, specify  1  2/19 (10.53%)  2
Localized edema  1  1/19 (5.26%)  1
Non-cardiac chest pain  1  2/19 (10.53%)  2
Pain  1  3/19 (15.79%)  3
Infections and infestations   
Lung infection  1  1/19 (5.26%)  1
Rash pustular  1  1/19 (5.26%)  1
Upper respiratory infection  1  1/19 (5.26%)  1
Investigations   
Alkaline phosphatase increased  1  2/19 (10.53%)  2
Creatinine increased  1  2/19 (10.53%)  2
Investigations - Other, specify  1  2/19 (10.53%)  2
Lipase increased  1  4/19 (21.05%)  4
Neutrophil count decreased  1  1/19 (5.26%)  1
Serum amylase increased  1  3/19 (15.79%)  3
Weight gain  1  1/19 (5.26%)  1
Weight loss  1  2/19 (10.53%)  2
White blood cell decreased  1  2/19 (10.53%)  2
Metabolism and nutrition disorders   
Anorexia  1  3/19 (15.79%)  3
Dehydration  1  1/19 (5.26%)  1
Hyperglycemia  1  1/19 (5.26%)  1
Hyperkalemia  1  3/19 (15.79%)  3
Hypernatremia  1  1/19 (5.26%)  1
Hypoalbuminemia  1  6/19 (31.58%)  6
Hyponatremia  1  4/19 (21.05%)  4
Hypophosphatemia  1  1/19 (5.26%)  1
Metabolism and nutrition disorders - Other, specify  1  2/19 (10.53%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/19 (10.53%)  2
Arthritis  1  1/19 (5.26%)  1
Back pain  1  2/19 (10.53%)  2
Chest wall pain  1  1/19 (5.26%)  1
Musculoskeletal and connective tissue disorder - Other, specify  1  3/19 (15.79%)  3
Myalgia  1  1/19 (5.26%)  1
Pain in extremity  1  1/19 (5.26%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain  1  1/19 (5.26%)  1
Nervous system disorders   
Dizziness  1  2/19 (10.53%)  2
Peripheral sensory neuropathy  1  1/19 (5.26%)  1
Psychiatric disorders   
Anxiety  1  1/19 (5.26%)  1
Insomnia  1  3/19 (15.79%)  3
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome  1  1/19 (5.26%)  1
Cough  1  4/19 (21.05%)  4
Dyspnea  1  4/19 (21.05%)  4
Hoarseness  1  1/19 (5.26%)  1
Laryngeal mucositis  1  1/19 (5.26%)  1
Nasal congestion  1  2/19 (10.53%)  2
Pleural effusion  1  3/19 (15.79%)  3
Pneumonitis  1  2/19 (10.53%)  2
Productive cough  1  1/19 (5.26%)  1
Wheezing  1  1/19 (5.26%)  1
Skin and subcutaneous tissue disorders   
Dry skin  1  1/19 (5.26%)  1
Pruritus  1  4/19 (21.05%)  4
Rash acneiform  1  2/19 (10.53%)  2
Vascular disorders   
Hypotension  1  1/19 (5.26%)  1
Thromboembolic event  1  1/19 (5.26%)  1
1
Term from vocabulary, CTCAE (4.03)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark Awad, MD, PhD
Organization: Dana-Farber Cancer Institute
Phone: 6176323468
EMail: mark_awad@dfci.harvard.edu
Layout table for additonal information
Responsible Party: Mark Awad, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03075527    
Other Study ID Numbers: 16-549
First Submitted: March 2, 2017
First Posted: March 9, 2017
Results First Submitted: August 23, 2019
Results First Posted: November 12, 2019
Last Update Posted: April 3, 2020