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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04807972
Ethics application status
Date submitted
17/03/2021
Date registered
19/03/2021

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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04807972