18 and older, any sex, with Pancreatic Cancer (Unresectable). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Primary· From first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196)
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE was defined as a new or
TEAEs
Group
Value
95% CI
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)
24
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)
12
SAEs
Group
Value
95% CI
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)
9
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)
6
Number of Participants Who Had Surgical Complications Post-ResectionPrimary· 30 days following discharge after surgery (up to Day 198)
Number of participants who had surgical complications (for example; surgical site infection, intra-abdominal abscess, or perioperative leak during surgery) has been reported
Group
Value
95% CI
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)
0
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)
0
Number of Participants Who Became Eligible for SurgerySecondary· After completion of 24 weeks of treatment with study drug
Group
Value
95% CI
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)
17
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)
2
Number of Participants in Whom R0 Resection Was AchievedSecondary· After completion of 24 weeks of treatment with study drug
R0 resection was determined by pathological examination of the surgical specimen after resection.
Group
Value
95% CI
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)
4
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)
1
Number of Participants in Whom R0 or R1 Resection Was AchievedSecondary· After completion of 24 weeks of treatment with study drug
R0 or R1 resection was determined by pathological examination of the surgical specimen after resection.
Group
Value
95% CI
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)
8
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)
1
Number of Participants With Complete Response (CR) or Partial Response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)Secondary· From randomization up to Week 52
CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduced in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Group
Value
95% CI
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)
5
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)
3
Median Overall SurvivalSecondary· From randomization until death from any cause, assessed up to 4 years
Overall survival was defined as the time from randomization until death from any cause.
Group
Value
95% CI
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)
19.38
13.34 – 27.73
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)
23.47
13.27 – 46.46
Median Progression-Free SurvivalSecondary· From randomization until objective tumor progression or death, assessed up to 4 years
Progression-free survival was defined as the time from randomization until objective tumor progression or death. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Group
Value
95% CI
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)
14.11
8.25 – 18.40
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)
11.63
3.88 – 20.40
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)
This is a Phase 1/2 trial to evaluate the safety, tolerability, and efficacy of FG-3019 administered with gemcitabine and nab-paclitaxel in the treatment of locally advanced, unresectable pancreatic cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06842498 — A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
· Phase 2
· recruiting
NCT04621331 — Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
· Phase 3
· withdrawn
NCT05301517 — A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemothe
· Phase 3
· completed
NCT04632940 — Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD
· Phase 3
· terminated
NCT04419558 — Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
· Phase 3
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kyntra Bio
Last refreshed: 2 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02210559.