Trial Outcomes & Findings for Durvalumab and "Booster" Radiation in Metastatic Adenocarcinoma of the Pancreas (NCT NCT03490760)

Last Updated: 2023-10-12

Results Overview

Time from initiation of durvalumab to progression per RECIST 1.1 or death, whichever comes first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions. Confirmation of PD for participants who are deemed clinically stable by the Investigator should be acquired preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of PD.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

1 year

Results posted on

2023-10-12

Participant Flow

Participant milestones

Participant milestones
Measure	Durvalumab Plus Radiation Therapy Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks plus 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5. Durvalumab: Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks Radiation Therapy: 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5.
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Durvalumab and "Booster" Radiation in Metastatic Adenocarcinoma of the Pancreas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Durvalumab Plus Radiation Therapy n=9 Participants Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks plus 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5. Durvalumab: Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks Radiation Therapy: 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	71 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Only 7 participants received study treatment. One participant voluntarily withdrew after signing consent, and one participant was a screen failure.

Outcome measures

Outcome measures
Measure	Durvalumab Plus Radiation Therapy n=7 Participants Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks plus 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5. Durvalumab: Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks Radiation Therapy: 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5.
Progression Free Survival	53 days Interval 51.0 to 53.5

SECONDARY outcome

Timeframe: 1 year

Population: Only 7 participants received study treatment. One participant voluntarily withdrew after signing consent, and one participant was a screen failure. An additional participant expired before their first follow-up imaging, so response could not be determined.

ORR is defined as the percentage of the patients who have a complete response (CR) or partial response (PR) as defined by RECIST 1.1. The patient's best overall response rate defined as the best response recorded from the start of the treatment until disease progression. Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR and PR requires a confirmatory scan preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of CR, PR, or stable disease (SD).

Outcome measures

Outcome measures
Measure	Durvalumab Plus Radiation Therapy n=6 Participants Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks plus 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5. Durvalumab: Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks Radiation Therapy: 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5.
Overall Response Rate (ORR)	0 Participants

SECONDARY outcome

Timeframe: 1 year

The clinical benefit rate is the percentage of patients that have achieved a CR, PR, or stable disease (SD) as defined by RECIST 1.1. Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; PD is defined as at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions; SD is defined as not meeting criteria for CR, PR, or SD. CR and PR requires a confirmatory scan preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of CR, PR, or stable disease (SD). Confirmation of PD for participants who are deemed clinically stable by the Investigator should be acquired preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of PD.

Outcome measures

Outcome measures
Measure	Durvalumab Plus Radiation Therapy n=6 Participants Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks plus 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5. Durvalumab: Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks Radiation Therapy: 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5.
Clinical Benefit Rate (CBR)	1 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Only 7 participants received study treatment; 3 participants demonstrated in-field progression.

In-field progression is defined as PD according to RECIST 1.1 criteria (at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions) within the original field or area where the participant had been treated with radiation therapy. Confirmation of PD for participants who are deemed clinically stable by the Investigator should be acquired preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of PD. The time to in-field progression is defined as the time from initiation of treatment to progression within the radiation.

Outcome measures

Outcome measures
Measure	Durvalumab Plus Radiation Therapy n=3 Participants Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks plus 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5. Durvalumab: Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks Radiation Therapy: 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5.
Time to In-field Progression	53 days Interval 51.0 to 53.5

SECONDARY outcome

Timeframe: 1 year

Population: Only 7 participants received study treatment. One participant voluntarily withdrew after signing consent, and one participant was a screen failure.

OS is defined as the time from first treatment until death. Patients who are alive will be censored at the last date of patient contact.

Outcome measures

Outcome measures
Measure	Durvalumab Plus Radiation Therapy n=7 Participants Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks plus 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5. Durvalumab: Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks Radiation Therapy: 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5.
Overall Survival (OS)	85 days Interval 75.0 to 175.0

Adverse Events

Durvalumab Plus Radiation Therapy

Serious events: 3 serious events

Other events: 6 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Durvalumab Plus Radiation Therapy n=7 participants at risk Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks plus 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5. Durvalumab: Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks Radiation Therapy: 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5.
Metabolism and nutrition disorders Hyperglycemia	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Gastrointestinal disorders Abdominal pain	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Infections and infestations Sepsis	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Renal and urinary disorders Acute cystitis	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Gastrointestinal disorders Rectal bleed	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Gastrointestinal disorders GI bleed	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Metabolism and nutrition disorders Hypoglycemia	14.3% 1/7 • Number of events 1 • 1 year, 3 months

Other adverse events

Other adverse events
Measure	Durvalumab Plus Radiation Therapy n=7 participants at risk Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks plus 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5. Durvalumab: Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks Radiation Therapy: 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5.
Renal and urinary disorders Urinary tract infection	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Hepatobiliary disorders Increased alkaline phosphatase	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Gastrointestinal disorders Abdominal pain	28.6% 2/7 • Number of events 3 • 1 year, 3 months
Gastrointestinal disorders Diarrhea	42.9% 3/7 • Number of events 3 • 1 year, 3 months
Musculoskeletal and connective tissue disorders Back pain	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Reproductive system and breast disorders Testicular pain	14.3% 1/7 • Number of events 1 • 1 year, 3 months
General disorders Fatigue	28.6% 2/7 • Number of events 2 • 1 year, 3 months
Gastrointestinal disorders Nausea	28.6% 2/7 • Number of events 2 • 1 year, 3 months
Gastrointestinal disorders Constipation	28.6% 2/7 • Number of events 2 • 1 year, 3 months
Gastrointestinal disorders Anorexia	28.6% 2/7 • Number of events 2 • 1 year, 3 months
Gastrointestinal disorders Vomiting	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Cardiac disorders Elevated troponin	14.3% 1/7 • Number of events 1 • 1 year, 3 months
General disorders Generalized weakness	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Metabolism and nutrition disorders Protein calorie malnutrition	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Blood and lymphatic system disorders Anemia	14.3% 1/7 • Number of events 3 • 1 year, 3 months
Hepatobiliary disorders Low Albumin on Blood	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Infections and infestations Fever	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Renal and urinary disorders Hyponatremia	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Nervous system disorders Seizure	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Respiratory, thoracic and mediastinal disorders Aspiration pneumonia	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Vascular disorders Bilateral pulmonary embolism	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Vascular disorders Deep vein thrombosis	14.3% 1/7 • Number of events 1 • 1 year, 3 months
Respiratory, thoracic and mediastinal disorders Shortness of breath	14.3% 1/7 • Number of events 1 • 1 year, 3 months

Additional Information

Michael Chuong, M.D.

Miami Cancer Institute at Baptist Health, Inc.

Phone: (786) 596-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place