Clinical trial NCT04807972: 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
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pancreatic Cancer
Keywords: Metastatic Pancreatic Cancer Disease
ABBV-927
Modified Folfirinox (mFFX)
Budigalimab
ABBV-181
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 on day 3 of every 28 day cycle, modified FOLFIRINOX as IV Infusion in Phase 1b 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.

Detailed description: Study study was terminated before the Phase 2 portion of the study began.

Eligibility criteria: 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.

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).

Primary outcomes:
measure: Phase 1b: Percentage of participants experiencing Adverse Events
timeFrame: Up to 6 months
measure: Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Laboratory (Hematological and Chemistry) Values
timeFrame: Up to 6 months
measure: Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Vital Signs
timeFrame: Up to 6 months
measure: Phase 1b: Number of Participants with Dose Limiting Toxicities (DLT)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Phase 1b: Maximum Plasma Concentration (Cmax)
timeFrame: Up to approximately 3 months
measure: Phase 1b: Time to Maximum Observed Plasma Concentration (Tmax)
timeFrame: Up to approximately 3 months
measure: Phase 1b: Area Under the Concentration-time Curve Over the Time Interval (AUC) in Plasma
timeFrame: Up to approximately 3 months.
measure: Phase 1b: Objective Response Rate (ORR)
timeFrame: Up to approximately 27 months
measure: Phase 1b: Clinical Benefit Rate (CBR)
timeFrame: Up to approximately 27 months
measure: Phase 1b: Duration of Response (DOR) for Participants Who Achieve a Documented Confirmed Response of CR/PR
timeFrame: Up to approximately 27 months
measure: Phase 1b: Progression Free Survival (PFS)
timeFrame: Up to approximately 24 months after study drug discontinuation
measure: Phase 1b: 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)
timeFrame: Up to approximately 25 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: UCHSC Anschultz Cancer Pavilion /ID# 227841
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins Hospital /ID# 226713
state: Maryland
city: Cleveland
country: United States
facility: Univ Hosp Cleveland /ID# 226807
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus /ID# 231135
state: Ohio
city: Hershey
country: United States
facility: Penn State Hershey Medical Ctr /ID# 229837
state: Pennsylvania
city: Clayton
country: Australia
facility: Monash Medical Centre /ID# 231379
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health /ID# 231378
state: Victoria
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 229555
state: H_efa
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 226812
state: Tel-Aviv
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 230280
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 230282
state: Seoul Teugbyeolsi
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials, LLC /ID# 228210
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 230226
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 230102
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet /ID# 230139
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: