Trial Outcomes & Findings for DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (NCT NCT03439085)
NCT ID: NCT03439085
Last Updated: 2024-07-09
Results Overview
Will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Will be estimated with 95% confidence interval.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2024-07-09
Participant Flow
The study was activated on 11/14/2018 and closed to new patient entry on 08/12/2021. The study was terminated on 09/20/2022 and all recruitment was done in a medical clinic setting.
Participant milestones
| Measure |
Treatment Group
Patients received 7 mg of MEDI0457 intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks starting at week 4.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Treatment Group
Patients received 7 mg of MEDI0457 intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks starting at week 4.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Screen Failure
|
20
|
Baseline Characteristics
DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers
Baseline characteristics by cohort
| Measure |
Treatment Group
n=41 Participants
Patients received 7 mg of MEDI0457 intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks starting at week 4.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Two patients were not evaluable for response due to rapid clinical deterioration
Will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Will be estimated with 95% confidence interval.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
Patients received 7 mg of MEDI0457 intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks starting at week 4.
|
|---|---|
|
Overall Response Rate (ORR)
|
21 percentage of participants
Interval 6.0 to 46.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsDisease control rate is defined as N (%) patients with CR, PR, or SD by 24 weeks on study using RECIST version 1.1. For SD determination for DCR, the patient must have lack of progression for the first 24 weeks on study. Disease control rate will be assessed in the Response-evaluable and As-treated populations. Will be evaluated by RECIST version 1.1. Will be estimated with 95% confidence interval.
Outcome measures
| Measure |
Treatment Group
n=21 Participants
Patients received 7 mg of MEDI0457 intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks starting at week 4.
|
|---|---|
|
Disease Control Rate
|
37 percentage of participants
Interval 16.0 to 62.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsProgression Free Surival is defined as time in months from start of study treatment to first documentation of objective tumor progression as assessed by RECIST v1.1; Will be summarized using the method of Kaplan and Meier and Cox proportional hazards models.
Outcome measures
| Measure |
Treatment Group
n=21 Participants
Patients received 7 mg of MEDI0457 intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks starting at week 4.
|
|---|---|
|
Median Progression Free Survival (PFS)
|
4.6 Months
Interval 2.8 to 7.2
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: The cervical cancer cohort had 12 participants. The non cervical cohort had 9 participants.
Will be summarized using the method of Kaplan and Meier and Cox proportional hazards models.
Outcome measures
| Measure |
Treatment Group
n=21 Participants
Patients received 7 mg of MEDI0457 intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks starting at week 4.
|
|---|---|
|
Median Overall Survival
Entire Population
|
17.7 months
Interval 7.6 to
upper limit of the confidence interval was not estimable due to an insufficient number of participants with events
|
|
Median Overall Survival
Cervical Cancer Cohort
|
7.6 months
Interval 3.7 to 17.7
|
|
Median Overall Survival
Non Cervical Cohort
|
0 months
insufficient number of participants with events
|
Adverse Events
Treatment Group
Serious events: 1 serious events
Other events: 21 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment Group
n=21 participants at risk
Patients received 7 mg of MEDI0457 intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks starting at week 4.
|
|---|---|
|
Investigations
Lipase increased
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
Other adverse events
| Measure |
Treatment Group
n=21 participants at risk
Patients received 7 mg of MEDI0457 intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks starting at week 4.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
3/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Investigations
Alanine aminotransferase - increased
|
23.8%
5/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Investigations
Alkaline phosphatase - increased
|
14.3%
3/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Psychiatric disorders
Anxiety
|
9.5%
2/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Gastrointestinal disorders
Ascites
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Investigations
Aspartate aminotransferase - increased
|
19.0%
4/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Investigations
Blood bilirubin increased
|
9.5%
2/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Investigations
CPK increased
|
9.5%
2/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Hepatobiliary disorders
Cholecystitis
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Investigations
Creatinine increased
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Investigations
Eosinophilia
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
General disorders
Fatigue
|
47.6%
10/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
General disorders
Fever
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
9.5%
2/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
3/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.5%
2/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
19.0%
4/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
General disorders
Injection site reaction
|
95.2%
20/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Investigations
Lipase increased
|
19.0%
4/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
14.3%
3/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
19.0%
4/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
General disorders
Pain
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
23.8%
5/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.5%
2/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
3/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Investigations
Serum amylase increased
|
14.3%
3/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Cardiac disorders
Sinus bradycardia
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • From the first dose through 30 days after the last dose of study medication, up to 2 years
|
Additional Information
Dr. Michael Frumovitz, Chief Patient Experience Ofc, Ofc of Chief Operating Officer
UT MD Anderson Cancer Center
Phone: (713) 792-9599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place