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Trial record 1 of 3 for:    TPIV 200,
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TPIV200/huFR-1 (A Multi-Epitope Anti-Folate Receptor Vaccine) Plus Anti-PD-L1 MEDI4736 (Durvalumab) in Patients With Platinum Resistant Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT02764333
Recruitment Status : Completed
First Posted : May 6, 2016
Results First Posted : November 30, 2021
Last Update Posted : November 30, 2021
Sponsor:
Collaborators:
AstraZeneca
Marker Therapeutics, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Cancer
Interventions Biological: TPIV200
Biological: Durvalumab
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vaccine
Hide Arm/Group Description

Patients will receive an intradermal (ID) injection of TPIV200 (500 μg per peptide) and GM-CSF (125 μg per peptide) on Day 1 of cycles 1-6. They will also receive intravenous (IV) injections of durvalumab (750mg) on Days 1 and 15 of cycles 1-12. Radiologic tumor assessment will be repeated every 12 weeks (or 3 cycles) during and after treatment, until time of progression. Treatment will continue until progression, intolerance, withdrawal, study completion, or study termination.

TPIV200

Durvalumab

Period Title: Overall Study
Started 29
Completed 28
Not Completed 1
Reason Not Completed
Ineligible             1
Arm/Group Title Vaccine
Hide Arm/Group Description

Patients will receive an intradermal (ID) injection of TPIV200 (500 μg per peptide) and GM-CSF (125 μg per peptide) on Day 1 of cycles 1-6. They will also receive intravenous (IV) injections of durvalumab (750mg) on Days 1 and 15 of cycles 1-12. Radiologic tumor assessment will be repeated every 12 weeks (or 3 cycles) during and after treatment, until time of progression. Treatment will continue until progression, intolerance, withdrawal, study completion, or study termination.

TPIV200

Durvalumab

Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 29 participants
64
(42 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
29
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Hispanic or Latino
2
   6.9%
Not Hispanic or Latino
27
  93.1%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   6.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
26
  89.7%
More than one race
0
   0.0%
Unknown or Not Reported
1
   3.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 29 participants
29
 100.0%
1.Primary Outcome
Title Overall Response Rate
Hide Description (CR+PR) and will be assessed by RECIST 1.1. Pre-defined deviations from RECIST will be permitted to allow select patients deemed to be benefitting from treatment to receive continued therapy.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vaccine
Hide Arm/Group Description:

Patients will receive an intradermal (ID) injection of TPIV200 (500 μg per peptide) and GM-CSF (125 μg per peptide) on Day 1 of cycles 1-6. They will also receive intravenous (IV) injections of durvalumab (750mg) on Days 1 and 15 of cycles 1-12. Radiologic tumor assessment will be repeated every 12 weeks (or 3 cycles) during and after treatment, until time of progression. Treatment will continue until progression, intolerance, withdrawal, study completion, or study termination.

TPIV200

Durvalumab

Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
Partial Response
1
   3.4%
Stable Disease
6
  20.7%
Progression of Disease
4
  13.8%
Not Entered
18
  62.1%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vaccine
Hide Arm/Group Description

Patients will receive an intradermal (ID) injection of TPIV200 (500 μg per peptide) and GM-CSF (125 μg per peptide) on Day 1 of cycles 1-6. They will also receive intravenous (IV) injections of durvalumab (750mg) on Days 1 and 15 of cycles 1-12. Radiologic tumor assessment will be repeated every 12 weeks (or 3 cycles) during and after treatment, until time of progression. Treatment will continue until progression, intolerance, withdrawal, study completion, or study termination.

TPIV200

Durvalumab

All-Cause Mortality
Vaccine
Affected / at Risk (%)
Total   4/29 (13.79%) 
Hide Serious Adverse Events
Vaccine
Affected / at Risk (%)
Total   9/29 (31.03%) 
Gastrointestinal disorders   
Colonic obstruction   3/29 (10.34%) 
General disorders   
Pain   1/29 (3.45%) 
Infections and infestations   
Kidney infection   1/29 (3.45%) 
Investigations   
Platelet count decreased   1/29 (3.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Other, spec   3/29 (10.34%) 
Nervous system disorders   
Stroke   1/29 (3.45%) 
Reproductive system and breast disorders   
Breast pain   1/29 (3.45%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   1/29 (3.45%) 
Skin and subcutaneous tissue disorders   
Rash maculo-papular   1/29 (3.45%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vaccine
Affected / at Risk (%)
Total   29/29 (100.00%) 
Endocrine disorders   
Hyperthyroidism   2/29 (6.90%) 
Gastrointestinal disorders   
Nausea   11/29 (37.93%) 
Constipation   5/29 (17.24%) 
Abdominal pain   4/29 (13.79%) 
Gastroesophageal reflux disease   4/29 (13.79%) 
Diarrhea   3/29 (10.34%) 
Vomiting   3/29 (10.34%) 
Bloating   2/29 (6.90%) 
General disorders   
Injection site reaction   11/29 (37.93%) 
Fatigue   8/29 (27.59%) 
Infections and infestations   
Bladder infection   2/29 (6.90%) 
Investigations   
Serum amylase increased   3/29 (10.34%) 
Lipase increased   2/29 (6.90%) 
Metabolism and nutrition disorders   
Anorexia   2/29 (6.90%) 
Musculoskeletal and connective tissue disorders   
Back pain   3/29 (10.34%) 
Myalgia   3/29 (10.34%) 
Arthralgia   2/29 (6.90%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   8/29 (27.59%) 
Cough   4/29 (13.79%) 
Skin and subcutaneous tissue disorders   
Rash maculo-papular   5/29 (17.24%) 
Pruritus   3/29 (10.34%) 
Rash acneiform   2/29 (6.90%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jason Konner, MD
Organization: Memorial Sloan Kettering Cancer Center
Phone: 848-225-6530
EMail: konnerj@MSKCC.ORG
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02764333    
Other Study ID Numbers: 16-011
First Submitted: May 4, 2016
First Posted: May 6, 2016
Results First Submitted: November 1, 2021
Results First Posted: November 30, 2021
Last Update Posted: November 30, 2021