Description:
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.
Title
- Brief 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
- 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
Clinical Trial IDs
- ORG STUDY ID:
M20-732
- SECONDARY ID:
2020-005767-31
- NCT ID:
NCT04807972
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| ABBV-927 | | Phase 1b Dose Escalation |
| Budiglimab | ABBV-181 | Phase 1b Dose Escalation |
| modified FOLFIRINOX | mFFX | Phase 1b Dose Escalation |
Purpose
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 Arms
| Name | Type | Description | Interventions |
|---|
| Phase 1b Dose Escalation | Experimental | Participants will receive escalating doses of ABBV-927 in combination with modified FOLFIRINOX (mFFX) and Budigalimab. | - ABBV-927
- Budiglimab
- modified FOLFIRINOX
|
| Phase 2 Cohort A | Experimental | Participants will receive modified FOLFIRINOX on Day 1 and Day 15 of each 28 day cycle. | |
| Phase 2 Cohort B | Experimental | Participants will receive modified FOLFIRINOX (Day 1 and Day 15) + ABBV-927 in each 28 day cycle. | - ABBV-927
- modified FOLFIRINOX
|
| Phase 2 Cohort C Expansion | Experimental | Participants will receive modified FOLFIRINOX (Day 1 and Day 15) + ABBV 927 and Budigalimab as Intravenous (IV) Infusion in each 28 day cycle. | - ABBV-927
- Budiglimab
- modified FOLFIRINOX
|
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).
| Maximum Eligible Age: | 75 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Phase 1b: Percentage of participants experiencing Adverse Events |
| Time Frame: | Up to 6 months |
| Safety Issue: | |
| Description: | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. |
Secondary Outcome Measures
| Measure: | Phase 1b and Phase 2: Maximum Plasma Concentration (Cmax) |
| Time Frame: | Up to approximately 3 months |
| Safety Issue: | |
| Description: | The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. |
| Measure: | Phase 1b and Phase 2: Time to Maximum Observed Plasma Concentration (Tmax) |
| Time Frame: | Up to approximately 3 months |
| Safety Issue: | |
| Description: | The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. |
| Measure: | Phase 1b and Phase 2: Area Under the Concentration-time Curve Over the Time Interval (AUC) in Plasma |
| Time Frame: | Up to approximately 3 months. |
| Safety Issue: | |
| Description: | The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma. |
| Measure: | Phase 1b and Phase 2: Objective Response Rate (ORR) |
| Time Frame: | Up to approximately 27 months |
| Safety Issue: | |
| Description: | ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) per investigator assessment according to RECIST version 1.1. |
| Measure: | Phase 1b and Phase 2: Clinical Benefit Rate (CBR) |
| Time Frame: | Up to approximately 27 months |
| Safety Issue: | |
| Description: | Clinical Benefit Rate (CBR) is defined as the percentage of participants whose best overall response is either Complete Response (CR), Partial Response (PR), or stable disease (SD) according to RECIST version 1.1. |
| Measure: | Phase 1b and Phase 2: Duration of Response (DOR) for Participants Who Achieve a Documented Confirmed Response of CR/PR |
| Time Frame: | Up to approximately 27 months |
| Safety Issue: | |
| Description: | DOR is defined as the time from the initial response of CR/PR per investigator review according to RECIST version 1.1 criteria to the first occurrence of radiographic disease progression, clinical progression or death from any cause whichever occurs first. |
| Measure: | Phase 1b and Phase 2: Progression Free Survival (PFS) |
| Time Frame: | Up to approximately 24 months after study drug discontinuation |
| Safety Issue: | |
| Description: | PFS is defined as the time from randomization to a documented radiographic disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, clinical progression or death from any cause, whichever occurs earlier. |
| Measure: | 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) |
| Time Frame: | Up to approximately 25 months |
| Safety Issue: | |
| Description: | Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) will measure participants' overall perceptions of their pancreatic cancer symptoms over time. |
| Measure: | Phase 2: Percentage of Participants Experiencing Adverse Events |
| Time Frame: | Up to approximately 27 months. |
| Safety Issue: | |
| Description: | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | AbbVie |
Trial Keywords
- Metastatic Pancreatic Cancer Disease
- ABBV-927
- Modified Folfirinox (mFFX)
- Budigalimab
- ABBV-181
- Cancer
Last Updated
June 29, 2021
