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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04807972




Registration number
NCT04807972
Ethics application status
Date submitted
17/03/2021
Date registered
19/03/2021
Date last updated
6/05/2024

Titles & IDs
Public title
Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis
Scientific title
A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination With Modified FOLFIRINOX (mFFX) With or Without Budigalimab Compared to mFFX in Subjects With Untreated Metastatic Pancreatic Adenocarcinoma
Secondary ID [1] 0 0
2020-005767-31
Secondary ID [2] 0 0
M20-732
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-927
Treatment: Drugs - Budiglimab
Treatment: Drugs - modified FOLFIRINOX

Experimental: Phase 1b Dose Escalation - Participants will receive escalating doses of ABBV-927 in combination with modified FOLFIRINOX (mFFX) and Budigalimab.

Experimental: Phase 2 Cohort A - Participants will receive modified FOLFIRINOX on Day 1 and Day 15 of each 28 day cycle.

Experimental: Phase 2 Cohort B - Participants will receive modified FOLFIRINOX (Day 1 and Day 15) + ABBV-927 in each 28 day cycle.

Experimental: Phase 2 Cohort C Expansion - Participants will receive modified FOLFIRINOX (Day 1 and Day 15) + ABBV 927 and Budigalimab as Intravenous (IV) Infusion in each 28 day cycle.


Treatment: Drugs: ABBV-927
Intravenous (IV) Infusion

Treatment: Drugs: Budiglimab
Intravenous (IV) Infusion

Treatment: Drugs: modified FOLFIRINOX
Intravenous (IV) Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1b: Percentage of participants experiencing Adverse Events
Timepoint [1] 0 0
Up to 6 months
Primary outcome [2] 0 0
Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Laboratory (Hematological and Chemistry) Values
Timepoint [2] 0 0
Up to 6 months
Primary outcome [3] 0 0
Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Vital Signs
Timepoint [3] 0 0
Up to 6 months
Primary outcome [4] 0 0
Phase 1b: Number of Participants with Dose Limiting Toxicities (DLT)
Timepoint [4] 0 0
Up to 6 months
Primary outcome [5] 0 0
Phase 2: Overall Survival
Timepoint [5] 0 0
48 months.
Secondary outcome [1] 0 0
Phase 1b and Phase 2: Maximum Plasma Concentration (Cmax)
Timepoint [1] 0 0
Up to approximately 3 months
Secondary outcome [2] 0 0
Phase 1b and Phase 2: Time to Maximum Observed Plasma Concentration (Tmax)
Timepoint [2] 0 0
Up to approximately 3 months
Secondary outcome [3] 0 0
Phase 1b and Phase 2: Area Under the Concentration-time Curve Over the Time Interval (AUC) in Plasma
Timepoint [3] 0 0
Up to approximately 3 months.
Secondary outcome [4] 0 0
Phase 1b and Phase 2: Objective Response Rate (ORR)
Timepoint [4] 0 0
Up to approximately 27 months
Secondary outcome [5] 0 0
Phase 1b and Phase 2: Clinical Benefit Rate (CBR)
Timepoint [5] 0 0
Up to approximately 27 months
Secondary outcome [6] 0 0
Phase 1b and Phase 2: Duration of Response (DOR) for Participants Who Achieve a Documented Confirmed Response of CR/PR
Timepoint [6] 0 0
Up to approximately 27 months
Secondary outcome [7] 0 0
Phase 1b and Phase 2: Progression Free Survival (PFS)
Timepoint [7] 0 0
Up to approximately 24 months after study drug discontinuation
Secondary outcome [8] 0 0
Phase 1b and Phase 2: Quality of Life(QoL)-Measure Participant Overall Perceptions of Their Change in Pancreatic Cancer Symptoms includes the Patient Global Impression of Severity (PGIS) and the the Patient Global Impression of Change (PGIC)
Timepoint [8] 0 0
Up to approximately 25 months
Secondary outcome [9] 0 0
Phase 2: Percentage of Participants Experiencing Adverse Events
Timepoint [9] 0 0
Up to approximately 27 months.

Eligibility
Key inclusion criteria
- Body weight >= 35 kg.

- Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with
metastatic disease.

- Measurable disease per Response Evaluation Criteria for Solid Tumors Version 1.1
(RECIST v1.1).

- Prior history of or clinically stable concurrent malignancy are eligible for
enrollment provided the malignancy is clinically insignificant, no treatment is
required, and the participant is clinically stable.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants with locally advanced disease.

- Participants with neuroendocrine (carcinoid, islet cell) or acinar pancreatic
carcinoma.

- Prior radiotherapy, surgery, or systemic anti-cancer therapy for the treatment of
metastatic pancreatic adenocarcinoma.

- Prior radiotherapy, surgery, or systemic anti-cancer therapy in the adjuvant setting,
or earlier, within the last 4 months.

- Prior radiotherapy to any measurable metastatic lesion at any time.

- Clinically significant third-space fluid accumulation (e.g., ascites or pleural
effusion).

- Known metastases to the central nervous system (CNS).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/03/2024
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre /ID# 231379 - Clayton
Recruitment hospital [2] 0 0
Austin Health /ID# 231378 - Heidelberg
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
Israel
State/province [5] 0 0
H_efa
Country [6] 0 0
Israel
State/province [6] 0 0
Tel-Aviv
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Seoul Teugbyeolsi
Country [8] 0 0
Puerto Rico
State/province [8] 0 0
Rio Piedras
Country [9] 0 0
Spain
State/province [9] 0 0
Barcelona
Country [10] 0 0
Spain
State/province [10] 0 0
Madrid
Country [11] 0 0
Spain
State/province [11] 0 0
Zaragoza

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Metastatic Pancreatic Cancer Disease is one of the most aggressive and deadliest forms of
cancer with very poor survival. This study will evaluate adverse events and change in disease
activity in participants 18 to 75 years of age with a body weight greater than or equal to 35
kg with Metastatic Pancreatic Cancer Disease treated with Intravenous (IV) infusion of
modified FOLFIRINOX (mFFX) combined with IV infusions of ABBV-927 with or without
Budigalimab.

ABBV-927 and Budigalimab are the investigational drugs being developed for treatment of
Metastatic Pancreatic Cancer Disease. In this study, doctors will enroll participants between
18 and 75 years of age with a body weight greater than or equal to 35 kg diagnosed diagnosed
with Metastatic Pancreatic Cancer Disease in 4 different groups, called treatment arms. Each
group will receive different treatments. Approximately 129 adult participants will be
enrolled in the study across approximately 27 sites worldwide.

Participants will receive ABBV-927 and Budigalimab as Intravenous (IV) Infusion in Phase 1b
and Phase 2 on day 3 of every 28 day cycle, modified FOLFIRINOX as IV Infusion in Phase 1b
and Phase 2 on Day1 and Day 15 of every 28 day cycle up to maximum of 2 years.

There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, blood tests,
checking for side effects and completing questionnaires.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04807972
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries